Document JrbD7x5ZvakopoXe7BZBQ653r
Pathology and Toxicology Riker Laboratories, Inc.
Building 270-3S-05, 3M Center St. Paul, Minnesota 55144-1000
ARSOGroasa
TWO YEAR ORAL (DIET) TOXICITY / CARCINOGENICITY STUDY OF FLUOROCHEMICAL FM-3924 IN RATS (RIKER Experiment No. 0281CR0012)
Conducted During April, 1981 - - May, 1983
Volume 2 o f 5
RIKER Laboratories, Inc. / 3M Company St. Paul, Minnesota 55144-1000 U.S.A.
001338
Suaaarized Single Tabulated Aniaal Report Individual Macroscopic and Microscopic Observations
Riker Laboratories, Inc. 3M FH-3924: Tno Year Oral Toxicity-Oncogenicity Study in Rats
Table: 2
Aniaal Nuaber: 1R-3761 Sex: Hale Fate: (Heefe= 106) Terainal Sacrifice
Group: ( 3) FH-3924 30 ppa
Macroscopic Observations: Skin P itu ita ry Kidney
Microscopic Observations: Adrenal Esophagus Liver
Pancreas Parathyroid P itu ita ry Salivary Gland Skin Thyroid Trachea
-Raised c irc u la r lesions, both hind fe et. -Snail raised dark area. -Pale area, one end of rig h t kidney.
-C o rtical vacuolation, local areas, a ild -Not exaained, aissing -Portal aononudear c e ll in f ilt r a t e , a ild Portal b ile duct p ro life ra tio n , a ild -Acinar atrophy, a ild -Not exaained, aissing -Adenoaa -Not exaained, aissing -Pododeraatitis, u lcerative, b ila te ra l, narked -Not exaained, aissing -Cyst, subaucosal
The fo llo n in g tissues aere found to be w ithin noraal l i i i t s : Spleen, Kidney, Heart, Lung, Testis/Epididyais, Prostate, Stoaach, Urinary Bladder.
Aniaal Nuaber! 1R-3762 Sex! Male Fate: !Neek= 106) Terainal Sacrifice
Group: ( 3) FH-3924 30 ppa
Macroscopic Observations: Skin
Microscopic Observations: Heart
Li ver
Lung P itu ita ry Preputial Gland Prostate Spleen
-Inflaaaed lesion, 1 ca d ia ., apparently healing, scrotal area.
-Myocarditis, chronic nonsuppurative, a u ltifo ca l, aild
-Portal aononudear c e ll in f iltr a t e , ainiaal Hepatocyte vacuolation, a u ltifo c a l, a ild -Vascular aineralization, a ild
-Adenoaa -Preputial adenitis, acute, aoderate -P ro s ta titis , acute, aoderate -Heaosiderosis, ainiaal
The follow ing tissues Here found to be n ith in noraal l ia it s : Kidney, Testis/Epididyais, Stoaach, Urinary Bladder, Adrenal, Thyroid, Parathyroid, Trachea, Esophagus, Salivary Gland, Pancreas.
Species: Rat Project Nuaber: 0281CR0012
001859
fi
Suaaarized STAR Page: 163
354
Suaaarized Single Tabulated Anieal Report (continued) Individual Macroscopic and Microscopic Observations
Piker Laboratories, Inc. 3H FM-3924: Two Year Oral Toxicity-Oncogenicity Study in Rats
Table: 2
Anieal Nuaber: 1R-3763 Sex: Hale Fate: (Heek= 106) Terainal Sacrifice
Group: ( 3) FH-3924 30 ppa
Macroscopic Observations: P itu ita ry
Microscopic Observations: Adrenal Heart
Kidney Liver
Lung
Pancreas Parathyroid P itu ita ry Thyroid Trachea
-Snail dark area.
-Pheochroaocytoaa, benign, u n ila te ra l -Myocarditis, chronic nonsuppurative, a ultifo cal, aild -Chronic progressive nephropathy, aoderate -Portal aononudear c e ll in f ilt r a t e , a ild Hepatocyte vacuolation, e u ltifo c a l, e ild -Vascular M ineralization, e ild Perivascular aononudear in f ilt r a t e , e ild -Acinar atrophy, aoderate -Not exaained, not in plane of section -Adenoaa -Ultiaobranchial cyst -Tracheitis, chronic, a ild
The follow ing tissues were Found to be w ithin noraal lie its *. Spleen, Testis/Epididyais, Prostate, Stoaach, Urinary Bladder, Esophagus, Salivary Gland.
Anieal Nuaber: 1R-3764 Sex: Male Fate: (Heek= 106) Terainal Sacrifice
Group: ( 3) FM-3924 30 ppa
Macroscopic Observations: Skin P itu ita ry Thyaus
Microscopic Observations: Adrenal Heart Liver
Lung
Parathyroid
-C ircular raised lesions, rig h t and le f t hind footpads.
-Saall dark area. -Possibly enlarged
-Sinusoidal ectasia, cortex, local areas, a ild Medullary c e ll hyperplasia, a u ltifo c a l, a ild
-Myocarditis, chronic nonsuppurative, a u ltifo ca l, aild
-Portal aononudear c e ll in f ilt r a t e , a ild Portal b ile duct p ro life ra tio n , a ild Negalocytosis, a ild -Vascular aineralization, a ild Pneuaonia, in t e r s t it ia l, chronic, a u ltifo c a l, a ild Perivascular aononudear in f ilt r a t e , ainiaal Hyperplasia, septal c e ll, focal, a ild
-Not exaained, not in plane of section
Species: Rat Project Nuaber: 0281CR0012
001940
Suaaarized STAR Page: 164
355
Suaaarized Single Tabulated Aniaal Report (continued) Individual Hacroscopic and Hicroscopic Observations
Riker Laboratories, Inc. 3H FH-3924: Tho Year Oral Toxicity-Oncogenicity Study in Rats
Table: 2
Aniaal Nuaber: 1R-3764 Sex: Hale Fate: (Neek= 106) Terainal Sacrifice
6roup: ( 3) FH-3924 30 ppa
Hicroscopic Observations (continued): P itu ita ry Prostate Skin Thysus
Thyroid
-Adenoaa -P ro s ta titis , acute, aoderate -Pododeraatitis, ulce ra tive , b ila te ra l, aarked -Not exaained, not in plane of section
Section of vessel and adipose tissue. -Hyperplasia, C c e ll, focal, a ild Ultieobranchial cyst
The following tissues were found to be w ithin noraal l i a i t s : Spleen, Kidney, Testis/Epididyais, Stoaach, Urinary Bladder, Trachea, Esophagus, Salivary Bland, Pancreas.
Aniaal Nuaber: 1R-3765 Sex: Hale Sroup'. I 3) FH-3924 30 ppa Fate: (Neek= 92) Sacrificed in extreais
Hacroscopic Observations: P itu ita ry Skin
Liver Hicroscopic Observations:
Adrenal Esophagus Kidney Liver
Lung Pancreas Parathyroid P itu ita ry Skin
Te5tis/Epididyai s
-Heaorrhagic aass, 1 ca dia. -Hair thinning in dorsal area.
Ulcerated lesions, both hind footpads. -S lig h tly pale
-Sinusoidal ectasia, cortex, d iffu se , aoderate -Not exaained, aissing -Chronic progressive nephropathy, a ild -Portal b ile duct p ro life ra tio n , ainiaal Portal aononudear c e ll in f ilt r a t e , ainiaal -Perivascular aononudear in f ilt r a t e , a ild - Is le t c e ll adenoaa -Not exaained, not in plane of section -Adenoaa -Pododeraatitis, ulcerative, aarked Atrophy, aoderate
Loss of hair fo llic le s and epideraal thickening, dorsal skin. -Not exaained, aissing
The following tissues were found to be w ithin noraal l ia it s : Spleen, Heart, Stoaach, Urinary Bladder, Prostate, Thyroid, Trachea, Salivary Bland.
Species: Rat Project Nuaber: 0281CR0012
Q01841
Suaaarized STAR Page: 16S
356
Suaearized Single Tabulated Anieal Report (continued) Individual Macroscopic and Microscopic Observations
Riker Laboratories, Inc. 3M FH-3924: Two Year Oral Toxicity-Oncogenicity Study in Rats
Table: 2
Anieal Nueber: 1R-3766 Sex: Hale Fate: (Meek: 106) Tereinal Sacrifice
Broup: ( 3) FH-3924 30 ppa
Macroscopic Observations:
Microscopic Observations: Kidney Liver
Parathyroid Thyroid Trachea
-No v is ib le lesions.
-Chronic progressive nephropathy, einieal -Portal eononudear c e ll in f ilt r a t e , e ild Portal b ile duct p ro life ra tio n , e ild Cystoid degeneration, fo c a l, e ild Megalocytosis, e ild -Not exaeined, aissing -Not exaained, aissing -Tracheitis, chronic, a ild
The following tissues were found to be w ithin noraal lia i t s : Spleen, Heart, Lung, Testis/Epididyais, Prostate, Stoaach, Urinary Bladder, Adrenal, Esophagus, Salivary Bland, P itu ita ry , Pancreas.
Anieal Nuaber: 1R-3767 Sex: Male Fate! (Neek= 106) Tereinal Sacrifice
6roup: ( 3) FH-3924 30 ppa
Macroscopic Observations: Microscopic Observations:
Adrenal
Heart Kidney Liver
Lung
Parathyroid
-No v is ib le lesions.
-C ortical vacuolation, local areas, a ild Medullary c e ll hyperplasia, a u ltifo c a l, aoderate -Myocarditis, chronic nonsuppurative, a ultifo cal, aild -Chronic progressive nephropathy, aoderate
-Portal eononudear c e ll in f ilt r a t e , a ild Portal b ile duct p ro life ra tio n , a ild Hepatocyte a lte ra tio n , vacuolated, a ild -Vascular a ineralization, a ild Perivascular aononudear in f ilt r a t e , a ild Heaorrhage, a u ltifo c a l, a ild
-Not exaained, not in plane of section
The follow ing tissues were found to be w ithin noraal li a i t s : Spleen, Testis/Epididyais, Prostate, Stoaach, Urinary Bladder, Thyroid, Trachea, Esophagus, Salivary Bland, P itu ita ry , Pancreas.
Species: Rat Project Nuaber: 0281CR0012
001842
Suaaarized STAR Page: 166
357
Suaaarized Single Tabulated Aniaal Report (continued) Individual Macroscopic and Microscopic Observations
Riker Laboratories, Inc. 3H FH-3924: Two Year Oral Toxicity-Oncogenicity Study in Rats
Table: 2
Aniaal Nuaber: 1R-376B Sex: Hale Fate: (Meek- 106) Terainal Sacrifice
6roup: (
FH-3924 30 ppa
Macroscopic Observations: Skin
Microscopic Observations: Adrenal Esophagus Heart
Kidney
Liver
Lung
Parathyroid Skin Spleen
-Raised, c irc u la r lesions, both hind footpads.
-Sinusoidal ectasia, cortex, a u ltifo c a l, ai Id -Not exaained, aissing -Myocarditis, chronic nonsuppurative, a u ltifo ca l, aild -Chronic progressive nephropathy, ainiaal Calculus, pelvic -Cystoid degeneration, a u ltifo c a l, a ild Hepatocyte a lte ra tio n , vacuolated, a u ltifo c a l, aoderate -Vascular aineralization, a ild Pneuaonia, in t e r s t it ia l, chronic, a u ltifo c a l, a ild M ineralization, fo cal, parenchyaal, a ild -Not exaained, not in plane of section -Pododeraatitis, ulce ra tive , b ila te ra l, aarked -Heaatopoiesis, extraaedullary, increased, a ild
The follow ing tissues were found to be w ithin noraal l ia it s : Testis/Epididyais, Prostate, Stoaach, Urinary Bladder, Thyroid, Trachea, Salivary Bland, P itu ita ry , Pancreas.
Aniaal Nuaber: 1R-3769 Sex: Hale Fate: (Heek= 106) Terainal Sacrifice
Group: ( 3) FM-3924 30 ppa
Macroscopic Observations: Microscopic Observations:
Adrenal Esophagus Heart Kidney Liver
Lung
-No v is ib le lesions.
-C ortical vacuolation, local areas, aoderate Sinusoidal ectasia, cortex, a ild
-Not exaained, aissing -Myocarditis, chronic nonsuppurative,
a u ltifo ca l, aild -Chronic progressive nephropathy, a ild
Calculus, pelvic -Cystoid degeneration, a u ltifo c a l, a ild
Hepatocyte a lte ra tio n , vacuolated, local areas, aoderate -Vascular aineralization, a ild Heaorrhage, local areas, aoderate
Species: Rat Projtct Hntftr: 0281CR012
001S43
Suaaarized STAR Page: 167
358
Suaaarized Single Tabulated Anieal Report (continued) Individual Macroscopic and Microscopic Observations
Riker Laboratories, Inc. 3M FH-3924: Two Year Oral Toxicity-Oncogenicity Study in Rats
Table: 2
Aniaal Nuaber: 1R-3769 Sex: Male Fate: (Neek= 106) Terainal Sacrifice
Broup: ( 3) FH-3924 30 ppa
Microscopic Observations (continued): Parathyroid P itu ita ry Testis/Epididyais Thyroid
-Not exaained, not in plane of section -Adenoaa -Vascular a in eralization, a ild -Cyst, co lloid
The following tissues Mere found to be w ithin noraal l ia it s : Spleen, Prostate, Stoaach, Urinary Bladder, Trachea, Salivary 61and, Pancreas.
Aniaal Nuaber: 1R-3770 Sex: Hale 6roup: { 31 FM-3924 30 ppa Fate: (Week3 102) Sacrificed in extreais
Macroscopic Observations: P itu ita ry
Microscopic Observations: Adrenal Esophagus Heart Kidney Liver
Lung
P itu ita ry
-Large aass, 1.5 x 0.8 ca.
-C ortical vacuolation, fo cal, aoderate Sinusoidal ectasia, cortex, focal, a ild
-Not exaained, aissing -Myocarditis, chronic nonsuppurative, diffuse ,
aoderate -Chronic progressive nephropathy, a ild -Portal aononudear c e ll in f ilt r a t e , aoderate Portal b ile duct p ro life ra tio n , a ild
Hepatocyte a lte ra tio n , vacuolated, a u ltifo c a l, a ild -Vascular aineralization, a ild Pneuaonia, in t e r s t it ia l, chronic, a u ltifo c a l, a ild Heaorrhage, local areas, aoderate -Adenoaa
The follow ing tissues were found to be w ithin noraal lia it s : Spleen, Testis/Epididyais, Prostate, Stoaach, Urinary Bladder, Thyroid, Parathyroid, Trachea, Salivary Gland, Pancreas.
A niial Kuaber: 1R-3771 Sex: Male Fate: (Meek= 106) Terainal Sacrifice
6roup: ( 3) FH-3924 30 ppa
Macroscopic Observations: Thyroid
Microscopic Observations: Adrenal
-Possibly s lig h tly enlarged. -C ortical vacuolation, fo cal, aoderate
Species: Rat Project Nuaber: 0281CR0012
001844
Suaaarized STAR Page: 166
359
Suaaarized Single Tabulated Aniaal Report (continued) Individual Macroscopic and Microscopic Observations
Riker Laboratories, Inc. 3M FH-3924: Tao Year Oral Toxicity-Oncogenicity Study in Rats
Table: 2
Aniaal Nuaber: 1R-3771
Sex: Hale
Fate: (Neek= 10b) Terainal S acrifice
Broup: ( 3) FH-3924 30 ppa
Microscopic Observations (continued): Esophagus Heart
Kidney Liver
Lung Pancreas Parathyroid P itu ita ry Prostate
-Not exaained, aissing -Myocarditis, chronic nonsuppurative,
a ultifo cal, aild -Chronic progressive nephropathy, aoderate -Hepatocyte vacuolation, a u ltifo c a l, a ild Negalocytosis, ainiaal -Vascular aineralization, a ild -Hyperplasia, is le t c e ll, fo cal, aoderate -Not exaained, not in plane of section -Adenosa -P ro s ta titis , acute, aarked
The following tissues Mere found to be u ith in noraal l i a i t s i .Spleen, Testis/Epididyais, Stoaach, Urinary Bladder, Thyroid, Trachea, Salivary Gland.
Aniaal Nuaber: 1R-3772 Sex: Male 6roup: ( 31 FH-3924 30 ppa Fate: (Neek= 101) Sacrificed in extreais
Macroscopic Observations: P itu ita ry
Microscopic Observations: Adrenal Esophagus Kidney Liver Lung
P itu ita ry Prostate Salivary Bland Stoaach Testis/Epididyais
Thyroid
-Raised aass, l ca dia.
-C ortical vacuolation, a u ltifo c a l, a ild -Not exaained, aissing -Chronic progressive nephropathy, a ild -Portal aononuclear c e ll in f ilt r a t e , a ild -Vascular aineralization, a ild Alveolar aacrophages, a u ltifo c a l, a ild Perivascular aononuclear in f ilt r a t e , a ild -Adenosa -Not exaained, aissing -Not exaained, aissing -Edeaa, subaucosal, aoderate -Tubule atrophy, asperaatogenesis, diffuse , b ila te ra l, aild -111t i aobranchial cyst F o llicu la r hyperplasia, cystic, u n ila te ra l, a ild
The follow ing tissues were found to be w ithin noraal lia i t s : Spleen, Heart, Urinary Bladder, Parathyroid,. Trachea, Pancreas.
Species: Rat Project Nuaber: 0281CR0012
001845
Suaaarized STAR Page: 169
360
Suaaarized Single Tabulated Aniaal Report (continued) Individual Macroscopic and Microscopic Observations
Riker Laboratories, Inc. 3N FH-3924: Tuo Year Oral Toxicity-Oncogenicity Study in Rats
Table: 2
Aniaal Nuaber: 1R-3773 Sex: Hale Fate: (Week* 106) Terainal Sacrifice
6roup: ( 3) FH-3924 30 ppa
Macroscopic Observations: Microscopic Observations!
Adrenal Esophagus Heart Kidney Liver
Lung Parathyroid P itu ita ry
-No v is ib le lesions.
-C ortical vacuolation, a u ltifo c a l, a ild Medullary c e ll hyperplasia, focal, ainiaal
-Not exaained, aissing -Myocarditis, chronic nonsuppurative,
a u ltifo ca l, aild -Chronic progressive nephropathy, aarked -Portal b ile duct p ro life ra tio n , a ild
Hepatocyte a lte ra tio n , vacuolated, focal, a ild Hegalocytosis, ainiaal Hepatocyte a lte ra tio n , basophilic, focal, a ild -Vascular aineralization, ainiaal -Not exaained, not in plane of section -Adenoaa
The fo llo u in g tissues Here found to be n ith in noraal li a i t s : Spleen, Testis/Epididyais, Prostate, Stoaach, Urinary Bladder, Thyroid, Trachea, Salivary Gland, Pancreas.
Aniaal Nuaber: 1R-3774 Sex: Hale Fate: (Neek= 104) Found Dead
Eroup: ( 3) FH-3924 30 ppa
Macroscopic Observations: Skin
P itu ita ry Kidney Microscopic Observations: Adrenal Kidney Liver
Lung
Pancreas Parathyroid P itu ita ry
-C ircu la r, ulcerated lesion, 0.3 ca dia, in dorsal area.
-Enlarged with heaorrhagic area, 0.B ca dia. -Appear p itte d
-Sinusoidal ectasia, cortex, a u ltifo c a l, a ild -Chronic progressive nephropathy, aarked -Portal aononudear c e ll in f ilt r a t e , a ild Portal b ile duct p ro life ra tio n , a ild Cystoid degeneration, a u ltifo c a l, a ild -Vascular aineralization, a ild Alveolar aacrophages, a u ltifo c a l, a ild -Hyperplasia, is le t c e ll, fo cal, aoderate -Fib ro sis, aoderate -Adenoaa
Species: Rat Project Nuaber: 0281CRQ012*
001846
Suaaarized STAR Page*. 170
361
Suaaarized Single Tabulated Aniaal Report (continued) Individual Macroscopic and Microscopic Observations
Riker Laboratories, Inc. 3H FM-3924: Two Year Oral Toxicity-Oncogenicity Study in Rats
Table: 2
Aniaal Nuaber: 1R-3774 Sex: Hale Fate: (Meek- 104) Found Dead
6roup: ( 3) FM-3924 30 ppa
Microscopic Observations (continued): Skin Spleen
-D eraatitis, chronic, a ild -Heaosiderosis, a ild
The following tissues were found to be w ithin noraal li a i t s : Heart, Testis/Epididyais, Prostate, Stoaach, Urinary Bladder, Thyroid, Trachea, Esophagus, Salivary Bland.
Aniaal Nucber: 1R-3775 Sex: Male Fate: (Week- 106) Terainal Sacrifice
Group: ( 3) FM-3924 30 ppa
Macroscopic Observations:
Microscopic Observations: Heart Kidney Liver
Lung P itu ita ry Prostate Trachea Urinary Bladder
-No v is ib le lesions.
-Myocardial fib ro s is , a u ltifo c a l, l i n i aal' -Chronic progressive nephropathy, aoderate -Hepatocyte vacuolation, a u ltifo c a l, ainiaal Negalocytosis, ainiaal -Vascular aineralization, a ild -Adenoaa -P ro s ta titis , acute, a ild -T ra che itis, chronic, aoderate -Not exaained, aissing
The following tissues were .found to be w ithin noraal lia i t s : Spleen, Testis/Epididyais, Stoaach, Adrenal, Thyroid, Parathyroid, Esophagus, Salivary Gland, Pancreas.
Aniaal Nuaber: 1R-3776 Sex: Hale Fate: (Week= 106) Terainal Sacrifice
Group: t 3) FM-3924 30 ppa
Macroscopic Observations: Eye P ituitary Skin
Microscopic Observations: Adrenal Esophagus Heart
-Opacity, le ft -Raised aass, 0.6 ca dia. -Raised ulcer, 1 ca d ia ., on back; raised
c irc u la r inflaaaed lesions, both hind footpads.
-Sinusoidal ectasia, cortex, d iffu s e , aoderate -Not exaained, aissing -Myocarditis, chronic nonsuppurative, a u ltifo ca l, aild
001847
Species: Rat Project Nuaber: 0281CR0012
Suaaarized STAR Page: 171
362
Suaaarized Single Tabulated Aniaal Report (continued) Individual Hacroscopic and Hicroscopic Observations
Riker Laboratories, Inc. 3H FH-3924: Tao Year Oral Toxicity-Oncogenicity Study in Rats
Table: 2
Aniaal Nuaber: 1R-3776 Sex: Hale Fate: (Heek* 106) Terainal Sacrifice
Broup: ( 3) FH-3924 30 ppa
Hicroscopic Observations (continued): Kidney Lung
Parathyroid P itu ita ry Skin
Chronic progressive nephropathy, a ild Pelvic aineralization, a ild Vascular a in e ra liz a tio n , a ild Alveolar aacrophages, u ltifo c a l, aoderate Perivascular aononudear in f ilt r a t e , a u ltifo c a l, aoderate Not exaained, aissing Adenoaa Pododeraatitis, u lcerative, b ila te ra l, aarked Basal c e ll tuaor, benign, back
The following tissues were found to be w ithin noraal li a i t s : Spleen, Liver, Testis/Epididyais, Prostate, Stoaach, Urinary Bladder, Thyroid, Trachea, Salivary Bland, Pancreas, Eye.
Aniaal Nuaber: 1R-3777 Sex: Hale Fate: (Week- 106) Terainal Sacrifice
Group: ( 3) FH-3924 30 ppa
Hacroscopic Observations: Hicroscopic Observations:
Adrenal Esophagus Kidney Liver
Lung Parathyroid Trachea
-No v is ib le lesions.
-C ortical vacuolation, focal, ainiaal -Not exaained, aissing -P y e litis , acute, u n ila te ra l, a ild -Portal aononudear c e ll in f ilt r a t e , ainiaal
Portal b ile duct p ro life ra tio n , ainiaal Hepatocyte vacuolation, c e ntrilo b ular, aoderate Hegalocytosis, aoderate Hepatocyte a lte ra tio n , vacuolated, a u ltifo c a l, a ild -Vascular a in e ra liza tio n , aoderate Heaorrhage, local areas, a ild -Not exaained, not in plane of section -Tracheitis, chronic, a ild
The following tissues were found to be w ithin noraal li a i t s : 5pleen, Heart, Testis/Epididyais, Prostate, Stoaach, Urinary Bladder, Thyroid, Salivary Gland, P itu ita ry , Pancreas.
Species: Rat Project Nuaber: 0281CR0012
Suaaarized STAR Page: 172
363
Suaaarized Single Tabulated Aniaal Report (continued) Individual Macroscopic and Microscopic Observations
Riker Laboratories, Inc. 3H FM-3924: Two Year Oral Toxicity-Oncogenicity Study in Rats
Table: 2
Aniaal Nuaber: 1R-3778 Sex: Male Fate: (Meek- 106) Terainal Sacrifice
6roup: ( 3) FM-3924 30 ppi
Macroscopic Observations: P itu ita ry
Microscopic Observations: Adrenal Esophagus Heart Kidney
Lung
Pancreas P itu ita ry Spleen Thyroid
-Raised, 0.7 ca d ia ., heaorrhagic lesion.
-Sinusoidal ectasia, cortex, d iffu se , ai Id Pheochrosocytoaa, benign, u n ila te ra l
-Not exaained, aissing -Myocarditis, chronic nonsuppurative,
a u ltifo c a l, ai Id -Chronic progressive nephropathy, aoderate
Pelvic Bineraiizatio n, aoderate Calculus, pelvic, b ila te ra l, narked -Vascular a in e ra liz a tio n , ai Id Pneuaonia, in t e r s t it ia l, chronic, a u ltifo c a l, a ild Alveolar eacrophages, fo c a l, a ild Perivascular aononudear in f ilt r a t e , a ild Heaorrhage, a u ltifo c a l, a ild - Is le t c e ll adenoaa -Adenoaa -Heaosiderosis, a ild -Hyperplasia, C c e ll, focal, a ild Cyst, co llo id
The follow ing tissues were found to be w ithin noraal U n its : Liver, Testis/Epididyais, Prostate, Stoaach, Urinary Bladder, Parathyroid, Trachea 5alivary Gland.
Aniaal Nuaber: 1R-3779 Sex'. Male Fate: (Meek- 106) Terainal Sacrifice
Group: ( 3) FM-3924 30 ppa
Macroscopic Observations: P itu ita ry Adrenal
Microscopic Observations: Adrenal Esophagus Kidney
Liver
-Saal1, 0.3 ca d ia ., heaorrhagic lesion. -L e ft adrenal enlarged.
-Pheochroaocytoaa, benign, u n ila te ra l -Not exaained, aissing -Chronic progressive nephropathy, a ild Pelvic aineralization, a ild Calculus, pelvic, aarked -Portal aononudear c e ll in f ilt r a t e , ainiaal Portal b ile duct p ro life ra tio n , a iniaal Cystoid degeneration, fo c a l, a ild Hepatocyte a lte ra tio n , vacuolated, fo c a l, a ild Negaiocytosis, ainiaal
Species: Rat Project Nuaber: 0281CR0012
V-
1:V
001849
Suaaarized STAR Page: 173*
^4
Suaaarized Single Tabulated fln iia l Report (continued) Individual Macroscopic and Microscopic Observations
Riker Laboratories, Inc. 3H FH-3924: Tuo Year Oral Toxicity-Oncogenicity Study in Rats
Table: 2
Anieal Nueber: 1R-3779 Sex: Male Fate: (Neek= 106) Tereinal Sacrifice
Group: ( 3) FH-3924 30 ppe
Microscopic Observations (continued): Lung Pancreas P itu ita ry
-Vascular aineralization, a ild -Hyperplasia, is le t c e ll, a u ltifo c a l, aoderate -Not examined, eissing
The follow ing tissues ere found to be w ithin noreal l ie it s : Spleen, Heart, Testis/Epididyais, Prostate, Stoeach, Urinary Bladder, Thyroid, Parathyroid, Salivary Gland, Trachea.
Ani aal Nueber: 1R-37B0 Sex.* Male Fate! (Meek= 106) Tereinal Sacrifice
Broup: ( 3) FH-3924 30 ppe
Macroscopic Observations:
Microscopic Observations: Adrenal Esophagus Kidney Liver Lung
-No v is ib le lesions.
-Sinusoidal ectasia, cortex, fo c a l, aoderate -Not exaained, eissing -Chronic progressive nephropathy, ainieal -Negaiocytosis, a ild -Vascular e in eralization, a ild Pneuaonia, in t e r s t it ia l, chronic, a u ltifo c a l, a ild Alveolar aacrophages, a u ltifo c a l, a ild Perivascular aononuclear in f ilt r a t e , a ild
The following tissues were found to be w ithin noreal li a i t s : Spleen, Heart, Testis/Epididyais, Prostate, Stoeach, Urinary Bladder, Thyroid, Parathyroid, Trachea, Salivary Gland, P itu ita ry , Pancreas.
Aniaal Nueber: 1R-3781 Sex: Hale Fate: (Heek= 106) Tereinal Sacrifice
Group: ( 3) FH-3924 30 ppa
Macroscopic Observations: Skin P itu ita ry
Microscopic Observations: Adrenal Esophagus Heart
Kidney
-Raised inflaaaed lesion le f t hind footpad. -Mass, 0.5 x 0.7 ca.
-Sinusoidal ectasia, cortex, diffuse, a ild -Not exaained, aissing -Myocarditis, chronic nonsuppurative, a u ltifo ca l, aild -Chronic progressive nephropathy, ainiaal Pelvic eineralization, a ild Calculus, p e lvic, aoderate
Species: Rat Project Nuaber: 0281CR0012
001850
-*
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Suaurized Single Tabulated Aniaal Report (continued) Individual Macroscopic and Microscopic [Riservations
Riker Laboratories, Inc. 3M FH-3924: Tuo Year Oral Toxicity-Oncogenicity Study in Rats
Table: 2
Aniaal Nuaber: 1R-3781 Sex: Hale Fate: (Meeks 106) Terainal S acrifice
Group: ( 3) FH-3924 30 ppa
Microscopic Observations (continued): Li ver Lung
Pancreas Parathyroid P itu ita ry Skin
-Megalocytosis, ainiaal -Vascular a in e ra liza tio n , a ild Alveolar aacrophages, a u ltifo c a l, a ild -Acinar atrophy, aoderate -Not exaained, not in plane of section -Adenoaa -Pododeraatitis, ulcerative, u nila te ra l, aarked
The fo llo u in g tissues uere found to be u ith in noraal lia i t s : Spleen, Testis/Epididyais, Prostate, Stoaach, Urinary Bladder, Thyroid, Trachea, Salivary 61and.
Aniaal Nuaber: 1R-3762 Sex: Male Group: ( 3) FH-3924 30 ppa Fate: (Neek= 82) Sacrificed in extreais
Macroscopic Observations: Skin
Spleen
Stoaach Lyaph Node (aesenteric) Microscopic Observations! Esophagus Heart Kidney
Liver Lung
Lyaph Node (aesenteric) Pancreas Parathyroid Prostate Skin
Spleen Stoaach Urinary Bladder
-Ulcerated, c irc u la r lesion, l e f t hind footpad.
-Enlarged u ith a u ltip le raised c irc u la r lesions, ranging froa 0.2 - 1 ca dia.
-Ulceration in p y lo ric valve area. -Enlarged
-Not exaained, aissing -Malignant lyaphoaa, aixed -Malignant lyaphoaa, aixed
Protein resorption droplets, a ild -Malignant lyaphoaa, aixed -Vascular aineralization, a ild
Malignant lyaphoaa, aixed -Malignant lyaphoaa, aixed -Malignant lyaphoaa, aixed -Not exaained, not in plane of section -P ro s ta titis , acute, aoderate -Pododeraatitis, ulcerative, u n ila te ra l, aarked -Malignant lyaphoaa, aixed -Ulcer, aoderate -E p ith e lia l hyperplasia, siaple, diffuse.
The fo llo u in g tissues uere found to be u ith in noraal l ia it s : Testis/Epididyais, Adrenal, Thyroid, Trachea, Salivary Gland, P itu ita ry .
Species: Rat Project Nuaber: 02B1CR0012
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Riker Laboratories, Inc. 3H FH-3924: Two Tear Oral Toxicity-Oncogenicity Study in Rats
Table: 2
Anieal Nueber: 1R-37B3 Sex*. Hale 6roup: ( 3) FH-3924 30 ppe Fate: IHeek= 96) Sacrificed in extreeis
Hacroscopic Observations: P itu ita ry Liver Kidney Testis/Epididyeis StDiach
Kicroscopic Observations: Adrenal Esophagus Heart Kidney Liver Parathyroid P itu ita ry Salivary Bland Stoeach Testis/Epididyeis
-Dark raised eass, 0.6 ce dia. -Pale -Pale, p itte d and enlarged. -Both testes appear sn ail. -Thickened a lls near pylorus.
-Pheochroeocytoea, benign, u n ila te ra l -Not exaeined, eissing -Hyocardial fib ro s is , local areas, e ild -Chronic progressive nephropathy, narked -Hepatocyte vacuolation, diffuse , coderate -Hyperplasia, narked -Adenoea -Not exaeined, eissing -Mineralization, e u ltifo ca l, e ild -Tubule atrophy, aspereatogenesis, b ila te ra l, eoderate
The following tissues Mere found to be w ithin noreal U n its : Spleen, Lung, Prostate, Urinary Bladder, Thyroid, Trachea, Pancreas.
Anieal Nueber: 1R-3784 Sex: Hale Fate: (Heek= 106) Tereinal Sacrifice
6roup: ( 3) FH-3924 30 ppe
Hacroscopic Observations:
Microscopic Observations: Adrenal
Esophagus Heart
Kidney Liver Lung
P itu ita ry Testis/Epididyeis
-No v is ib le lesions.
-C ortical vacuolation, focal, e ild Sinusoidal ectasia, cortex, d iffuse, e ild -Not exaeined, eissing
-H yocarditis, chronic nonsuppurative, e u ltifo ca l, eild
-Chronic progressive nephropathy, einieal -NegaiDcytosis, einieal -Vascular eineralization, e ild Heeorrhage, narked -Adenoea -Tubule atrophy, aspereatogenesis, b ila te ra l, eoderate
The follow ing tissues Mere found to be w ithin noreal 1ia its : Spleen, Prostate, Stoeach, Urinary Bladder, Thyroid, Parathyroid, Trachea, Salivary Bland,
Species: Rat Project Nueber: 0281CR0012
001852
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Suaaarized Single Tabuliteli ftnieal Report (continued) Individual Macroscopic and Microscopic Observations
Riker Laboratories, Inc. 3H FH-3924: Tuo Year Oral Toxicity-Oncogenicity Study in Rats
Table: 2
Aniaal Nueber: 1R-37B4 Sex: Hale Fate: (Meek* 106) Terminal Sacrifice
Group: ( 3) FH-3924 30 ppa
Microscopic Observations (continued): The fo llo u in g tissues uere found to be u ith in noraal l i a i t s (continued): Pancreas.
Aniaal Nuaber: 1R-3785 Sex: Male Fate: (Week- 106) Terainal Sacrifice
6roup: ( 3) FM-3924 30 ppa
Macroscopic Observations:
Microscopic Observations: Adrenal
Esophagus Liver
Lung Pancreas P itu ita ry
-No v is ib le lsions.
-Sinusodal ectasia, cortex, local areas, aoderate -Not exaained, aissing
-Portai aononudear c e ll in f ilt r a t e , a ild Hepatocyte vacuolation, a u ltifo c a l, a ild Hegalocytosis, a ild -Vascular a in eralization, a ild
-Acinar atrophy, a ild -Adenoaa
The fo llo u in g tissues uere found to be u ith in noraal l ia it s : Spleen, Kidney, Heart, Testis/Epididyais, Prostate, Stoaach, Urinary Bladder, Thyroid, Parathyroid, Trachea, Salivary Gland.
Aniaal Nuaber: 1R-37B6 Sex: Rale Fate: (Neek= 106) Terainal Sacrifice
Broup: ( 3) FH-3924 30 ppa
Macroscopic Observations: Liver
Microscopic Observations: Adrenal Heart Kidney Liver
Lung
-Dark lesion, 0.3 ca d ia ., in aedian lobe.
-Sinusoidal ectasia, cortex, u n ila te ra l, aarked
-Myocarditis, chronic nonsuppurative, a u ltifo c a l, ai Id
-Chronic progressive nephropathy, ainiaal Pelvic a in e ra liza tio n , aoderate
-Portal aononudear c e ll in f ilt r a t e , a ild Hepatocyte a lte ra tio n , vacuolated, local areas, aoderate Negaiocyto s is, ainiaal
-Vascular aineralization, a ild Hesorrhage, local areas, aoderate
Species: Rat Project Nuaber: 0281CR0012
001853
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Riker Laboratories, Inc. 3H FR-3924: Two Year Oral Toxicity-Oncogenicity Study in Rats
Table: 2
Anieal Nueber: 1R-3786 Sex: Male Fate: (Neek 106) Tereinal Sacrifice
Group: ( 3) FM-3924 30 ppe
Microscopic Observations (continued):
The fo llo u in g tissues Mere found to be w ithin noreal l i a i t s : Spleen, Testis/Epididyeis, Prostate, Stoeach, Urinary Bladder, Thyroid, Parathyroid, Trachea, Esophagus, Salivary Gland, P itu ita ry , Pancreas.
Anieal Nueber: 1R-3787 Sex: Male Fate: (Heek 106) Tereinal Sacrifice
6roup: ( 3) FM-3924 30 ppe
Macroscopic Observations:
Microscopic Observations: Adrenal Esophagus Kidney
Li ver
Lung
-No v is ib le lesions.
-Cortical vacuolation, focal, e ild -Not exaeined, eissing -Chronic progressive nephropathy, e ild
P y e litis , acute, u n ila te ra l, eoderate -Portal eononudear c e ll in f ilt r a t e , e ild
Portal b ile duct p ro life ra tio n , e ild Hegalocytosis, eoderate -Perivascular eononudear in f ilt r a t e , e ild Heeorrhage, local areas, eoderate
The follow ing tissues were found to be w ithin noreal li a i t s : Spleen, Heart, Testis/Epididyeis, Prostate, Stoeach, Urinary Bladder, Thyroid, Parathyroid, Trachea, Salivary Sland, P itu ita ry , Pancreas.
Anieal Nueber: 1R-3788 Sex: Male Fate: (Meek 106) Tereinal Sacrifice
Group: ( 3) FM-3924 30 ppe
Macroscopic Observations: Skin
Microscopic Observations: Esophagus Kidney Liver
Parathyroid Skin
Trachea
-C ircular inflaeeed lesion, le f t hind footpad.
-Not exaeined, eissing -Chronic progressive nephropathy, einieal -Portal eononudear c e ll in f ilt r a t e , einieal Portal b ile duct p ro life ra tio n , einieal Hegalocytosis, eoderate -Not exaeined, not in plane of section -Pododereatitis, ulcerative, u nila te ra l,
narked -Tracheitis, chronic, e ild
The follow ing tissues were found to be w ithin noreal l ia it s : Spleen, Heart, Lung, Testis/Epididyeis, Prostate, Stoeach, Urinary Bladder, Adrenal, Thyroid,
Species: Rat Project Nueber: 0281CR0012
001854
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Suuarized Single Tabulated A niial Report (continued) Individual Macroscopic and Microscopic Observations
Riker Laboratories, Inc. 3H FH-3924: Two Year Oral Toxicity-Oncogenicity Study in Rats
Table: 2
A n iia l Nuiber: 1R-37BB Sex: Hale Fate: (Neek= 106) T eriinal Sacrifice
Broup: ( 3) FH-3924 30 ppi
Microscopic Observations (continued): The following tissues were found to be w ithin norsal l i i i t s (continued): Salivary Gland, P itu ita ry , Pancreas.
A n iia l Nuiber: 1R-3789 Sex: Hale Group: ( 3) FH-3924 30 ppi Fate: (Keek* .79) Sacrificed in e x tre iis
Hacroscopic Observations: P ituitary
Microscopic Observations: Heart
Kidney Liver
Lung
Parathyroid P itu ita ry Spleen
-Enlarged due to 1 x 0.7 c i lass.
-Myocarditis, chronic nonsuppurative, u ltifo ca l, aiId
-Chronic progressive nephropathy, a in iia l -Portal aononuclear c e ll in f ilt r a t e , i i I d Hepatocyte vacuolation, e u ltifo c a l, a ild Hegalocytosis, i i I d -Vascular M ineralization, a ild Alveolar aacrophages, e u ltifo c a l, i i I d -Not exaiined, not in plane of section -Adenoia -Heiosiderosis, aild
The follow ing tissues were found to be w ithin norial l i i i t s : T estis/E p id id yiis, Prostate, Stoiach, Urinary Bladder, Adrenal, Thyroid, Trachea, Esophagus, Salivary Gland, Pancreas.
A niial Nuiber: 1R-3790 Sex: Hale Fate: (Neek= 106) T eriina l Sacrifice
6roup: ( 3) FH-3924 30 ppi
Macroscopic Observations: Skin Liver
Microscopic Observations: Adrenal Esophagus Heart Kidney
Liver
Lung
-Raised in fla iie d lesions, both hind footpads. -Raised pale lass, 1.5 x 1 c i d ia ., caudate
lobe.
-C ortical vacuolation, a u ltifo c a l, ii I d -Not exaiined, lis s in g -Myocardial fib ro s is , fo cal, a in iia l -Pelvic aineralization, lin ia a l One of pair present -Hegalocytosis, a ild Hepatocellular carcinoia -Vascular aineralization, a ild Pneuionia, in t e r s t it ia l, chronic, u ltifo c a l,
ild
Alveolar aacrophages, e u ltifo c a l, a ild Perivascular aononuclear in f ilt r a t e , a ild
Species: Rat Project Nuiber: 02B1CR0012
001S5S
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Riker Laboratories, Inc. 3H FH-3924: Two Year Oral Toxicity-Oncogenicity Study in Rats
Table: 2
Anieal Nuaber: 1R-3790 Sex: Hale Fate: (Week- 106) Terainal Sacrifice
Group: ( 3) FH-3924 30 ppa
Hicroscopic Observations (continued): Skin Testis/Epididyais Thyroid
. -Pododematitis, ulcerative, b ila te ra l, -Vascular aineralization, a ild -C c e ll adenoaa
F o llic u la r adenoaa
aarked
The folloNing tissues aere found to be aithin noraal li a it s : Spleen, Prostate, Stoaach, Urinary Bladder, Parathyroid, Trachea, Salivary Bland, P itu ita ry , Pancreas.
Aniaal Nuaber: 1R-3791 Sex: Hale Fate: (Week: 106) Terainal Sacrifice
6roup: ( 3) FH-3924 30 ppa
Hacroscopic Observations: Testis/Epididyais
Hicroscopic Observations: Adrenal Esophagus Heart Kidney
Liver
Lung Testis/Epididyais Trachea
-Right te s tis saall.
-Cortical vacuolation, a u ltifo c a l, a ild -Not exaained, aissing -H yocarditis, chronic nonsuppurative,
local areas, aoderate -Chronic progressive nephropathy, a ild
Pelvic Bineraiizatio n, ainiaal Calculus, pelvic, aoderate -Portal b ile duct p ro life ra tio n , a ild Hepatocyte vacuolation, c e ntrilo b ular, aoderate Cystoid degeneration, focal, a ild Hepatocyte a lte ra tio n , vacuolated, focal, a ild Negaiocyto sis, aoderate -Vascular aineralization, a ild Alveolar aacrophages, a u ltifo c a l, a ild -Tubule atrophy, asperaatogenesis, u n ila te ra l, narked -Tracheitis, chronic, a ild
The follow ing tissues ere found to be w ithin noraal li a i t s : Spleen, Prostate, Stoaach, Urinary Bladder, Thyroid, Parathyroid, Salivary Gland, P itu ita ry , Pancreas.
Species: Rat Project Nuaber: 0281CR0012
001856
Suaaarized STAR Page: 1B0
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Suaaarized Single Tabulated Aniaal Report (continued) Individual Macroscopic and Microscopic Observations
Riker Laboratories, Inc. 3H FH-3924: Tmo Year Oral Toxicity-Oncogenicity Study in Rats
Table: 2
Aniaal Nuaber: 1R-3792 Sex: Hale 6roup: ( 3) FH-3924 30 ppa Fate: (Week= 103) Sacrificed in extreais
Macroscopic Observations: Liver
Microscopic Observations: Esophagus Heart
Liver
Lung
Parathyroid
-Possibly s lig h tly pale.
-Not exaained, aissing -Myocarditis, chronic nonsuppurative, a u ltifo c a l, aild -Portal aononudear c e ll in f ilt r a t e , a ild Portal b ile duct p ro life ra tio n , a ild -Vascular a in e ra liz a tio n , a ild Branuloaa, a u ltifo c a l, a ild -Not exaained, not in plane of section
The following tissues were found to be w ithin noraal li a i t s : Spleen, Kidney, Testis/Epididyais, Prostate, Stosach, Urinary Bladder, Adrenal, Thyroid, Trachea, Salivary 61and, P itu ita ry , Pancreas.
Aniaal Nuaber: 1R-3793 Sex: Male Fate: (Week? 106) Terainal Sacrifice
6roup: ( 3) FH-3924 30 ppa
Macroscopic Observations: Skin P itu ita ry Lyaph Node (aesenteric)
Microscopic Observations: Esophagus Heart Kidney
Liver Lung
Lyaph Node (aesenteric) P ituitary Skin
Thyroid
Urinary Bladder
-Raised c irc u la r lesion, le f t hind footpad. -Raised aass, 0.7 ca dia. -Appear heaorrhagic
-Not exaained, aissing -Myocardial fib ro s is , local areas, a ild -Chronic progressive nephropathy, aoderate
Pelvic aineralization, a ild -Hegalocytosis, ainiaal -Vascular aineralization, a ild
Alveolar aacrophages, a u ltifo c a l, a ild Perivascular aononudear in f ilt r a t e , a ild -Hesorrhage, aoderate -Adenoaa -Pododeraatitis, ulcerative, u n ila te ra l, aarked -Hyperplasia, C c e ll, a u ltifo c a l, a ild Ultiaobranchial cyst -Calculus E pithelial hyperplasia, siaple, d iffuse, a ild
The fallow ing tissues Mere found to be w ithin noraal li a i t s : Spleen, Testis/Epididyais, Prostate, Stoaach, Adrenal, Parathyroid, Trachea, Salivary Gland,
Species: Rat Project Nuaber: 02B1CR0012
001857
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Suaaarized Single Tabulated Aniaal Report (continued) Individual Macroscopic and Microscopic Observations
Riker Laboratories, Inc. 3N FN-3924: Tao Year Oral Toxicity-Oncogenicity Study in Rats
Table: 2
Aniaal Nuaber: 1R-3793 Sex! Hale Fate: (Neek= 106) Terainal Sacrifice
Sroup: ( 3) FH-3924 30 ppa
Microscopic Observations (continued): The folloNing tissues ere found to be w ithin noraal l i a i t s (continued): Pancreas.
Aniaal Nuaber: 1R-3794 Sex: Hale Fate: (Neek= 106) Terainal Sacrifice
Group: ( 31 FM-3924 30 ppa
Macroscopic Observations:
Microscopic Observations: Adrenal Esophagus Heart
Kidney Liver
Lung
Parathyroid Prostate Thyroid
-No v is ib le lesions.
-Sinusoidal ectasia, cortex, d iffu se , aoderate -Not exaained, aissing -Myocarditis, chronic nonsuppurative, a u ltifo ca l, aild -Chronic progressive nephropathy, a ild -Portal aononudear c e ll in f ilt r a t e , a ild Hepatocyte vacuolation, a u ltifo c a l, aoderate Hepatocyte a lte ra tio n , vacuolated, a u ltifo c a l, a ild Megalocytosis, a ild -Vascular aineralization, a ild Heaorrhage, local areas, aoderate -Adenoaa -P ro s ta titis , acute, ainiaal -Ultiaobranchial cyst
The -following tissues were found to be w ithin noraal l ia it s : Spleen, Testis/Epididyais, Stoaach, Urinary Bladder, Trachea, Salivary Gland, P itu ita ry , Pancreas.
Aniaal Nuaber: 1R-3795 Sex: Male Fate: (Week- 106) Terainal Sacrifice
Group: ( 3) FH-3924 30 ppa
Macroscopic Observations: Skin
Microscopic Observations: Adrenal
Heart
-F ira , s lig h tly raised aass, 1 ca d ia ., le f t side.
-Medullary c e ll hyperplasia, fo cal, a ild C ortical degeneration, fo c a l, a ild One of pair present
-Myocarditis, chronic nonsuppurative, a u ltifo cal, aild
Species: Rat Project Nuaber: 0281CR0012
001&S8
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Riker Laboratories, Inc. 3H FH-3924: Tao Year Oral Toxicity-Oncogenicity Study in Rats
Table: 2
Aniaal Nuaber: 1R-3795 Sex: Male Fate: (Meek* 106) Terainal S acrifice
Group: ( 3) FH-3924 30 ppa
Microscopic Observations (continued): Kidney Liver
Lung
Parathyroid Prostate Skin Spleen
-Chronic progressive nephropathy, a ild -Portal aononudear c e ll in f ilt r a t e , a ild Portal b ile duct p ro life ra tio n , a ild Hepatocyte vacuolation, a u ltifo c a l, a ild Hepatocyte a lte ra tio n , vacuolated, a u ltifo c a l, a ild Megalocytosis, ainiaal -Vascular aineralization, a ild Alveolar aacrophages, local areas, aoderate Perivascular aononuclear in f ilt r a t e , a ild -Not exaained, not in plane of section -P ro s ta titis , acute, aoderate -Fibroaa -Heaosiderosis, a ild
The folloN ing tissues ere found to be w ithin noraal l i n t s : Testis/Epididyais, Stoaach, Urinary Bladder, Thyroid, Trachea, Esophagus, Salivary 61and, P itu ita ry , Pancreas.
Aniaal Nuaber: 1R-3796 Sex: Hale Group: ( 3) FM-3924 30 ppa Fate: (Neek= 99) Sacrificed in extreais
Macroscopic Observations: P itu ita ry Skin Adrenal
Microscopic Observations: Adrenal Heart
Kidney Liver
Lung
Parathyroid P itu ita ry Skin
-Raised aass, 0.6 ca dia. -Ulcerated rig h t hind footpad. -Both appear enlarged.
-Sinusoidal ectasia, cortex, d iffu se , aarked -M yocarditis, chronic nonsuppurative, a u ltifo ca l, aild -Chronic progressive nephropathy, a ild -Hepatocyte vacuolation, a u ltifo c a l, a ild Telangiectasis, focal, a ild -Vascular a in e ra liza tio n , a ild Pneuaonia, in t e r s t it ia l, chronic, a u ltifo c a l, a ild Alveolar aacrophages, a u ltifo c a l, a ild Perivascular aononudear in f ilt r a t e , a ild -Not exaained, not in plane of section -Adenoaa -Pododeraatitis, ulcerative, u n ila te ra l, narked
Species: Rat Project Nuaber: 0281CR0012
001SS9
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Riker Laboratories, Inc. 3N FM-3924: Tho Year Oral Toxicity-Oncogenicity Study in Rats
Table: 2
Anieal Nueber: 1R-3796 Sex: Male 6roup: ( 3) FM-3924 30 ppe Fate: (Neek= 99) Sacrificed in extreeis
Microscopic Observations (continued): Thyroid Urinary Bladder
-Ultieobranchial cyst -Not exaained, aissing
The 4ollowing tissues Mere found to be Hi th in noreal li e i t s : Spleen, Testis/Epididyeis, Prostate, Stoaach, Trachea, Esophagus, Salivary Bland, Pancreas.
Anieal Nueber: 1R-3797 Sex: Hale Fate: (Meek= 94) Found Dead
6roup: ( 3) FM-3924 30 ppe
Macroscopic Observations: P itu ita ry Urinary Bladder
Microscopic Observations'. Adrenal Liver
Lung Pancreas P itu ita ry Prostate Spleen Urinary Bladder
-Raised eass, 1 ce dia. -Calculus in luaen, appears to be blocking
uretheral o rific e .
-Cortical vacuolation, e u ltifo c a l, eiId -Portal eononudear c e ll in f ilt r a t e , e ild Portal b ile duct p ro life ra tio n , eoderate -Vascular eineralization, e ild -Not exaained, aissing -Adenoea -P ro s ta titis , acute, narked -Heeosiderosis, eoderate -C y s titis , acute, eoderate E pithelial hyperplasia, siaple, diffuse, eoderate
The following tissues Mere found to be w ithin noreal lie it s : Kidney, Heart, Testis/Epididyeis, Stoaach, Thyroid, Parathyroid, Trachea, Esophagus, Salivary Bland.
Anieal Nueber: 1R-379B Sex: Male Fate: (Neek= 106) Tereinal Sacrifice
Group: ( 3) FM-3924 30 ppe
Macroscopic Observations: Prostate
Microscopic Observations: Esophagus Kidney Liver
-F ire eass, 3.5 ce d ia ., involving neck of bladder.
-Not exaained, aissing -Chronic progressive nephropathy, e ild -Portal eononudear c e ll in f ilt r a t e , e ild Portal b ile duct p ro life ra tio n , e ild Nepatocyte a lte ra tio n , vacuolated, e u ltifo c a l, e ild Megalocytosis, einiaal
Species: Rat Project Nueber: 0281CR0012
001S60
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Riker Laboratories, Inc. 3H FH-3924: Two Year Oral Toxicity-Oncogenicity Study in Rats
Table: 2
Anieal Nuaber: 1R-3798 Sex: Hale Fate: (Neek= 106) Terinai Sacrifice
6roup: ( 3) FH-3924 30 ppa
Hicroscopic Observations (continued): Lung
Parathyroid P itu ita ry Prostate
Spleen
Thyroid
Urinary Bladder
-Vascular aineralization, e ild Alveolar aacrophages, a u lti-fo ca lf a ild Perivascular aononudear in f ilt r a t e , a ild -Neoplastic c e ll in f iltr a t e -Cyst, pars d is ta lis -P ro s ta titis , chronic, diffuse, in t e r s it it ia l, aarked -Heaatopoiesis, extraaedullary, increased, aoderate -C c e ll carei nona Cyst, c o llo id -E p ith e lia l hyperplasia, siaple, diffuse, aoderate C y s titis , chronic, a ild
The folloN ing tissues were found to be w ithin noraal H a lts : Heart, 5toaach, Adrenal, Trachea, Salivary 61and, Pancreas, Saall In te stine , Large In te stine , Testis/Epididyais.
Aniaal Nueber: 1R-3799 Sex: Hale Fate: (Neek* 106) Terminal Sacrifice
Broup: ( 3) FH-3924 30 ppa
Hacroscopic Observations! Hicroscopic Observations:
Adrenal Heart
Kidney Liver
Lung Pancreas Parathyroid
-No v is ib le lesions.
-Sinusoidal ectasia, cortex, a ild -Hyocardial fib ro s is , local areas, a ild Hyocarditis, chronic nonsuppurative, a u ltifo ca l, aild -Chronic progressive nephropathy, a ild -Portal aononudear c e ll in f ilt r a t e , a ild Cystoid degeneration, a ild Hepatocyte a lte ra tio n , vacuolated, a u ltifo c a l, aoderate Hegalocytosis, ainiaal -Vascular a in e ra liza tio n , a ild Heaorrhage, local areas, a ild -P ancreatitis, chronic, local areas, aarked -Not exaained, not in plane of section
The follow ing tissues were found to be w ithin noraal lia i t s : Spleen, Testis/Epididyais, Prostate, Stoaach, Urinary Bladder, Thyroid, Trachea, Esophagus,
Species: Rat Project Nuaber: 0281CR0012
001861
Suaaarized STAR Page: 185
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Suaaarized Single Tabulated Aniaal Report (continued) Individual Hacroscopic and Hicroscopic Observations
Riker Laboratories, Inc. 3H FM-3924: Two Year Oral Toxicity-Oncogenicity Study in Rats
Table: 2
Aniaal Nuaber: 1R-3799 Sex! Hale Fate: (Neek= 106) Terainal Sacrifice
6roup: ( 3) FH-3924 30 ppa
Hicroscopic Observations (continued): The follow ing tissues were found to be w ithin noraal l i a i t s (continued): Salivary 61and, P itu ita ry .
Aniaal Nuaber: 1R-3B00 Sex'. Hale 6roup: ( 3) FH-3924 30 ppa Fate: INeek= 96) Sacrificed in extreais
Hacroscopic Observations: P itu ita ry Kidney
Hicroscopic Observations: Adrenal Kidney Liver
Lung
Pancreas Prostate Testis/Epididyais
-Raised aass, 1.3 ca dia. -Enlarged, pale and p itte d .
-Sinusoidal ectasia, cortex, local areas, a ild -Chronic progressive nephropathy, narked -Hepatocyte a lte ra tio n , vacuolated, a u ltifo c a l, a ild Hegalocytosis, ainiaal -Vascular a in eralization, a ild Heaorrhage, local areas, aoderate -Acinar atrophy, ainiaal -P ro s ta titis , acute, a ild -P o lya rteritis, aild
The follow ing tissues were found to be w ithin noraal l ia it s : Spleen, Heart, Stoaach, Urinary Bladder, Thyroid, Parathyroid, Trachea, Esophagus, Salivary Gland, P itu ita ry .
Aniaal Nuaber: 1R-3B01 Sex: Hale Group: ( 3) FH-3924 30 ppa Fate: (Week- 76) Sacrificed in extreais
Hacroscopic Observations: P itu ita ry Adrenal Testis/Epididyais
Hicroscopic Observations: Adrenal
Kidney Liver
Lung
-Heaorrhagic aass, 1 x 0.8 ca. -Right adrenal appears enlarged. -L e ft te s tis appears sn ail.
-Sinusoidal ectasia, cortex, narked One of pair present
-Chronic progressive nephropathy, a ild -Hepatocyte vacuolation, a u ltifo c a l, a ild Hepatocyte a lte ra tio n , vacuolated, a u ltifo c a l, a ild -Vascular a in e ra liza tio n , a ild Perivascular aononudear in f ilt r a t e , a ild Heaorrhage, local areas, aoderate
Species: Rat Project Nuaber: 0281CR0012
001862
Suaaarized STAR Page: 1B6
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Suaaarized Single Tabulated Aniaal Report (continued) Individual Macroscopic and Microscopic Observations
Riker Laboratories, Inc. 3H FH-3924: Tuo Year Oral Toxicity-Oncogenicity Study in Rats
Table: 2
Aniaal Nuaber: 1R-3B01 Sex: Hale 6roup: ( 3) FH-3924 30 ppa Fate: (Neek= 76) Sacrificed in extreais
Microscopic Observations (continued): Pancreas P ituitary Prostate Spleen Testis/Epididyais
-Acinar atrophy, a ild -Adenoaa -Not exaained, aissing -Heaosiderosis, a ild -Tubule atrophy, asperaatogenesis, u n ila te ra l, aarked
The follD uing tissues were found to be w ithin noraal U n its : Heart, Stoaach, Urinary Bladder, Thyroid, Parathyroid, Trachea, Esophagus, Salivary Bland.
Aniaal Nuaber: 1R-3802 Sex: Male Fate: INeek= 106) Terainal Sacrifice
Broup: ( 3) FH-3924 30 ppa
rc:* m
Macroscopic Observations: Thorax (internal) Spleen Liver Lyaph Node (aesenteric) Lyaph Node (abdoainal) Testis/Epididyais Adrenal
Microscopic Observations: Adrenal Kidney Liver
Lyaph Node (abdoainal)
P itu ita ry Prostate Spleen
-F ille d with pale yellow flu id . -Greatly enlarged) pale raised lesions, 0.6 ca
dia. -Mottled with irregular surface. -S lig h tly enlarged and heaorrhagic. -Renal lyaph nodes s lig h tly enlarged and
heaorrhagic. -B ila te ra lly saall -Clear cyst, 1 ca d ia ., rig h t adrenal.
-C ortical vacuolation, a u ltifo c a i, a ild One of pair present
-Chronic progressive nephropathy, a ild Pyelonephritis, acute, aoderate
-Portal b ile duct p ro life ra tio n , a ild Hepatocyte vacuolation, ce n triio b u la r, aoderate Malignant lyaphoaa, h is tio c y tic
-Vascular a in era liza tion , a ild Malignant lyaphoaa, h is tio c y tic Heaorrhage, a u ltifo c a i, a ild -Sinusoidal ectasia, aarked Malignant lyaphoaa, h is tio c y tic Heaorrhage, a ild -Not exaained, aissing -P ro s ta titis , acute, aarked -Malignant lyaphoaa, h is tio c y tic
Species: Rat Project Nuaber: 02B1CR0012
001863
Suaaarized STAR Page: 1B7
378
Suaaarized Single Tabulated Aniaal Report (continued) Individual Macroscopic and Microscopic Observations
Riker Laboratories, Inc. 3M FM-3924: Two Year Oral Toxicity-Oncogenicity Study in Rats
Table: 2
Aniaal Nuaber: 1R-3802 Sex: Male Fate: (Neek= 106) Terainal Sacrifice
Group: ( 3) FM-3924 30 ppa
Microscopic Observations (continued): Stoaach Trachea Urinary Bladder
-Ulcer -T ra che itis, acute, a ild -E p ithe lia l hyperplasia, siaple, diffuse aarked C y s titis , acute, aarked
Ulcer
The following tissues were found to be w ithin noraal l i a i t s : Heart, Testis/Epididyais, Thyroid, Parathyroid, Esophagus, Salivary Gland, Pancreas.
Aniaal Nuaber: 1R-3803 Sex: Hale Fate: (Week- 106) Terainal Sacrifice
Group: ( 3) FM-3924 30 ppa
Macroscopic Observations: P itu ita ry Prostate
Microscopic Observations: Heart Kidney Liver
Lung
Parathyroid P itu ita ry Prostate 5pleen Stoaach Urinary Bladder
-Raised lesion, 0.5 ca dia. -Edeaatous
-Myocardial fib ro s is , local areas, aoderate -Chronic progressive nephropathy, aoderate -Portal aononuclear c e ll in f ilt r a t e , a ild Portal b ile duct p ro life ra tio n , a ild -Vascular a in eralization, a ild Alveolar aacrophages, a u ltifo c a l, a ild -Not exaained, not in plane of section -Adenoaa -P ro s ta titis , acute, aarked -Heaosiderosis, a ild -G a s tritis , acute, diffuse , aoderate -E p ith e lia l hyperplasia, siaple, diffuse, aoderate C y s titis , acute, d iffu se , a ild
The fo llo a in g tissues were found to be w ithin noraal li a i t s : Testis/Epididyais, Adrenal, Thyroid, Trachea, Esophagus, Salivary Gland, Pancreas.
Species: Rat Project Nuaber: 0281CR0012
001864
Suaaarized STAR Page: 188
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Suaaarized Single Tabulated Aniaal Report (continued) Individual Macroscopic and Hicroscopic Observations
Riker Laboratories, Inc. 3M FH-3924: Two Year Oral Toxicity-Oncogenicity Study in Rats
Table: 2
Aniaal Nuaber: 1R-3804 Sex: Hale Group: ( 3) FH-3924 30 ppa Fate*. (Heek= 75) Sacrificed in extreais
Hacroscopic Observations: Liver Kidney Hesentery Testis/Epididyais
Hicroscopic Observations: Heart
Kidney Liver Lung
Hesentery Pancreas
Parathyroid P ituitary Prostate Spleen Testis/Epididyais
-Pale -Pale, p itte d and enlarged. -Nodular aesenteric vessels. -Testes b ila te r a lly seal 1.
-Myocarditis, chronic nonsuppurative, a u ltifo c a l, ai Id
-Chronic progressive nephropathy, aarked -Hepatocyte vacuolation, local areas, a ild -Vascular a in eralization, a ild Heaorrhage, local areas, a ild -P o ly a rte ritis , aarked -Acinar atrophy, a ild P olyarteritis, aild -Hyperplasia, aoderate -Adenoaa -Not exaained, aissing -Heaosiderosis, a ild -Tubule atrophy, asperaatogenesis, aoderate P o ly a rte ritis , aoderate
The follow ing tissues were found to be w ithin noraal lim its : Stoaach, Urinary Bladder, Adrenal, Thyroid, Trachea, Esophagus, Salivary Gland.
Aniaal Nuaber*. 1R-3605 Sex: Hale Fate: (Week- 106) Terminal Sacrifice
Group: ( 3) FH-3924 30 ppa
Hacroscopic Observations: Hicroscopic Observations:
Adrenal Heart Kidney Li ver
Lung
-No v is ib le lesions.
-C ortical degeneration, focal, a ild -Myocarditis, chronic nonsuppurative, local areas, a ild -Chronic progressive nephropathy, a ild -Portal aononudear c e ll in f ilt r a t e , ainiaal Portal b ile duct p ro life ra tio n , a ild Hepatocyte vacuolation, a ild Hegalocytosis, a ild Hepatocyte a lte ra tio n , basophilic, a u ltifo c a l, a ild -Vascular aineralization, a ild Perivascular aononudear in f ilt r a t e , a ild
Species: Rat Project Nuaber: 02B1CR0012
ooises
Suaiarized 5TAR Page: 1B9
380
Suaaarized Single Tabulated Aniaal Report (continued) Individual Macroscopic and Microscopic Observations
Riker Laboratories, Inc. 3H FH-3924: Too Year Oral Toxicity-Oncogenicity Study in Rats
Table: 2
Aniaal Nuaber: 1R-3B0S Sex: Hale Fate: (Week* 106) Terainal Sacrifice
Group: ( 3) FH-3924 30 ppa
Microscopic Observations (continued): Pancreas P itu ita ry
- Is le t c e ll adenoaa -Adenoaa
The fo llo nin g tissues aere found to be Mithin noraal l ia it s : Spleen, Testis/Epididyais, Prostate, Stoaach, Urinary Bladder, Thyroid, Parathyroid, Trachea, Esophagus, Salivary Bland.
Aniaal Nuaber: 1R-3806 Sex: Hale Fate: (Neek= 106) Terainal Sacrifice
Group: ( 3) FH-3924 30 ppa
Macroscopic Observations: Skin
Microscopic Observations: Adrenal
Kidney Liver
Lung P itu ita ry Salivary Gland Skin
-Raised c irc u la r inflaaaed lesions, both hind footpads.
-Sinusoidal ectasia, cortex, d iffuse, a ild Medullary c e ll hyperplasia, fo cal, a ild One of pair present
-Chronic progressive nephropathy, a ild -Portal aononudear c e ll in f ilt r a t e , a ild
Megalocytosis, ainiaal Hepatocyte a lte ra tio n , basophilic, focal, a ild -Vascular a in eralization, a ild Perivascular aononudear in f ilt r a t e , a ild -Adenoaa -Not exaained, aissing -Pododeraatitis, ulcerative, b ila te ra l, aarked
The folloMing tissues Mere found to be n ith in noraal l ia it s : Spleen, Heart, Testis/Epididyais, Prostate, Stoaach, Urinary Bladder, Thyroid, Parathyroid, Trachea, Esophagus, Pancreas.
Aniaal Nuaber: 1R-3807 Sex: Male Fate: (Neek= 106) Terainal Sacrifice
Group: ( 3) FH-3924 30 ppa
Macroscopic Observations: Kidney
Microscopic Observations: Heart
Kidney
-Ulcerated area, 0.7 ca d ia ., rig h t kidney.
-Myocarditis, chronic nonsuppurative, a u ltifo ca l, aild
-Chronic progressive nephropathy, a ild
Species: Rat Project Nuaber: 02B1CR0012
00X866
Suaaarized STAR Page: 190
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Suaaarized Single Tabulated Aniaal Report (continued) Individual Macroscopic and Microscopic Observations
Riker Laboratories, Inc. 3M FH-3924: Two Year Oral Toxicity-Oncogenicity Study in Rats
Table: 2
fln iia l Nuaber! 1R-3807 Sex: Hale Fate: (Neek= 106) Terainal Sacrifice
6roup: ( 3) FH-3924 30 ppa
Microscopic Observations (continued): Liver
Lung
-Hepatocyte vacuolation, a u ltifo c a l, a ild Hepatocyte a lte ra tio n , vacuolated, aulti-Focai, a ild Megalocytosis, a ild
-Vascular aineralization, a ild
The following tissues were found to be w ithin noraal l ia it s : Spleen, Testis/Epididyais, Prostate, Stoaach, Urinary Bladder, Adrenal, Thyroid, Parathyroid, Trachea, Esophagus, Salivary Eland, P itu ita ry , Pancreas.
Aniaal Nuaber: 1R-3B08 Sex: Male Fate: (kleek= 106) Terainal Sacrifice
Group: ( 3) FH-3924 30 ppa
Macroscopic Observations: P itu ita ry Liver
Microscopic Observations: Adrenal Heart
Kidney Liver
Lung
P itu ita ry Thyroid
-Saall raised aass, 0.4 ca dia. -Large aass, 5 x 3 x 2 ca, in aedian lobe.
-C ortical vacuolation, d iffu se , aoderate -Myocarditis, chronic nonsuppurative, a u ltifo ca l, aild -Chronic progressive nephropathy, a ild -Portal aononudear c e ll in f ilt r a t e , a ild Portal b ile duct p ro life ra tio n , a ild Cystoid degeneration, fo cal, a ild Hyperplastic nodule -Vascular aineralization, a ild Perivascular aononudear in f ilt r a t e , a ild Hyperplasia, septal c e ll, focal, aoderate -Adenoaa -C ce ll adenoaa
The follow ing tissues were found to be w ithin noraal lia its *. Spleen, Testis/Epididyais, Prostate, Stoaach, Urinary Bladder, Parathyroid, Trachea, Esophagus, Salivary Gland, Pancreas.
Species: Rat Project Nuaber: 0281CR0012
-V
001867
Suaaarized STAR Page: 191
382
Sueaarized Single Tabulated Anieal Report (continued) Individual Macroscopic and Microscopic Observations
Riker Laboratories, Inc. 3M FH-3924: Teo Year Oral Toxicity-Oncogenicity Study in Rats
Table: 2
Anieal Nueber: 1R-3809 Sex: Hale 6roup: ( 3) FH-3924 30 ppe Fate: (Week- 70) Sacrificed in extreeis
Macroscopic Observations: Skin
Eye
Microscopic Observations: Adrenal Eye
Liver
Lung
Pancreas Parathyroid Salivary Gland Skin
Urinary Bladder
-Hass, 3.5 ce d ia ., containing grey-yellae caseous exudate, rig h t la te ra l head.
-Right eye atrophied with corneal ulceration, red exudate around eye.
-Nat exaeined, eissing -K e ra titis , acute, u n ila te ra l, earked
Large, perforated corneal ulcer. -Portal aononuclear c e ll in f ilt r a t e , e ild Hepatocyte vacuolation, e u ltifo c a l, e ild Hegalocytosis, ninieal -Vascular e in e ra liza tio n , e ild Perivascular aononuclear in f ilt r a t e , e ild Hetastatic neoplase -Acinar atrophy, eoderate -Not exaeined, not in plane of section -Atrophy -Squaaous c e ll carcinoea, head
Poorly d iffe re n tia te d , ulcerated with extensive necrosis; in f iltr a t iv e . -Not exaeined, eissing
The following tissues ere found to be e ith in noreal li e i t s : Spleen, Kidney, Heart, Testis/Epididyais, Prostate, Stoaach, Thyroid, Trachea, Esophagus, P ituitary.
Anieal Nueber: 1R-3810 Sex: Hale Group: ( 3) FH-3924 30 ppe Fate: (Neek= 99) Sacrificed in extreeis
Macroscopic Observations: P itu ita ry Skin
Microscopic Observations: Adrenal Kidney Liver
Lung
-Raised dark nass, 1 ce dia. -Ulcerated rig h t hind footpad.
-Sinusoidal ectasia, cortex, d iffuse, eild -Chronic progressive nephropathy, e ild -Portal aononuclear c e ll in f ilt r a t e , e ild Hepatocyte vacuolation, e u ltifo c a l, e ild Hegalocytosis, ainieal -Vascular e ineralization Alveolar eacrophages, e u ltifo c a l, e ild Perivascular aononuclear in f ilt r a t e , e ild
Species: Rat Project Nueber: 0281CR0012
0186S
Sueearized STAR Page: 192
383
Suaaarized Single Tabulated Aniaal Report- (continued) Individual Hacroscopic and Hicroscopic Observations
Riker Laboratories, Inc. 3H FH-3924: Tao Year Oral Toxicity-Oncogenicity Study in Rats
Table: 2
Aniaal Nuaber: 1R-3B10 Sex: Hale 6roup: ( 3) FH-3924 30 ppa Fate: (Meek- 99) Sacrificed in extreais
Hicroscopic Observations (continued): P ituitary Skin
-Adenoaa -Pododeraatitis, ulcerative, u n ila te ra l,
aarked
The fo lloaing tissues aere found to be a ith in noraal li a i t s : Spleen, Heart, Testis/Epididyais, Prostate, Stoaach, Urinary Bladder, Thyroid, Parathyroid, Trachea, Esophagus, Salivary Bland, Pancreas.
Aniaal Nuaber: 1R-4B21 Sex: Feaale Group: ( 3) FH-3924 30 ppa Fate: (Heek- 03! Found Dead
Hacroscopic Observations: P itu ita ry
Microscopic Observations: Adrenal
Kidney
Liver Lung
Ovary P itu ita ry Spleen llte rjs
-Heacrrhagic aass, ! x 0.8 ca.
-Sinusoidal ectasia, cortex, aoderate Nodular hyperplasia, cortex, a ild Cortical degeneration, a ild -Chronic progressive nephropathy, ainiaal Pelvic aineralization, ainiaal
-Hepatocyte vacuclaticn, u ltifocal, a ild -Vascular aineralization, a ild
Edena, a ild -Tubular hyperplasia, b ila te ra l, a ild -Adenoaa -Heaosiderosis, a ild -Not exaained, ai ssi ng
The following tissues ere found to be w ithin nornal l ia it s : Hea^i, Kaceary Bland, Stoaach, Urinary Bladder, Thyroid, Parathyroid, Trachea, Esophagus, Salivary Bland, Pancreas.
Aniaal Nuaber: 1R-4B22 Sex: Feaale Sroup: ! 3) FH-3924 30 ppei Fate: Keefc= 104': Sacrificed in extreais
Hacroscopic Observations: P itu ita ry Haaaary Bland
Liver Spleen
-Raised aass, 0.5 ca dia. -Heaorrhagic, necrotic aass, 3 x 2 ca, in the
pectoral area. -Scattered pale fo c i. -Possibly enlarged
it f t o D l T l O K H U . / t f / K A O S C - O jp iC . O G S t Z R . V f r T 7 0 f J
y - A /o XTS S U * . r t>
,
s r i u o y 0/4/zcjTP*.
i&*+r eye
/A /rr
Species: Rat Project Nuaber: 02B1CR0012
001S69
Suaaarized STAR Page: 193
384
Suaaarized Single Tabulated Aniaal Report (continued) Individual Hacroscopic and Hicroscopic Observations
Riker Laboratories, Inc. 3H FH-3924: Two Year Oral Toxicity-Oncogenicity Study in Rats
Table: 2
Aniaal Nuaber: 1R-4822 Sex: Feaale Group: ( 3) FH-3924 30 ppa Fate: (Neek= 104) Sacrificed in extreais
Hicroscopic Observations (continued): Adrenal
Kidney
Liver
Lung Haaaary Gland P itu ita ry Spleen
Uterus
-C ortical vacuolation, a ild Sinusoidal ectasia, cortex, aoderate -Pelvic aineralization, aild Hyperplasia, pelvic epitheliua, p ap illary, aoderate -Necrosis, local areas, aoderate Heaatopoiesis, extraaedullary, a ild -Perivascular aononudear in f ilt r a t e , a ild Heaorrhage, local areas, a ild -Adenocarcinoaa, p a p illa ry -Adenoaa -Heaatopoiesis, extraaedullary, increased, aarked -Not exaained, aissing
The following tissues were found to be w ithin noraal 1ia its : Heart, Ovary, Stoaach, Urinary Bladder, Thyroid , Parathyroid, Trachea, Esophagus, Salivary Gland, Pancreas, Eye.
Aniaal Nuaber: 1R-4823 Sex: Feaale 6roup: ( 3) FH-3924 30 ppa Fate: (Neek= 105) Terainal Sacrifice
Hacroscopic Observations; P ituitary Haaaary Bland
Hicroscopic Observations: Adrenal Kidney Liver
Lung
Haaaary Gland Parathyroid P itu ita ry Salivary Gland Thyroid
-Hass, 0.4 ca dia. -Lobular aass, 7.5 x 5 x 2.5 ca, throat area.
-Sinusoidal ectasia, cortex, aarked -Pelvic aineralization, ainiaal -Hepatocyte vacuolation, a u ltifo c a l, ainiaal Hepatocyte a lte ra tio n , vacuolated, a ild -Vascular aineralization, a ild Alveolar aacrophages, fo cal, ainiaal Heaorrhage, local areas, a ild -Fibroadenoaa -Not exaained, not in plane of section -Adenocarcinoaa -Not exaained, aissing -Adenocarcinoaa, fo llic u la r
The follow ing tissues were found to be w ithin noraal l ia it s : Spleen, Heart, Uterus, Ovary, Stoaach, Urinary Bladder, Trachea, Esophagus, Pancreas.
Species: Rat Project Nueber: 0281CR0012
001870
Suaaarized STAR Page: 19* ~
385
Suaaarized Single Tabulated Aniaal Report (continued) Individual Macroscopic and Microscopic Observations
Riker Laboratories, Inc. 3M FM-3924: Tea Year Oral Toxicity-Oncogenicity Study in Rats
Table: 2
Aniaal Nuaber: 1R-4B24 Sex: Feaale Group: ( 3) FM-3924 30 ppa Fate: (Week* 102) Found Dead
Macroscopic Observations: Naaaary Gland
Microscopic Observations: Adrenal
Liver Maaaary Gland Ovary Pancreas Parathyroid P itu ita ry Salivary Gland Skin Spleen
Thyroid Urinary Gladder
-Mass, 9 x & x 1.5 ca, inguinal area; aass. x 6 x 5 ca, rig h t a x illa ry area, ulcerated and bleeding.
-Sinusoidal ectasia, cortex, a ild Adenoaa, c o rtic a l
-Necrosis, centri lobular, aarked -Fibroadenoaa -Cyst -Not exaained, aissing -Not exaained, aissing -Adenoaa -Not exaained, aissing -Fibroaa -HeaatDpoiesis, extraaedullary, increased, a ild -Not exaained, aissing -Not exaained, aissing
The Following tissues nere Found to be w ithin noraal li a i t s : Kidney, Heart, Lung, Uterus, Stoaach, Trachea, Esophagus.
Aniaal Nuaber: 1R-4825 Sex: Feaale 6roup: ( 3) FH-3924 30 ppa Fate: (Heek= 102) Sacrificed in extreais
Macroscopic Observations: P itu ita ry Maaaary Gland
Microscopic Observations: Adrenal Esophagus Kidney Lung
Maaaary Gland
Pancreas P itu ita ry Salivary Gland Uterus
-Raised dark aass, 1.2 ca dia. -Hass in perineal area; appears to be
intlaaaed ilk cyst.
-Sinusoidal ectasia, cortex, a ild -Not exaained, aissing -Chronic progressive nephropathy, a ild -Vascular a in era liza tion , a ild Alveolar aacrophages, a u ltiF o c a l, a ild -6alactocele Lobular hyperplasia -Acinar atrophy, a ild -Adenoaa -Not exaained, aissing -Not exaained, aissing
Species: Rat Project Mueber: 0281CR0012
04*87*
Suaaarized STAR Page: 195
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Suaaarized Single Tabulated Aniaal Report (continued) Individual Macroscopic and Microscopic Observations
Riker Laboratories, Inc. 3M FH-3924: Two Year Oral Toxicity-Oncogenicity Study in Rats
Table: 2
Aniaal Nuaber: 1R-4825 Sex: Feeale 6roup: ( 3) FH-3924 30 ppa Fate: (Week* 102) Sacrificed in extreais
Microscopic Observations (continued):
The follow ing tissues were found to be w ithin noraal 1ia its : Spleen, Liver, Heart, Ovary, Stoaach, Urinary Bladder, Thyroid, Parathyroid, Trachea.
Aniaal Nuaber: 1R-4826 Sex: Feaale Broup: ( 3) FH-3924 30 ppa Fate: (Neek= 105) Terainal Sacrifice
Macroscopic Observations: Naaaary 61and
P itu ita ry Microscopic Observations:
Adrenal Heart
Kidney Liver Lung
Maaaary Bland
Ovary P itu ita ry Spleen Thyroid
-Hass, 3 x 2 ca, throat area; aass 3 ca d ia ., le ft a x illa ; saall a ilk cyst, right a xilla .
-Raised dark lesion, 0.7 ca dia.
-Sinusoidal ectasia, cortex, aarked -Myocardial fib ro s is , a u ltifo c a l, a ild Myocarditis, chronic nonsuppurative, a u ltifo ca l, ainiaal -Pelvic aineralization, ainiaal -Hepatocyte vacuolation, a u ltifo c a l, ainiaal -Vascular a in e ra liza tio n , a ild Alveolar aacrophages, a u ltifo c a l, a ild -Fibroadenoaa Adenocarcinoaa, tubular Balactocele -Tubular hyperplasia, b ila te ra l, a ild -Adenoaa -Heaosiderosis, a ild -Hyperplasia, C c e ll, focal, a ild Ultiaabranchial cyst
The fo llo u in g tissues were found to be w ithin noraal l ia it s : Uterus, Stoaach, Urinary Bladder, Parathyroid, Trachea, Esophagus, Salivary Bland, Pancreas.
Aniaal Nuaber: 1R-4827 Sex: Feaale Broup: ( 3) FH-3924 30 ppa Fate: (Heek= 105) Terainal Sacrifice
Macroscopic Observations: Maaaary Bland P ituitary
Microscopic Observations: Adrenal
-F ire aass, 1.5 ca d ia ., throat area. -Mass, 0.7 ca dia.
-C ortical degeneration, local areas, a ild
Species: Rat Project Nuaber: 02B1CR0012
00187#
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Hiker Laboratories, Inc. 3H RI-3924: Tao Year Oral Toxicity-Oncogenicity Study in Rats
Table: 2
Aniaal Nuaber: 1R-4827 Sex: Feaale Broup: ( 3) FH-3924 30 ppa Fate: (Heek= 105) Terainal S acrifice
Hicroscopic Observations (continued): Heart
Kidney Liver
Lung Haaaary Gland Ovary
P itu ita ry Uterus
-Hyocarditis, chronic nonsuppurative, a u ltifo c a l, ai Id
-Chronic progressive nephropathy, ainiaal Pelvic aineralization, a ild
-Portal aononudear c e ll in f ilt r a t e , a ild Portal b ile duct p ro life ra tio n , a ild Hepatocyte vacuolation, a u ltifo c a l, ainiaal Hepatocyte a lte ra tio n , vacuolated, a ild
-Vascular a in eralization, ainiaal -Adenocarcinoaa -Within noraal lia it s One of pair present -Adenona -Cystic glands, aarked
The follow ing tissues were found to be Hi th in noraal li a i t s : Spleen, Stoaach, Urinary Bladder, Thyroid, Parathyroid, Trachea, Esophagus, Salivary Bland, Pancreas.
Aninal Nuaber: 1R-4828 Sex: Feaale 6roup: t 3) FH-3924 30 ppa Fate: (Neek= 95) Sacrificed in extreais
Hacroscopic Observations: P itu ita ry Haaaary 61and
Hicroscopic Observations: Adrenal Heart Kidney Liver Lung
Haaaary Bland Parathyroid P itu ita ry Thyroid Uterus
-Heaorrhagic aass, 1.4 x 0.8 c i dia. -Snail aass, 2.4 x 2 x 1 ca d ia ., rig h t
a xilla .
-Sinusoidal ectasia, cortex, aoderate -Hyocardial fib ro s is , a u ltifo c a l, a ild -Chronic progressive nephropathy, focal -Hepatocyte vacuolation, ce n trilo b u la r, -Vascular aineralization, a ild
Alveolar aacrophages, a u ltifo c a l, a ild Heaorrhage, local areas, a ild -Fibroadenoaa -Not exaained, aissing -Adenoaa -Not exaained, aissing -Cystic glands, aoderate
The folloHing tissues Here found to be nithin noraal lia it s : Spleen, Ovary, Stoaach, Urinary Bladder, Trachea, Esophagus, Salivary Bland, Pancreas.
Species: Rat Project Nuaber: 02B1CR0012
001873
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Riker Laboratories, Inc. 3H FH-3924: Two Tear Oral Toxicity-Oncogenicity Study in Rats
Table: 2
Aniaal Nutber: 1R-4829 Sex: Feeale Group: ( 3) FH-3924 30 ppe Fate: (Neek= 105) Terminal Sacrifice
Macroscopic Observations: Skin Adrenal
Microscopic Observations: Adrenal Heart
Kidney Liver Lung
Naiaary 61and Mesentery
Ovary Pancreas P itu ita ry
-Hair loss on forelegs. -Right adrenal involved in a eass, 3 x 2 cai
le f t adrenal enlarged.
-Sinusoidal ectasia, cortex, aarked Pheochroaocytoaa, aalignant, u n ila te ra l
-Myocardial fib ro s is , local areas, a ild Myocarditis, chronic nonsuppurative, local areas, a ild -Chronic progressive nephropathy, aoderate Pelvic a in e ra liza tio n , aoderate -Hepatocyte vacuolation, a u ltifo c a l, ainiaal
-Vascular aineralization, a ild Pneuaonia, in t e r s t it ia l, chronic, a u ltifo c a l, a ild Perivascular aononudear in f ilt r a t e , a ild Heaorrhage, a u ltifo c a l, a ild
-6alactocele -Leioayosarcoaa
Tuaor not described grossly. Highly anaplastic. -Tubular hyperplasia, a ild -Not exaained, aissing -Adenoaa
The follow ing tissues were found to be w ithin noraal lia its *. Spleen, Uterus, Stoaach, Urinary Bladder, Thyroid, Parathyroid, Trachea, Esophagus, Salivary Gland, 5kin.
Aniaal Nuaber: 1R-4B30 Sex: Feaale Group: ( 3) FH-3924 30 ppa Fate: (Week* 105) Tereinal Sacrifice
Macroscopic Observations: P itu ita ry Haaaary 61and
Uterus
Microscopic Observations: Adrenal Kidney
-Saall dark lesion, 0.2 ca dia. -Mass, 2.5 x 1.3 ca, rig h t a x illa ; cystic
aass, 5 x 4 x 2.5 ca, rig h t inguinal. -Heaorrhagic cystic lesion, 2 x 1.3 ca, rig h t
horn.
-C ortical degeneration, fo ca l, a ild -Nephrosis, tubular, aarked
Species: Rat Project Nuaber: 0281CR0012
001874
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Suaaarized Single Tabulated Aniaal Report (continued) Individual Macroscopic and Microscopic Observations
Riker Laboratories, Inc. 3M FM-3924: Tno Year Oral Toxicity-Oncogenicity Study in Rats
Table: 2
Aniaal Nuaber: 1R-4B30 Sex: Feaale Group: ( 3) FM-3924 30 ppa Fate: (Heek- 105) Terainal Sacrifice
Microscopic Observations (continued): Liver
Lung
Maaiary 61and Parathyroid P itu ita ry Uterus
-Portal aononudear c e ll in f ilt r a t e , a ild Portal b ile duct p ro life ra tio n , a ild Hepatocyte vacuolation, a u ltifo c a l, a ild
-Pneuaonia, in t e r s t it ia l, chronic, a u ltifo c a l a ild Perivascular aononudear in f ilt r a t e , a ild -Fibroadenoaa -Not exaained, not in plane of section -Adenoaa -Polyp
The following tissues were found to be w ithin noraal li a i t s : Spleen, Heart, Ovary, Stoaach, Urinary Bladder, Thyroid, Trachea, Esophagus, Salivary Gland, 'Pancreas.
Aniaal Nuaber: 1R-4831 Sex: Feaale Group: ( 3) FM-3924 30 ppa Fate: (Neek= 96) Sacrificed in extreais
Macroscopic Observations: P itu ita ry
Microscopic Observations: Adrenal kidney Liver
Lung
P itu ita ry Salivary Gland Spleen
-Heaorrhagic aass, 1 ca dia.
-Sinusoidal ectasia, cortex, aild -Pelvic aineralization, aild -Hepatocyte vacuolation, a u ltifo c a l, ainiaal Pigaent, brown, local areas, a ild -Vascular a in e ra liza tio n , a ild Pneuaonia, in t e r s t it ia l, chronic, a u ltifo c a l, a ild Heaorrhage, a u ltifo c a l, a ild -Adenoaa -Heaorrhage -Heaosiderosis, aoderate
The following tissues were Found to be w ithin noraal l ia it s : Heart, Uterus, Ovary, Haaaary Gland, Stoaach, Urinary Bladder, Thyroid, Parathyroid, Trachea, Esophagus, Pancreas.
Species: Rat Project Nuaber: 0281CR0012
001875
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Riker Laboratories, Inc. 3M FH-3924: Tmo Year Oral Toxicity-Oncogenicity Study in Rats
Table: 2
Anieal Nueber: 1R-4832 Sex: Feeale Group: ( 3) FH-3924 30 ppa Fate: (Meek: 105) Terminal Sacrifice
Macroscopic Observations: Ovary
Microscopic Observations: Adrenal Esophagus Liver
Lung
Ovary Parathyroid P itu ita ry Salivary Gland Thyroid Trachea
-Saall nodular aass, 0.8 ca d ia ., le f t ovary.
-Sinusoidal ectasia, cortex, a ild -Not exaained, aissing -Hepatocyte vacuolation, a u ltifo c a l, a ild Regalocytosis, a ild -Vascular M ineralization, a ild Pneuaonia, in t e r s t it ia l, chronic, a u ltifo c a l, a ild Alveolar aacrophages, a u ltifo c a l, a ild -Tubular adenoaa -Not exaained, aissing -Adenoaa -Not exaained, aissing -Not exaained, aissing -Not exaained, aissing
The fo llo u in g tissues were found to be M ithin n on al l i i i t s : Spleen, Kidney, Heart, Uterus, Maseary Gland, !Stoaach, Urinary Bladder, Pancreas, Eye.
Anisal Nusber: 1R-4833 Sex: Fesale Group: ( 3) FH-3924 30 ppa Fate: (Meek: 86) Sacrificed in extreais
Macroscopic Observations: Haasary Gland
Liver Microscopic Observations:
Adrenal
Kidney Lung
Naaaary 61and Spleen
-Large aass, 15 x 12 x 3 ca, ulcerated surface, inguinal area.
-Appears enlarged
-C ortical vacuolation, focal, a ild Sinusoidal ectasia, cortex, aarked
-Pelvic aineralization, ainiaal -Vascular aineralization, a ild
Pneuaonia, in t e r s t it ia l, chronic, a u ltifo c a l, a ild Alveolar aacrophages, a u ltifo c a l, a ild -Fibroadenoaa -Heaatopoiesis, extraaedullary, increased, aoderate
The fo llo u in g tissues Mere found to be w ithin noraal l i s it s : Liver, Heart, Uterus, Ovary, Stoaach, Urinary Bladder, Thyroid, Parathyroid, Trachea, Esophagus, Salivary Gland, P itu ita ry , Pancreas, Lyapb Node (aesenteric)..
Species: Rat Project timber: 02B1CR0012
001876
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Suaaarized Single Tabulated Aniaal Report (continued) Individual Hacroscopic and Hicroscopic Observations
Riker Laboratories, Inc. 3H FH-3924: Teo Year Oral Toxicity-Oncogenicity Study in Rats
Table: 2
Aniaal Nuaber: 1R-4834 Sex: Feaale Broup: ( 3) FH-3924 30 ppa Fate: (Ueek= 105) Terainal Sacrifice
Hacroscopic Observations: Haaaary Bland
Hicroscopic Observations: Adrenal
Esophagus Kidney Liver
Lung
Haaaary Bland Pancreas P itu ita ry Thyroid
-Lobulated aass, 6.5 x 5 x 3 ca, rig h t inguinal area.
-C ortical vacuolation, focal, a ild Sinusoidal ectasia, cortex, a ild
-Not exaained, aissing -Pelvic aineralization, ainiaal -Portal aononudear c e ll in f ilt r a t e , a ild
Hepatocyte a lte ra tio n , vacuolated, a u l t i f ocal, a ild Portal b ile duct p ro life ra tio n , a ild -Vascular aineralization, a ild Pneuaonia, in t e r s t it ia l, chronic, a u ltifo c a l, a ild Alveolar aacrophages, a u ltifo c a l, a ild -Fibroadenoaa -Not exaained, aissing -No diagnosis, inadequate section -C c e ll carcinoaa
The folloHing tissues ere found to be w ithin noraal li a i t s : Spleen, Heart, Uterus, Ovary, StDaach, Urinary Bladder, Parathyroid, Trachea, Salivary Gland.
Aniaal Nuaber: 1R-4835 Sex: Feaale 6roup: ( 3) FH-3924 30 ppa Fate: (Week= 105) Terainal Sacrifice
Hacroscopic Observations:
Hicroscopic Observations: Adrenal Liver
Lung
Pancreas Salivary Gland Thyroid
-No v is ib le lesions.
-Sinusoidal ectasia, cortex, aoderate -Hepatocyte vacuolation, a u ltifo c a l, a ild Hepatocyte a lte ra tio n , vacuolated, a u ltifo c a l,
a ild -Vascular aineralization, a ild Heaorrhage, a u ltifo c a l, a ild -Not exaained, aissing -Not exaained, aissing -Hyperplasia, C c e ll, a u ltifo c a l, ainiaal
The fo llo iiin g tissues Here found to be w ithin noraal li a i t s : Spleen, Kidney, Heart, Uterus, Ovary, Haaaary 61and, Stoaach, Urinary Bladder, Parathyroid, Trachea, Esophagus, P itu ita ry , Lyaph Node laesenteric).
Species: Rat Project Nuaber*. 02B1CR0012
001877
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Riker Laboratories, Inc. 3H FH-3924: Tuo Year Oral Toxicity-Oncogenicity Study in Rats
Table: 2
Aniaal Nuaber: 1R-4836 Sex: Fenale Group: ( 3) FH-3924 30 ppn Fate: (Meek* 105) T eriinal Sacrifice
Macroscopic Observations: Eye H am ry 61and
Microscopic Observations! Eye
Liver
Lung
Maseary Gland Ovary P itu ita ry Skin Urinary Bladder
-Opacity, rig h t eye. -Spherical nodule, 1 cn d ia ., perineal area;
ass, 11.5 x 11 x 2.5 ce, le f t la te ra l area.
-Cataract, unilateral Retinal atrophy, diffuse , u n ila te ra l, aarked
-Portal aononudear c e ll in f ilt r a t e , ai Id Portal b ile duct p ro life ra tio n , a ild Hepatocyte a lte ra tio n , vacuolated, focal, a ild -Vascular a in e ra liza tio n , a ild Alveolar aacrophages, a ild Heaorrhage, a u ltifo c a l, a ild
-Adenocarcinoaa -Tubular hyperplasia, b ila te r a l, aarked -Not exaained, aissing -Lipoaa -Not exaained, aissing
The fo llo nin g tissues were found to be w ithin noraal l ia it s : Spleen, Kidney, Heart, Uterus, Stoaach, Adrenal, Thyroid, Parathyroid, Trachea, Esophagus, Salivary Gland, Pancreas.
Aniaal Nuaber: 1R-4637 Sex: Feaale Group: ( 3) FH-3924 30 ppa Fate: (Neek* 87) Found Dead
Macroscopic Observations:
Microscopic Observations: Kidney
Liver
Lung P itu ita ry Salivary 61and Urinary Bladder
-No v is ib le lesions.
-Pelvic aineralization, a ild Hyperplasia, pelvic epitheliua, a ild
-Portal aononudear c e ll in f ilt r a t e , a ild Portal b ile duct p ro life ra tio n , a ild Hepatocyte vacuolation, a u ltifo c a l, a ild
-Vascular a in era liza tion , a ild -Not exaained, aissing -Not exaained, aissing -Not exaained, aissing
The follow ing tissues aere found to be w ithin noraal li a i t s : Spleen, Heart, Uterus, Ovary, Maaaary Gland, Stoaach, Adrenal, Thyroid, Parathyroid, Trachea,
Species: Rat Project Nuaber: 02B1CR0012
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Riker Laboratories, Inc. 3M FM-3924: Two Tear Oral Toxicity-Oncogenicity Study in Rats
Table: 2
Aniaal Huaber: 1R-4837 Sex: Feaale Broup: ( 3) FM-3924 30 ppa Fate: (Week- 87) Found Dead
Microscopic Observations (continued): The following tissues were found to be w ithin noraal l i a i t s (continued): Esophagus, Pancreas, Saall Intestine.
Aniaal Nuaber: 1R-4838 Sex: Feaale Broup: ( 3) FM-3924 30 ppa Fate: (Keek* 98) Sacrificed in extreais
Macroscopic Observations: P ituitary Spleen Liver Haaaary Gland
Microscopic Observations: Adrenal Kidney
Liver Lung Maaaary 61and
Pancreas Parathyroid P itu ita ry Spleen
Thyroid
-Enlarged -Enlarged -Pale -Hass, 3.S x 1.5 ca, a u ltilo b u la r, perineal
area; ulcerated a u ltilo b u la r aass, G x 5 x 4 c a , rig h t la te ra l area.
-Sinusoidal ectasia, cortex, aoderate -Pelvic aineralization, ainiaal Nephrosis, tubular, wild -Heaatopoiesis, extraaedullary, ainiaal -Vascular aineralization, a ild -Adenocarcinoaa, tubular Adenocarcinoaa, p ap illary -Not exaained, aissing -Not exaained, aissing -Adenoaa -Heaatopoiesis, extraaedullary, increased, aarked -Not exaained, aissing
The following tissues were found to be w ithin noraal l ia it s : Heart, Uterus, Ovary, Stoaach, Urinary Bladder, Trachea, Esophagus, Salivary Gland, Eye.
Aniaal Nuaber: 1R-4839 Sex: Feaale Group: ( 3) FM-3924 30 ppa Fate: (Heek= 105) Terainal S acrifice
Macroscopic Observations: Skin
Microscopic Observations: Adrenal Kidney
Liver
-Hair loss on fo re lia b s.
-Sinusoidal ectasia, cortex, aoderate -Chronic progressive nephropathy, ainiaal Pelvic aineralization, a ild -Hepatocyte vacuolation, a u ltifo c a l, a ild
Species: Rat Project Nuaber: 02B1CR0012
001879
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Suaaarized Single Tabulated Aniaal Report (continued) Individual Nacroscopic and Hicroscopic Observations
Riker Laboratories, Inc. 3H FH-3924: Two Year Oral Toxicity-Oncogenicity Study in Rats
Table: 2
Aniaal Nueber: 1R-4B39 Sex: Fetale Group: ( 3) FN-3924 30 ppe Fate: (Neek= 105) Terainal S acrifice
Hicroscopic Observations (continued): Lung Ovary Parathyroid P itu ita ry Urinary Bladder
-Vascular aineralization, a ild -Tubular adenoaa -Not exaained, not in plane of section -Adenoaa -Not exaained, aissing
The folloMing tissues Mere found to be w ithin noraal l ia it s : Spleen, Heart, Uterus, Haaaary 61and, Stoaach, Thyroid, Trachea, Esophagus, Salivary Bland, Pancreas, Skin.
Aniaal Nuaber: 1R-4B40 Sex*. Feaale Group: ( 3) FH-3924 30 ppa Fate: (Neek= 93) Sacrificed in extreais
Nacroscopic Observations: P itu ita ry Thorax (internal)
Liver Vagina
Hicroscopic Observations: Adrenal Heart Kidney
Liver
Lung Lyaph Node (thoracic) Haaaary 61and Ovary Parathyroid P itu ita ry Spleen
Uterus
-Appears soaeahat enlarged. -Fatty tu a o r-lik e aass, 2 x 2 ca, in anterior
thorax. -Pale and aottled. -Polypoid aass, ulcerated surface, 3 x 1.5 ca,
attached to cervix, prolapsing to outside.
-Necrosis, d iffu se , u n ila te ra l, aarked -Myocardial fib ro s is , local areas, a ild -Chronic progressive nephropathy, ainiaal Pelvic a in e ra liza tio n , aoderate -Portal aononudear c e ll in f ilt r a t e , ainiaal Portal b ile duct p ro life ra tio n , ainiaal Hepatocyte vacuolation, local areas, a ild Heaatopoiesis, extraaedullary, ainiaal -Vascular aineralization, a ild -Lyaphosarcoaa -Not exaained, aissing -Tubular hyperplasia, u n ila te ra l, a ild -Not exaained, not in plane of section -Adenoaa -Heaatopoiesis, extraaedullary, increased, aoderate -Polyp
Tuaor arising froa cervix. Surface necrotic and ulcerated.
Species: Rat Project Nuaber: 0281CR0012
001880
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Riker Laboratories, Inc. 3H FM-3924: Tao Year Oral Toxicity-Oncogenicity Study in Rats
Table: 2
Anieal Nueber: 1R-4840 Sex: Feeale Group: ( 3) FH-3924 30 ppa Fate: (Meek- 93) Sacrificed in extreais
Microscopic Observations (continued):
The fo llo u in g tissues were found to be w ithin noraal li a i t s : Stoaach, Urinary Bladder, Thyroid, Trachea, Esophagus, Salivary Stand, Pancreas, lyaph Node (aesenteric).
Aniaal Nuaber: 1R-4641 Sex: Feaale Group: ( 3) FM-3924 30 ppa Fate: (Heek= 101) Sacrificed in extreais
Macroscopic Observations: Haasary Gland
Adrenal Liver Pancreas
Abdoaen (in te rn al) Lyaph Node (aesenteric) Uterus
Microscopic Observations: Adrenal
Kidney Liver Lyaph Node (aesenteric) Haaaary Gland Pancreas P itu ita ry Stoaach
Urinary Bladder Uterus
-Subcutaneous aass, 4.5 x 3 x 2 ca, rig h t a xilla .
-L e ft adrenal enlarged. -Pale -M ultilobulated heaorrhagic aass, 4.5 x 3 x
3.5 ca, in area of pancreas involving the caudate liv e r lobe. -F ille d with bloody flu id . -Enlarged -M u ltilo bu lar cystic aass, 5 x 5.5 x 2.5 ca, near cervix.
-Sinusoidal ectasia, cortex, aarked Malignant lyaphoaa, h is tio c y tic
-Chronic progressive nephropathy, a ild -Portal b ile duct p ro life ra tio n , ainiaal -Malignant lyaphoaa, h is tio c y tic -Lobular hyperplasia -Malignant lyaphoaa, h is tio c y tic -Not exaained, aissing -Ulcer Malignant lyaphoaa, h is tio c y tic -Malignant lyaphoaa, h is tio c y tic -Cystic glands, a ild Malignant lyaphoaa, h is tio c y tic
The follow ing tissues aere found to be a ith in noraal lia i t s : Spleen, Heart, Lung, Ovary, Thyroid, Parathyroid, Trachea, Esophagus, Salivary Gland.
Species: Rat Project Nuaber: 0281CR0012
001881
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Riker Laboratories, Inc. 3H FH-3924: Tmo Year Oral Toxicity-Oncogenicity Study in Rats
Table: 2
Aniaal Nuaber: 1R-4B42 Sex: Feaale 6roup: ( 3) FH-3924 30 ppa Fate: (Heek 105) Terainal Sacrifice
Macroscopic Observations: Skin
P ituitary Maaaary Gland
Microscopic Observations: Adrenal Kidney Liver
Lung
Maaaary Gland
Ovary Pancreas
P itu ita ry Skin
Thyroid
-Raised inflaaaatory lesion on rig h t hind footpad.
-Mass, 0.7 ca dia. -Lobular aass, 2.5 x 2 ca, le f t inguinal area:
lobular aass, 3 x 2 ca, rig h t inguinal area; lobular aass, 6 x 5 x 3.5 ca, right a xilla .
-Sinusoidal ectasia, cortex, aarked -Pelvic aineralization, ainiaal -Portal aononudear c e ll in f ilt r a t e , ainiaal Portal b ile duct p ro life ra tio n , ainiaal -Vascular a in e ra liz a tio n , a ild Heaorrhage, diffuse , aarked -Fibroadenoaa Fibroadenoaa Fibroadenoaa -Tubular hyperplasia, b ila te ra l, Moderate -Acinar atrophy, aarked Is le t c e ll adenoaa -Adenoaa -Pododeraatitis, ulcerative, u n ila te ra l, aarked -Hyperplasia, C c e ll, focal, a ild
The follow ing tissues Mere found to be w ithin noraal li a i t s : Spleen, Heart, Uterus, Stoaach, Urinary Bladder, Parathyroid, Trachea, Esophagus, Salivary Gland.
Aniaal Nuaber: 1R-4843 Sex: Feaale Broup: ( 3) FH-3924 30 ppa Fate: (Neek= B5) Found Dead
Macroscopic Observations: P itu ita ry Naaaary 61and
Microscopic Observations: Adrenal Liver
Lung Pancreas Parathyroid
-C ircular raised aass, 0.B ca dia. -Saall ilk cyst in inguinal area.
-Sinusoidal ectasia, cortex, aarked -Portal aononudear c e ll in f ilt r a t e , a ild Portal b ile duct p ro life ra tio n , a ild -Vascular a in era liza tion , a ild -Not exaained, aissing -Not exaained, aissing
Species: Rat Project Nuaber: 0281CR0012
001882
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Suaaarized Single Tabulated Aniaal Report (continued) Individual Macroscopic and Microscopic Observations
Riker Laboratories, Inc. 3M FM-3924: Tao Year Oral Toxicity-Oncogenicity Study in Rats
Table: 2
Anieal Nueber: 1R-4B43 Sex: Feeale Broup: < 3) FM-3924 30 ppa Fate: tHeek- BS) Found Dead
Microscopic Observations (continued); P itu ita ry Salivary 61and Spleen Stooach Thyroid Trachea
-Adenoaa -Not exaained, aissing -Heaosiderosis, aoderate -Not exaained, aissing -Not exaained, aissing -Not exaained, aissing
The fo llo a in g tissues Mere found to be w ithin nortal l io it s : Kidney, Heart, Uterus, Ovary, Haaeary 61and, Urinary Bladder, Esophagus.
Aniaal Nuaber: 1R-4844 Sex: Feaale Group: ( 3) FM-3924 30 ppa Fate: (Neek= 105) Terainal Sacrifice
Macroscopic Observations: P itu ita ry
Microscopic Observations: Adrenal Kidney Lung Ovary Pancreas Parathyroid P itu ita ry Thyroid
-Raised dark aass, 0.7 ca dia.
-Sinusoidal ectasia, cortex, a ild -Chronic progressive nephropathy, a ild -Perivascular aononudear in f ilt r a t e , a ild -Cyst, unilateral -Not exaained, aissing -Not exaained, aissing -Adenoaa -Not exaained, aissing
The -Fallowing tissues Nere found to be w ithin noraal I ia it s : Spleen, Liver, Heart, Uterus, Haaaary Gland, Stoaach, Urinary Bladder, Trachea, Esophagus, Salivary Gland.
Aninal Nuaber: 1R-4B45 Sex: Feaale Group: ( 3) FM-3924 30 ppa Fate: (Heek= 84) Sacrificed in extreais
Macroscopic Observations: P itu ita ry Liver
Microscopic Observations: Adrenal Liver
Lung
-Raised aass, 0.7 ca dia. -S lig h tly pale
-C ortical degeneration, local areas, aoderate -Portal aononudear c e ll in f ilt r a t e , a ild Portal b ile duct p ro life ra tio n , aoderate Hepatocyte vacuolation, d iffu se , aoderate -Vascular aineralization, a ild
Species: Rat Project Muaber: 02B1CR0012
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Suaaarized Single Tabulated Aniaal Report (continued) Individual Hacroscopic and Hicroscopic Observations
Riker Laboratories, Inc. 3H FN-392*: Tao Year Oral Toxicity-Oncogenicity Study in Rats
Table: 2
Anieal Nuiber: 1R-4845 Sex: Feaale Sroup: ( 3) FH-3924 30 ppa Fate: (Neek= 84) Sacrificed in extreais
Microscopic Observations (continued): Pancreas P itu ita ry
-Not exaained, aissing -Adenoaa
The folloH ing tissues were found to be w ithin noraal l i a i t s : Spleen, Kidney, Heart, Uterus, Ovary, Haaaary Gland, Stoaach, Urinary Bladder, Thyroid, Parathyroid, Trachea, Esophagus, Salivary Bland, Lyaph Node (aesenteric).
Aniaal Nuaber: 1R-4846 Sex: Feaale Broup: ( 3) FH-3924 30 ppa Fate: (Neek= 84) Found Dead
Macroscopic Observations: P itu ita ry Naaaary Bland
Hicroscopic Observations: Adrenal
Kidney Liver
Lung Haaaary Eland Pancreas P itu ita ry Spleen Thyroid
-Large heaorrhagic aass, 1.2 x 1 ca. -M u ltilo bu lar aass, 2.5 x 1 ca, perineal area.
-Sinusoidal ectasia, cortex, ainiaal One of pair present
-Pelvic aineralization, aiId -Portal aononudear c e ll in f ilt r a t e , a ild
Portal b ile duct p ro life ra tio n , a ild -Vascular a in eralization, a ild -Fibroadenoaa -Not exaained, aissing -Adenoaa -Heaosiderosis, a ild -Ultiaobranchial cyst
The f o l 1awing tissues Mere found to be w ithin noraal li a i t s : Heart, Uterus, Ovary, Stoaach, Urinary Bladder, Parathyroid, Trachea, Esophagus, Salivary Bland.
Aniaal Nuaber: 1R-4847 Sex: Feaale Broup: ( 3) FH-3924 30 ppa Fate: (Neek= 105) Sacrificed in extreais
Hacroscopic Observations: Heart Adrenal
Kidney Hicroscopic Observations:
Adrenal
-Possible p e rica rd itis -L e ft adrenal enlarged due to aass, 1.5 ca
dia. -Appear p itte d
-Carcinoaa, c o rtic a l, u n ila te ra l C ortical atrophy, u n ila te ra l, aarked Atrophy in non-neoplastic gland.
Species: Rat Project Nuaber: 0281CR0012
0018S4
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Suaaarized Single Tabulated Aniaal Report (continued) Individual Macroscopic and Microscopic Observations
Riker Laboratories, Inc. 3H FH-3924: Two Year Oral Toxicity-Oncogenicity Study in Rats
Table: 2
Aniaal Nuaber: 1R-4847 Sex: Feaale 6roup: ( 3) FH-3924 30 ppa Fate: (Week- 105) Sacrificed in extreais
Microscopic Observations (continued): Heart Kidney
Lung
Maaaary Bland Pancreas P itu ita ry
-P e ric a rd itis , chronic, d iffu se , aoderate -Chronic progressive nephropathy, aoderate Pyelonephritis, acute, u n ila te ra l, narked -Vascular aineralization, a ild Metastatic neoplasa P le u ritis , chronic, diffuse , aoderate -Not exaained, aissing -Not exaained, aissing -Not exaained, aissing
The follow ing tissues were found to be w ithin noraal l ia it s : Spleen, Liver, Uterus, Ovary, Stoaach, Urinary Bladder, Thyroid, Parathyroid, Trachea, Esophagus, Salivary Bland.
Aniaal Nuaber: 1R-4848 Sex: Feaale Group: ( 3) FH-3924 30 ppa Fate: (Heek= 65) Found Dead
Macroscopic Observations: Liver Skin Kidney
Microscopic Observations: Adrenal Esophagus Liver Lung Maaaary Bland Ovary Pancreas Parathyroid P itu ita ry Salivary 61and Skin
Thyroid Trachea Urinary Bladder
-Pale -Subcutaneous aass, 2 x 1.5 ca. -Mottled
-Not exaained, aissing -Not exaained, aissing -Portal b ile duct p ro life ra tio n , ainiaal -Vascular a in e ra liza tio n , a ild -Adenocarcinoaa -Not exaained, aissing -Not exaained, aissing -Not exaained, aissing -Adenoaa -Not exaained, aissing -Subcutaneous aass not available fo r
aicroscopic exaaination -Not exaained, aissing -Not exaained, aissing -Not exaained, aissing
The following tissues were found to be w ithin ncraal lia it s : Spleen, Kidney, Heart, Uterus, Stoaach, Brain.
Species: Rat Project Nuaber: 0281CR0012
001885
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S u m m e d Single Tabulated Anieal Report (continued) Individual Macroscopic and Microscopic Observations
Riker Laboratories, Inc. 3M FH-3924: Two Year Oral Toxicity-Oncogenicity Study in Rats
Table: 2
Anisal Musber: 1R-4849 Sex: Fesale Broup: ( 3) FN-3924 30 ppa Fate: (Heek= 10S) Tereinal Sacrifice
Macroscopic Observations: P itu ita ry
Microscopic Observations: Adrenal
Kidney Liver
Lung
Pancreas P itu ita ry Thyroid
-Raised sass, 1.3 c i dia.
-Sinusoidal ectasia, cortex, sarked C ortical degeneration, local areas, eoderate
- P y e litis , acute, u n ila te ra l, s ild -Portal eononudear c e ll in f ilt r a t e , a ild Necrosis, focal, eiId -Vascular aineralization, s ild Alveolar sacrophages, s u itifo c a l, s ild -Not exaiined, eissing -Adenosa -C c e ll adenosa
The following tissues were found to be w ithin norsal l i s it s : Spleen, Heart, Uterus, Ovary, Hassary Bland, Stosach, Urinary Bladder, Parathyroid, Trachea, Esophagus, Salivary Gland.
Anisal Musber: 1R-4B50 Sex: Fesale Group: ( 3) FH-3924 30 pps Fate: (Neek= 86) Sacrificed in extreais
Macroscopic Observations! Massary Gland
Spleen Microscopic Observations'.
Adrenal Kidney Liver Lung
Massary Gland Ovary Parathyroid P itu ita ry Skin Spleen
Thyroid
-F irs sass, 9 x 8 x 5 cs, in l e f t a x illa , extending up over back; cystic sass, 3 cs dia, le f t inguinal area.
-S lig h tly enlarged
-Sinusoidal ectasia, cortex, sild -Chronic progressive nephropathy, s ild -Hesatopoiesis, extrasedullary, s ild -Vascular sine ra lizatio n, s ild Hesorrhage, local areas, noderate -Fibroadenona -Tubular hyperplasia, s ild -Not exasined, aissing -Not exasined, sissing -Fibrosarcosa -Hesatopoiesis, extrasedullary, increased, sarked -Not exasined, sissing
The follow ing tissues were found to be w ithin norsal l i s it s : Heart, Uterus, Stosach, Urinary Bladder, Trachea, Esophagus, Salivary Gland, Pancreas, Brain,
Species: Rat Project Nusber: 02B1CR0012
001886 S u m m e d STAR Page: 210
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Riker Laboratories, Inc. 3H FH-3924: Tuo Year Oral Toxicity-Oncogenicity Study in Rats
Table: 2
Aniaal Nuaber: 1R-4B50 Sex: Feaale Group: ( 3) FH-3924 30 ppa Fate: (Keeks 86) Sacrificed in extreais
Microscopic Observations (continued): The follow ing tissues were found to be a ith in noraal l i a i t s (continued): Lyaph Node (aesenteric).
Aniaal Nuaber: 1R-4851 Sex: Feaale Group: < 3) FH-3924 30 ppa Fate: (Neek= 104) Found Dead
Macroscopic Observations: Liver Spleen Uterus
P itu ita ry Stoaach Haaaary Gland
Microscopic Observations: Adrenal
Kidney
Liver
Lung
Maaaary Gland
P itu ita ry Skin Spleen
Stoaach Thyroid Urinary Bladder Uterus
-Pale -Enlarged -Dark aass, 2 x 0.7 ca, in rig h t uterine horn
near cervix. -Enlarged with a dark aass, 0.2 ca dia. -M ultiple foci of erosions. -Mass, 2 x 1.5 ca, le f t a x illa ; a u ltilo b u la r
aass, 5.5 x 2 x 3.5 ca, rig h t inguinal area; cystic aass, 6 x 2 x 4 ca, perineal area.
-C o rtical vacuolation, local areas, aoderate Sinusoidal ectasia, cortex, narked Heaatopoiesis, extraaedullary, aoderate
-Pelvic aineralization, a ild Heaatopoiesis, extraaedullary, aoderate Nephrosis, tubular, aoderate -Necrosis, c e n trilo b u la r, aoderate Heaatopoiesis, extraaedullary, aoderate -Vascular aineralization, a ild Pneuaonia, acute exudative, a u ltifo c a l, a ild -Fibroadenoaa Galactocele Adenocarcinoaa
Extensive necrosis and inflaaaation. -Adenoaa -Fibroaa -Heaatopoiesis, extraaedullary, increased, narked -Necrosis, fo cal, aucosal, a ild -Hyperplasia, C c e ll, focal, a ild -E p ithe lia l hyperplasia, siaple, diffuse, a ild -Heaangioaa
Large neoplasa with cavernous vascular spaces; extensive throabosis and inflaaaation.
Species: Rat Project Nuaber: 0281CR0012
001887
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Suaaarized Single Tabulated Aniaal Report (continued) Individual Hacroscopic and Hicroscopic Observations
Rifcer Laboratories, Inc. 3H FH-3924: Tao Year Oral Toxicity-Oncogenicity Study in Rats
Table: 2
Aniaal Nuaber: 1R-4B51 Sex: Feaale Group: ( 3) FH-3924 30 ppa Fate: (Neek= 104) Found Dead
Hicroscopic Observations (continued):
The follow ing tissues Here Found to be w ithin noraal U n its : Heart, Ovary, Parathyroid, Trachea, Esophagus, Salivary 61and, Pancreas.
Aniaal Nuaber: 1R-4852 Sex: Feaale Group: ( 3) FH-3924 30 ppa Fate: (Heek= 100) Found Dead
Hacroscopic Observations: Kaaaary Gland
P itu ita ry Hicroscopic Observations:
Adrenal
Kidney
Liver
Lung Haaaary 61and Pancreas Parathyroid P itu ita ry Spleen
-Large a u ltilo b u la r aass, 9 x 7 x 4.5 ca in right a xilla .
-S lig h tly enlarged
-Sinusoidal ectasia, cortex, aoderate Heaatopoiesis, extraaedullary, a ild
-Pelvic aineralization, a ild Heaatopoiesis, extraaedullary, a ild -Hepatocyte vacuolation, aultiF ocal, a ild Necrosis, ce n trilo b u la r, a ild Heaatopoiesis, extraaedullary, a ild -Vascular a in e ra liza tio n , a ild -Fibroadenoaa -Not exaained, aissing -Not exaained, not in plane oF section -Adenoaa -Heaatopoiesis, extraaedullary, increased, narked
The Folloning tissues Here Found to be w ithin noraal U n its : Heart, Uterus, Ovary, Stoaach, Urinary Bladder, Thyroid, Trachea, Esophagus, Salivary Bland.
Aniaal Nuaber: 1R-4853 Sex: Feaale Group: ( 3) FH-3924 30 ppa Fate: (Neek= 88) SacriFiced in extreais
Hacroscopic Observations: P ituitary
Nicroscopic Observations: Adrenal Liver Lung
-Raised heaorrhagic aass, 1 x 0.5 ca.
-Sinusoidal ectasia, cortex, a ild -Hepatocyte vacuolation, p e rip o rta l, a ild -Vascular aineralization, a ild Perivascular aononudear in F iltr a te , a ild Heaorrhage, a ultiF ocal, a ild
Species: Rat Project Nuaber: 02B1CR0012
001888
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Suiiarized Single Tabulated A n iia l Report (continued) Individual Hacroscopic and Microscopic Observations
Riker Laboratories, Inc. $1 FH-3924: Tno Year Oral Toxicity-Oncogenicity Study in Rats
Table: 2
A niial Nuiber: 1R-4853 Sex: Feiale Group: ( 3) FH-3924 30 ppi Fate: (Reek= SB) Sacrificed in e x tre iis
Microscopic Observations (continued): Ovary Pancreas P itu ita ry Spleen
-Mot exaained, lis s in g -Not exaiined, lis s in g -Adenoia -Heiosiderosis, eoderate
The following tissues were found to be w ithin nonal l i i i t s : Kidney, Heart, Uterus, Maiiary Gland, Stoiach, Urinary Bladder, Thyroid, Parathyroid, Trachea, Esophagus, Salivary G1and.
Aniial Nuiber: 1R-4854 Sex: Feiale 6roup: ( 3) FH-3924 30 ppi Fate: <Neek= 105) T eninal Sacrifice
Hacroscopic Observations: P itu ita ry Maiiary Gland
Microscopic Observations: Adrenal
Kidney
Liver
Lung
Maiiary 61and Ovary Pancreas Parathyroid P itu ita ry Thyroid
-Heiorrhagic lass, 1 c i dia. -Cystic lobular lass, b x 5 x 3 c i, le ft
inguinal area.
-Sinusoidal ectasia, cortex, larked C ortical degeneration, a u ltifo c a l, l i l d
-Chronic progressive nephropathy, i i I d Pelvic aineralization, a ild
-Portal aononuclear c e ll in f ilt r a t e , l i n i i a l Portal b ile duct p ro life ra tio n , l i n i i a l -Vascular lin e ra liz a tio n , l i l d Perivascular lononudear in f iltr a t e , l i n iia l
-Fibroadenoia -Tubular hyperplasia, b ila te ra l, larked - Is le t c e ll adenoia -Not exaiined, lis s in g -Adenoia -Not exaiined, lis s in g
The following tissues were found to be w ithin norial l i i i t s : Spleen, Uterus, Stoiach, Urinary Bladder, Trachea, Esophagus, Salivary Gland, Heart.
Species: Rat Project Nuiber: 0281CR0012
001889
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Riker Laboratories, Inc. 3H FH-3924: Two Year Oral Toxicity-Oncogenicity Study in Rats
Table: 2
Aniaal Nuaber: 1R-4B55 Sex: Feaale Sroup: ( 3) FH-3924 30 ppa Fate: (Neek= 105) Terainal Sacrifice
Hacroscopic Observations: P itu ita ry Haaaary Gland
Hicroscopic Observations: Adrenal Kidney Liver
Lung Haaaary Gland
Ovary Pancreas P itu ita ry
-Raised aass, 0.5 ca dia. -Hass, 5 x 3 ca, rig h t a x illa ; f ir a aass, 11 x
6 x 3 ca, rig h t inguinal area.
-Sinusoidal ectasia, cortex, aarked Cortical degeneration, aoderate
-Chronic progressive nephropathy, a ild Pelvic aineralization, a ild -Portal aononudear c e ll in f ilt r a t e , a ild Portal b ile duct p ro life ra tio n , a ild Heaatopoiesis, extraaedullary, ainiaal
-Alveolar aacrophages, a u ltifo c a l, a ild 6ranuloaa, focal, a iniaal
-Fibroadenoaa Adenocarcinoaa Adenocarcinoaa appears to arise froa a
fibroadenoaa. -Tubular hyperplasia, b ila te ra l, a ild -Acinar atrophy, a ild -Adenoaa
The follow ing tissues were found to be w ithin noraal li a i t s : Spleen, Heart, Uterus, Stoaach, Urinary Bladder, Thyroid, Parathyroid, Trachea, Esophagus, Salivary Bland, Lyaph Node (aesenteric).
Aniaal Nuaber: 1R-4856 Sex: Feaale Group: ( 3) FH-3924 30 ppa Fate: (Neek= 91) Sacrificed in extreais
Hacroscopic Observations: P itu ita ry
Hicroscopic Observations: Adrenal Kidney Liver
Lung P itu ita ry Salivary 61and Stoaach
Uterus
-Large heicrrhagic aass, 1 x 1.5 ca.
-Sinusoidal ectasia, cortex, ainiaal -Chronic progressive nephropathy, ainiaal -Portal aononudear c e ll in f ilt r a t e , ainiaal Hepatocyte vacuolation, p e rip o rta l, a ild -Heaorrhage, a u ltifo c a l, a ild -Adenoaa -Not exaained, aissing -Edeaa, subaucosal, aoderate Granulosa, ainiaal -Polyp
Species: Rat Project Nuaber: 02B1CR0012
001S90
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Riker Laboratories, Inc. 3H FH-3924: Two Year Oral Toxicity-Oncogenicity Study in Rats
Table: 2
Aniaal Nuaber: 1R-4B56 Sex: Feaale Group: ( 3) FH-3924 30 ppa Fate: (Keek- 91) Sacrificed in extreais
Microscopic Observations (continued):
The Following tissues were found to be w ithin noraal l ia it s : Spleen, Heart, Ovary, Maaaary Gland, Urinary Bladder, Thyroid, Parathyroid, Trachea, Esophagus, Pancreas, Brain, Lyaph Node (aesenteric).
Aniaal Nuaber: 1R-4B57 Sex: Feaale Group: ( 3) FH-3924 30 ppa Fate: (Heek= 0) Sacrificed in extreais
Macroscopic Observations: Liver Spleen Uterus
Microscopic Observations: Adrenal Kidney Liver Lung
Maaaary Gland Parathyroid Salivary Gland Spleen
Urinary Bladder Uterus
-Pale -Enlarged -Prolapsed through cervix.
-C ortical vacuolation, ainiaal -Chronic progressive nephropathy, ainiaal -Heaatopoiesis, extraaedullary, ainiaal -Vascular a in e ra liza tio n , ainiaal Heaorrhage, local areas, ai Id -Not exaained, aissing -Not exaained, not in plane of section -Not exaained, aissing -Heaatopoiesis, extraaedullary, increased, aarked -Not exaained, aissing -Infla aa a tion , acute, aarked
Inflaaaation lia ite d to prolapsed portion of uterus. Not considered a a e tr itis .
The following tissues were found to be w ithin noraal l i a i t s : Heart, Ovary, Stoaach, Thyroid, Trachea, Esophagus, P itu ita ry , Pancreas, Large Intestine, Lyaph Node (aesenteric).
Aniaal Nuaber: 1R-4BS8 Sex: Feaale Group: ( 3) FH-3924 30 ppa Fate: (Week= 105) Terainal Sacrifice
Macroscopic Observations: P ituitary
Microscopic Observations: Kidney Liver
-Heaorrhagic aass, 0.5 ca dia.
-Pelvic aineralization, a ild -Hepatocyte vacuolation, a u ltifo c a l, a ild
Heaatopoiesis, extraaedullary, ainiaal
Species: Rat Project Nuaber: 02B1CR0012
001891
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Riker Laboratories, Inc. 3N FH-3924: Teo Year Oral Toxicity-Oncogenicity Study in Rats
Table: 2
Anieal Nueber: 1R-4B58 Sex: Feeale Group: ( 3) FH-3924 30 ppe Fate: (Neek= 10S) Terainal Sacrifice
Microscopic Observations (continued): Lung Pancreas P ituitary
-Vascular e in eralization, -Acinar atrophy, e ild -Adenoea
eiId
The fo llo itin g tissues were found to be ttith in noreal l ie it s : Spleen, Heart, Uterus, Ovary, Maeeary Gland, Stoeach, Urinary Bladder, Adrenal, Thyroid, Parathyroid, Trachea, Esophagus, Salivary Gland.
Anieal Nueber: 1R-4859 Sex: Feeale Group: ! 3) FH-3924 30 ppe Fate: (Neek= 105) Tereinal Sacrifice
Macroscopic Observations:
Microscopic Observations: Adrenal Heart
Kidney Liver
Lung
Salivary 61and Uterus
-No v is ib le lesions.
-Sinusoidal ectasia, cortex, earked -Myocardial fib ro s is , e u ltifo c a l, e ild Myocarditis, chronic nonsuppurative, e u ltifo ca l, eild -Chronic progressive nephropathy, earked -Portal eononuclear c e ll in f ilt r a t e , e ild Portal b ile duct p ro life ra tio n , e ild Hepatocyte vacuolation, e u ltifo c a l, e ild -Vascular eineralization, e ild Alveolar eacrophages, e u ltifo c a l, e ild -Sialadenitis, chronic, e ild -Cystic glands, soderate
The follow ing tissues were found to be w ithin noreal li e i t s : Spleen, Ovary, Maeeary Gland, Stoeach, Urinary Bladder, Thyroid, Parathyroid, Trachea, Esophagus, P itu ita ry , Pancreas.
Anieal Nueber! 1R-4860 Sex: Feeale Group: ( 3) FH-3924 30 ppe Fate: (Neek= 72) Sacrificed in extreeis
Macroscopic Observations: Skin
Microscopic Observations: Kidney Liver
-Circuescribed ulcerated eass, 0.4 ce d ia ., l e f t hind fo o t; large subcutaneous eass, 3 x 10 x 11 ce, rig h t inguinal area.
-Chronic progressive nephropathy, einieal -Heeatopoiesis, extraaedullary, e inieal
Species: Rat Project Nueber: 02B1CR0012
001892
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Riker Laboratories, Inc. 3H FH-3924: Teo Year Oral Toxicity-Oncogenicity Study in Rats
Table: 2
Aniial Nuiber: 1R-4860 Sex: Feiale Group: ( 3) FH-3924 30 ppi Fate: (Neek= 72) Sacrificed in e x tre iis
Microscopic Observations (continued): Lung Maaiary Gland Ovary Parathyroid Skin
Spleen Thyroid
-Vascular a in eralization, a in iia l Hyperplasia, septal c e ll, focal, a ild -Not exaained, aissing
-Cyst, unilateral -Not exaained, aissing -Pododeraatitis, ulcerative, u n ila te ra l,
aarked Fibrosa Large lesion froa inguinal area. Extensive
necrosis. -Heaatopoiesis, extraaedullary, increased,
aoderate -Not exaained, aissing
The following tissues were found to be w ithin noraal l ia it s : Heart, Uterus, Stoaach, Urinary Bladder, Adrenal, Trachea, Esophagus, Salivary 61and, P itu ita ry , Pancreas.
Aniaal Nuaber: 1R-4861 Sex! Feaale Group: ( 3) FH-3924 30 ppa Fate: (Neek= 105) Terainal Sacrifice
Macroscopic Observations: Lyaph Node (aesenteric)
Microscopic Observations: Adrenal
Kidney Liver
Lung Lyaph Node (aesenteric) Uterus
-Enlarged
-C ortical vacuolation, local areas, aoderate Sinusoidal ectasia, cortex, aoderate
-Chronic progressive nephropathy, ainiaal -Portal aononuclear c e ll in f ilt r a t e , a ild Hepatocyte vacuolation, a u ltifo c a l, a ild -Vascular a in e ra liza tio n , a ild -Sinusoidal ectasia, aoderate -Cystic glands, aoderate
The following tissues ere found to be w ithin noraal l ia it s : Spleen, Heart, Ovary, Maaaary Gland, Stoaach, Urinary Gladder, Thyroid, Parathyroid, Trachea, Esophagus, Salivary Gland, P itu ita ry , Pancreas.
Species: Rat Project Nuaber: 02B1CR0012
001S93
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Suuarized Single Tabulated flnieal Report (continued) Individual Macroscopic and Microscopic Observations
Riker Laboratories, Inc. 3H FM-3924: Two Year Oral Toxicity-Oncogenicity Study in Rats
Table: 2
Anieal Nueber: 1R-4B62 Sex: Feeale Group: ( 3) FM-3924 30 ppa Fate: (Neek= 93) Sacrificed in extreeis
Macroscopic Observations: P itu ita ry Stoeach Liver
Microscopic Observations: Adrenal Heart
Kidney
Liver
Lung
Pancreas P itu ita ry Skin Spleen Stoeach
Urinary Bladder
-Mass, 1 x O.B ce. -Enlarged gastric rugae. -Pale and eottled.
-Sinusoidal ectasia, cortex, aoderate -Myocarditis, chronic nonsuppurative, eulti-focal, einiaal -Chronic progressive nephropathy, e ild Pelvic eineralization, einiaal -Portal aononudear c e ll in f ilt r a t e , e ild Portal b ile duct p ro life ra tio n , e ild Hepatocyte vacuolati on, d iffu se , aarked Necrosis, fo cal, einiaal -Vascular e in era liza tion , e ild Perivascular aononudear in f ilt r a t e , e ild -Not exaained, eissing -Adenoaa -Lipoea -Heaosiderosis, e ild -G a s tritis , acute, aoderate Edeaa, subaucosal, aoderate -E p ithe lia l hyperplasia, staple, diffuse, e ild
The f o il OKing tissues were found to be w ithin noraal lie i t s : Uterus, Ovary, Maaaary Gland, Thyroid, Parathyroid, Trachea, Esophagus, Salivary Gland.
Aniaal Nuaber: 1R-4B63 Sex! Feaale Group: ( 3) FM-3924 30 ppa Fate: (Neek= 105) Terainal Sacrifice
Macroscopic Observations: P itu ita ry Maaaary Gland
Microscopic Observations: Adrenal Kidney Liver Lung Maaaary 61and
Ovary
-Mass, 0.3 c i dia. -Mass, 1.5 x 1 ca, perineal area; cystic aass,
2.5 x 1.5 x 1 ca, le f t a x illa .
-Sinusoidal ectasia, cortex, ainiaal -Chronic progressive nephropathy, a ild -Hepatocyte vacuolation, a u ltifo c a l, a ild -M ineralization, fo cal, parenchyaal, a ild -Adenocarcinoaa Lobular hyperplasia -Cyst, unilateral
Species: Rat Project Nuaber: 0281CR0012
001894
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409
Suaaarized Single Tabulated Aniaal Report (continued) Individual Hacroscopic and Microscopic Observations
Riker Laboratories, Inc. 3H FH-3924: Tho Year Oral Toxicity-Oncogenicity Study in Rats
Table: 2
Aniaal Nuaber: 1R-4863 Sex: Feaale Group! ( 3) FH-3924 30 ppa Fate: (Neek= 105) Terainal Sacrifice
Microscopic Observations (continued): P itu ita ry
-Adenoaa
The fo llo a in g tissues uere found to be w ithin noraal l i a i t s : Spleen, Heart, Uterus, Stoaach, Urinary Bladder, Thyroid, Parathyroid, Trachea, Esophagus, Salivary Gland, Pancreas.
Aniaal Nuaber: 1R-4B64 Sex: Feaale Group: ( 3) FH-3924 30 ppa Fate: (Neek= 105) Terainal Sacrifice
Hacroscopic Observations: Microscopic Observations:
Adrenal Kidney Liver
Lung
-No v is ib le lesions.
-Sinusoidal ectasia, cortex, aoderate -Chronic progressive nephropathy, ainiaal -Portal aononudear c e ll in f ilt r a t e , a ild Portal b ile duct p ro life ra tio n , a ild Hepatocyte a lte ra tio n , vacuolated, focal, a ild -Vascular aineralization, a ild
The follow ing tissues Here found to be w ithin noraal l ia it s : Spleen, Heart, Uterus, Ovary, Kaaaary Bland, Stoaach, Urinary Bladder, Thyroid, Parathyroid, Trachea, Esophagus, Salivary 61and, P itu ita ry , Pancreas.
Aniaal Nuaber: 1R-4865 Sex: Feaale Group: ( 3) FH-3924 30 ppa Fate: (Neek= 105) Terainal Sacrifice
Hacroscopic Observations: P itu ita ry Haaaary Gland Adrenal
Hicroscopic Observations: Adrenal
Esophagus Heart
Kidney
Lung
-Raised lesion, 0.5 ca dia. -Hass, 3 x 2 x 2 ca, perineal area. -L e ft enlarged, aass 1 x 0.6 ca.
-Sinusoidal ectasia, cortex, narked Nodular hyperplasia, cortex, aoderate Cortical degeneration, local areas, aoderate -Not exaained, aissing
-Myocarditis, chronic nonsuppurative, a u ltifo ca l, aild
-Chronic progressive nephropathy, a ild Pelvic aineralization, a ild
-Vascular aineralization, a ild Alveolar aacrophages, fo cal, a ild Perivascular aononudear in f ilt r a t e , a ild
Species: Rat Project Nuaber: 0261CR0012
001895
Suaaarized STAR Page: 219
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Suaaarized Single Tabulated Aniaal Report (continued) Individual Hacroscopic and Hicroscopic Observations
Riker Laboratories, Inc. 3H FH-3924: Tao Year Oral Toxicity-Oncogenicity Study in Rats
Table: 2
Aniaal Nueber: 1R-4865 Sex: Feeale Group: ( 3) FH-3924 30 ppa Fate: (Week- 105) Terainal Sacrifice
Hicroscopic Observations (continued): Haaaary Gland
Ovary
Parathyroid P itu ita ry Spleen Thyroid Trachea
-Fibroadenoaa Galactocele -Cyst, unilateral Tubular hyperplasia, u n ila te ra l, aoderate -Not exaained, aissing -Adenoaa -Heaosiderosis, ai 1d -Not exaained, aissing -Not exaained, aissing
The f o il owing tissues Mere found to be w ithin noraal li a i t s : Liver, Uterus, Stoaach, Urinary Bladder, Salivary Gland, Pancreas.
Ani sal Nuaber: 1R-4866 Sex: Feaale Group: ( 3) FH-3924 30 ppa Fate: (Heek= 91) Sacrificed in extreais
Hacroscopic Observations: P itu ita ry Thyaus Kidney Adrenal Haaaary Gland
Hicroscopic Observations: Adrenal
Heart
Kidney
Liver Lung
Haaaary 61and Parathyroid P itu ita ry Salivary Gland
-Enlarged due to heaorrhagic aass, 1 ca dia. -Appears enlarged -Possibly enlarged -L e ft adrenal enlarged. -Ulcerated a u ltilo b u la r aass, 3 x 2.5 x 2 ca,
in rig h t a x illa .
-C ortical vacuolation, local areas, u n ila te ra l aoderate Sinusoidal ectasia, cortex, u n ila te ra l, aoderate Cortical degeneration, local areas, u n ila te ra l, aoderate
-Hyocarditis, chronic nonsuppurative, a u ltifo c a l, ai Id
-Chronic progressive nephropathy, aoderate Pelvic aineralization, ainiaal
-Portal aononudear c e ll in f ilt r a t e , a ild -Vascular aineralization, a ild Heaorrhage, d iffuse, aarked -Adenocarcinoaa -Not exaained, not in plane of section -Adenoaa -Not exaained, aissing
Species: Rat Project Nuaber: 0281CR0012
001896
Suaaarized STAR Page: 220
41 1
Suaaarized Single Tabulated Aniaal Report (continued) Individual Macroscopic and Microscopic Observations
Riker Laboratories, Inc. 3H FH-3924: Teo Year Oral Toxicity-Oncogenicity Study in Rats
Table: 2
Aniaal Nuaber: 1R-4B66 Sex: Feaale Broup: ( 3) FH-3924 30 ppa Fate: (Neek= 91) Sacrificed in extreais
Microscopic Observations (continued): Thyaus
-Lyaphosarcoaa
The follow ing tissues were found to be M ithin noraal l ia it s : Spleen, Uterus, Ovary, Stoaach, Urinary Bladder , Thyroid, Trachea, Esophagus, Pancreas, Lyaph Node (aesenteric).
Aniaal Nuaber: 1R-4867 Sex: Feaale Broup: ( 3) FH-3924 30 ppa Fate: (Neek= 87) Sacrificed in extreais
Macroscopic Observations: P itu ita ry Naaaary Bland Adrenal
Microscopic Observations: Adrenal Kidney
Lung
P itu ita ry Spleen Stoaach Uterus
-Heaorrhagic aass, 1.3 x 1 ca. -M ilk cysts in perineal area. -L e ft adrenal enlarged with dark raised
lesion, 0.2 ca dia.
-Sinusoidal ectasia, cortex, aarked -Chronic progressive nephropathy, ainiaal P y e litis , acute, u n ila te ra l, ainiaal -Vascular aineralization, a ild Alveolar aacrophages, a ild Perivascular aononuclear in f ilt r a t e , a ild -Adenoaa -Heaosiderosis, aoderate -Ulcer -Cystic glands, aoderate
The follow ing tissues were found to be w ithin noraal li a i t s : L iver, Heart, Ovary, Naaaary Bland, Urinary Bladder, Thyroid, Parathyroid, Trachea, Esophagus, Salivary Gland, Pancreas.
Aniaal Nuaber: 1R-4868 Sex: Feaale Group: ( 3) FH-3924 30 ppa Fate: (Week: 96) Sacrificed in extreais
Macroscopic Observations: P itu ita ry
Microscopic Observations: Adrenal Kidney Liver Lung
-Raised heaorrhagic aass, 0.9 ca dia.
-Sinusoidal ectasia, cortex, aoderate -Chronic progressive nephropathy, ainiaal -Hepatocyte vacuolation, a u ltifo c a l, ainiaal -Vascular aineralization, a ild Alveolar aacrophages, a u ltifo c a l, a ild Perivascular aononuclear in f ilt r a t e , a ild Heaorrhage, local areas, aoderate
Species: Rat Project Nuaber: 0281CR0012
001897
Suaaarized STAR Page: 221
412
Suaaarized Single Tabulated flniaal Report (continued) Individual Macroscopic and Microscopic Observations
Riker Laboratories, Inc. 3M FH-3924: Two Year Oral Toxicity-Oncogenicity Study in Rats
Table: 2
Aniaal Nuaber: 1R-4B6B Sex: Feaale Broup: ( 3) FH-3924 30 ppa Fate: (Heek= 96) Sacrificed in extreais
Microscopic Observations (continued): Ovary P ituitary Spleen
-Tubular hyperplasia, u n ila te ra l, a ild -Adenoaa -Heaosiderosis, aoderate
The following tissues were found to be w ithin noraal li a i t s : Heart, Uterus, Maaaary Gland, Stoaach, Urinary Bladder, Thyroid, Parathyroid, Trachea, Esophagus, Salivary Bland, Pancreas.
Aniaal Nuaber: 1R-4869 Sex: Feaale Group: ( 3) FH-3924 30 ppa Fate: (Meek: 105) Terainal Sacrifice
Macroscopic Observations: Maaaary Gland
Microscopic Observations: Adrenal
Kidney
Liver
Lung
Maaaary 61and Pancreas Parathyroid P itu ita ry Spleen
Uterus
-Mass, 8 x 6 x 4 ca, perineal area.
-Sinusoidal ectasia, cortex, a ild Medullary c e ll hyperplasia, focal, a ild
-Hyperplasia, pelvic epitheliua, u n ila te ra l, a ild
-Hepatocyte vacuolation, a u ltifo c a l, ainiaal Hepatocyte a lte ra tio n , basophilic, focal, ainiaal
-Vascular aineralization, a ild Alveolar aacrophages, a u ltifo c a l, a ild -Adenocarcinoaa -Not exaained, aissing -Not exaained, not in plane of section -Adenoaa -Heaatopoiesis, extraaedullary, increased, a ild -Polyp
The -foiloxing tissues were found to be w ithin noraal l ia it s : Heart, Ovary, Stoaach, Urinary Bladder, Thyroid, Trachea, Esophagus, Salivary 61and.
Aniaal Nuaber: 1R-4B70 Sex: Feaale Group: ! 3) FM-3924 30 ppa Fate: (Week? 105) Terainal Sacrifice
Macroscopic Observations: P itu ita ry
Microscopic Observations: Adrenal
-Saall dark raised lesion, 0.3 ca dia. -Sinusoidal ectasia, cortex, aoderate
Species: Rat Project Nuaber: 0281CR0012
001S9S
Suaaarized STAR Page: 222
413
Suaaarized Single Tabulated Aniaal Report (continued) Individual Hacroscopic and Hicroscopic Observations
Riker Laboratories, Inc. 3H FH-3924: Tao Year Oral Toxicity-Oncogenicity Study in Rats
Table: 2
Aniaal Nuaber: 1R-4870 Sex: Feaale Group: ( 3) FH-3924 30 ppa Fate: (Week: 105) Terainal Sacrifice
Hicroscopic Observations (continued): Heart Kidney
Liver Lung P itu ita ry Thyroid
-Endocarditis, chronic, focal, a ild -Chronic progressive nephropathy, ainiaal Pelvic a in e ra liza tio n , aoderate -Hepatocyte vacuolation, p e rip o rta l, aoderate -Vascular aineralization, ainiaal -Adenoaa -Not exaained, not in plane of section
The follow ing tissues Mere found to be w ithin noraal l ia it s : Spleen, Uterus, Ovary, Haaaary Gland, Stoaach, Urinary Bladder, Parathyroid, Trachea, Esophagus, Salivary 61and, Pancreas.
Species: Rat Project Nuaber: 0281CR0012
001899
Suaaarized STAR Page: 223
414
Suaaarized Single Tabulated Aniaal Report Individual Macroscopic and Microscopic Observations
Ritter Laboratories, Inc. 3M FH-3924: Tno Year Oral Toxicity-Oncogenicity Study in Rats
Table: 2
Aniaal Nuaber: 1R-3811 Sex: Male Fate: (Neek= 106) Terainal Sacrifica
Group: < 4) FM-3924 10 ppa
Hacroscopic Observations: Microscopie Observations:
Heart fcidney Li ver
Lung
-No v is ib le lesions.
-Myocarditis, chronic nonsuppurative, a u ltifo ca l, aild
-Chronic progressive nephropathy, a ild -Portal aononudear c e ll in f ilt r a t e , a ild Portal b ile duct p ro life ra tio n , a ild Cystoid degeneration, fo cal, a ild -Vascular a ineralization, a ild
The Fallowing tissues Mere found to be w ithin noraal li a i t s : Spleen, Testis/Epididyais, Prostate, Stoaach, Urinary Bladder, Adrenal, Thyroid, Parathyroid, Trachea, Esophagus, Salivary Gland, P itu ita ry , Pancreas.
A niial Nuaber: 1R-3812 Sex: Male Group: i 4) FM-3924 10 ppa Fate: (Week- 87) Sacrificed in extreais
Macroscopic Observations: P itu ita ry
Microscopic Observations: Adrenal Kidney
Liver
Lung
P itu ita ry Prostate Spleen
-Large heaorrhagic aass, 1.2 x 1 ca dia.
-Sinusoidal ectasia, cortex, diffuse, a ild -Chronic progressive nephropathy, a ild Pelvic aineralization, a ild -Portal b ile duct p ro life ra tio n , a ild Portal aononudear c e ll in f ilt r a t e , a ild -Vascular aineralization, a ild Heaorrhage, local areas, aoderate -Adenoaa -P ro s ta titis , acute, aarked -Heaosiderosis, aoderate
The following tissues were found to be w ithin noraal li a i t s : Heart, Testis/Epididyais, Stoaach, Urinary Bladder, Thyroid, Parathyroid, Trachea, Esophagus, Salivary Gland, Pancreas.
Species: Rat Project Nuaber: 0281CR0012
001900
Suaaarized STAR Page: 224
415
Suaaarized Single Tabulated Aniaal Report (continued) Individual Macroscopic and Microscopic Observations
Riker Laboratories, Inc. 3H FM-3924: Two Year Oral Toxicity-Oncogenicity Study in Rats
Table: 2
Aniaal Nuaber: 1R-3813 Sex: Male Fate: (Neek= 106) Terainal Sacrifice
6roup: ( 4) FM-3924 10 ppa
Macroscopic Observations:
Microscopic Observations; Adrenal Esophagus Heart
Kidney Liver
Lung
Pancreas Parathyroid P itu ita ry Salivary Gland Thyroid Trachea
-No v is ih le lesions.
-Cortical vacuolation, focal, a ild -Not exaained, aissing -Myocarditis, chronic nonsuppurative, a u ltifo ca l, aild -Chronic progressive nephropathy, a ild -Portal aononudear c e ll in f ilt r a t e , a ild Megalocytosis, ainiaal Necrosis, a u ltifo c a l, a ild -Vascular a in era liza tion , a ild Alveolar aacrophages, a u ltifo c a l, a ild -Not exaained, aissing -Not exaained, aissing -Adenoaa -Not exaained, aissing -Not exaained, aissing -Not exaained, aissing
The following tissues were found to be w ithin noraal lia i t s : Spleen, Testis/Epididyais, Prostate, Stoaach, Urinary Bladder.
Aniaal Nuaber: 1R-3B14 Sex: Hale Fate: (Heek= 106) Terainal Sacrifice
6roup: ( 4) FM-3924 10 ppa
Macroscopic Observations: Skin
Adrenal Microscopic Observations:
Adrenal Heart
Kidney Liver
Lung
Parathyroid Skin
-Circular raised inflaaaatory lesion, le ft hind footpad.
-Right adrenal s lig h tly enlarged.
-Pheochroaocytoaa, benign, u n ila te ra l -Myocarditis, chronic nonsuppurative, a u ltifo ca l, aild -Chronic progressive nephropathy, a ild -Portal aononudear c e ll in f ilt r a t e , a ild Portal b ile duct p ro life ra tio n , a ild Megalocytosis, a ild -Vascular aineralization, a ild Perivascular aononudear in f ilt r a t e , a ild -Mot exaained, not in plane of section -Pododeraatitis, ulcerative, u n ila te ra l, narked
Species: Rat Project Nuaber: 0281CR0012
001901
Suaaarized STAR Page: 225
416
Suaaarized Single Tabulated Aniaal Report (continued) Individual Macroscopic and Microscopic Observations
Riker Laboratories, Inc. 3M FM-3924: Tmo Year Oral Toxicity-Oncogenicity Study in Rats
Table: 2
Aniaal Nuaber! 1R-3814 Sex: Male Fate: (Heek= 106) Terainal Sacrifice
Group: I 4) FM-3924 10 ppa
Microscopic Observations (continued): Trachea
-Tracheitis, chronic, a ild
The fo llo v in g tissues Mere found to be w ithin noraal 1ia its : Spleen, Testis/Epididyais, Prostate, Stoaach, Urinary Bladder, Thyroid, Esophagus, Salivary Gland, P itu ita ry , Pancreas.
Aniaal Nuaber: 1R-3B15 Sex: Male 6roup: ( 4) FM-3924 10 ppa Fate: (Neek= 105) Sacrificed in extreais
Macroscopic Observations: Abdoaen (internal) Esophagus Spleen Liver
Prostate Testis/Epididyais Stoaach Microscopic Observations: Kidney Liver
Lung
P itu ita ry Prostate Testis/Epididyais
Urinary Bladder
-F ille d with red flu id . -Enlarged with thickened Mails. -Appears saall -Median and le f t la te ra l lobes appear shrunken
with very rough surface? le f t la te ra l and caudate lobes pale with a a u lti lobular aass, 3.5 x 2.5 x 2.5 ca. -Appears saall -Both testes s a a ll. -M u ltiple focal areas of ulceration.
-Chronic progressive nephropathy, a ild -Portal aononudear c e ll in f ilt r a t e , aoderate Hepatocellular carcinoaa Atrophy, aarked Fibrosis, p o rta l, aarked -Vascular a in e ra liza tio n , a ild Alveolar aacrophages, a ild Metastatic neoplasa -Cyst, pars interaedia -P ro s ta titis , acute, aarked -Tubule atrophy, asperaatogenesis, b ila te ra l, aoderate -E p ithe lia l hyperplasia, siaple, diffuse, aild
The Following tissues Mere found to be w ithin noraal li a i t s : Spleen, Heart, Stoaach, Adrenal, Thyroid, Parathyroid, Trachea, Esophagus, Salivary Gland, Pancreas.
Species: Rat Project Nuaber: 0281CR0012
001903
Suaaarized STAR Page: 226
417
Suaaarized Single Tabulated Aniaal Report (continued) Individual Macroscopic and Microscopic Observations
Riker Laboratories, Inc. 3H FH-3924: Two Year Oral Toxicity-Oncogenicity Study in Rats
Table: 2
Aniaal Nuaber: 1R-3B16 Sex: Male Fate: (Ueek= 106) Terainal Sacrifice
6roup: ( 4) FH-3924 10 ppa
Macroscopic Observations: Microscopic Observations:
Adrenal Heart Kidney Liver Lung
Testis/Epididyais
-No v is ib le lesions.
-Nodular hyperplasia, cortex, fo c a l, a ild -Myocarditis, chronic nonsuppurative, a ultifo cal, aild -Chronic progressive nephropathy, a ild -Portal aononudear c e ll in f ilt r a t e , a ild Hegalocytosis, ainiaal -Vascular a in e ra liza tio n , a ild Alveolar aacrophages, a u ltifo c a l, a ild Perivascular aononudear in f ilt r a t e , a ild Heaorrhage, local areas, aoderate -Hesothelioaa, benign
Nell d iffe re n tia te d , p a p illa ry neoplasa arising froa capsules of both testes.
The following tissues were found to be w ithin noraal li a i t s : Spleen, Prostate, Staaach, Urinary Bladder, Thyroid, Parathyroid, Trachea, Esophagus, Salivary Sland, P itu ita ry , Pancreas.
Aniaal Nuaber: 1R-3B17 Sex! Male Fate: (Neek= 106) Terainal Sacrifice
Group: ( 4) FH-3924 10 ppa
Macroscopic Observations: Haaaary Gland
Microscopic Observations'. Li ver Lung
Parathyroid P itu ita ry Skin
-Large, f ir a , subcutaneous aass, 9 x 6 x 5 ca, in l e f t inguinal area
-Hegalocytosis, ainiaal -Vascular aineralization, a ild Pneuaonia, in t e r s t it ia l, chronic, a u ltifo c a l, a ild Alveolar aacrophages, a u ltifo c a l, a ild -Not exaained, not in plane of section -Adenoaa -Fibroaa
The follow ing tissues were found to be w ithin noraal li a i t s : Spleen, Kidney, Heart, Testis/Epididyais, Prostate, Stoaach, Urinary Bladder, Adrenal, Thyroid, Trachea, Esophagus, Salivary Gland, Pancreas.
Species: Rat Project Nuaber: 0281CR0012
001903
.
Suaaarized STAR Page: 227
..a
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Suaaarized Single Tabulated Aniaal Report (continued) Individual Macroscopic and Microscopic Observations
Riker Laboratories, Inc. 3M FH-3924: Tao Year Oral Toxicity-Oncogenicity Study in Rats
Table: 2
Aniaal Nuaber: 1R-3818 Sex: Male Fate: (Meeks 76) Found Dead
Group : I 4) FH-3924 10 ppa
Macroscopic Observations: P itu ita ry
Microscopic Observations: Adrenal
Kidney Lung P itu ita ry
-Large heaorrhagic aass, 1.3 x 0.4 ca.
-M ithin noraal l i n t s One of pair present
-Chronic progressive nephropathy, a ild -Vascular a in era liza tion , a ild -Adenoaa
The folloNing tissues aere found to be w ithin noraal lia it s : Spleen, Liver, Heart, Testis/Epididyais, Prostate, Stoaach, Urinary Bladder, Thyroid, Parathyroid, Trachea, Esophagus, Salivary SI and, Pancreas.
Aniaal Nuaber: 1R-3819 Sex: Male Fate: (Meek: 106) Terainal Sacrifice
Broup: ( 4) FM-3924 10 ppa
Macroscopic Observations: Skin
Microscopic Observations: Adrenal Heart Kidney Liver Lung
P itu ita ry Salivary 61and Skin
Trachea
-Raised ulcerated, inflaaaed region on rig h t hind footpad.
-C ortical vacuolation, a u ltifo c a l, a ild -Myocardial fib ro s is , a u ltifo c a l, a ild -Chronic progressive nephropathy, a ild -Megalocytosis, ainiaal -Vascular aineralization, a ild Alveolar aacrophages, a u ltifo c a l, a ild Perivascular aononudear in f ilt r a t e , a ild -Adenoaa -Not exaained, aissing -Pododeraatitis, ulcerative, u nilate ral, aarked -Tracheitis, chronic, a ild
The following tissues were found to be within noraal li a i t s : Spleen, Testis/Epididyais, Prostate, Stsiach, Urinary Bladder, Thyroid, Parathyroid, Esophagus, Pancreas.
Species: Rat Project Nuaber: 0281CR0012
001904
Suaaarized 5TAR Page: 22B
4 1^9
Sueearized Single Tabulated Anieal Report (continued) Individual Macroscopic and Microscopic Observations
Riker Laboratories, Inc. 3M FH-3924: Tuo Year Oral Toxicity-Oncogenicity Study in Rats
Table: 2
Anieal Nueber: 1R-3B20 Sex: Male Fate: (Week* 106) Tereinal Sacrifice
6roup: ( 4) FH-3924 10 ppi
Macroscopic Observations: P itu ita ry Kidney
Microscopic Observations: Heart Kidney Liver
Lung
Pancreas Parathyroid P itu ita ry Stoeach Testis/Epididyeis
-Bark lesion, 0.4 x 0.2 ce. -Enlarged, pale and p itte d .
-Myocardial fib ro s is , local areas, eoderate -Chronic progressive nephropathy, earked -Portal eononudear c e ll in f ilt r a t e , e ild Portal b ile duct p ro life ra tio n , e ild Hegalocytosis, einieal -Vascular eineralization, e ild Perivascular eononudear in f ilt r a t e , e ild -P o ly a rte ritis , eoderate -Not exaeined, not in plane of section -Adenoea -Not exaeined, eissing -P o ly a rte ritis , eoderate
The following tissues were found to be w ithin noreal li a i t s : Spleen, Prostate, Urinary Bladder, Adrenal, Thyroid, Trachea, Esophagus, Salivary Bland.
Anieal Nueber: 1R-3B21 Sex: Male Group: I 4) FH-3924 ID ppe Fate! (Week* 85) Sacrificed in extreeis
Macroscopic Observations: P ituitary
Microscopic Observations: Adrenal
Kidney Lung Parathyroid P itu ita ry Spleen Stoeach
-Large eass, 1.3 x 1 ce.
-Within noreal l i e i t s One of pair present
-Chronic progressive nephropathy, eoderate -Vascular e in era liza tion , e ild -Not exaeined, not in plane of section -Adenoea -Heeosiderosis, eoderate -Ulcer, earked
The fo llo u in g tissues were found to be w ithin noreal li e i t s : Liver, Heart, Testis/Epididyeis, Prostate, Urinary Bladder, Thyroid, Trachea, Esophagus, Salivary Bland, Pancreas.
Species: Rat Project Nueber: 02B1CR0012
001905
Sueearized STAR Page: 229
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Suaaarized Single Tabulated Aniaal Report (continued) Individual Hacroscopic and Hicroscopic Observations
Riker Laboratories, Inc. 3H FH-3924: Tmo Year Oral Toxicity-Oncogenicity Study in Rats
Table: 2
Aniaal Nuaber: 1R-3822 Sex: Hale Fate: (Week- 106) Terainal Sacrifice
Group: ( 4) FH-3924 10 ppa
Hacroscopic Observations:
Hicroscopic Observations: Liver
Lung P itu ita ry
-No v is ib le lesions.
-Portal aononudear c e ll in f ilt r a t e , a ild Portal b ile duct p ro life ra tio n , a ild Negaiocyto s is, ainiaal -Vascular a in e ra liza tio n , a ild
-Adenoaa
The -following tissues Mere found to be w ithin noraal l i n t s : Spleen, Testis/Epididyais, Stoaach, Urinary Bladder, Adrenal, Thyroid, Parathyroid, Trachea Esophagus, Salivary Bland, Pancreas, Kidney, Heart, Prostate.
Aniaal Nuaber: 1R-3B23 Sex: Hale Group: ( 4) FH-3924 10 ppa Fate: (Week- 85) Sacrificed in extreais
Hacroscopic Observations: Pancreas
Kidney Hicroscopic Observations:
Adrenal Kidney Liver
Lung
Thyroid
-Saall nodule, 0.5 x 0.7 ca, in area of pancreas.
-Rough surface
-Sinusoidal ectasia, cortex, a u ltifo c a l, a ild -Chronic progressive nephropathy, a ild -Portal aononudear c e ll in f ilt r a t e , ainiaal Portal b ile duct p ro life ra tio n , ainiaal -Vascular aineralization, a ild Heaorrhage, local areas, a ild -Ultiaobranchial cyst
The follow ing tissues Mere found to be w ithin noraal l ia it s : Spleen, Heart, Testis/Epididyais, Prostate, Stoaach, Urinary Bladder, Parathyroid, Trachea Esophagus, Salivary Gland, P itu ita ry , Pancreas.
Aniaal Nuaber: 1R-3824 Sex: Hale Fate: (Neek= 106) Terainal Sacrifice
Group: ( 4) FH-3924 10 ppa
Hacroscopic Observations:
Hicroscopic Observations: Adrenal Kidney Li ver
-No v is ib le lesions.
-C ortical vacuolation, a u ltifo c a l, a ild -Chronic progressive nephropathy, aarked -Portal aononudear c e ll in f ilt r a t e , ainiaal Portal b ile duct p ro life ra tio n , a iniaal
Species: Rat Project Nuaber: 0281CR0012
001906
Suaaarized STAR Page: 230
Suaaarized Single Tabulated Aniaal Report (continued) Individual Hacroscopic and Hicroscopic Observations
Riker Laboratories, Inc. 3H FH-3924: Tao Year Oral Toxicity-Oncogenicity Study in Rats
Table: 2
Aniaal Nuaber: 1R-3B24 Sex: Hale Fate: (bieek- 106) Terainal Sacrifice
6roup: ( 4) FH-3924 10 ppa
Microscopic Observations (continued): Lung
Pancreas Parathyroid P itu ita ry Testis/Epididyais
-Vascular aineralization, a ild Heaorrhage, local areas, aoderate - Is le t c e ll adenoaa -Nat exaained, not in plane of section -Cyst, pars interaedia -P o lya rte ritis, ainiaal
The fo llo uin g tissues ere found to be a ith in noraal l ia it s ! Spleen, Heart, Prostate, Stoaach, Urinary Bladder, Thyroid, Trachea, Esophagus, Salivary Gland.
Aniaal Nuaber: 1R-3B25 Sex: Male Fate: (Heek- 106) Terainal Sacrifice
Group: ( 4) FH-3924 10 ppa
Macroscopic Observations: Kidney
Microscopic Observations: Kidney
Liver
Lung
Parathyroid P itu ita ry Salivary 61and Trachea
-Raised pale aass, 0.4 ca d ia ., in cortex of rig h t kidney.
-Chronic progressive nephropathy, a ild Adenoaa Encapsulated, p a p illa ry pattern.
-Portal aononudear c e ll in f ilt r a t e , a ild Portal b ile duct p ro life ra tio n , a ild Negalocytosis, ainiaal -Vascular aineralization, a ild Alveolar aacrophages, a u ltifo c a l, a ild -Not exaained, not in plane of section -Adenoaa -Not exaained, aissing -Tracheitis, chronic, a ild
The folloHing tissues aere found to be a ith in noraal lia i t s : Heart, Testis/Epididyais, Prostate, Stoaach, Urinary Bladder, Adrenal, Thyroid, Esophagus, Pancreas, Spleen.
Aniaal Nuaber: 1R-3826 Sex: Hale Fate: (Neek= 106) Terainal Sacrifice
Group: ( 4) FH-3924 10 ppa
Macroscopic Observations:
Microscopic Observations: Adrenal
-No v is ib le lesions. -C ortical degeneration, fo ca l, a ild
Species: Rat Project Nuaber: 0281CR0012
001307
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Riker Laboratories, Inc. 3M FH-3924: Two Vear Oral Toxicity-Oncogenicity Study in Rats
Table: 2
Aniaal Nuaber: 1R-3B26 Sex: Male Fate: (Neek= 106) Terainal Sacrifice
Group: ( 4) FH-3924 10 ppa
Microscopic Observations (continued): Heart Kidney Liver
Lung P itu ita ry
-Myocarditis, chronic nonsuppurative, aultiFocal, ainiaal -Chronic progressive nephropathy, ainiaal -Hepatocyte vacuolation, a u ltifo c a l, ainiaal Hepatocyte a lte ra tio n , vacuolated, local areas, aoderate Megalocytosis, a ild -Vascular a in era liza tion , a ild -Not exaained, aissing
The following tissues Mere found to be w ithin noraal li a i t s : Spleen, Testis/Epididyais, Prostate, Stoaach, Urinary Bladder, Thyroid, Parathyroid, Trachea, Esophagus, Salivary 61and, Pancreas.
Aniaal Nuaber: 1R-3827 Sex: Male Fate! (Keek* 106) Terainal Sacrifice
Group: ( 4) FH-3924 10 ppa
Macroscopic Observations: Skin
Microscopic Observations: Adrenal Heart Kidney Liver
Lung
Salivary 61and Skin
-C irc u la r, raised inflaaaed lesions, both hind footpads.
-C o rtical vacuolation, local areas, a ild Pheochroaocytoaa, benign
-Myocardial fib ro s is , local areas, aoderate Endocarditis, chronic, diffuse , aoderate
-Chronic progressive nephropathy, a ild -Portal aononudear c e ll in f ilt r a t e , a ild Portal b ile duct p ro life ra tio n , a ild
Megalocytosis, ainiaal -Vascular aineralization, aild Pneuaonia, in t e r s t it ia l, chronic, a u ltifo c a l, a ild Alveolar aacrophages, a u ltifo c a l, a ild -Not exaained, aissing -Pododeraatitis, u lcerative, b ila te ra l, aarked
The follow ing tissues were found to be w ithin noraal li a i t s : Spleen, Testis/Epididyais, Prostate, Stoaach, Urinary Bladder, Thyroid, Parathyroid, Trachea, Esophagus, P itu ita ry , Pancreas.
Species: Rat Project Nuaber: 0281CR0012
001908
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Sueearized Single Tabulated Anieal Report (continued) Individual Macroscopic and Microscopic Observations
Riker Laboratories, Inc. 3N FH-3924: Two Tear Oral Toxicity-Oncogenicity Study in Rats
Table: 2
Anieal Nuiber: 1R-3828 Sex: Male Fate: (Week* 106) Tereinal S acrifice
Group: ( 4) FM-3924 10 ppa
Macroscopic Observations: Lyeph Node (mesenteric)
Microscopic Observations: Heart
Kidney Liver
Lung
Lyeph Node (eesenteric) Pancreas Parathyroid
-Soft heeorrhagic eass, 1.5 ce dia.
-Myocardial fib ro s is , u lt ifocal, e ild Myocarditis, chronic nonsuppurative, eultifocal, eild
-Chronic progressive nephropathy, e ild -Portal eononuclear c e ll in f ilt r a t e , e ild
Portal b ile duct p ro life ra tio n , e ild -Vascular Bineraiizatio n, ainiaal Alveolar eacrophages, e u ltifo c a l, e ild Perivascular eononuclear in f ilt r a t e , e ild Heeorrhage, local areas, eoderate -Heeangiosarcoea -Acinar atrophy, e ild -Not exaeined, not in plane of section
The follow ing tissues were found to be w ithin noreal lia its *. Spleen, Testis/Epididyais, Prostate, Stoeach, Urinary Bladder, Adrenal, Thyroid, Trachea, Esophagus, Salivary Gland, P itu ita ry .
Anieal Nueber: 1R-3B29 Sex: Male Fate: (Neek= 106) Tereinal Sacrifice
Group: ( 4) FM-3924 ID ppa
Macroscopic Observations: P itu ita ry Kidney
Microscopic Observations: Adrenal
Kidney
Liver
Lung Pancreas P ituitary
-Heeorrhagic eass, 0.B x 0.6 ce. -Hydronephrosis, rig h t kidney.
-Sinusoidal ectasia, cortex, e u ltifo c a l, e ild Medullary c e ll hyperplasia C ortical degeneration, focal, e ild -Chronic progressive nephropathy, e ild Pelvic aineralization, e ild Calculus, pelvic Hydronephrosis, unilate ral
-Portal eononuclear c e ll in f ilt r a t e , e ild Portal b ile duct p ro life ra tio n , e ild Cystoid degeneration, e u ltifo c a l, e ild -Vascular aineralization, e ild Perivascular eononuclear in f ilt r a t e , e ild -Acinar atrophy, e ild -Adenoaa
Species: Rat Project Nueber: 02B1CR0012
001909
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Riker Laboratories, Inc. 3M FH-3924: Tho Year Oral Toxicity-Oncogenicity Study in Rats
Table: 2
Aniaal Nuaber: 1R-3829 Sex: Male Fate: (Week- 106) Terainal S acrifice
6roup: ( 4) FH-3924 10 ppa
Microscopic Observations (continued): Spleen Thyroid Urinary Bladder
-Heaosiderosis, a ild -C c e ll adenoaa -Papilloaa
The fo llo nin g tissues Here found to be w ithin noraal lia it s : Heart, Testis/Epididyais, Prostate, Stoaach, Parathyroid, Trachea, Esophagus, Salivary 61and.
Aniaal Nuaber: 1R-3830 Sex: Hale Fate: (Neek= 106) Terainal Sacrifice
6roup: ( 4) FH-3924 10 pps
Macroscopic Observations: Thyroid
Microscopic Observations: Kidney Liver
Lung
Prostate Testis/Epididyais Thyroid Trachea
-S lig h tly enlarged
-Chronic progressive nephropathy, ainiaal -Portal aononudear c e ll in f ilt r a t e , a ild Portal b ile duct p ro life ra tio n , a ild Hepatocyte a lte ra tio n , vacuolated, a u ltifo c a l, a ild Hegalocytosis, ainiaal -Vascular aineralization, a ild Alveolar aacrophages, local areas, aoderate -P ro s ta titis , acute, aoderate -Vascular aineralization, ainiaal -C c e ll adenoaa -T ra che itis, chronic, aoderate
The following tissues Here found to be w ithin noraal li a i t s : Heart, Stoaach., Urinary Bladder, Adrenal, Parathyroid, Esophagus, Salivary Gland, P itu ita ry , Pancreas, Spleen.
Aniaal Nuaber: 1R-3831 Sex: Hale Fate: (Meek- 101) Found Dead
6roup: ( 4) FH-3924 10 ppa
Macroscopic Observations: Skin
Liver Kidney
-Raised ulcerated lesion, 1 ca d ia ., with scab foraation, le ft side; fir a subcutaneous aass, 4 x 4 x 2.5 ca, rig h t inguinal area; ulcerated lesion, rig h t hind footpad.
-Saall pale foci in several lobes. -Pale aass, 0.5 ca d ia ., in pelvic region of
rig h t kidney, another pale aass,
Species: Rat Project Nuaber: 02B1CR0012
I'
001910
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Suaaarized Single Tabulated Aniaal Report (continued) Individual Macroscopic and Microscopic Observations
Riker Laboratories, Inc. 3H FH-3924: Two Year Oral Toxicity-Oncogenicity Study in Rats
Table: 2
Aniaal Nuaber: 1R-3831 Sex: Male Fate: (Neek= 101) Found Dead
6roup: ( 4) FH-3924 10 ppa
Macroscopic Observations (continued):
Kidney (continued) Microscopic Observations:
Adrenal Kidney
Liver Lung Pancreas Skin
Spleen Stoaach
-0.2 ca d ia ., in cortex.
-Medullary c e ll hyperplasia, a u ltifo c a l, a ild -Chronic progressive nephropathy, a ild Protein resorption droplets, aarked Malignant lyaphoaa, h is tio c y tic -Malignant lyaphoaa, h is tio c y tic -Vascular a in e ra liza tio n , a ild Malignant lyaphoaa, h is tio c y tic -Acinar atrophy, ainiaal -Pododeraatitis, ulcerative, u n ila te ra l, aarked Malignant lyaphoaa, h is tio c y tic
M ultiple subcutaneous tuaors. Ulcerated lesion froa side consists of deraal neoplastic in f ilt r a t e with ulcerated surface. -Heaatopoiesis, extraaedullary, increased, a ild -Not exaained, aissing
The following tissues were found to be w ithin noraal lia its .' Heart, Testis/Epididyais, Prostate, Urinary Bladder, Thyroid, Parathyroid, Trachea, Esophagus, Salivary Eland, P itu ita ry .
Aniaal Nuaber: 1R-3832 Sex! Male Fate: (Neek= 106) Terainal Sacrifice
Group: ( 4) FH-3924 10 ppa
Macroscopic Observations: Microscopic Observations:
Kidney Liver
Lung Thyroid
-No v is ib le lesions.
-Chronic progressive nephropathy, ainiaal -Portal aononudear c e ll in f ilt r a t e , a ild Portal b ile duct p ro life ra tio n , a ild
Hegalocytosis, ainiaal -Vascular aineralization, a ild Alveolar aacrophages, a ild -C c e ll adenoaa
The following tissues ere found to be w ithin noraal li a i t s : Spleen, Heart, Testis/Epididyais, Prostate, Stoaach, Urinary Bladder, Adrenal, Parathyroid, Trachea, Esophagus, Salivary Gland, P itu ita ry , Pancreas.
Species: Rat Project Nuaber: 0281CR0012
001911
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Riker Laboratories, Inc. 3H FH-3924: Two Year Oral Toxicity-Oncogenicity Study in Rats
Table: 2
Aniaal Nuaber: 1R-3833 Sex! Hale Group: ( 4) FH-3924 10 ppa Fate: (Neek= 102) Sacrificed in extreais
Hacroscopic Observations: Eye P itu ita ry Spleen
Hicroscopic Observations: Adrenal
Eye Heart
Kidney Liver
Lung P itu ita ry Spleen
Thyroid
-Focal corneal opacity in both eyes. -Dark aass, 0.5 ca dia. -S lig h tly enlarged
-C ortical vacuolation, local areas, a ild Sinusoidal ectasia, cortex, d iffuse, a ild One of pair present -K e ra titis , chronic, focal, b ila te ra l, a ild
-Hyocardial fib ro s is , a u ltifo c a l, a ild Hyocarditis, chronic nonsuppurative, a ultifo cal, aild -Chronic progressive nephropathy, a ild
-Hepatocyte vacuolation, a u ltifo c a l, a ild H ito tic a c tiv ity , increased, diffuse, a ild -Vascular aineralization, ainiaal -Adenoaa -Heaatopoiesis, extraaedullary, increased, aoderate -Hyperplasia, fo llic u la r c e ll, d iffuse , a ild
The fallow ing tissues were found to be w ithin noroal l ia it s : Testis/Epididyais, Prostate, Stoaach, Urinary Bladder, Parathyroid, Trachea, Esophagus, Salivary Sland, Pancreas.
Aniaal Nuaber: 1R-3834 Sex! Hale Group: ( 4) FH-3924 10 ppa Fate: (Neek= 70) Sacrificed in extreais
Hacroscopic Observations: Liver Kidney
Hicroscopic Observations: Heart
Kidney
Liver
-S lig h tly pale -S lig h t hydronephrosis, le f t kidney.
-Hyocarditis, chronic nonsuppurative, local areas, aild
-Chronic progressive nephropathy, ainiaal Hyperplasia, pelvic epitheliua, a u ltifo c a l, a ild -Portal aononudear c e ll in f ilt r a t e , a ild Portal b ile duct p ro life ra tio n , a ild Hepatocyte vacuolation, a u ltifo c a l, a ild Cystoid degeneration, fo cal, a ild Hegalocytosis, ainiaal
Species: Rat Project Nuaber: 0281CR0012
001912
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Suaaarized Single Tabulated Aniaal Report (continued) Individual Macroscopic and Microscopic Observations
Riker Laboratories, Inc. 3H FM-3924: Two Year Oral Toxicity-Oncogenicity Study in Rats
Table: 2
Aniaal Nuaber: 1R-3834 Sex: Male Sroup: ( 4) FH-3924 10 ppa Fate: (Meek= 70) Sacrificed in extreais
Microscopic Observations (continued): Lung P ituitary Salivary Gland
-Alveolar aacrophages, a u ltifo c a l, a ild -Adenoaa -Not exaained, aissing
The following tissues ere found to be ith in noraal li a i t s : Spleen, Testis/Epididyais, Prostate, Stoaach, Urinary Bladder, Adrenal, Thyroid, Parathyroid, Trachea, Esophagus, Pancreas.
Aniaal Nuaber: 1R-3835 Sex: Male Fate: (Neek= 106) Terainal Sacrifice
Sroup: (
FM-3924 10 ppa
Macroscopic Observations: Microscopic Observations:
Heart
Kidney Liver
Lung P itu ita ry
-No v is ib le lesions.
-Myocardial fib ro s is , local areas, aoderate Myocarditis, chronic nonsuppurative, local areas, a ild
-Chronic progressive nephropathy, ainiaal -Portal aononudear c e ll in f ilt r a t e , a ild
Hepatocyte a lte ra tio n , vacuolated, a u ltifo c a l, a ild -Vascular a in e ra liza tio n , ainiaal Perivascular aononudear in f ilt r a t e , a ild -Adenoaa
The following tissues were found to be w ithin noraal lia it s : 5pleen, Testis/Epididyais, Prostate, Stoaach, Urinary Bladder, Adrenal, Thyroid, Parathyroid, Trachea, Esophagus, Salivary Gland, Pancreas.
Aniaal Nuaber: 1R-3836 Sex: Hale Fate: (Neek= 106) Terainal Sacrifice
6roup: ( 4) FH-3924 10 ppa
Macroscopic Observations: Eye Skin
Stoaach Kidney
Microscopic Observations'. Adrenal
-Right and le f t eyes appear cloudy. -Raised c irc u la r aass, 1.5 ca d ia ., dorsal
area. -Enlarged gastric rugae. -Several raised d e a r cysts, 0.B ca d ia ., in
le f t kidney.
-C ortical vacuolation, focal, a ild
Species: Rat Project Nuaber: 0281CR0012
001813
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Suaaarized Single Tabulated Aniaal Report (continued) Individual Hacroscopic and Hicroscopic Observations
Riker Laboratories, Inc. SI FH-3924: Two Year Oral Toxicity-Oncogenicity Study in Rats
Table: 2
Aniaal Nuaber: 1R-3836 Sex: Hale Fate: (Heek= 106) Terainal Sacrifice
Group: ( 4) FH-3924 10 ppa
Hicroscopic Observations (continued): Eye Heart Kidney
Liver Lung Skin Thyroid
-Cataract, b ila te ra l -Hyocardial fib ro s is , a u ltifo c a l, ai Id -Chronic progressive nephropathy, aoderate Cyst, c o rtic a l -Portal aononudear c e ll in f ilt r a t e , a ild -Vascular aineralization, a ild -Cyst, demal inclusion -F o llic u la r hyperplasia, cystic, u n ila te ra l,
aarked
The follow ing tissues were found to be w ithin noraal l ia it s : Spleen, Testis/Epididyais, Prostate, Stoaach, Urinary Bladder, Parathyroid, Trachea, Esophagus, Salivary Gland, P itu ita ry , Pancreas.
Aniaal Nuaber: 1R-3837 Sex: Hale Fate: (Neek= 106) Terainal Sacrifice
6roup: ( 4) FH-3924 10 ppa
Hacroscopic Observations: Eye
Hicroscopic Observations! Adrenal Eye Heart Kidney Liver
Lung Pancreas P itu ita ry
-Saall corneal lesion, rig h t eye.
-C ortical vacuolati on, fo c a l, a ild Nodular hyperplasia, cortex, aoderate
-K e ra titis , chronic, u n ila te ra l, aarked -Myocarditis, chronic nonsuppurative, a u ltifo ca l, aild -Chronic progressive nephropathy, a ild -Portal aononudear c e ll in f ilt r a t e , a ild Portal b ile duct p ro life ra tio n , a ild Hepatocyte vacuolation, a u ltifo c a l, a ild Hepatocyte a lte ra tio n , vacuolated, a u ltifo c a l, a ild Hegalocytosis, ainiaal Fibrosis, focal, aild -Vascular aineralization, a ild Heaorrhage, a u ltifo c a l, a ild -Hyperplasia, acinar c e ll, nodular, aoderate -Adenoaa
The following tissues were found to be w ithin noraal lia it s : Spleen, Testis/Epididyais, Prostate, Stoaach, Urinary Bladder, Thyroid, Parathyroid, Trachea, Esophagus, Salivary Gland.
Species: Rat Project Nuaber: 0281CR0012
001914
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Suaaarized Single Tabulated Aniaal Report (continued)' Individual Itacroscopic and Microscopic Observations
Riker Laboratories, Inc. 3M FM-3924: Tao Year Oral Toxicity-Oncogenicity Study in Rats
Table: 2
Aniaal Nuaber: 1R-363B Sex: Hale 6roup: < 4) FH-3924 10 ppa Fate: (Neek= 93) Sacrificed in extreais
Macroscopic Observations: Soft Tissues (neck)
Microscopic Observations: Adrenal Esophagus Kidney Liver Lung Soft Tissues (neck)
Testis/Epididyais
-F ira white aass, 2.5 x 2 ca in ventral neck area, possibly arising froa body of cervical vertebrae; aass beginning to involve esophagus and trachea, constricting thea.
-Pheochroaocytoaa, benign, u n ila te ra l -Not exaained, aissing -Chronic progressive nephropathy, ainiaal Pelvic aineralization, a ild -Portal aononudear c e ll in f ilt r a t e , a ild -Vascular aineralization, a ild Pneuaonia, foreign body, a u ltifo c a l, aoderate -Fibrosarcoaa
Tuaor does not appear to arise froa bone. Saall area of reactive cartilage with aineralization. Locally in filtr a tiv e . -Vascular aineralization, a ild
The follow ing tissues were found to be w ithin noraal lia i t s : Spleen, Heart, Prostate, Stoaach, Urinary Bladder, Thyroid, Parathyroid, Trachea, Salivary Gland, P itu ita ry , Pancreas.
Aniaal Nuaber: 1R-3839 Sex! Male Fate: (Week= 106) Terainal Sacrifice
Group: ( 4) FM-3924 10 ppa
Macroscopic Observations: Kidney
Microscopic Observations: Adrenal Heart
Kidney
Liver
Lung P itu ita ry
-Pale and p itte d , s lig h tly enlarged; rig h t hydronephrosis.
-Sinusoidal ectasia, cortex, fo c a l, aoderate -Myocarditis, chronic nonsuppurative, a ultifo cal, aild -Chronic progressive nephropathy, aarked Hydronephrosis, u n ila te ra l -Portal aononudear c e ll in f ilt r a t e , a ild Portal b ile duct p ro life ra tio n , a ild Negaiocytosis, ainiaal -Perivascular aononudear in f ilt r a t e , a ild -Hyperplasia, focal, pars d is ta lis , a ild
The follow ing tissues were found to be w ithin noraal l ia it s : Spleen, Testis/Epididyais, Prostate, Stoaach, Urinary Bladder, Thyroid, Parathyroid, Trachea,
Species: Rat Project Nuaber: 02B1CR0012
001915
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Suaaarized Single Tabulated Aniaal Report (continued) Individual Macroscopic and Microscopic Observations
Riker Laboratories, Inc. 3H FH-3924: Two Year Oral Toxicity-Oncogenicity Study in Rats
Table: 2
Aniaal Nuaber: 1R-3839 Sex: Male Fate: (Week- 106) Terainal Sacrifice
6roup: ( 4) FH-3924 10 ppa
Microscopic Observations (continued): The following tissues were found to be w ithin noraal l i a i t s (continued): Esophagus, Salivary Gland, Pancreas.
Aniaal Nuaber: 1R-3840 Sex: Male Group: I 4) FH-3924 10 ppa Fate: (Keek* 57) Sacrificed in extreais
Macroscopic Observations: Lung
Heart Liver Microscopic Observations: Esophagus Heart Kidney Lung
Soft Tissues (thorax)
-Large yellowish grey aass f i l l s entire throacic cavity and displaces noraal lung tissue dorsally. Mass aeasures 4 x 4.5 x 2 ca, adhered to le f t la te ra l thoracic N all, rig h t apical lung lobe collapsed.
-Muscle appears flabby. -Pale
-Not exaained, aissing -E p ica rd itis, chronic, focal, a ild -Mineralization, a u ltifo ca l, c o rtica l, aild -Vascular aineralization, a ild Atelectasis, diffuse , aarked -Liposarcoaa
The following tissues were found to be w ithin noraal li a i t s : Spleen, Liver, Testis/Epididyais, Prostate, Stoaach, Urinary Gladder, Adrenal, Thyroid, Parathyroid, Trachea, Salivary Gland, P itu ita ry , Pancreas.
Aniaal Nuaber: 1R-3841 Sex: Hale Fate: (Heek= 106) Terainal Sacrifice
Group: 4) FH-3924 10 ppa
Macroscopic Observations: Skin
Microscopic Observations: Kidney Liver
Skin Testis/Epididyais Trachea
-Raised c irc u la r lesions on both hind footpads.
-Chronic progressive nephropathy, ainiaal -Portal aononudear c e ll in f ilt r a t e , a ild Portal b ile duct p ro life ra tio n , a ild Hegalocytosis, ainiaal -Pododeraatitis, ulce ra tive , b ila te ra l, aarked -Vascular aineralization, a ild -Tracheitis, chronic, a ild
Species: Rat Project Nuaber: 0281CR0012
001916
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Suaaarized Single Tabulated Aniaal Report (continued) Individual Hacroscopic and Nicroscopic Observations
Riker Laboratories, Inc. 3H FH-3924: To Year Oral Toxicity-Oncogenicity Study in Rats
Table: 2
Aniaal Nuaber: 1R-3841 Sex: Hale Fate: (Neek= 106) Terainal Sacrifice
6roup: ( 4) FH-3924 10 ppa
Hicroscopic Observations (continued):
The folloMing tissues were found to be w ithin noraal l ia it s : Spleen, Heart, Lung, Prostate, Stoaach, Urinary Bladder, Adrenal, Thyroid, Parathyroid, Esophagus, Salivary Gland, P itu ita ry , Pancreas.
Aniaal Nuaber: 1R-3842 Sex! Hale Fate: (Heek= 84) Found Dead
6roup! ( 4) FH-3924 10 ppa
Hacroscopic Observations: Liver Saall Intestine Large Intestine
Hicroscopic Observations: Adrenal
Esophagus Liver Lung
Pancreas Parathyroid P itu ita ry Prostate Salivary 61and Spleen Thyroid Trachea Urinary Bladder 6eneral Coaaent
-Pale aottled -Heaorrhagic -Heaorrhagic
-Within noraal l i a i t s One of pair present
-Not exaained, aissing -Hepatocyte vacuolation, p e rip o rta l, aoderate -Vascular a in e ra liz a tio n , a ild Edeaa, local areas, a ild -Not exaained, aissing -Not exaained, aissing -Not exaained, aissing -Not exaained, aissing -Not exaained, aissing -Heaosiderosis, a ild -Not exaained, aissing -Not exaained, aissing -Not exaained, aissing -Host tissues have advanced a u to ly tic changes.
The fo llo u in g tissues ere found to be ith in noraal l ia it s : Kidney, Heart, Testis/Epididyais, Stoaach.
Aniaal Nuaber: 1R-3843 Sex: Hale Fate: (Heek 106) Terainal Sacrifice
Group: 1 4) FH-3924 10 ppa
Hacroscopic Observations: Testis/Epididyais
Hicroscopic Observations: Kidney
Liver
-Left te stis saall.
-Chronic progressive nephropathy, aoderate Pelvic aineralization, a ild
-Portal aononudear c e ll in f ilt r a t e , a ild Hepatocyte vacuolation, ce n trilo b u la r, a ild Cystoid degeneration, fo cal, a ild Hepatocyte a lte ra tio n , vacuolated, a u ltifo c a l, a ild Hegalocytosis, ainiaal
Species: Rat Project Nuaber: 0281CR0012
001917
432
*i e
Suaaarized Single Tabulated flniaal Report (continued) Individual Macroscopic and Microscopic Observations
Riker Laboratories, Inc. 3H FM-3924: Two Year Oral Toxicity-Oncogenicity Study in Rats
Table: 2
Aniaal Nuaber: 1R-3843 Sex! Male Fate: (Week* 106) Terainal Sacrifice
Group: ( 4) FM-3924 10 ppa
Microscopic Observations (continued): Lung Pancreas Testis/Epididyais
Thyroid
-Vascular M ineralization, a ild -Acinar atrophy, a ild -Tubule atrophy, asperaatogenesis, u n ila te ra l, aarked -Ultiisobranchial cyst
The following tissues were found to be w ithin noraal 1ia its : Spleen, Heart, Prostate, Stoaach, Urinary Bladder, Adrenal, Parathyroid, Trachea, Esophagus, Salivary Bland, P itu ita ry .
Aninal Nuaber: 1R-3B44 Sex: Male Fate: (Heek= i 06) Terainal Sacrifice
Group: 1 4! FM-3924 10 ppa
Macroscopic Observations: kidney
Microscopic Observations: Esophagus Heart
Kidney Liver
Lung Pancreas
Parathyroid Prostate Thyroid
-Fluid f ille d cyst on le f t kidney.
-Not exaained, aissing -Myocarditis, chronic nonsuppurative, a u ltifo ca l, aild -Chronic progressive nephropathy, aoderate -Portal aononudear c e ll in f ilt r a t e , a ild Portal b ile duct p ro life ra tio n , a ild Hepatocyte vacuolation, a u ltifo c a l, a ild Megalocytosis, ainiaal -Vascular a in eralization, ainiaal -Acinar atrophy, aoderate P o ly a rte ritis , aoderate -Not exaained, not in plane of section -Hyperplasia, focal, aoderate -Hyperplasia, C c e ll, aoderate
The following tissues were found to be w ithin noraal l ia it s : Spleen, Testis/Epididyais, Stoaach, Urinary Bladder, Adrenal, Trachea, Salivary Gland, P itu ita ry .
Aniaal Nuaber: 1R-3B45 Sex: Hale Fate: (Heeks 106) Terainal Sacrifice
Group: ( 4) FM-3924 10 ppa
Macroscopic Observations: Eye
Microscopic Observations: Eye
-Right eye atrophied, no tissues to be taken -Retinal atrophy, local areas, a ild
Species: Rat Project Nuaber: 0281CR0012
001918
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Rifcer Laboratories, Inc. 3H FH-3924: Two Year Oral Toxicity-Oncogenicity Study in Rats
Table: 2
Anita] Nutber: 1R-3845 Sex: Hale Fate: (Meek- 106) Tertinal Sacrifice
Sroup: ( 4) FH-3924 10 ppt
Microscopic Observations (continued): Heart
Kidney Liver
Lung Parathyroid
-Myocarditis, chronic nonsuppurative, tu ltifo ca l, tild
-Chronic progressive nephropathy, t i l d -Portal eononudear c e ll in f ilt r a t e , t i l d Portal b ile duct p ro life ra tio n , t i l d Megalocytosis, t i l d -Perivascular eononudear in f ilt r a t e , t i l d -Not exaeined, not in plane of section
The following tissues were found to be w ithin nornal l i t i t s : Spleen, Testis/Epididyais, Prostate, Stoaach, Urinary Bladder, Adrenal, Thyroid, Trachea, Esophagus, Salivary Bland, P itu ita ry , Pancreas.
Aninal Nutber: 1R-3846 Sex: Male Fate: (Neek= 106) Tertinal Sacrifice
Sroup: ( 4) FH-3924 10 ppt
Macroscopic Observations: Microscopic Observations:
Adrenal Kidney Liver
Lung P itu ita ry Trachea
-No v is ib le lesions.
-C ortical degeneration, focal, t i l d -Chronic progressive nephropathy, t i l d -Portal eononudear c e ll in f ilt r a t e , t i l d Hepatocyte a lte ra tio n , vacuolated, tu ltifo c a l, tild Megalocytosis, t in it a l Necrosis, focal, t in it a l -Pneutonia, in t e r s t it ia l, chronic, fo c a l, t i l d Perivascular eononudear in f ilt r a t e , t i l d -Cyst, pars di stai is -Tracheitis, chronic, loderete
The following tissues were found to be w ithin nortal l i t i t s : Spleen, Heart, Testis/Epididyais, Prostate, Stoaach, Urinary Bladder, Thyroid, Parathyroid, Esophagus, Salivary Gland, Pancreas.
Species: Rat Project Nutber: 0281CR0012
001919
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Riker Laboratories, Inc. 3H FH-3924: Two Year Oral Toxicity-Oncogenicity Study in Rats
Table: 2
Aniaal Nuaber: 1R-3B47 Sex: Hale Group: ( 4) FH-3924 10 ppa Fate: (Week- 100) Sacrificed in extreais
Hacroscopic Observations: Soft Tissues (leg) Liver
Hicroscopic Observations: Bone Kidney
Liver Lung
Parathyroid P itu ita ry Thyroid Urinary Bladder
-Swollen rig h t and le f t hind fe e t. -Possibly s lig h tly aottled.
-A rth ritis , synovitis! jo in ts, b ila te ra l, aild -Chronic progressive nephropathy, a ild Cyst, c o rtic a l -Portal aononudear c e ll in f ilt r a t e , a ild -Vascular aineralization, a ild Perivascular aononudear in f ilt r a t e , a ild -Not exaained, aissing -Adenoaa -Not exaained, aissing -Calculus
The fo llo nin g tissues Mere found to be w ithin noraal li a i t s ! Spleen, Heart, Testis/Epididyais, Prostate, Stoaach, Adrenal, Trachea, Esophagus, Salivary Gland, Pancreas.
Aniaal Nuaber: 1R-384B Sex: Hale Fate: INeek= 106) Terainal Sacrifice
6roup: ( 4) FH-3924 10 ppa
Hacroscopic Observations: P itu ita ry Adrenal
Hicroscopic Observations: Adrenal
Kidney Liver
Lung
Lyaph Node P ituitary Prostate Testis/Epididyais
-Raised aass, 0.5 ca dia. -Enlarged
-Nodular hyperplasia, cortex, aarked One of pair present
-Chronic progressive nephropathy, a ild -Portal aononudear c e ll in f ilt r a t e , a ild Portal b ile duct p ro life ra tio n , a ild Hegalocytosis, ainiaal -Vascular aineralization, a ild Pneuaonia, in t e r s t it ia l, chronic, a u ltifo c a l, a ild Alveolar aacrophages, a u ltifo c a l, a ild -Sinusoidal ectasia, aoderate -Adenoaa -Hyperplasia, focal, aoderate -P o lya rte ritis, aild
The follow ing tissues were found to be w ithin noraal lia i t s : Spleen, Heart, Stoaach, Urinary Bladder, Thyroid, Parathyroid, Trachea, Esophagus,
Species: Rat Project Nuaber: 02B1CR0012
001920
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Riker Laboratories, Inc. 3H FH-3924: Two Year Oral Toxicity-Oncogenicity Study in Rats
Table: 2
Aniaal Kuaber: 1R-3848 Sex: Hale Fate: (Week- 106) Terainal Sacrifice
Group: ( 4) FH-3924 10 ppa
Microscopic Observations (continued): The follow ing tissues were found to be w ithin noraal l i a i t s (continued): Salivary Gland, Pancreas.
Aniaal Muaber 1R-3849 Sex: Hale Fate: (Neek= 106) Terainal Sacrifice
Group: ( 4) FH-3924 10 ppa
Macroscopic Observations: Microscopic Observations:
Adrenal Ki dney Liver
Lung Parathyroid P itu ita ry
-No v is ib le lesions.
-C ortical vacuolation, local areas, a ild Nodular hyperplasia, cortex, fo cal, a ild
-Chronic progressive nephropathy, a ild -Portal aononuclear c e ll in f ilt r a t e , a ild Portal b ile duct p ro life ra tio n , a ild Hepatocyte vacuolation, ce n trilo b u la r, a ild Megalocytosis, a ild -Vascular aineralization, ainiaal Heaorrhage, a u ltifo c a l, a ild -Not exaained, not in plane of section -Adenoaa
The following tissues were found to be w ithin noraal li a i t s : Spleen, Heart, Testis/Epididyais, Prostate, Stoaach, Urinary Bladder, Thyroid, Trachea, Esophagus, Salivary Gland, Pancreas.
Aniaal Nuaber! 1R-38S0 Sex: Hale Fate: (Week- 106) Terainal Sacrifice
6roup: ( 4) FH-3924 10 ppa
Macroscopic Observations: P ituitary
Microscopic Observations: Liver
Lung
Parathyroid P itu ita ry Prostate Spleen
-Raised c irc u la r aass, 0.S ca dia.
-Portal aononuclear c e ll in f ilt r a t e , a ild Portal b ile duct p ro life ra tio n , a ild Hepatocyte a lte ra tio n , vacuolated, a u ltifo c a l a ild
-Vascular aineralization, a ild Alveolar aacrophages, a u ltifo c a l, a ild -Not exaained, not in plane of section -Adenoaa -P ro s ta titis , acute, a ild -Heaosiderosis, a ild
Species: Rat Project Nuaber: 02B1CR0012
001921
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Riker Laboratories, Inc. 3H FH-3924: Two Year Oral Toxicity-Oncogenicity Study in Rats
Table: 2
Aniaal Nuaber: 1R-38S0 Sex: Hale Fate: (Heek- 106) Terainal Sacrifice
6roup: ( 4) FH-3924 10 ppa
Hicroscopic Observations (continued):
The Following tissues were found to be w ithin noraal U n its : Kidney, Heart, Testis/Epididyais, Stoaach, Urinary Bladder, Adrenal, Thyroid, Trachea, Esophagus, Salivary Gland, Pancreas.
Aniaal Nuaber: 1R-3851 Sex: Hale Fate: (Week: 106) Terainal Sacrifice
Group: I 4) FH-3924 10 ppa
Hacroscopic Observations: Adrenal Testis/Epididyais
Hicroscopic Observations: Adrenal Heart Kidney Liver
Lung P itu ita ry Testis/Epididyais
-L e ft enlarged, 1 ca d ia ., dark. -Left te stis saall.
-Pheochroaocytoaa, aalignant, b ila te ra l -Hyocardial fib ro s is , a u ltifo c a l, a ild -Chronic progressive nephropathy, aoderate -Portal aononudear c e ll in f ilt r a t e , ainiaal Hepatocyte vacuolation, a u ltifo c a l, a ild Hepatocyte a lte ra tio n , vacuolated, a u ltifo c a l, a ild -Vascular aineralization, ainiaal -Hyperplasia, a u ltifo c a l, pars d is ta lis , a ild -Tubule atrophy, asperaatogenesis, u n ila te ra l, aarked
The fallowing tissues were found to be w ithin noraal l ia it s : Spleen, Prostate, Stoaach, Urinary Bladder, Thyroid, Parathyroid, Trachea, Esophagus, Salivary Gland, Pancreas.
Aniaal Nuaber: 1R-3852 Sex: Hale Fate: (Ueek= 106) Terainal Sacrifice
Group: 1 4) FH-3924 10 ppa
Hacroscopic Observations:
Hicroscopic Observations: Heart Kidney Liver
-No v is ib le lesions.
-Hyocarditis, chronic nonsuppurative, a ild -Pelvic aineralization, a u ltifo c a l, a ild -Portal aononudear c e ll in f ilt r a t e , a ild Hepatocyte vacuolation, a u ltifo c a l, ainiaal Hepatocyte a lte ra tio n , vacuolated, a u ltifo c a l,
a ild Hegalocytosis, a ild
Species: Rat Project Nuaber: 0291CR0012
001922
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Riker Laboratories, Inc. 3M FH-3924: Tuo Year Oral Toxicity-Oncogenicity Study in Rats
Table: 2
Aniaal Nuaber: 1R-3852 Sex: Hale Fate: (Week- 106) Terainal Sacrifice
Group: ( 4) FH-3924 10 ppa
Microscopic Observations (continued): Lung
-Vascular aineralization, a ild Perivascular aononudear in f ilt r a t e , a ild
The follow ing tissues were found to be w ithin noraal li a i t s : Spleen, Testis/Epididyais, Prostate, Stoaach, Urinary Bladder, Adrenal, Thyroid, Parathyroid, Trachea, Esophagus, Salivary Gland, P itu ita ry , Pancreas.
Aniaal Nuaber: 1R-3B53 Sex: Male Fate: (Neek= 106) Terainal Sacrifice
Group: ( 4) FH-3924 10 ppa
Macroscopic Observations: Microscopic Observations:
Heart Kidney
Liver
Lung
Testis/Epididyais Trachea
-No v is ib le lesions.
-Myocarditis, chronic nonsuppurative, a ild -Chronic progressive nephropathy, a ild Pelvic aineralization, a ild P y e litis , acute, a ild Hyperplasia, pelvic epitheliua, a ild -Portal aononudear c e ll in f ilt r a t e , a ild Portal b ile duct p ro life ra tio n , a ild Hepatocyte a lte ra tio n , vacuolated, a u ltifo c a l, ainiaal Hegalocytosis, ainiaal -Vascular aineralization, ainiaal Alveolar aacrophages, a u ltifo c a l, a ild Perivascular aononudear in f ilt r a t e , a ild -Vascular aineralization, aininal -Tracheitis, chronic, a ild
The following tissues were found to be w ithin noraal li a i t s : 5pleen, Prostate, Stoaach, Urinary Bladder, Adrenal, Thyroid, Parathyroid, Esophagus, Salivary Gland, P itu ita ry , Pancreas, Eye.
Aniaal Nuaber: 1R-3B54 Sex: Nale Fate: (Neek= 106) Terainal Sacrifice
Group: ! 4) FH-3924 10 ppa
Macroscopic Observations: P ituitary Kidney
Microscopic Observations: Heart
-Raised dark aass, 0.5 ca dia. -Pale
-Myocarditis, chronic nonsuppurative, d iffu se , aoderate
Species: Rat Project Nuaber: 0281CR0012
001.923
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Riker Laboratories, Inc. 3H FH-3924: Tuo Year Oral Toxicity-Oncogenicity Study in Rats
Table: 2
Anieal Nuaber: 1R-3054 Sex: Hale Group! ( 4) FH-3924 10 ppa Fate: (Ueek= 106) Tereinal Sacrifice
Hicroscopic Observations (continued): Kidney Liver
Lung
Pancreas P itu ita ry Salivary 61and Testis/Epididyais
-Chronic progressive nephropathy, narked -Portal aononudear c e ll in f ilt r a t e , a ild Portal b ile duct p ro life ra tio n , a ild Hepatocyte a lte ra tio n , vacuolated, a u ltifo c a l a ild -Vascular a in era liza tion , a ild Heaorrhage, a u ltifo c a l, a ild -Acinar atrophy, a ild -Adenoaa -Not exaained, aissing -P olyarteritis, aild
The follow ing tissues aere found to be w ithin noraal lia i t s : Spleen, Prostate, Stoaach, Urinary Bladder, Adrenal, Thyroid, Parathyroid, Trachea, Esophagus.
Aniaal Nuaber: 1R-3855 Sex: Hale Fate: (Heek= 106) Terainal Sacrifice
Group: ( 4) FH-3924 10 ppa
Hacroscopic Observations: Hicroscopic Observations:
Adrenal Kidney
Liver
Lung Parathyroid P ituitary Testis/Epididyais Thyroid
-No v is ib le lesions.
-C o rtical vacuolation, local areas, a ild Nodular hyperplasia, cortex, a ild
-Chronic progressive nephropathy, a ild Pelvic aineralization, a ild Calculus, pelvic -Portal aononudear c e ll in f ilt r a t e , a ild Portal b ile duct p ro life ra tio n , a ild Cystoid degeneration, focal, ainiaal Hepatocyte a lte ra tio n , vacuolated, a u ltifo c a l, a ild
-Vascular aineralization, a ild Alveolar aacrophages, a ild -Not exaained, aissing -Not exaained, aissing -Vascular a in era liza tion , aoderate -Not exaained, aissing
The follow ing tissues were found to be w ithin noraal l ia it s : Spleen, Heart, Prostate, Stoaach, Urinary Bladder, Trachea, Esophagus, Salivary Gland, Pancreas.
Species: Rat Project Nuaber: 02B1CR0012
001924
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Riker Laboratories, Inc. 3N FM-3924: To Year Oral Toxicity-Oncogenicity Study in Rats
Table: 2
Aniaal Nuaber: 1R-3856 Sex: Male Fate: (Meek- 106) Terainal Sacrifice
Group: ( 4) FM-3924 10 ppa
Macroscopic Observations: P itu ita ry Liver
Microscopic Observations: Heart
Kidney
Liver
Lung P itu ita ry Salivary Gland Spleen Stoaach Testis/Epididyais Thyroid
-Large heaorrhagic nass, 1.2 x 1 ca. -Pale and aottled.
-Myocardial Fibrosis, a u ltiF o ca l, a ild Myocarditis, chronic nonsuppurative, a ultifo cal, aild -Chronic progressive nephropathy, aoderate P y e litis , acute, ainiaal
-Portal aononuclear c e ll in f ilt r a t e , a ild Portal b ile duct p ro life ra tio n , a ild Hepatocyte vacuolation, p e rip o rta l, aarked -Vascular a in era liza tion , a ild -Adenoaa -Not exaained, aissing -Heaosiderosis, a ild -Ulcer -Vascular aineralization, a ild -Hyperplasia, C c e ll, Focal, a ild
The fo llo itin g tissues ere Found to be w ithin noraal U n its : Prostate, Urinary Bladder, Adrenal, Parathyroid, Trachea, Esophagus, Pancreas.
Aniaal Nunber: 1R-3857 Sex: Male Fate: (Keek* 106) Terainal Sacrifice
Group: ( 4) FM-3924 10 ppa
Macroscopic Observations: Microscopic Observations:
Adrenal Heart
Kidney Liver
Lung
Testis/Epididyais
-No v is ib le lesions.
-C ortical degeneration, Focal, a ild -Myocardial Fibrosis, diffuse , a ild Myocarditis, chronic nonsuppurative, a u ltifo ca l, aild -Chronic progressive nephropathy, ainiaal -Portal aononuclear c e ll in f ilt r a t e , a ild Portal b ile duct p ro life ra tio n , a ild Hepatocyte vacuolation, a u ltifo c a l, a ild Megalocytosis, ainiaal -Vascular aineralization, a ild Alveolar aacrophages, a u ltifo c a l, a ild Perivascular aononuclear in f ilt r a t e , a ild -Vascular aineralization, a ild
Species: Rat Project Nuaber: 0281CR012
001925
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Suaaarized Single Tabulated Aniaal Report (continued) Individual Macroscopic and Microscopic Observations
Riker Laboratories, Inc. 3M FM-3924: Two Year Oral Toxicity-Oncogenicity Study in Rats
Table: 2
Aniaal Nuaber: 1R-3857 Sex: Hale Fate: (Week- 106) Terainal S acrifice
6roup: ( 4) FH-3924 10 ppa
Microscopic Observations (continued):
The follow ing tissues were found to be w ithin noraal l ia it s : Spleen, Prostate, Stoaach, Urinary Bladder, Thyroid, Parathyroid, Trachea, Esophagus, Salivary 61and, P itu ita ry , Pancreas.
Aninal Nuaber: 1R-385S Sex: Male Fate: (Week* 106) Terainal Sacrifice
6roup: ( 4) FH-3924 10 ppa
Macroscopic Observations:
Microscopic Observations: Adrenal Kidney Liver
Lung
-No v is ib le lesions.
-Pheochroaocytoaa, benign, u n ila te ra l -Chronic progressive nephropathy, ai Id -Portal aononudear c e ll in f ilt r a t e , a ild
Portal b ile duct p ro life ra tio n , a ild Negalocytosis, ainiaal -Vascular a in e ra liz a tio n , a ild Alveolar aacrophages, a u ltifo c a l, a ild Perivascular aononudear in f ilt r a t e , a ild
The following tissues were found to be w ith in noraal l ia it s : Spleen, Heart, Testis/Epididyais, Prostate, Stoaach, Urinary Bladder, Thyroid, Parathyroid, Trachea, Esophagus, Salivary 61and, P itu ita ry , Pancreas.
Aniaal Nuaber: 1R-3859 Sex: Hale Fate! (Week* 106) Terainal Sacrifice
Group: < 4) FH-3924 10 ppa
Macroscopic Observations: Testis/Epididyais
Microscopic Observations: Adrenal Heart
Kidney Liver
Lung P itu ita ry Testis/Epididyais
-Both testes enlarged due to extensive edeaa.
-C ortical vacuolation, local areas, aoderate -Myocarditis, chronic nonsuppurative, a ultifo cal, aild -Chronic progressive nephropathy, a ild -Portal aononudear c e ll in f ilt r a t e , a ild Portal b ile duct p ro life ra tio n , a ild Cystoid degeneration, fo cal, a ild -Vascular aineralization, ainiaal -Adenoaa -Tubule atrophy, asperaatogenesis, b ila te ra l, aarked
Species: Rat Project Nuaber: 02B1CR0012
001926
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Riker Laboratories, Inc. 3H FH-3924: Tao Year Oral Toxicity-Oncogenicity Study in Rats
Table: 2
Aniaal Nuaber: 1R-3859 Sex: Male Fate: (Week* 106) Terainal Sacrifice
Group: ( 4) FH-3924 10 ppa
Hicroscopic Observations (continued):
The following tissues were found to be w ithin noraal lia it s : Spleen, Prostate, Stoaach, Urinary Bladder, Thyroid, Parathyroid, Trachea, Esophagus, Salivary Gland, Pancreas.
Aniaal Nuaber: 1R-3860 Sex: Hale Fate: (Week* 106) Terainal Sacrifice
Group: I 4) FH-3924 10 ppa
Hacroscopic Observations: Soft Tissues (neck) P itu ita ry
Hicroscopic Observations: Heart
Kidney
Liver
Lung
Pancreas P itu ita ry Soft Tissues (neck)
-F ira aass, 2.5 x 2.2 ca, le f t side of neck. -Raised aass, 0.6 ca dia.
-H yocarditis, chronic nonsuppurative, a ultifo cal, aild
-Chronic progressive nephropathy, a ild Pelvic aineralization, a ild
-Portal aononudear c e ll in f ilt r a t e , a ild Hegalocytosis, ainiaal -Vascular a in e ra liza tio n , a ild Alveolar aacrophages, a u ltifo c a l, a ild -Acinar atrophy, a ild -Adenoaa -Fibroaa
The following tissues were found to be w ithin noraal l ia it s : Spleen, Testis/Epididyais, Prostate, Stoaach, Urinary Bladder, Adrenal, Thyroid, Parathyroid, Trachea, Esophagus, Salivary Gland.
Aniaal Nuaber: 1R-4871 Sex: Feaale Group! ( 4) FH-3924 10 ppa Fate: (Week* 76) Found Dead
Hacroscopic Observations:
Hicroscopic Observations: Adrenal Lung Haaaary Gland Ovary
P itu ita ry
-No v is ib le lesions
-C ortical vacuolation, local areas, aoderate -Vascular a in era liza tion , a ild -Not exaained, aissing -Within noraal lia it s One of pair present -Adenoaa
The following tissues were found to be w ithin noraal l ia it s : Spleen, Liver, Kidney, Heart, Uterus, Stoaach, Urinary Bladder, Thyroid, Parathyroid, Trachea,
Species: Rat Project Nuaber: 02B1CR0012
001927
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Riker Laboratories, Inc. 3M FM-3924: Two Year Oral Toxicity-Oncogenicity Study in Rats
Table: 2
Aniaal Nuaber: 1R-4B71 Sex: Feaale Group: ( 4) FH-3924 10 ppa Fate: (Meek* 76) Found Dead
Microscopic Observations (continued): The folloN ing tissues were Found to be w ithin noraal l i a i t s (continued): Esophagus, Salivary Bland, Pancreas.
Aniaal Nuaber: 1R-4872 Sex: Feaale 6roup: < 4) FH-3924 10 ppa Fate: (Neek= 105) Terainal Sacrifice
Macroscopic Observations: P itu ita ry Skin
Microscopic Observations: Adrenal Liver Lung Parathyroid P itu ita ry Spleen
-Mass, 0.7 ca dia. -Hair loss, abdoaen and fo re lia b .
-Sinusoidal ectasia, cortex, aoderate -Hepatocyte vacuolation, a u ltifo c a l, ainiaal -Vascular aineralization, a ild -Not exaained, not in plane of section -Adenoaa -Heaosiderosis, a ild
The follow ing tissues were found to be w ithin noraal li a i t s : Kidney, Heart, Uterus, Ovary, Maanary 61and, Stoaach, Urinary Bladder, Thyroid, Trachea, Esophagus, Salivary Gland, Pancreas, Skin.
Aniaal Nuaber: 1R-4873 Sex: Feaale Group: ( 4) FM-3924 10 ppa Fate: !Week= 105) Terainal Sacrifice
Macroscopic Observations:
Microscopic Observations: Adrenal Heart Kidney Liver
Lung
-No v is ib le lesions.
-Sinusoidal ectasia, cortex, aoderate -Myocardial fib ro s is , local areas, aoderate -Chronic progressive nephropathy, a ild -Hepatocyte vacuolation, a u ltifo c a l, a ild Hepatocyte a lte ra tio n , vacuolated,
local areas, a ild -Vascular aineralization, a ild Heaorrhage, local areas, aoderate
The follow ing tissues were found to be w ithin noraal li a i t s : Spleen, Uterus, Ovary, Maaaary Gland, Stoaach, Urinary Bladder, Thyroid, Parathyroid, Trachea, Esophagus, Salivary Gland, P itu ita ry , Pancreas.
Species: Rat Project Nuaber: 0281CR0012
001928
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Rifcer Laboratories, Inc. 3H FH-3924: Too Year Oral Toxicity-Oncogenicity Study in Rats
Table: 2
A niial Nuiber: 1R-4B74 Sex: Feaale Group: ( 4) FH-3924 10 ppa Fate: (Week= 90) Found Dead
Macroscopic Observations: P ituitary
Microscopic Observations: Kidney Liver
P itu ita ry Spleen
-Mass, 1 x 0.7 c i.
-Chronic progressive nephropathy, l i l d -Portal aononuclear c e ll in f ilt r a t e , i i I d Portal b ile duct p r o liFeration, loderete Hepatocyte vacuolation, p e rip o rta l, loderate -Adenoia -Heiosiderosis, l i ld
The Following tissues were Found to be w ithin noraal l i i i t s : Heart, Lung, Uterus, Ovary, Hauary Gland, Stoiach, Urinary Bladder, Adrenal, Thyroid Parathyroid, Trachea, Esophagus, Salivary Gland, Pancreas.
Aniial Nuiber: 1R-4B75 Sex: Feiale Group: ( 4) FH-3924 10 ppi Fate: (Week- 104) Found Dead
Macroscopic Observations: Skin Liver P itu ita ry
Microscopic Observations: Adrenal
Esophagus Eye Kidney
Liver
Lung
Hauary 61and Ovary Pancreas Parathyroid P itu ita ry Salivary Gland Spleen Thyroid Trachea Urinary Bladder
-Large lass, 11 x 13 c i, rig h t side. -Pale and aottled. -Dark red lass.
-C ortical vacuolation, local areas, l i l d
Sinusoidal ectasia, cortex, derate
-Not exaiined, lis s in g
-No diagnosis, inadequate section
-Pelvic aineralization, derate
One oF pair present
-Portal b ile duct p ro lite ra tio n , l i l d
Necrosis, ce ntrilobular, iId
-Alveolar eacrophages, su ltiF o cal, l i l d
Throibus, iu ltiF o c a l, derate
-Fibroadenoia
-Not exaiined, lis s in g
-Not exaiined, lis s in g
-Not exaiined, lis s in g
-Not exaiined, lis s in g
-Not exaiined, lis s in g
,
-Heiosiderosis, derate
-Not exaiined, lis s in g
-Not exaiined, lis s in g
-Not exaiined, lis s in g
Species: Rat Project Nuiber: 02B1CR0012
001929
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Suaaarized Single Tabulated Aniaal Report (continued) Individual Hacroscopic and Hicroscopic Observations
Riker Laboratories, Inc. 3H FH-3924: Two Year Oral Toxicity-Oncogenicity Study in Rats
Table: 2
Aniaal Nuaber: 1R-4875 Sex: Feaale 6roup: ( 4) FH-3924 10 ppa Fate: (Neek= 104) Found Dead
Microscopic Observations (continued):
The following tissues were Found to be w ithin norail li a i t s : Heart, Uterus, Stoaach.
Aniaal Nuaber: 1R-4876 Sex: Feaale 6roupi ( 4! FH-3924 10 ppa Fate: (Heek= 105) Terainal Sacrifice
Hacroscopic Observations: Haaaary Bland
Hicroscopic Observations: Adrenal Liver
Lung Haaaary Bland Thyroid Uterus
-Lobular aass, 5.5 x 5 x 2 ca, rig h t a x illa .
-Sinusoidal ectasia, cortex, aoderate -Hepatocyte a lte ra tio n , vacuolated, focal, i id -Vascular a in e ra liza tio n , aiId -Fibroadenoaa -Ultiaobranchial cyst -Polyp
The follow ing tissues were found to be w ithin noraal li a i t s : Spleen, Kidney, Heart, Ovary, Stoaach, Urinary Bladder, Parathyroid, Trachea, Esophagus, Salivary Eland, P itu ita ry , Pancreas.
Aniaal Nuaber! 1R-4877 Sex: Feaale Broup: ( 4) FH-3924 10 ppa Fate: (Heek= 84) Sacrificed in extreais
Hacroscopic Observations: P ituitary
Hicroscopic Observations! Adrenal Kidney
Liver Lung
P itu ita ry Salivary Bland Spleen Thyroid
-Raised aass, 1 ca dia.
-Sinusoidal ectasia, cortex, a ild -Chronic progressive nephropathy, a ild Pelvic aineralization, ainiaal -Hepatocyte vacuolation, p e rip o rta l, aoderate -Vascular a in e ra liza tio n , a ild Perivascular aononudear in f ilt r a t e , a ild Heaorrhage, a u ltifo c a l, a ild -Adenoaa -Not exaained, aissing -Heaosiderosis, a ild -Ultiaobranchial cyst
The follow ing tissues were found to be w ithin noraal li a i t s : Heart, Uterus, Ovary, Haaaary Gland, Stoaach, Urinary Bladder, Parathyroid, Trachea, Esophagus,
Species: Rat Project Nuaber: 02B1CR0012
001930
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Suaaarized Single tabulated Aniaal Report (continued) Individual Macroscopic and Microscopic Observations
Riker Laboratories, Inc. 3H FM-3924: Tao Year Oral Toxicity-Oncogenicity Study in Rats
Table: 2
Aniaal Nuaber: 1R-4877 Sex: Feaale Group: ( 4) FM-3924 10 ppa Fate: (Meek- 04) Sacrificed in extreais
Microscopic Observations (continued): The fo llo ttin g tissues aere found to be a ith in noraal l i a i t s (continued): Pancreas.
Aniaal Nuaber: 1R-4878 Sex: Feaale Group: ( 4) FM-3924 10 ppa Fate: (Meek 105) Terainal Sacrifice
Macroscopic Observations: Haaiary Gland P itu ita ry
Microscopic Observations: Adrenal
Kidney
Liver
Lung
Haaaary Gland Ovary P itu ita ry Uterus
-F ira aass, b x 4 x 2 ca, rig h t a x illa . -Raised aass, 0.5 ca dia.
-Sinusoidal ectasia, cortex, u n ila te ra l, aoderate -Pelvic a in e ra liza tio n , aoderate P y e litis , acute, u n ila te ra l, a ild
-Hepatocyte vacuolation, p e rip o rta l, a ild Hepatocyte a lte ra tio n , vacuolated, focal, a ild -Vascular aineralization, a ild Alveolar aacrophages, a u ltifo c a l, a ild Pneuaonia, in t e r s t it ia l, chronic, a u ltifo c a l, a ild -Fibroadenoaa -Tubular hyperplasia, b ila te ra l, a ild -Adenoaa -Cystic glands, aoderate
The follow ing tissues were found to be w ithin noraal li a i t s : Spleen, Heart, Stoaach, Urinary Bladder, Thyroid, Parathyroid, Trachea, Esophagus, Salivary Gland, Pancreas.
Aniaal Nuaber: 1R-4879 Sex: Feaale Group: ( 4) FM-3924 10 ppa Fate: (Meek* 84) Found Dead
Macroscopic Observations: Soft Tissues (leg)
Liver
P itu ita ry Microscopic Observations:
Adrenal
-Hass, 7 x 3 x 2 ca, g r it t y texture, le f t hind leg.
-S lig h tly enlarged with a u ltip le pale lesions, 0.1 - 0.5 ca d ia ., on a ll lobes.
-Heaorrhagic aass, 0.3 x 0.5 ca.
-Sinusoidal ectasia, cortex, aoderate
Species: Rat Project Nuaber: 02B1CR0012
001931 `
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Suaearized Single Tabulated Anieal Report (continued) Individual Macroscopic and Microscopic Observations
Riker Laboratories, Inc. 3M FM-3924: Two Year Oral Toxicity-Oncogenicity Study in Rats
Table: 2
Anieal Nuaber: 1R-4879 Sex: Feeale Group: ( 4) FM-3924 10 ppe Fate: (Week- 84) Found Dead
Microscopic Observations (continued): Heart Kidney Liver
Lung
Pancreas Parathyroid P itu ita ry Skin
Spleen Thyroid
-Malignant lyephoea, h is tio c y tic -Protein resorption droplets, eiId -Malignant lyephoea, h is tio c y tic Necrosis, local areas, eoderate -Vascular eineralization, o ild Malignant lyephoea, h is tio c y tic Heeorrhage, local areas, eiId -Not exaeined, eissing -Not exaeined, eissing -Adenoea -Malignant lyephoea, h is tio c y tic
Gross lesion froe le f t hindleg. -Heeosiderosis, a ild -Not exaeined, eissing
The follow ing tissues were found to be w ithin noreal l ie it s : Uterus, Ovary, Maeaary Gland, Stoeach, Urinary Bladder, Trachea, Esophagus, Salivary Gland.
Anieal Nuaber: 1R-48B0 Sex: Feeale Group: ( 4) FM-3924 10 ppe Fate: (Heek= 78) Found Dead
Macroscopic Observations: Uterus P itu ita ry
Microscopic Observations: Kidney Liver Lung Haaeary 61and Pancreas P itu ita ry Salivary Gland Spleen
-Both horns f i l l e d with dark flu id . -Heeorrhagic aass, 0.4 ce dia.
-Pelvic eineralization, a ild -Hepatocyte vacuolation, p e rip o rta l, eiId -Vascular eineralization, a ild -Adenocarcinoea -Not exaeined, eissing -Adenoea -Not exaeined, eissing -Heeosiderosis, eoderate
The follow ing tissues were found to be w ithin noreal l ie it s : Heart, Uterus, Ovary, Stoeach, Urinary Bladder, Adrenal, Thyroid, Parathyroid, Trachea Esophagus.
Species: Rat Project Nuaber: 0261CR0012
001932
Sueaarized STAR Page: 25b
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Sueaarized Single Tabulated Anieal Report (continued) Individual Macroscopic and Microscopic Observations
Riker Laboratories, Inc. 3M FH-3924: Two Year Oral Toxicity-Oncogenicity Study in Rats
Table: 2
Anieal Nueber: 1R-4B81 Sex: Fecale Group: ( 4) FH-3924 10 ppe Fate: (Heek= 105) Tereinal Sacrifice
Macroscopic Observations: Maseary Gland Uterus
Microscopic Observations: Adrenal Heart
Kidney Liver
Lung Maeeary Gland Ovary Parathyroid Uterus
-Lobular eass, 5 x 3 x 2 ce, r ig h t a x illa . -Cystic lesion, 2 x 0.8 ce, l e f t horn.
-Sinusoidal ectasia, cortex, e ild -Myocarditis, chronic nonsuppurative, e ultifo cal, eild -Chronic progressive nephropathy, einieal -Hepatocyte vacuolation, e u ltifo c a l, e ild
Hepatocyte a lte ra tio n , vacuolated, focal, e ild -Vascular e in eralization, e ild -Lobular hyperplasia -Cyst, unilateral -Not exaoined, not in plane of section -Polyp
The follow ing tissues were found to be w ithin noreal l ie it s : Spleen, Stoeach, Urinary Bladder, Thyroid, Trachea, Esophagus, Salivary 61and, P itu ita ry , Pancreas.
Anieal Nueber: 1R-4882 Sex: Feeale Group: ( 4) FH-3924 10 ppe Fate: (Week= 105) Tereinal Sacrifice
Macroscopic Observations: Maeeary 61and
Microscopic Observations: Adrenal Heart Liver
Lung
Maeeary Gland
-Seal1 eass, 2 ce d ia ., rig h t inguinali large eass 5 x 5 x 1 ce, le f t inguinal; eass, 4 x 4 x 1 ce, rig h t a x illa ry
-Sinusoidal ectasia, cortex, earked -Myocarditis, chronic nonsuppurative, e u ltifo ca l, eild -Portal eononudear c e ll in f ilt r a t e , einieal Portal b ile duct p ro life ra tio n , einieal Heaatopoiesis, extraeedullary, einieal -Vascular eineralization, e ild Pneueonia, in t e r s t it ia l, chronic, e u ltifo c a l, e ild -Fibroadenoea Galactocele Lobular hyperplasia Lobular hyperplasia
Species: Rat Project Nueber: 0281CR0012
001933
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Suaaarized Single Tabulated Aniaal Report (continued) Individual Macroscopic and Microscopic Observations
Riker Laboratories, Inc. 3N FH-3924: Tuo Year Oral Toxicity-Oncogenicity Study in Rats
Table: 2
Aniaal Nuaber: 1R-48B2 Sex: Feaale Group: ( 4) FH-3924 10 ppa Fate: (Neek= 105) Terainal Sacrifice
Hicroscopic Observations (continued): Ovary Uterus
'Cyst, bila tera l -Hyperplasia, endoaetrial, aoderate
The fo llo u in g tissues ere found to be ith in noraal l ia it s : Spleen, Kidney, 5toaach, Urinary Bladder, Thyroid, Parathyroid, Trachea, Esophagus, Salivary Gland, P itu ita ry , Pancreas.
Aniaal Nuaber: 1R-4B83 Sex: Feaale Group: ( 4) FH-3924 10 ppa Fate: (Neek= 105) Terainal Sacrifice
Macroscopic Observations'. P itu ita ry Haaaary 61and
Hicroscopic Observations: Adrenal Kidney
Liver
Haaaary Gland
Ovary Pancreas P itu ita ry Salivary Gland Spleen
-Hass, 1 ca dia. -Cystic lobular aass, 5 x 3.5 x 2 ca, rig h t
a x illa ; lobular aass, 4 x 4 x 3 ca, rig h t inguinal; lobular aass, 5 x 5.5 x 2.5 ca, le f t inguinal.
-Sinusoidal ectasia, cortex, a ild -Pelvic aineralization, a ild Nephrosis, tubular, aarked -Portal aononuclear c e ll in f ilt r a t e , a ild Portal b ile duct p ro life ra tio n , a ild Heaatopoiesis, extraaedullary, ainiaal -Fibroadenoaa Galactocele Adenocarcinoaa Fibroadenoaa -Not exaained, aissing -Hyperplasia, is le t c e ll, a ild -Adenoaa -Not exaained, aissing -Heaatopoiesis, extraaedullary, increased, aoderate
The fo llo u in g tissues were found to be w ithin noraal l ia it s : Heart, Lung, Uterus, Stoaach, Urinary Bladder, Thyroid, Parathyroid, Trachea, Esophagus.
Species: Rat Project Nuaber: 0281CR0012
001934
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Suaaarized Single Tabulated Aniaal Report (continued) Individual Macroscopic and Microscopic Observations
Riker Laboratories, Inc. 3H FH-3924: Tuo Year Oral Toxicity-Oncogenicity Study in Rats
Table: 2
Aniaal Nuaber: 1R-4B84 Sex: Feaale 6roup: { 4) FH-3924 10 ppa Fate*. (Neek= 105) Terainal S acrifice
Macroscopic Observations: Maaaary Gland
Kidney
Uterus
Microscopic Observations: Adrenal Heart Kidney
Liver Lung Maaaary Gland Ovary Pancreas P itu ita ry Salivary Gland Spleen
Uterus
-Large lobular aass, 10 x 8 x 5 ca, perineal area.
-Congenital absence of le f t kidney; rig h t kidney enlarged x ith saall cysts.
-Congenital absence of le f t uterus and ovary; rig h t side appears noraal.
-Sinusoidal ectasia, cortex, narked -Myocardial fib ro s is , local areas, a ild -Chronic progressive nephropathy, aoderate Hydronephrosis, b ila te ra l -Heaatopoiesis, extraaedullary, ainiaal -Hyperplasia, septal c e ll, focal, a ild -Fibroadenoaa -Cyst -Not exaained, aissing -Not exaained, aissing -Not exaained, aissing -Heaatopoiesis, extraaedullary, increased, a ild -Cystic glands, aoderate
The folloMing tissues ere found to be M ithin noraal 1i its : Stonach, Urinary Bladder, Thyroid, Parathyroid, Trachea, Esophagus.
Aniaal Nuaber: 1R-48B5 Sex: Feaale Group: ( 4) FH-3924 10 ppa Fate: (Neek= 105) Terainal Sacrifice
Macroscopic Observations: P itu ita ry Maaaary Gland
Microscopic Observations: Adrenal C lito ra l Gland
Kidney
Liver
Lung
-Hass, 0.6 ca dia. -F irn aass, 2.5 x 2 x 1 ca, le f t a x illa .
-Sinusoidal ectasia, cortex, a ild -Cyst, aoderate Inflaaaation, chronic, aoderate -Chronic progressive nephropathy, a ild Pelvic aineralization, a ild -Hepatocyte vacuo!ation, a u ltifo c a l, a ild Hepatocyte a lte ra tio n , vacuolated,
local areas, a ild -Vascular aineralization, a ild
Species: Rat Project Nuaber: 0281CR012
001935
-
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Suaaarized Single Tabulated Aniaal Report (continued) Individual Macroscopic and Microscopic Observations
Riker Laboratories, Inc. 3M FH-3924: Tao Year Oral Toxicity-Oncogenicity Study in Rats
Table: 2
Aniaal Nuaber: 1R-48B5 Sex: Feaale Group: ( 4) FH-3924 10 ppa Fate: (Heek= 105) Terainal SacriFice
Microscopic Observations (continued): Maaaary Gland P itu ita ry Thyroid
-Fibroadenoaa -Adenoaa -Ultiaobranchial cyst
The Following tissues were Found to be w ithin noraal l ia it s : Spleen, Heart, Uterus, Ovary, Stoaach, Urinary Bladder, Parathyroid, Trachea, Esophagus Salivary Gland, Pancreas.
Aniaal Nuaber: 1R-4B86 Sex: Feaale 6roup: ( 4) FH-3924 10 ppa Fate: (Meeks 99) Found Dead
Macroscopic Observations: Maaaary Gland
Liver Adrenal Urinary Gladder P itu ita ry Microscopic Observations: Adrenal Heart Kidney
Liver Lung
Maaaary Bland Salivary 61and Spleen
Urinary Bladder
Uterus
-Large lobular Fira aass, 14.5 x 11 x 4.5 ca, * in inguinal area. -Pale -Enlarged with a u ltip le pale Foci. -Thickened walls -S lig h tly enlarged
-Sinusoidal ectasia, cortex, aarked -Myocardial Fibrosis, a ultiF ocal, a ild -Pelvic aineralization, a ild Hyperplasia, pelvic epitheliua, a ild Heaatopoiesis, extraaedullary, a ild -Necrosis, c e n trilo b u la r, aoderate -Vascular aineralization, a ild Alveolar aacrophages, aultiF ocal, a ild -Fibroadenoaa -Not exaained, aissing -Heaatopoiesis, extraaedullary, increased, aoderate -E p ith e lia l hyperplasia, papillary, diffuse, aarked
Areas oF squaaous aetaplasia oF hyperplastic epitheliua. C y s titis , chronic, diFFuse, aarked -Cystic glands, aarked
The Following tissues were Found to be w ithin noraal l ia it s : Ovary, Stoaach, Thyroid, Parathyroid, Trachea, Esophagus, P itu ita ry , Pancreas.
Species: Rat Project Nuaber: 02B1CR0012
001936
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Suaaarized Single Tabulated flniaal Report (continued) Individual Hacroscopic and Hicroscopic Observations
Riker Laboratories, Inc. 3N FH-3924: Tao Year Oral Toxicity-Oncogenicity Study in Rats
Table: 2
Anieal Nuaber: 1R-4887 Sex: Feaale Group: ( 4) FH-3924 10 ppa Fate: (Heek= 100) Sacrificed in extreais
Hacroscopic Observations: P itu ita ry Liver
Hicroscopic Observations: Adrenal Kidney
Liver
Lung
P itu ita ry Spleen Uterus
-Raised ass, 0.8 ca dia. -Appears pale and aottled.
-C ortical vacuolation, local areas, a:Id -Chronic progressive nephropathy, a ild Pelvic aineralization, a ild -Portal aononudear c e ll in f ilt r a t e , a ild Portal b ile duct p ro life ra tio n , a ild Hepatocyte vacuolation, p e rip o rta l, aoderate Hepatocyte a lte ra tio n , basophilic, local areas, aoderate -Vascular aineralization, a ild Alveolar aacrophages, a u l t i f ocal, a ild Granuloaa, fo cal, ainiaal -Adenoaa -Heaosiderosis, a ild -Polyp
The fo llo xin g tissues were found to be a ith in noraal li a i t s : Heart, Ovary, Haaaary Gland, Stoaach, Urinary Bladder, Thyroid, Parathyroid, Trachea, Esophagus, Salivary Gland, Pancreas.
Aniaal Nuaber: 1R-4888 Sex: Feaale Group: ( 4) FH-3924 10 ppa Fate: (Week- 77) Found Dead
Hacroscopic Observations: Skin
Hicroscopic Observations: Esophagus Kidney Li ver Lung
Pancreas Parathyroid Salivary 61and Spleen Thyroid Trachea
-Hair thinning, dorsal area and head.
-Not exaained, aissing -N ephritis, acute, fo cal, a ild -Hepatocyte vacuolation, p e rip o rta l, a ild -Vascular aineralization, a ild Edeaa, local areas, aoderate Pneuaonia, bronchopneuaonia, d iffu se , acute, aoderate -Not exaained, aissing -Not exaained, aissing -Not exaained, aissing -Heaosiderosis, a ild -Not exaained, aissing -Not exaained, aissing
Species: Rat Project Nuaber: 02B1CR0012
001937
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Suaaarized Single Tabulated Aniaal Report (continued) Individual Hacroscopic and Hicroscopic Observations
Riker Laboratories, Inc. 3H FH-3924: Two Year Oral Toxicity-Oncogenicity Study in Rats
Table: 2
Aniaal Nuaber: 1R-4888 Sex: Feaale Group: ( 4) FH-3924 10 ppa Fate: (Neek= 77) Found Dead
Hicroscopic Observations (continued): Uterus
-Not exaained, aissing
The follow ing tissues were found to be w ithin noraal l ia it s : Heart, Ovary, Haaaary Gland, Stoaach, Urinary Bladder, Adrenal, P itu ita ry , Skin.
Aniaal Nuaber: 1R-4889 Sex: Feaale Group: ( 4) FH-3924 10 ppa Fate: (Neek= 105) Terainal Sacrifice
Hacroscopic Observations: P itu ita ry
Hicroscopic Observations: Adrenal Kidney
Liver Lung
Haaaary 61and P itu ita ry
-Heaorrhagic aass, 0.7 ca dia.
-Sinusoidal ectasia, cortex, aarked -Chronic progressive nephropathy, ai Id Pelvic aineralization, a ild -Hepatocyte vacuolation, a u ltifo c a l, a ild -Vascular a in e ra liz a tio n , a ild Pneuaonia, in t e r s t it ia l, chronic, a u ltifo c a l, a ild Perivascular aononudear in f ilt r a t e , a ild -Galactocele -Adenoaa
The follow ing tissues were found to be w ithin noraal l i a i t s : Spleen, Heart, Uterus, Ovary, Stoaach, Urinary Bladder, Thyroid, Parathyroid, Trachea, Esophagus, Salivary 61and, Pancreas.
Aniaal Nuaber: 1R-4890 Sex: Feaale Group: ( 4) FH-3924 10 ppa rate! (Neek= 94) Sacrificed in extreais
Hacroscopic Observations: P itu ita ry Liver
Hicroscopic Observations: Adrenal Kidney
Liver Lung
P itu ita ry Spleen
-Reddened aass, 1 ca dia. -Appears pale
-Sinusoidal ectasia, cortex, a ild -Chronic progressive nephropathy, ainiaal Pelvic aineralization, ainiaal -Hepatocyte vacuolation, d iffu se , aarked -Vascular aineralization, a ild
Alveolar aacrophages, local areas, a ild -Adenoaa -Heaosiderosis, a ild
Species: Rat Project Nuaber! 0281CR0012
001938
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Suaaarized Single Tabulated Aniaal Report (continued) Individual Hacroscopic and Hicroscopic Observations
Riker Laboratories, Inc. 3H FN-3924: Two Year Oral Toxicity-Oncogenicity Study in Rats
Table: 2
Aniaal Nuaber: 1R-4890 Sex: Feaale Group: ( 4) FH-3924 10 ppa Fate: (Heek= 94) Sacrificed in extreais
Hicroscopic Observations (continued):
Urinary Bladder
,
-Transitional c e ll carcinoaa Invasive subepithelial tuaor. High a ito tic a c tiv ity ; diffuse inflaaaatory ce ll in filtra te .
The following tissues were found to be a ith in noraal lia i t s : Heart, Uterus, Ovary, Haaaary Gland, Stoaach, Thyroid, Parathyroid, Trachea, Esophagus, Salivary Bland, Pancreas, Large Intestine.
Aniaal Nuaber: 1R-4891 Sex: Feaale Group: ! 4) FH-3924 10 ppa Fate: (Week- 7B) Sacrificed in extreais
Hacroscopic Observations: Skin P itu ita ry Liver
Adrenal Hicroscopic Observations:
Adrenal
Kidney Liver
Lung Pancreas P itu ita ry
-Hair loss on head, leg, rig h t ear. -Heaorrhagic aass, 0.7 x 0.6 ca. -Saall yellowish lesion, 0.3 x 0.2 ca, on the
outer area near fissure of aedian lobe. -Right adrenal possibly s lig h tly enlarged.
-Within noraal l i a i t s One of pair present
-Chronic progressive nephropathy, a ild -Hepatocyte vacuolation, c e ntrilo b ular, local areas, a ild -Vascular a in eralization, a ild -Not exaained, aissing -Adenoaa
The fallow ing tissues ere found to be w ithin noraal l ia it s : Spleen, Heart, Uterus, Ovary, Haaaary Gland, Stoaach, Urinary Bladder, Thyroid, Parathyroid, Trachea, Esophagus, Salivary Gland, Brain, Skin.
Aniaal Nuaber! 1R-4892 Sex: Feaale Group: ( 4) FH-3924 10 ppa Fate: (Week5 105) Terainal Sacrifice
Hacroscopic Observations: P itu ita ry Haaaary 61and
-Hass, 0.7 ca dia. -F ira aass, 6.5 x 5.5 x 4.5 ca, rig h t a x illa ;
lobular aass, 3.5 x 3 x 2 ca, in throat area; f ir a aass, 4 x 3 x 3 ca, in le f t a x illa ; aass, 2 x 1.5 x 1.2 ca,
Species: Rat Project Nuaber: 0281CR0012
001939
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Suaaarized Single Tabulated Aniaal Report (continued) Individual Macroscopic and Microscopic Observations
Riker Laboratories, Inc. 3H ' FM-3924: Tao Year Oral Toxicity-Oncogenicity Study in Rats
Table: 2
Aniaal Nuaber: 1R-4892 Sex: Feaale Group: ( 4) FM-3924 10 ppa Fate: (Neek= 105) Terainal Sacrifice
Macroscopic Observations (continued):
Haaaary Bland (continued) Microscopic Observations:
Adrenal Kidney Liver
Lung
Haaaary 61and
Pancreas P itu ita ry
- le ft inguinal.
Sinusoidal ectasia, cortex, aarked -Chronic progressive nephropathy, ainiaal -Portal aononudear c e ll in f ilt r a t e , ainiaal Hepatocyte vacuolation, a u ltifo c a l, a ild Hepatocyte a lte ra tio n , basophilic, focal, a ild -6ranuloaa, focal, a ild Heaorrhage, local areas, aoderate Vascular a in e ra liza tio n , a ild -Fibroadenoaa Fibroadenoaa Fibroadenoaa -Acinar atrophy, aoderate -Adenoaa
The fo l 1owing tissues ere found to be w ithin noraal l ia it s : Spleen, Heart, Uterus, Ovary, Stoaach, Urinary Bladder, Thyroid, Parathyroid, Trachea, Esophagus, Salivary 61and.
Aniaal Nuaber: 1R-4B93 Sex: Feaale 6roup: ( 4) FM-3924 10 ppa Fate: (Neek= 81) Sacrificed in extreais
Macroscopic Observations: P itu ita ry
Microscopic Observations: Adrenal Liver
Lung
Parathyroid P itu ita ry Spleen
-Enlarged due to a red aass, 1.4 x 0.7 ca.
-Sinusoidal ectasia, cortex, aoderate -Portal aononuclear c e ll in f ilt r a t e , a ild
Portal b ile duct p ro life ra tio n , a ild -Vascular aineralization, ainiaal Perivascular aononuclear in f ilt r a t e , a ild -Not exaained, not in plane of section -Adenoaa -Heaosiderosis, aoderate
The follow ing tissues were found to be w ithin noraal l ia it s : Uterus, Ovary, Haaaary Bland, Stoaach, Urinary Bladder, Thyroid, Trachea, Esophagus, Salivary Gland, Pancreas, Heart, Kidney.
Species: Rat Project Nuaber: 0281CR012
001940
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S u m m e d Single Tabulated A n iia l Report (continued) Individual Macroscopic and Microscopic Observations
Riker Laboratories, Inc. 3H FH-3924: Two Year Oral Toxicity-Oncogenicity Study in Rats
Table: 2
Aniaal Nuaber: 1R-4894 Sex: Feaale Broup: ( 4) FM-3924 10 ppa Fate: (Week: 105) Terainal Sacrifice
Macroscopic Observations: Haaaary Gland
Microscopic Observations: Liver Lung Pancreas Parathyroid P itu ita ry Thyroid Uterus
-C ircular nodule, 1.5 ca d ia ., a ilk cyst which ruptured upon in cisio n .
-Hepatocyte vacuolation, a u ltifo c a l, a iId -Vascular aineralization, a ild -Acinar atrophy, aoderate -Not exaained, not in plane of section -Adenoaa -Ultiaobranchial cyst -Cystic glands, a ild
The following tissues were found to be w ithin noraal lia i t s : Spleen, Kidney, Heart, Ovary, Maaaary Bland, Stoaach, Urinary Bladder, Adrenal, Trachea, Esophagus, Salivary Bland.
Aninal Nuaber: 1R-4B95 Sex'. Feaale Group: I 4) FM-3924 10 ppa Fate: (Neek= 80) Sacrificed in extreais
Macroscopic Observations:
Microscopic Observations: Heart
Liver
Lung P itu ita ry
-No v is ib le lesions.
-Myocarditis, chronic nonsuppurative, a u ltifo ca l, aild
-Hepatocyte vacuolation, a u ltifo c a l, a ild Necrosis, focal, ainiaal -Heaorrhage, local areas, aoderate
-Adenoaa
The following tissues were found to be w ithin noraal li a i t s : Spleen, Kidney, Uterus, Ovary, Haaaary Bland, Stoaach, Urinary Bladder, Adrenal, Thyroid, Parathyroid, Trachea, Esophagus, Salivary Bland, Pancreas.
Aniaal Nuaber: 1R-4896 Sex: Feaale 6roup: ( 4) FM-3924 10 ppa Fate: (Meek- 105) Terainal Sacrifice
Macroscopic Observations: Haaaary Bland Kidney
Microscopic Observations: Adrenal
-Lobular aass, 4 x 3 x 2 ca, le f t a x illa . -Pale and p itte d .
-C ortical vacuolation, local areas, a ild Sinusoidal ectasia, cortex, a ild
Species: Rat Project Nuaber: 0281CR0012
001941
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Suaaarized Single Tabulated Aniaal Report (continued) Individual Hacroscopic and Microscopic Observations
Riker Laboratories, Inc. 3M FH-3924: Txo Year Oral Toxicity-Oncogenicity Study in Rats
Table: 2
Aniaal Nuaber: 1R-4896 Sex: Feaale 6roup: ( 4) FH-3924 10 ppa Fate: (Neek= 10S) Terainal Sacrifice
Microscopic Observations (continued): Kidney Liver
Lung Haaaary Gland Ovary
Pancreas P itu ita ry Uterus
-Chronic progressive nephropathy, aarked -Portal aononudear c e ll in f ilt r a t e , ainiaal Portal b ile duct p ro life ra tio n , ainiaal Hepatocyte a lte ra tio n , basophilic, focal, a ild -Alveolar aacrophages, fo cal, ainiaal -Fibroadenoaa -Cyst, unilateral Tubular hyperplasia, b ila te ra l, aoderate -P o ly a rte ritis , aarked -Adenoaa -P o ly a rte ritis , aoderate
The fo llo x in g tissues were found to be w ithin noraal li a i t s : Spleen, Heart, Stoaach, Urinary Bladder, Parathyroid, Trachea, Esophagus, Salivary 61and, Thyroid.
Aniaal Nuaber: 1R-4B97 Sex: Feaale Group: ( 4) FH-3924 10 ppa Fate: (Heek= 105) Terainal Sacrifice
Macroscopic Observations: P itu ita ry
Microscopic Observations: Adrenal Kidney Liver
Lung
Ovary P itu ita ry
-Soft heaorrhagic aass, 0.i> ca dia.
-Sinusoidal ectasia, cortex, aarked -Chronic progressive nephropathy, ainiaal Pelvic aineralization, ainiaal -Portal aononudear c e ll in f ilt r a t e , a ild Hepatocyte a lte ra tio n , basophilic, focal,
ainiaal Hepatocyte vacuolation, p e rip o rta l, aoderate -Alveolar aacrophages, fo c a l, ainiaal Cyst
Large cystic bronchus with squaaous aetaplasia of epithetiua; f ille d with keratin. Vascular a in era liza tion , a ild -Cyst, unilateral Tubular hyperplasia, b ila te ra l, a ild -Adenoaa
The fo llo x in g tissues xere found to be x ith in noraal li a i t s : Spleen, Heart, Uterus, Haaaary 61and, Stoaach, Urinary Bladder, Thyroid, Parathyroid, Trachea,
Species: Rat Project Nuaber: 02B1CRQ012
001942
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Riker Laboratories, Inc. 3H FM-3924: Tuo Year Oral Toxicity-Oncogenicity Study in Rats
Table: 2
Aniaal Nuaber: 1R-4897 Sex: Feaale 6roup: ( 4) FM-3924 10 ppa Fate: (Neeks 105) Terainal Sacrifice
Microscopic Observations (continued): The following tissues were found to be w ithin noraal l i a i t s (continued): Esophagus, Salivary Gland, Pancreas, Brain.
Aniaal Nuaber: 1R-4898 Sex: Feaale Group: ( 4) FM-3924 10 ppa Fate: (Week- 87) Found Dead
Macroscopic Observations! Lung Uterus P itu ita ry
Microscopic Observations: Adrenal
Heart
Liver Lung
Ovary P itu ita ry Uterus
-Appeared to be f ille d with red flu id . -Appeared enlarged, flu id f ille d and darkened. -Enlarged, 0.8 x 0.6 ca.
-Sinusoidal ectasia, cortex, aoderate C ortical degeneration, local areas, aoderate
-Myocarditis, chronic nonsuppurative, a u ltifo c a l, ainiaal
-Hepatocyte vacuolation, a u ltifo c a l, a ild -Vascular aineralization, a ild Edeaa, local areas, aoderate -No diagnosis, inadequate section -Adenoaa -Cystic glands, aarked Hydroaetra, aarked
The following tissues were found to be w ithin noraal l i a i t s : Spleen, Kidney, Haaaary Gland, Stoaach, Urinary Bladder, Thyroid, Parathyroid, Trachea, Esophagus, Salivary Gland, Pancreas.
Aniaal Nuaber'. 1R-4899 Sex: Feaale Group: ( 4) FM-3924 10 ppa Fate: (Keek: 80) Found Dead
Macroscopic Observations: Skin Kidney
Uterus P itu ita ry Microscopic Observations: Adrenal Esophagus Lung
-Subcutaneous Bass, 2.5 x 3 ca, le f t inguinal. -Cyst, 0.5 x 0.3 ca, on e x te rio r of le f t
kidney. -Appeared enlarged; rig h t Fallopian tube dark. -Large heaorrhagic aass, 1.5 x 1 ca.
-Not exaained, aissing -Not exaained, aissing -Vascular aineralization, a ild Perivascular aononudear in f ilt r a t e , a ild Edeaa, local areas, aoderate
Species: Rat Project Nuaber: 0281CR0012
00194a
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Riker Laboratories, Inc. 3M FM-3924: Two Year Oral Toxicity-Oncogenicity Study in Rats
Table: 2
Anieal Nueber: 1R-4899 Sex; Feaale 6roup: ( 4) FM-3924 10 pps Fate: (Heek= 80) Found Dead
Microscopic Observations (conti Maeeary Bland
Parathyroid P itu ita ry Spleen Thyroid Trachea Urinary Bladder
-Lobular hyperplasia Balactocele -Not exaeined, eissing -Adenoaa -Heaosiderosis, a ild -Not exaained, aissing -Not exaained, aissing -Not exaained, aissing
The following tissues ere found to le w ithin noraal U n its : Liver, Kidney, Heart, Uterus, Ovary, Stoaach, Salivary Gland, Pancreas.
Aniaal Nuaber: 1R-490 Sex: Feaale Group: < 4) FM-3924 10 ppa Fate: (Neek= 95) Sacrificed in extreais
Macroscopic Observations: Spleen Liver Large Intestine
Lyaph Node (aesenteric) Saall Intestine Microscopic Observations'. Adrenal
Heart
Kidney
Large Intestine
Liver Lung
Lyaph Node (aesenteric) Maaaary Gland Ovary
-Enlarged -S lig h tly pale with rough surface. -Mass, 3.5 x 2.3 x 1.5 ca, protruding froa
cecua at ileocecal valve area, possibly causing a re s tric tio n in valve area resu ltin g in a gross enlargeaent of the ileua. -S lig h tly enlarged. -N alls thickened near cecua.
-Sinusoidal ectasia, cortex, aoderate Malignant lyaphoaa, h is tio c y tic
-Myocarditis, chronic nonsuppurative, fo cal, ainiaal -Malignant lyaphoaa, h is tio c y tic Protein resorption droplets, aarked -Malignant lyaphoaa, h is tio c y tic Massive neoplastic involveaent of cecal wall with ulceration of luaenal surface. -Malignant lyaphoaa, h is tio c y tic
-Vascular aineralization, ainiaal Malignant lyaphoaa, h is tio c y tic -Malignant lyaphoaa, h is tio c y tic
-Not exaained, aissing -Malignant lyaphoaa, h is tio c y tic
Species: Rat Project Nuaber: 02B1CR0012
001944
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Riker Laboratories, Inc. 3M FM-3924: Two Year Oral Toxicity-Oncogenicity Study in Rats
Table: 2
Aniaal Nuaber: 1R-49GG Sex: Feaale 6roup: ( 4) FH-3924 10 ppa Fate: (Keek* 95) Sacrificed in extreais
Microscopic Observations (continued): Pancreas Saall Intestine Spleen Thyroid Urinary Bladder
-Malignant lyaphoaa, h is tio c y tic -Malignant lyaphoaa, h is tio c y tic -Malignant lyaphoaa, h is tio c y tic -Ultiaobranchial cyst -Malignant lyaphoaa, h is tio c y tic
The following tissues were Found to be w ithin noraal U n its : Uterus, Stoaach, Parathyroid, Trachea, Esophagus, P itu ita ry , Salivary Gland.
Aniaal Nuaber: 1R-4901 Sex: Feaale Group: ( 4) FM-3924 10 ppa Fate: (He'ek= 56) Sacrificed in extreais
Macroscopic Observations: Skin
Microscopic Observations: Eye Kidney Liver Lung
Maaeary Gland
Pancreas Spleen
Uterus
-Large sternal subcutaneous nass, aeasuring 10 x 9 x 5 ca.
-K e ra titis , chronic, u nila te ra l, a ild -Pelvic aineralization, ainiaal -Heaatopoiesis, extraaedullary -Vascular a in e ra liza tio n , a ild Pneuaonia, in t e r s t it ia l, chronic, a u ltifo c a l,
aoderate Perivascular aononudear in f ilt r a t e , aoderate Heaorrhage, a u ltifo c a l, a ild -Fibroadenoaa
Sternal aass. -Not exaained, aissing -Heaatopoiesis, extraaedullary, increased, aoderate -Not exaained, aissing
The following tissues ere Found to be w ithin noraal l ia it s : Heart, Ovary, Stoaach, Urinary Bladder, Adrenal, Thyroid, Parathyroid, Trachea, Esophagus, Salivary Gland, P itu ita ry , Large Intestine.
Species: Rat P ro je c t Nuaber: 02B1CR0012
001945 Suaaarized STAR Page: 269
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Riker Laboratories, Inc. 3M FH-3924: Two Year Oral Toxicity-Oncogenicity Study in Rats
Table: 2
Aniaal Nuaber: 1R-4902 Sex: Feaale Broup: ( 4) FH-3924 10 ppa Fate: (Meek- 101) Found Dead
Macroscopic Observations'. P itu ita ry
Microscopic Observations'. Adrenal
Kidney Liver Lung P itu ita ry Spleen
-Heaorrhagic aass, 0.6 ca dia.
-Sinusoidal ectasia, cortex, a ild C ortical degeneration, local areas, a ild
-Pelvic aineralization, a ild -Hepatocyte vacuolation, a u ltifo c a l, a ild -Vascular a in era liza tion , a ild -Adenoaa -Heaosiderosis, a ild
The fallow ing tissues were found to be w ithin noreal l ia it s : Heart, Uterus, Ovary, Haaaary Gland, Stoaach, Urinary Bladder, Thyroid, Parathyroid, Trachea, Esophagus, Salivary Gland, Pancreas.
Aniaal Nuaber: 1R-4903 Sex: Feaale Group: ( 4) FH-3924 10 ppa Fate! (Heek= 105) Terainal Sacrifice
Macroscopic Observations: P itu ita ry
Microscopic Observations: Adrenal Heart
Kidney Liver
Lung P itu ita ry
-Soft heaorrhagic aass, 0.7 ca.
-Sinusoidal ectasia, cortex, Barked -Myocarditis, chronic nonsuppurative, a u ltifo ca l, ainiaal -Pelvic aineralization, a ild -Portal b ile duct p ro life ra tio n , a ild Hepatocyte a lte ra tio n , basophilic, local areas, aoderate -Vascular aineralization, a ild -Adenoaa
The following tissues were found to be w ithin noraal li a i t s : Spleen, Uterus, Ovary, Haaaary Gland, Stoaach, Urinary Bladder, Thyroid, Parathyroid, Trachea, Esophagus, Salivary Gland, Pancreas.
Aniaal Nuaber: 1R-4904 Sex: Feaale Group: ( 4) FH-3924 10 ppa Fate: Meek= 95) Found Dead
Macroscopic Observations: Haaaary Gland
Spleen
-M ultilobular aass, 5 x 2.5 x 1.2 ca, in rig h t a x illa . ; aass, upper shoulder area of rig h t fo re lia b , 3 x 3.4 x 2.5 ca.
-Enlarged
Species: Rat Project Nuaber: 0281CR0012
001946
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Riker Laboratories, Inc. 3M FM-3924: Tuo Year Oral Toxicity-Oncogenicity Study in Rats
Table: 2
Aniaal Nuaber: 1R-4904 Sex: Feaale Group: ( 4) FM-3924 10 ppa Fate: (Neek= 95) Found Dead
Macroscopic Observations (continued):
Liver (continued) Microscopic Observations:
Adrenal Kidney Liver
Lung Maaaary Gland
Parathyroid Salivary 61and Spleen
-Pale
-Sinusoidal ectasia, cortex, a ild -Pelvic aineralization, a ild -Hepatocyte vacuolation, c e n trilo b u la r, aoderate Necrosis, ce n trilo b u la r, a ild -Vascular a in e ra liza tio n , a ild -Adenocarcinoaa Adenocarcinoaa -Not exaained, not in plane oF section -Not exaained, aissing -Heaatopoiesis, extraaedullary, increased, aarked
The following tissues were Found to be w ithin noraal 1ia its : Heart, Uterus, Ovary, Stoaach, Urinary Bladder, Thyroid, Trachea, Esophagus, P itu ita ry , Pancreas.
Aniaal Nuiber: 1R-4905 Sex: Feaale Group: I 4) FM-3924 10 ppa Fate: (Week= 105) Terainal Sacrifice
Macroscopic Observations:
Microscopic Observations: Adrenal Heart
Liver
Lung
Uterus
-No v is ib le lesions.
-Sinusoidal ectasia, cortex, aoderate -Myocarditis, chronic nonsuppurative, aultiFocal, ainiaal -Portal aononudear c e ll in F iltra te , a ild Portal b ile duct proliF eration, a ild -Pneuaonia, in t e r s t it ia l, chronic, aultiF ocal, a ild -Hydroaetra, aarked Polyp
The Following tissues were Found to be w ithin noraal lia it s : Spleen, Kidney, Ovary, Maaaary Bland, Stoaach, Urinary Bladder, Thyroid, Parathyroid, Trachea, Esophagus, Salivary 61and, P itu ita ry , Pancreas.
Species: Rat Project Nuaber: 02B1CR0012
001947
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Riker Laboratories, Inc. 3M FH-3924: Two Year Oral Toxicity-Oncogenicity Study in Rats
Table: 2
A n iia l Nuaber: 1R-4906 Sex: Feaale 6roup: ( 4) FH-3924 10 ppa Fate: (Meek= 75) Sacrificed in extreais
Macroscopic Observations: P itu ita ry Maaiary Gland
Microscopic Observations: Adrenal Kidney Lung
Haaaary 61and P itu ita ry Spleen
-Raised red aass, 1.2 x 0.8 ca. -Nodular cystic aass, 2 x 0.5 ca, in rig h t
inguinal area.
-Sinusaidal ectasia, cortex, aoderate -Chronic progressive nephropathy, ainiaal -Pneuionia, in t e r s t it ia l, chronic, a u ltifo c a l, a ild Heaorrhage, local areas, a ild -Lobular hyperplasia -Adenoaa -Heaosiderosis, aoderate
The follow ing tissues were found to be w ithin norial li a i t s ! Liver, Heart, Uterus, Ovary, Stoaach, Urinary Bladder, Thyroid, Parathyroid, Trachea, Esophagus, Salivary Gland, Pancreas, Skin.
Aniaal Nuaber: 1R-4907 Sex: Feaale Group: ( 4) FH-3924 10 ppa Fate: (Neek= 105) Terainal Sacrifice
Macroscopic Observations: P itu ita ry Haaaary Gland
Microscopic Observations: Adrenal Kidney Li ver
Lung
Haaaary 61and
P itu ita ry Uterus
-Soft heaorrhagic aass, 1 ca dia. -Dark aass, 4 x 4 x 3.5 ca, in perineal area.;
lobular aass, 5 x 4 x 3 ca, in le f t inguinal area.
-Sinusoidal ectasia, cortex, aarked -Chronic progressive nephropathy, a ild -Portal aononudear c e ll in f ilt r a t e , a ild
Portal b ile duct p ro life ra tio n , a ild -Vascular a in e ra liza tio n , a ild Pneuaonia, in t e r s t it ia l, chronic, a u ltifo c a l, a ild Alveolar aacrophages, a u ltifo c a l, a ild -Fibroadenoaa Adenocarcinoaa -Adenoaa -Cystic glands, aarked
The follow ing tissues were found to be w ithin noraal lia i t s : Spleen, Heart, Ovary, Stoaach, Urinary Bladder, Thyroid, Parathyroid, Trachea, Esophagus, Salivary 61and, Pancreas.
Species: Rat Project Nuaber: 0281CR0012
001948
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Riker Laboratories, Inc. 3(1 FH-3924: Two Year Oral Toxicity-Oncogenicity Study in Rats
Table: 2
Aniaal Nuaber: 1R-4908 Sex: Feaale Broup: ( 4) FH-3924 10 ppa Fate: (Heek= 67) Sacrificed in extreais
Macroscopic Observations: P itu ita ry Haaaary Gland
Adrenal Microscopic Observations:
Adrenal Kidney
Lung (laaaary Gland
Parathyroid P itu ita ry Spleen
-Large heiorrhagic aass, 1.2 ca dia. -Cystic aaaaary glands f ille d with white flu id
in perineal and rig h t a x illa ry areas. -Right adrenal enlarged.
-Sinusoidal ectasia, cortex, aarked -Chronic progressive nephropathy, ainiaal Pelvic a in e ra liza tio n , aarked Hyperplasia, pelvic epitheliua, a ild -Heaorrhage, local areas, aoderate -Galactocele Galactocele -Not exaained, not in plane of section -Adenoaa -Heaosiderosis, aoderate
The follow ing tissues were found to be w ithin noraal lia its *. Liver, Heart, Uterus, Ovary, Stoaach, Urinary Bladder, Thyroid, Trachea, Esophagus, Salivary Gland, Pancreas.
Aniaal Nuaber: 1R-4909 Sex: Feaale Group! ( 4) FH-3924 10 ppa Fate: (Heek= 103) Sacrificed in extreais
Hacroscopic Observations: Stoaach P itu ita ry Haaaary Gland
Thorax (in te rn al) Lung Liver
Kidney Hicroscopic Observations:
Adrenal
Kidney
-M u ltiple focal areas of ulceration. -Heaorrhagic aass, 0.7 ca dia. -Subcutaneous aass, 2.5 x 2 ca, in rig h t
a xilla . -F ille d with flu id . -Heaorrhagic, a ll lobes. -Pale, aottled, with scattered yellowish foci
and an irre gu la r surface. -Pale and p itte d .
-C ortical vacuolation, local areas, a ild Sinusoidal ectasia, cortex, aoderate Malignant lyaphoaa, h is tio c y tic
-Chronic progressive nephropathy, a ild Pelvic aineralization, a ild Malignant lyaphoaa, h is tio c y tic Protein resorption droplets, aarked
Species: Rat Project Nuaber: 02B1CR0012
001949
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Riker Laboratories, Inc. 3M FH-3924: Two Year Oral Toxicity-Oncogenicity Study in Rats
Table: 2
Aniaal Nuaber: 1R-4909 Sex: Feaale Group: ( 4) FH-3924 10 ppa Fate: (Neek= 103) Sacrificed in extreais
Microscopic Observations (continued): Liver Lung
Haaaary 61and
Pancreas Parathyroid P itu ita ry Spleen Stoaach Urinary Bladder Uterus
-Malignant lyaphoaa, h is tio c y tic -Vascular a in eralization, a ild Malignant lyaphoaa, h is tio c y tic Heaorrhage, d iffu se , aarked -Fibroadenoaa Malignant lyaphoaa, h is tio c y tic -Malignant lyaphoaa, h is tio c y tic -Not exaained, not in plane of section -No diagnosis, inadequate section -Malignant lyaphoaa, h is tio c y tic -Malignant lyaphoaa, h is tio c y tic -Malignant lyaphoaa, h is tio c y tic -Cystic glands, aarked
The following tissues aere found to be w ithin noraal li a i t s : Heart, Ovary, Thyroid, Trachea, Esophagus, Salivary Gland.
Aniaal Nuaber: 1R-4910 Sex: Feaale 6roup: ( 4) FH-3924 10 ppa Fate: <Heek= 85) Sacrificed in extreais
Macroscopic Observations: P itu ita ry Haaaary Gland
Microscopic Observations: kidney Liver
Lung
P itu ita ry Spleen
-Heaorrhagic aass, 1 x 0.5 ca. -M ilk cyst in perineal area.
-Vacuolation, conv. tub. epitheiua, a ild Pigaent, conv. tub. epitheliua, brown, a ild
-Portal aononudear c e ll in f ilt r a t e , a ild Portal b ile duct p ro life ra tio n , a ild Hepatocyte vacuolation, c e n trilo b u la r, a ild Hepatocyte a lte ra tio n , basophilic, a u ltifo c a l, a ild -Vascular a in era liza tion , a ild Alveolar aacrophages, a ild -Adenoaa
-Heaosiderosis, aoderate
The follow ing tissues were found to be w ithin noraal li a i t s : Heart, Uterus, Ovary, Haaaary Gland, Stoaach, Urinary Bladder, Adrenal, Thyroid, Parathyroid, Trachea, Esophagus, Salivary 61and, Pancreas.
Species: Rat Project Nuaber: 02B1CR0012
00195#
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Riker Laboratories, Inc. 3H FH-3924: Two Year Oral Toxicity-Oncogenicity Study in Rats
Table: 2
Aniaal Nuaber: 1R-4911 Sex: Feaale Group: ( 4) FM-3924 10 ppa Fate: (Neek= 97) Sacrificed in extreais
Macroscopic Observations: Adrenal P itu ita ry Haaaary 61and
Microscopic Observations: Adrenal C lito ra l Gland Heart Kidney Liver Lung
Haaaary Gland
Ovary P itu ita ry
-Enlarged -Possibly s lig h tly enlarged. -Subcutaneous a u ltilo b u la r aass, 8.5 x 5.5 x
4.5 ca, rig h t a x illa , subcutaneous a u ltilo b u la r cystic aass, 5 x 4.5 x 2 ca, in l e f t a x illa , subcutaneous cystic, a u ltilo b u la r aass, B x 7 x 3 ca, in throat area, f i l l e d with tan colored flu id
-Sinusoidal ectasia, cortex, aarked -Cyst -Myocarditis, chronic nonsuppurative, a u ltifo ca l, aiId -Pelvic aineralization, ainiaal Nephrosis, tubular, aoderate -Hepatocyte a lte ra tio n , basophilic, a u ltifo c a l, a ild -Vascular aineralization, a ild Pneuaonia, in t e r s t it ia l, chronic, a u ltifo c a l, a ild Alveolar aacrophages, a u ltifo c a l, a ild Perivascular aononudear in f ilt r a t e , a ild Granuloaa, a u ltifo c a l, a ild -Fibroadenoaa Galactocele Fibroadenoaa Adenocarcinoaa
Tuaor arising in area of lobular hyperplasia. -Cyst, unilateral -Adenoaa
The following tissues were found to be w ithin noraal lia its .' Spleen, Uterus, Stoaach, Urinary Bladder, Thyroid, Parathyroid, Trachea, Esophagus, Salivary 61 and, Pancreas.
Species: Rat Project Nuaber: 02B1CR0012
001951
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Riker Laboratories, Inc. 3M FM-3924: Tao Year Oral Toxicity-Oncogenicity Study in Rats
Table: 2
Aniaal Nuaber: 1R-4912 Sex: Feaale Group: ( 4) FH-3924 10 ppa Fate: (Heek= 89) Sacrificed in extreais
Macroscopic Observations: P itu ita ry
Microscopic Observations: Kidney
Liver Lung
Ovary P itu ita ry Spleen
-Heaorrhagic aass, 1 ca dia.
-Chronic progressive nephropathy, ainiaal Pelvic aineralization, ainiaal P y e litis , acute, a ild -Hepatocyte vacuolation, d iffu se , oderate
-Vascular aineralization, a ild Perivascular aononudear in f ilt r a t e , a ild Atelectasis, local areas, a ild Heaorrhage, a u ltifo c a l, a ild
-Tubular hyperplasia, b ila te ra l, aoderate -Adenoaa -Heaosiderosis, aarked
The following tissues ere found to be w ithin noraal 1ia its : Heart, Uterus, Haaeary Gland, Stoaach, Urinary Bladder, Adrenal, Thyroid, Parathyroid, Trachea, Esophagus, Salivary Bland, Pancreas.
Aniaal Nuaber: 1R-4913 Sex: Feaale Group: 1 4) FM-3924 10 ppa Fate: (Neek* 99) Sacrificed in extreais
Macroscopic Observations: P itu ita ry Haaaary Gland
Microscopic Observations: Adrenal Kidney
Liver
Lung
Haaaary Gland P itu ita ry Salivary Gland Stoaach Thyroid
-Heaorrhagic aass, 1.2 ca dia. -Lobulated aass, 3 ca d ia ., rig h t inguinal.
-Sinusoidal ectasia, cortex, a ild -Chronic progressive nephropathy, a ild Hyperplasia, pelvic epitheliua, a u ltifo ca l a ild -Portal aononudear c e ll in f ilt r a t e , a ild Portal b ile duct p ro life ra tio n , a ild Hepatocyte vacuolation, a u ltifo c a l, a ild -Vascular a in era liza tion , a ild Alveolar aacrophages, a u ltifo c a l, a ild -Fibroadenoaa -Adenoaa -Not exaained, aissing -G a s tritis , acute -C ce ll adenoaa
The follow ing tissues were found to be w ithin noraal l ia it s : Spleen, Heart, Uterus, Ovary, Urinary Bladder, Parathyroid, Trachea, Esophagus, Pancreas.
Species: Rat Project Nuaber: 0281CR0012
001952
Suaaarized STAR Page: 276
467
Suaaarized Single Tabulated Aniaal Report (continued) Individual Macroscopic and Microscopic Observations
Riker Laboratories, Inc. 3N FH-3924: Tuo Year Oral Toxicity-Oncogenicity Study in Rats
Table: 2
Aniaal Nuaber: 1R-4914 Sex: Feaale Group: ( 4) FH-3924 10 ppa Fate: (Week= 105) Terainal Sacrifice
Macroscopic Observations: P itu ita ry Haaaary Bland
Microscopic Observations! Adrenal Heart Kidney Liver
Lung
Haaaary Bland P itu ita ry Uterus
-Heaorrhagic aass, 0.4 ca dia. -Large f ir a aass, 8 x 6 x 4 ca, le f t a x illa ;
saall cystic aass, 2 ca d ia ., in le f t inguinal area.
-Sinusoidal ectasia, cortex, a ild -Myocarditis, chronic nonsuppurative, focal, a ild -Chronic progressive nephropathy, ainiaal Pelvic aineralization, a ild -Kepatocyte vacuolation, a u ltifo c a l, a ild Hepatocyte a lte ra tio n , basophilic, focal,
ainiaal -Vascular aineralization, ainiaal Alveolar aacrophages, a u ltifo c a l, a ild
Perivascular aononudear in f ilt r a t e , ainiaal -Fibroadenoaa Adenocarcinoaa, p a p illa ry -Adenoaa -Cystic glands, a ild
The folloHing tissues ere found to be w ithin noraal l ia it s : Spleen, Ovary, Stoaach, Urinary Bladder,, Thyroid, Parathyroid, Trachea, Esophagus, Salivary Gland, Pancreas.
Aniaal Nuaber: 1R-4915 Sex: Feaale Group: ( 4) FH-3924 10 ppa Fate: (Week= 82) Found Dead
Macroscopic Observations: Kidney Liver
Microscopic Observations: Adrenal
Esophagus Liver Lung
Ovary
Pancreas
-Mottled -Pale
-Pheochroaocytoaa, benign One of pair present -Not exaained, aissing
-Hepatocyte vacuolation, d iffu se , aarked -Vascular a in era liza tion , a ild Alveolar aacrophages, a u ltifo c a l, a ild -Within noraal li a i t s One of pair present -Not exaained, aissing
Species: Rat Project Nuaber: 02B1CR0012
001953 Suaaarized STAR Page: 277
468
Suaaarized Single Tabulated Aniaal Report (continued) Individual Hacroscopic and Microscopic Observations
Riker Laboratories, Inc. 3H FH-3924: Tao Year Oral Toxicity-Oncogenicity Study in Rats
Table: 2
Aniaal Nuaber: 1R-4915 Sex: Feaale Group: ( 4) FH-3924 10 ppa Fate: (Neek= 82) Found Dead
Microscopic Observations (continued): Parathyroid P itu ita ry Salivary Gland Thyroid Trachea Urinary Bladder
-Not exaained, aissing -Not exaained, aissing -Not exaained, aissing -Not exaained, aissing -Not exaained, aissing -Not exaained, aissing
The Following tissues were Found to be w ithin noraal l ia it s : Spleen, Kidney, Heart, Uterus, Maaaary Gland, Stoaach, Eye.
Aniaal Nuaber: 1R-4916 Sex: Feaale Group: ( 4) FH-3924 10 ppa Fate: (Neek= 105) Terainal Sacrifice
Hacroscopic Observations: Maaaary 61and
Adrenal
Microscopic Observations: Adrenal
Kidney Liver
Lung
Maaaary Gland Parathyroid Spleen
Thyroid
-M ultilo bu lar aass, 13.5 x 8 x 4.5 ca, rig h t a x illa and la te ra l area.
-L e ft adrenal enlarged due to aass, 1.7 ca dia.
-Sinusoidal ectasia, cortex, aarked Enlargeaent oF le f t gland due to aassive sinusoidal ectasia.
-Pelvic aineralization, ainiaal -Hepatocyte a lte ra tio n , vacuolated, Focal,
a ild -Alveolar aacrophages, a u ltifo c a l, a ild
Pneuaonia, in t e r s t it ia l, chronic, a u ltifo c a l a ild -Fibroadenoaa -Not exaained, not in plane of section -Heaatopoiesis, extraaedullary, increased, ainiaal -Ultiaobranchial cyst
The Following tissues were Found to be hi thin noraal l ia it s : Heart, Uterus, Ovary, Stoaach, Urinary Bladder, Trachea, Esophagus, Salivary Gland, P itu ita ry , Pancreas.
Species: Rat Project Nuaber: 02B1CR0012
001954
Suaaarized STAR Page: 276
469
Suaaarized Single Tabulated Aniaal Report (continued) Individual Macroscopic and Microscopic Observations
Riker Laboratories, Inc. 3H FH-3924: Tho Year Oral Toxicity-Oncogenicity Study in Rats
Table: 2
Aniaal Nuiber: 1R-4917 Sex: Feaale Group: ( 4) FH-3924 10 ppa Fate: (Week- 105) Terainal Sacrifice
Hacroscopic Observations: P itu ita ry
Microscopic Observations: Adrenal Kidney
Lung
Ovary P itu ita ry
-Raised aass, 0.9 ca dia.
-Sinusoidal ectasia, cortex, aoderate -Pelvic aineralization, a ild Calculus, p elvic, aoderate -Vascular a in era liza tion , a ild Pneuaonia, in t e r s t it ia l, chronic, a u ltifo c a l, a ild Perivascular aononudear in f ilt r a t e , a ild -Tubular hyperplasia, b ila te ra l, a ild -Adenoaa
The folloNing tissues Mere found to be Mithin noraal U n its : Spleen, Liver, Heart, Uterus, Naaaary Sland, Stoaach, Urinary Bladder, Thyroid, Parathyroid, Trachea, Esophagus, Salivary Sland, Pancreas, Eye.
Aniaal Nuaber: 1R-4918 Sex: Feaale Group: I 4) FH-3924 10 ppa Fate: (Heek= 105) Terainal Sacrifice
Hacroscopic Observations: P itu ita ry Liver Stoaach Uterus
Microscopic Observations: Adrenal
Esophagus Kidney Liver
Lung
Pancreas P itu ita ry Spi een
Stoaach
-Hass, l.B ca dia. -Pale -Raised aass, 1.3 x 1 ca. -Large f ir a cervical aass, 3.5 x 3.5 ca.
-Sinusoidal ectasia, cortex, a ild C ortical degeneration, local areas, aoderate -Not exaained, aissing
-Chronic progressive nephropathy, a ild -Portal aononudear c e ll in f ilt r a t e , a ild Portal b ile duct p ro life ra tio n , a ild Hepatocyte vacuolation, d iffu se , a ild -Vascular aineralization, a ild Heaorrhage, local areas, aoderate -Not exaained, aissing -Adenoaa -Heaatopoiesis, extraaedullary, increased, a ild -Ulcer, d iffu se , aarked
Gross appearance of a aass due to extensive ulceration with edeaa of subaucosa.
Species: Rat Project Nuaber: 02S1CR0012
001955
S u a u riifld STAR R>9. : 279
470
Suaaarized Single Tabulated Aniaal Report (continued) Individual Macroscopic and Microscopic Observations
Riker Laboratories, Inc. 3N FM-3924: Tao Year Oral Tonicity-Oncogenicity Study in Rats
Table: 2
Aniaal Nuaber: 1R-4918 Sex: Feaale Group: < 4) FM-3924 10 ppa Fate: (Week= 105) Terainal Sacrifice
Microscopic Observations (continued): Uterus
-M e tritis , acute, a ild Leioayoaa
Mass froa cervix; extensive necrosis.
The follow ing tissues were found to be w ithin noraal lia i t s : Heart, Ovary, Maaiary Gland, Urinary Bladder, Thyroid, Parathyroid, Trachea, Salivary Gland, Eye.
Aniaal Nuaber: 1R-4919 Sex: Feaale Group: ( 4) FM-3924 10 ppa Fate: (Neek= 105) Terainal Sacrifice
Macroscopic Observations: Thyroid P itu ita ry Adrenal
Microscopic Observations: Adrenal
Kidney
Li ver Lung
Ovary P itu ita ry Thyroid
-One appears enlarged. -Soft heaorrhagic aass, 0.6 ca dia. -Right adrenal enlarged.
-Sinusoidal ectasia, cortex, u n ila te ra l, aarked Cortical degeneration, u n ila te ra l, aarked Adenoaa, u n ila te ra l Extensive sinusoidal ectasia and degeneration in non-neoplastic gland.
-Chronic progressive nephropathy, a ild Pelvic aineralization, a ild
-Hepatocyte vacuolation, a u ltifo c a l, a ild -Vascular aineralization, a ild Metastatic neoplasa -Tubular hyperplasia, b ila te ra l, aoderate -Adenoaa -C c e ll carcinoaa
In filtr a tiv e , well d iffe re n tia te d ; s o lita ry aetastasis in lung.
The follow ing tissues were found to be w ithin noraal lia it s : Spleen, Heart, Uterus, Maaaary Gland, Stoaach, Urinary Bladder, Parathyroid, Trachea, Esophagus, Salivary Gland, Pancreas.
Species: Rat Project Nuaber: 02B1CR0012
001956
Suaaarized STAR Page: 2B0
471
Suaaarized Single Tabulated flnieal Report (continued) Individual Macroscopic and Microscopic Observations
Riker Laboratories, Inc. 3H FH-3924: To Year Oral Toxicity-Oncogenicity Study in Rats
Table: 2
Anieal Nuaber: 1R-4920 Sex.* Feaale Group: ( 4) FH-3924 10 ppa Fate: (Neek= 60) Found Dead
Macroscopic Observations: Liver
Skin
Microscopic Observations: Adrenal Kidney Liver Lung Maaaary 61and P itu ita ry Skin Spleen
Thyroid
-Pale, scattered white nodules on a ll lobes, 0.1 - 1 ca dia.
-Subcutaneous aass behind le f t shoulder, 6 ca dia. by 2 ca th ick with 3 ca dia. ulcerated area.
-Heaatopoiesis, extraaedullary, ainiaal -Protein resorption droplets, aarked -Malignant lyaphoaa, h is tio c y tic -Vascular a in e ra liza tio n , a ild -Not exaained, aissing -Adenoaa -Malignant lyaphoaa, h is tio c y tic -Heaatopoiesis, extraaedullary, increased, a ild -Ultiaobranchial cyst
The Following tissues aere found to be w ithin noraal l i a i t s : Heart, Uterus, Ovary, Stoaach, Urinary Bladder, Parathyroid, Trachea, Esophagus, Salivary Gland, Pancreas.
Species: Rat Project Nuaber: 02B1CR0012
001957
Suaaarized STAR Page: 2B1
472
Tissue Inventory Table: 3
Riker Laboratories, Inc. 3N FH-3924: Tuo Year Oral Toxicity-Oncogenicity Study in Rats - One Year In te ri*
Project Nuiber: 0281CROC12 Species: Rat
Tissue Naie
Dose Group Naie: CONTROL 0 pp* 1111111111111111111111111 RRRRRRRRRRRRRRRRRRRRRRRRR
Aniial Nuiber5 - ---------------------------------------------------------------------- - -
3333333333333334444444444 5555555555555555555556666 1 12 2 2 3 4 4 5 5 5 6 7 7 8 7 B0 8 B9 0 0 12 67027536019B0508258901800
Sex N H N H H H MH H N N H H H F F F F F F F F F F
Adrenal Aorta Bone Harrow Brain Esophagus Eye Heart Kidney Large Intestine Liver Lung Lyiph Node (aesenteric)
4 4 4 4 4 4 4 4 4444444 4 4 4 4 4 4 4 4 4 4
4 4 4 4 4 4 4 4 4444444 4 4 4 4 4 4 4 4 4 4
4 4 4 4 4 4 4 4 444444c4444 4 44444
4 4 4 4 4 4 4 4 4444444 4 4 4 4 4 4 4 4 4 4
4 4 4 4 4 4 4 4 4444444 4 4 4 4 4 4 4 4 4 4
44444444 4444444 44444444 4444444 44444444 4444444 44444444 4444444 44444444 4444444 44444444 4444444 C+ C+ + + + + 4444444
4444444444 4444444444 4444444444 4^44444444 4444444444 4444444444 C444444C + 4
Hanary Gland
++- +
4444444444
Ovary Pancreas
4444444444
4 4 4 4 4 4 4 4 + ++ + + + + 4 4 4 4 4 4 4 4 4 4
Parathyroid P itu ita ry Prostate Salivary Gland S iall Intestine
c c c c +c +++ 44C + + + + + + 44444444 + 44444444 + 44444444 +
++ C C + C C C C + C + + + C +
++ + + + + 4 4 4 4 4 4 4 4 4 4 ++ + + + + ++ + + + 4 4 4 4 4 4 4 4 4 4 ++ + + + + 4 4 4 4 4 4 4 4 4 4
Spinal Cord
4 4 4 4 4 4 4 4 + 4+ + + + C 4 4 4 C + + + + + +
Spleen
4 4 4 4 4 4 4 4 4 44 4 4 4 4 4 4 4 4 4 4 4 4 4 4
Stoiach T e s tis /E p id id y iis
4 44 4 4 4 4 4 4 4 4 4 4 4 4 4 4
+ + + + + + + + 4 44 4 4 4 4
Thyroid Trachea
c c c c + + 4 44 4 4 4 4 4 4 4 4 4 4 4 4 4 4 + + + + + + + + 4 44 4 4 4 4 4 4 4 4 4 4 4 4 4 4
Urinary Bladder
+ + + + + 4 + + 4 44 4 4 4 4 4 [ + 4 4 4 4 4 4 c
Uterus
4444444444
------------------------------j|,E following tissue(s) were not required by protocol
Hesentary
------------- + --------------------- - - 4
Skin
---------------------------------- - - -
4
Ureter
........ ........ ................ ............
A 4 indicates that a diagnosis was aade. A - indicates that no diagnosis or coiient was aade.
473
A c indicates only a nondiagnostic couent was aade. Please refer to the Single Tabulated Aniaal Report.
Tissue Inventory Page: 282
Tissue Inventory (continued) Table: 3
Riker Laboratories, Inc. 3N FH-3924: Two Year Oral Toxicity-Oncogenicity Study in Rats - One Year In te ria
Project Nutber: 0281CR0012 Species: Rat
Tissue Naae
Dose 6roup Naae: CONTROL 0 ppa 1 11 1 1 R RR R R
Aniaal Nuabers 44444 66666 23334 9 0 12 0
Sex F F F F F
Adrenal Aorta Bone Narrow Brain Esophagus Eye Heart Kidney Large Intestine Liver Lung Lyaph Node (aesenteric) Nacaary SI and Ovary Pancreas
+++++ c ++++ +++++ +++++ ++ ++ + ++ ++ + +++++ +++ + ++ ++ + ++ +++ +++++ ++C + ++ ++ t * + + + + +++++
Parathyroid P itu ita ry
c c c +c +++++
Prostate Salivary SI and Saall Intestine Spinal Cord Spleen Stoaach -
+ +++ +++++ +++++ + + + + + +++++
Testis/Epididyais
Thyroid Trachea
+c +++ + ++
Urinary Bladder Uterus
++c ++ t ++++
------------------------------ The follow ing tis s u e 's ' were not required by protocol
Hesentary
-------------
Skin
----------
Ureter
-------------
A + in d ic a te s th a t a diagnosis was aade. A - in d ic a te s th a t no diagnosis or coaaent was Bade.
A c indicates only a nondiagnostic coaaent was aade. Please refer to the Single Tabulated Aniaal Report.
001959
Tissue Inventory Page: 2B3
Tissue Inventory (continued)
Table: 3
Ri leer Laboratories, Inc. 3H
FH-3924: Tuo Year Oral Toxicity-Oncogenicity Study in Rats - One Year In te ri
Project Nuiber: 0281CR0012 Species: Rat
Tissue Naee
Dose Group Naie: Fft-3924 100 ppi 11111111l 1111111111111111 RRRRRRRRRRRRRRRRRRRRRRRRR
Aniaal Nuabers ----------------------------------------------------------------- -------
3333333333333334444444444
4677777777777777777777777
9 9 11122 2 2 33 33 4 45 66 677 B8B8 6914501272367787013590235
Sex H H H H N H H H N M H H H N H F F F F F F F F F F
A d re n a l
+ + + + + +++ + + + ++ + + ++ + + + ++
A orta
+ + + ++ + + + + + + + ++ + + + ++ + + + ++
Bone H arrow
+ + + ++ +++ + + + +++ + + + + ++ + ++
B ra in
+ + + + +++ + + + +++ + + ++ + + + ++
Esophagus
Eye Heart Kidney
Large Intestine Liver Lung
+ + + ++ + +++ + + + +++ + + ++ + ++ + + C
+ + + ++ + +++ + + + +++ + + ++ + ++ + ++ + + + ++ + f ++ + + + t ++ + + ++ + ++ + ++ + + + ++ + +++ + + + +++ + + ++ + ++ + ++
+ + C ++ + +++ + + + +++ + + ++ + ++ + ++ + + + + +++ + + + +++ + + ++ + ++ + ++ + + + ++ + +++ + + + +++ + + + + ++ + ++
Lyaph Node (aesenteric) Maaaary Gland Ovary Pancreas
Parathyroid
Pituitary
Prostate Salivary Gland Stall Intestine Spinal Cord Spleen
+ + + ++ + ++t + c + +++ + + ++ + c + + ++ -------------- - - - * - - + - - - + + + + + + 4 + + + - - -- - - --- --- --- ----- + + +C + ++ + ++ + 4 4 - + 4' + c + + + + + + + + + + + + + + + + + +
c c + c +c c + c c + c + c c c + c c c + c +c c
+ 4 + + c c + + *, + + + + + * + + + + + + + + + +
m * h h h h h f ............................... + + 4 +c + ++ + +c + ++ + + ++ + + ++ + ++ 4' 44' 4' + 4' + 4-4' 4-44- +4- 44- 4- 4' 4- + +44' 4' + 4- +4' 4 + + ++4'4- + + c++ ++ ++ + + + + + + ++ ++ + + + ' +4' ++ ++ + + + + * +
S to ia ch
Testis/Epididyais
C ++ ++ + +++ + + + +++ ++ ++ + + + + + +
4- ++ +4' + +4' + 4' + 4' +4' + - ----------------------
Thyroid Trachea
4-c + c + + + + * c + + + + + + + + + + + c + + + + + + 4'+ + + + 4' + + 4 + + 4' + 4- + 4-4-4- + + + 4'
Urinary Bladder Uterus
4' + 4- + 4- + c + + + + + + + + + + c + + + + + + + . . . . . . . . . . . . . . . . . . . . . . + + + 4- + + + + + +
------------------------------ The Following tissue(s) were not required by protocol
Nesentary
---------------- ---------------------------
Skin .....................................
Ureter
------------- ------------------------ -
A + indicates that a diagnosis was aade. A - indicates that no diagnosis or coaaent was aade.
A c indicates only a nondiagnostic coaaent was aade. Please reFer to the Single Tabulated Aniaal Report.
001960
Tissue Inventory Page: 284
475
Tissue Inventory (continued) Table: 3
Riker Laboratories, Inc. 3H FM-3924: Tko Year Oral Toxicity-Oncogenicity Study in Rats - One Year In te ria
Project Nuaber: 02B1CR0012 Species: Rat
Tissue Naae
Dose 6roup Naae: Fit-3924 100 ppa 11111 RRRRR
Aniaal Nuabers 44444 7 7 7 B8 8890 1 783hb
Sex F F F F F
Adrenal Aorta Bone Narrou Brain Esophagus Eye Heart Kidney Large Intestine Liver Lung Lyaph Node (aesenteric) Naaaarv Gland Ovary Pancreas Parathyroid P itu ita ry
++++ ++++t +++++ + + + + +c c++ +++++
++++ +++++ +++++ t ++++ +++++ ++++
++ ++ +++++ +++++ +c c c c ++++
Prostate Salivary Gland Saall Intestine Spinal Cord
+ C + + +++++ +++++
Spleen
++++
Stoaach
+ ++++
Testi s/Epi didyai s Thyroid
+C+++
Trachea Urinary Bladder Uterus
c +++ ++++t +++++
------------------------------ The Fallowing tissue(s) ere not required by protocol
Hesentary
- - +- -
Skin ------- --- -
Ureter
-------------
A + indicates that a diagnosis was Bade. A - indicates that no diagnosis or coaaent aas aade.
00196J.A c indicates only a nondiagnostic coaaent was aade. Please refer to the Single Tabulated Aniaal Report. Tissue Inventory Page: 285
Tissue Inventory
Riker Laboratories, Inc. 3H FH-3924: Two Year Oral Toxicity-Oncogenicity Study in Rats
Project Nuaber: 0281CR0012 Species: Rat
Table: 4
Tissue Naae
Dose Group Naie: CONTROL 0 ppa 1111111111111111111111111 RRRRRRRRRRRRRRRRRRRRRRRRR
Ani sal Nuabers - ---------------------- - - ------------------------- --------------3333333333333333333333333 5555555555555555555555555 1122222223333333334444444 8913454890123467890124578
Sex H H H H H H H H H N H H H H H H H H H H H H H H H
Adrenal Aorta Bone Narrow Brain Esophagus Eye Heart Kidney Large Intestine Liver Lung Lyaph Node (aesenteric) Naanary 61and Ovary Pancreas Parathyroid P itu ita ry Prostate Salivary G1and Saall Intestine Spinal Cord Spleen Stonach Testis/Epididyais Thyroid Trachea Urinary Bladder Uterus ------------------------------T(,e following tissue(s)
Bone C lito ra l Bland Harder!an Bland Lyaph Node Lyaph Node (abdoainal) Lyaph Node (thoracic) Hesentary
4444444444444444444444444 4444444444444444444444444 4444444444444444440+44444 4444444444444444444444444 4C+ + + + + + + + + + + + + + + + + + + + + + + 4 4 44 4 4 4 4 4 44 4 C + + C+ + + + + + C+ + 4444444444444444444444444 4444444444444444444444444 ++++ ++4+ 4+++++++++++ +++++ 4444444444444444444444444 4444444444444444444444444 4444[ 444 4444444c H t M H H
4 4 4 4 4 4 4 4 4 44 4 4 4 4 [ 4 * 4 4 4 4 4 4 4 C + C + C C + + C ++ + + C + C C C + + + C + + C 4444444444444444444444444 4 4 4 4 4 4 4 4 C ++ + + + + + + + C C + + + + + 4 4 4 4 4 4 4 4 C ++ + + + + + + + 4 + + + + + 4 4444444444444444444444444 444444444444444444C ++++++ 4444444444444444444444444 4444444444444444444444444 4444444444444444444C +++++ C 4 4 4 4 4 4 4 4 4 4 4 4 C + C+ + + + C + + + + 4444444444444444444444444 444444444444444444CC +++++
were not required by protocol ------------- + ---------------------------
A 4 indicates that a diagnosis was aade. A - indicates that no diagnosis or consent was aade.
477
A c indicates only a nondiagnostic coaaent was aade. Please refer to the Single Tabulated Aniaal Report.
001962
Tissue Inventory Page: 286
Tissue Inventory (continued)
Riker Laboratories, Inc. 3M FH-3924: Tao Year Oral Toxicity-Oncogenicity Study in Rats
Project Nuaber: 0281CR0012 Species: Rat
Table: 4
Tissue Naae
Preputial Bland Skin Soft Tissues (abdoaen) Soft Tissues (head) Soft Tissues (leg) Soft Tissues (neck) Soft Tissues (thorax) Thyaus Unidentified Tissue General Coaaent
Dose Group Naae: CONTROL 0 ppa 1111111111111111111111111 RRRRRRRRRRRRRRRRRRRRRRRRR
Aniaal N u a b e rs---------------- --------------------------------- ------------------------
3333333333333333333333333
5555555555555555555555555
1122222223333333334444444
8 9 1345 68 90 12 34 b 78 90 12 4 57 B Sex H H H H H N H H H H H H N N H H H N H N H N H N H
------------------------- --------------------------------- - - - - + - + + ---------- + ..................+ + ---------+ ------------------------- - -------------------------------------------------------- ---------------------------------------------------------------------------------------------------------------------------- ---------------------------------------------------------- ------------------------------------------------ -- --------------------------------------------------------------------------- - + --------------------- -------------------------------------------------------------------------------------------------------------------------------------- - -------------------
A + indicates that a diagnosis aas Bade. A - indicates that no diagnosis or coaaent aas aade.
478
A c indicates only a nondiagnostic coaaent aas aade. Please refer to the Single Tabulated Aniaal Report.
001963
Tissue Inventory Page: 287
Tissue Inventory (continued)
Riker Laboratories, Inc. 3H FH-3924: Two Year Oral Toxicity-Oncogenicity Study in Rats
Project Nuiber: 0281CR0012 Species: Rat
Table: 4
Tissue Naie
Dose Group Naie: CONTROL 0 ppi 1111111111111111111111111 R R RR RR RR RR RR RR RRR RR R RR RR R
Ani sai N u ib e r5 -------------------------------------------------------------------------3333333333333333333333333 5555555555555555555555555 4555555566666666677777777 9234567801234567912346789
Sex N N N H N H N N N H H N H H M N N N H N H H N N H
Adrenal
t+t++++++++++c+++++++++++
Aorta
4444444444444[44444444444
Bone Harrow
444444444C ++C+ ++ ++ ++ ++ + ++
Brain
4444444444444444444444444
Esophagus
4444444444444c*4444444444
Eye + + C + + + + + + + + + + C + + + + + + + + + + +
Heart
4444444444444444444444444
Kidney
++++++++++++++++++++++4++
Large Intestine
44C + + + + + + + + + + C + + + + + + + + + + +
Liver
4444444444444444444444444
Lung
4444444444444444444444444
Lyiph Node (lesenteric)
44C + + + + + + + + + + C + + + + + + C + + + +
Haiiary Gland
Ovary
Pancreas
4 4 C + + + + + + + + +C C + + + + + + + + 4 4 4
Parathyroid
C C + C C C + C + C C +C C C + + C C C C C + + C
P itu ita ry
444444444444( C * 4 t [ H M M 4
Prostate
4444444444444C +++++++++++
Salivary Gland
4 * [ H M +M [ * C C M H H [ f * H
S iall Intestine
4 4 C 4 4 4 4 4 4 4 4 4 4 C ++ ++ ++4 4 4 4 4
Spinal Cord
4 4 4 4 4 4 4 4 4 C + +C + + + + + + + + + + + +
Spleen
4444444444444444444444444
Stoiach
444444444444444444C ++++++
Testi s/Epi d id y ii s
4444444444444444444444444
Thyroid
C44444444C+ + + C+ ++ + ++ ++ + + +
Trachea
+ 444444444444C +4444444444
Urinary Bladder
4444444444444C + + + + ++ + C+ + +
Uterus
------------------------------ Xhe following tissue's) were not required by protocol
Bone
--------------------------------- 4 --------------- ---
C lito ra l Gland
Harderian Gland
Lyiph Node
ly ip h Node (abdoiinal)
Lyiph Node (thoracic)
Hesentary
4 ------------- 4
A 4 indicates that a diagnosis was lade. A - indicates that no diagnosis or conent was lade.
479
001964A c indicates only a nondiagnostic couent was aade. Please refer to the Single Tabulated Aniial Report. Tissue Inventory Page: 288
Tissue Inventory (continued!
Ri leer Laboratories, Inc. 3N FH-3924: Tuo Year Oral Toxicity-Oncogenicity Study in Rats
Project Nuaber: 02B1CR0012 Species: Rat
Table: 4
Tissue Naae
Preputial Bland Skin Soft Tissues (abdoaen) Soft Tissues (head) Soft Tissues (leg) Soft Tissues (neck) Soft Tissues (thorax) Thyaus Unidentified Tissue General Coaaent
Dose Group Naae: CONTROL 0 ppa 1111111111111111111111111 RRRRRRRRRRRRRRRRRRRRRRRRR
Aniaal N u a b e rs------------------- ------------------ - - ------------- - - - - 3333333333333333333333333 5555555555555555555555555 4555555566666666677777777 9234567801234567912346789
Sex N H M H H H H N H H H H I I H H N H N H H I I N N I I H
------- ------------------------------ --------------------------------------------------------------- + + - + - + ------------+ - - + + ------------------- --------------------------------------------------------------- --------------------------------------------------- --- - - ------------------------------------- --- - -------------------------------------------------------------------------------------------------------------------------------------- --------------------------------------------------------------- --------------------------------------------- ------------------------------------- - - - ------------------------------------------------------------------------------ - - - - - -
A + in d ica tes th a t a diagnosis Mas aade. A - in d ica te s th a t no diagnosis or coaaent uas aade.
480
001965A c indicates only a nondiagnostic coaaent uas aade. Please refer to the Single Tabulated Aniaal Report Tissue Inventory Page*. 2B9
Tissue Inventory (continued)
Riker Laboratories, Inc. 3H Fit-3924: Two Year Oral Toxicity-Oncogenicity Study in Rats
Project Nuaber: 02B1CR0012 Species: Rat
Table: 4
Tissue Naae
Dose Group Naae! CONTROL 0 ppa 1111111111111111111111111 RRRRRRRRRRRRRRRRRRRRRRRRR
Aniaal Nuaber5 4444444444444444444444444 5555555555555555556646666 7778888889999999990000000 6790134671234567890234567
Sex F F F F F F F F F F F F F F F F F F F F F F F F F
Adrenal Aorta Bone Narrow Brain Esophagus Eye Heart Kidney Large Intestine Liver Lung Lyaph Node (aesenteric) Naaaary Bland Ovary Pancreas
+ + + 4+ + + + 4444 444444444 4 + + 4 c + 4 + 4 4 4 4 C4 4 4 4 4 + 4 4 C4 4 4 444+ 444+ t 444 444444444444+ 4+ 4+ 4+ 4+ 4444 444444+ 444444 4 + 4 c 4 + + 4 4 4 4 + 4 4 4 4 4 4 4 4 4 C4 4 C 4 + 4 + + 4 + 4 + 4 4 4 4 4 4 4 4 CCC4 4 4 + 4 + 4+ 444+ + 4444 + 44+ + 4+ 444+ + 4+ 4+ + + + + 4444 444+ 4+ 444+ 444 4 + + 4 + + 4 4 + + 4 4 4 4 4 4 4 4 4 + C4 4 4 + t 44+ 4+ 44444 444444444+ 444 4+ 4+ 4+ + 44444 44+ 4444+ 444+ 4 4 c c c 4 4 4 4 CC4 C4 CC4 4 4 4 4 4 + 4 4 44+ + 4+ + + 44+ 4 4444444444444 + + 4 + 4 + + C4 4 4 4 4 4 4 4 4 4 4 + 4 + + C4 4 + 4 + 4 + 4 4 4 4 4 C4 4 + 4 4 + + 4 + 4 + 4
Parathyroid P itu ita ry
+ + c c c c c CCCCc CCCCCCCCCCCc C + + + + 4 4 + + 4 4 4- 4 + + + + 4 4 + + 4 + + + +
Prostate Salivary Gland Saall Intestine Spinal Cord Spleen Stoaach
c + 4 + 4 4 + 4 C4 4 4 4 4 c 4 + 4 4 + 4 4 + 4 C + + + + + + + + + 4 4 4 C+ 4 4 4 4 4 + 4 4 + 4 4 + + 4+ 4+ + 4+ 4 4+ 4 + 444+ 44+ + 44 + + + + 4 4 + 4444 44 444 4444+ + + + 4
44+ + 4 4+ 4444 4+ + + 4444444 444
Testi s/Epi di dyai s Thyroid Trachea Urinary Bladder
+ + 4+ 4+ 4444 444 44 4 4 4+ 4444 + + + + + 4 + + 4+ + 444+ + 4+ 4+ 4444+ + + 4+ 4+ + + 4 + 4 4 4 + + 4 4 + + + 4 + 4 4 4
Uterus
++4* ++ 444 44 444+44444444+
------------------------------ The follow ing tis s u e is i were not required by protocol
Bone
------------- ------------------------------
C lito ra l Gland
------------------------------- - - - -
Harderian Gland
---------------------- - ----------------
Lyaph Node
------------- - -------------------------
Lyaph Node (abdoainall
---------------------- - ----------------
Lyaph Node (thoracic)
-------------------------------------------
Mesentary
---------------------- ---------------------
A + indicates that a diagnosis was aade. A - indicates that no diagnosis or coaaent was aade.
481
A c indicates only a nondiagnostic coaaent was aade. Please refer to the Single Tabulated Aniaal Report.
001966
Tissue Inventory Page: 290
Tissue Inventory (continued)
Riker Laboratories, Inc. 3H FH-3924: Two Year Oral Toxicity-Oncogenicity Study in Rats
Project Nuaber: 02B1CR0012 Species: Rat
Table: 4
Tissue Naie
Preputial SI and Skin Soit Tissues (abdoaen) Soit Tissues (head) Soit Tissues (leg) Soit Tissues (neck) Soit Tissues (thorax) Thyaus Unidentiiied Tissue General Coaaent
Dose Group Naie: CONTROL 0 ppi i 111111111111111111111111 RRRRRRRRRRRRRRRRRRRRRRRRR
Aniaal Nuabers - ------------------------------- --------------------------------------4444444444444444444444444 5555555555555555556666666 777B8B88B9999999990000000 6790134671234567890234567
Sex F F F F F F F F F F F F F F F F F F F F F F F F F
---------------------------------------------------- --------- - + ................+ ........................................+ -------------------------------------------------------------------- ------------------------------------------------------------------------------------------------------------------------------------------ ------------------------------------------------------------------------------------------------- ----------------------------------- -------------------------------------------------------------------------------------------------------------------------------------------- -
A + indicates that a diagnosis aas aade. A - indicates that no diagnosis or coaaent was aade.
482
A c indicates only a nondiagnostic coaaent uas aade. Please r ef er to the Single Tabulated Aniaal Report
001967
Tissue Inventory Page: 291
Tissue Inventory (continued)
Riker Laboratories, Inc. 3H FH-3924: Two Year Oral Toxicity-Oncogenicity Study in Rats
Project Mueber: 0281CR0012 Species: Rat
Table*. 4
Tissue Naae
Dose 6roup Naee: CONTROL 0 ppe 1111111111111111111111111 RRRRRRRRRRRRRRRRRRRRRRRRR
Aniaal Nuabers 44 44 44 44 44 44 444444 44 44 44 4 6 b b b b b b 6 b b b b b b b b bb 6 6 6 6 6 6 6 0 1 11 1l l 1 l 12 2222222 33 33 33 3 9 1 *L4 3 4 5 b 7 8 9 1 2 3 4 5 6 7 8 3 4 5 6 7 8 9
Sex F F F F F F F F F F F F F F F F F F F F F F F F F
Adrenal Aorta Bone Harrow Brain
+++++4 +4 ++4 +4 ++++++4 +4 ++4 ++* + c t ++++c +++4 +4 c +4 4 ++4 +++++++++ +++++++++++++++ +++++++++ +* + + 4 + + + +++++++
Esophagus Eye Heart Kidney Large intestine Liver Lung
+++c 4 +++c c c +c +c ++c c c c 4 +c + ++c +++* ++c + ++c+++++c4 4 4 +++++++++++++4 ++++++4 +++ ++4 + + + + + + + + + + + + + 4 4 c + + c * + + + + + + + + + + + + +4 +++4 4 + + +++++ +++ * + ++ +++++ + + + ++ ++ ++ ++ ++ ++ + + 4 4 4 ++ 4
Lyaph Node (aesenteric) Haaaary 61and Ovary
++++++ ++++ ++++ ++++++ +++++
* + 4 + + + cc c++4 +++4 +++++++c 4 ++++++4 +++4 +4 +++4 +4 +++++4
Pancreas Parathyroid P itu ita ry
n
r
+++++++++4 ++++++4 ++4 ++++ c cc cc c cc cc c cc ccc c c c +c+
+++++++c +++c +4 ++++++c ++c +
Prostate Salivary 61and Saall Intestine
+4 +4 ++++++4 +4 ++4 +4 c +c +++c +++4 4 ++4 ++++4 4 4 4 ++4 ++4 4 +
Spinal Cord Spleen
++++c +++++4 +4 ++c 4 4 +4 ++ +++4 +++4 +4 +++4 4 4 4 4 4 4 + +
Stoaach
+++4 +4 +++++++++4 ++4 ++++4
Testis/Epididyais
Thyroid Trachea
+++++4 ++ ++++++++++++4 ++4 +++4 +4 +4 ++4 +4 4 +4 4 +4 4 4 ++4
Urinary Bladder
+++4 +++4 ++4 +++4 +4 +++++4 4 +
Uterus
4 + 4 4 +++ 4 +++++++++4 4 +++
The follow ing tissue(s) were not required by protocol
Bone
C lito ra l Sland
Harderian Sland
Lyaph Node
Lyaph Node (abdoainal)
Lyaph Node (thoracic)
Hesentary
A + indicates that a diagnosis was aade. A - indicates that no diagnosis or consent was aide.
433
A c indicates only a nondiagnostic coaaent was aade. Please refer to the Single Tabulated Aniaal Report.
001968
Tissue Inventory Page: 292
Tissue Inventory (continued)
Rifcer Laboratories, Inc. 3H FH-3924: Tno Year Oral Toxicity-Oncogenicity Study in Rats
Project Nuaber: 0281CR0012 Species: Rat
Table: 4
Tissue Naie
Preputial Gland Skin Soft Tissues (abdoaen) Soft Tissues (head) Soft Tissues (leg) Soft Tissues (neck) Soft Tissues (thorax) Thyeus Unidentified Tissue General Coeaent
Dose 6roup Naie: CONTROL 0 pp* 1111111111111111111111111 RRRRRRRRRRRRRRRRRRRRRRRRR
Aniial N u e b e rs------------------------------------------------------------------------4444444444444444444444444
6666666666666666666666666
0111111111222222223333333 9123456789123456783456789 Sex F F F F F F F F F F F F F F F F F F F F F F F F F
------------------------------------------------.......................... ------- - ---------------------- - ---------------- - ------------------------------------------- - ------------------- - ------------------- -- ---------------------------------------------------------------------------------------------- --------------------------------------------------------------------------- - ---------------- ---------------- ----------------------
A + indicates that a diagnosis Mas aade. A - indicates that no diagnosis or coaaent Mas aade.
484
A c indicates only a nondiagnostic coaaent Mas aade. Please refer to the Single Tabulated Aniaal Report
001969
Tissue Inventory Page: 293
Tissue Inventory (continued)
Riker Laboratories, Inc. 3H FH-3924: Two Year Oral Toxicity-Oncogenicity Study in Rats
Project Nuaber: 02B1CR0012 Species: Rat
Table: 4
Tissue Naae
Dose 6roup Naae: FH-3924 100 ppa
1111111111111111111111111
RRRRRRRRRRRRRRRRRRRRRRRRR
Aniaal Nuabers 3333333333333333333333333 6677777777777777777777777 9900000000001111111222222 7 B0 1 2 3 45 67 8902 3 67 B93 45 689
Sex H H N H N H H N H H H N N H H H N H H H H N H H H
Adrenal
4444444444444444444444444
Aorta
C4444444444444444444C ++++
Bone Harro*
4444444444444444444444444
Brain
4444444444444444444444444
Esophagus
C+ + + + + + + C+ C+ ++ ++ + + + + + +C+ +
Eye
4444444444444444444444444
Heart
4444444444444444444444444
Kidney
4444444444444444444444444
Large Intestine
4444444444444444444444444
Liver
4444444444444444444444444
Lung
4444444444444444444444444
Lyeph Node (aesenteric)
4444444444C ++++++++++++++
Haaaary 61and
Ovary
Pancreas
C + + + + + + + C+++ + ++ ++ + + + ++ + + +
Parathyroid
C + C + + + + C+ C + C+ CC + + + + + + C + + C
Pituitary
C4444444444444444444444C +
Prostate
C444444444444444444444444
Salivary Bland
c++++++c++++++++++++t+t++
Saall Intestine
4444444444444444444444444
Spinal Cord
4444444444444444444444444
Spleen
+ + + + + + + + + + 4 + + + + + + + + + + + + +
Stoaach
4444444444444444444444444
Testi s/Epi didyai b
4444444444444444444444444
Thyroid
C444 444 44444444444444444
Trachea
C444444C ++ ++ ++ ++ ++ ++ ++ +++
Urinary Bladder
[444444444444444444444444
Uterus
The following tissue(s) were not required by protocol
Bone
4 4 ---------
Clitoral Gland
Harderian 61and
Lyaph Node
Lyaph Node (abdoainal)
Lyaph Node (thoracic)
Hesentary
A 4 indicates that a diagnosis was aade. A - indicates that no diagnosis or coaaent was aade.
485
001970A c indicates only a nondiagnostic coaaent aas aade. Please refer to the Single Tabulated Aniaal Report Tissue Inventory Page: 294
Tissue Inventory (continued)
Riker Laboratories, Inc. 3H FH-3924: Two Year Oral Toxicity-Oncogenicity Study in Rats
Project Nueberl 0281CR0012 Species: Rat
Table: 4
Tissue Naae
Preputial Gland Skin Soft Tissues (abdoaen) Soft Tissues (head) Soft Tissues (leg) Soft Tissues (neck) Soft Tissues (thorax) Thyaus Unidentified Tissue General Consent
Dose 6roup Naae*. FH-3924 100 ppa 1111111111111111111111111 RRRRRRRRRRRRRRRRRRRR RRRRR
Aniaal Nuabers------------------------- -- ---------- -- -----------------------3333333333333333333333333 6677777777777777777777777 9900000000001111111222222 7801234567890236789345689
Sex H H H H H H H H H H H H H H H H H H H H H H H H H
---------------------- - - - ----------------- + - + ---------------------------------+ - -------------- ------------ ------ --------+ ------------------------------ - - + ----------------------------------------------------------------------------------- -- ---------------------------------------------------------------------------------------------- ' --------------------------------------------------------- - - -------------------------------------------------
A + indicates hat a diagnosis was aade. A - indicates that no diagnosis or coaaent was aade.
0 0 1 9 7 1A c indicates inly a nondiagnostic coaaent was aade. Pleaserefer to the Single Tabulated Aniaal Report. Tissue Inventory Page: 295
486
Tissue Inventory (continued)
Riker Laboratories) Inc. 3H FH-3924: Two Year Oral Toxicity-Oncogenicity Study in Rats
Project Muaber: 0281CR0012 Species: Rat
Table: 4
Tissue Naae
Dose 6roup Naae: FH-3924 100 ppa 11l l l 1l l 1111l l 11l l 1111111 RRRRRRRRRRRRRRRRRRRRRRRRR
Aniaal Nuabers 3. 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 7 7 777 7 7 7 77 77 77 77 77 7 7 77 777 33 33 334 4 44 44 44 5 5 55 5 55 5 55 6 0 145890 123 45690 12345i 7890
Sex H H H H H N H H H H H H H H H H H H H H H H H H H
Adrenal
+ 4 4 +++4 ++4 4 4 4 4 4 ++++4 4 4 4 4
Aorta
+++++++++++C +C 4 4 4 4 4 4 4 4 4 4 4
Bone Harrow
++++++4 +++4 4 4 4 4 4 4 4 4 +4 4 4 4 4
Brain
++4 ++++4 ++4 4 4 4 4 4 4 4 4 +4 4 4 4 4
Esophagus Eye
++++++++++4 4 4 4 +C 4 4 4 4 4 4 4 4 4 4 +c c ++4 +++4 4 4 4 4 4 4 4 4 4 4 4 4 4 4
Heart
4 4 +++4 ++4 +4 4 4 4 4 4 4 4 ++4 4 4 4 4
Kidney
4 +++++++++4 4 4 4 4 4 4 4 4 4 4 4 4 4 4
Large Intestine
++c c ++++4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4
Liver
+4 + 4 4 ++4 +4 4 4 4 4 4 4 4 4 4 4 4 4 4 4
Lung
++4 4 4 ++4 4 +4 4 4 4 4 4 4 4 4 4 4 4 4 4 4
Lyaph Node (aesenteric)
4 +c c +++c c C +4 4 C +4 4 C 4 4 4 4 4 4
Haaaary Gland
Ovary
Pancreas Parathyroid Pituitary Prostate Salivary Gland Saall Intestine
c c +4 ++++C +C 4 4 4 4 4 4 4 4 4 4 4 +c 4 cc c c +cc C C C 4 4 4 C 4 4 ++C 4 4 4 +4 +4 +++4 4 C 4 4 4 4 4 4 4 4 4 4 4 ++ ++4 +4 +c 4 4 +c C +4 4 +++++++ ++c ++4 ++4 +4 4 4 4 C ++C 4 4 4 4 4 4 4 4 +c c ++++++4 4 4 4 4 4 4 4 4 4 4 4 4 4 4
Spinal Cord Spleen
+4 +4 4 + +4 +4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 +4 4 +4 ++++4 4 4 ++4 4 4 4 +4 4 4 4 4 4
Stoaach
++4 ++++4 4 4 4 4 4 4 4 4 4 4 4 ++4 4 4
Testi s/Epidi dyai s
+4 4 +4 +4 4 4 4 4 4 4 4 4 4 ++++4 4 4 4 4
Thyroid Trachea
+4 4 +c +4 +4 4 4 4 4 4 +C 4 4 +4 4 4 ++C +4 4 +4 4 ++4 4 4 4 4 4 4 C ++++4 4 4 4 4
Urinary Bladder
+4 4 +4 +++4 4 4 +++4 4 4 4 4 4 4 4 C 4
Uterus
................. - .............. ........
-------------------------- j(,e following tissue(s) were not required by protocol
Bone ..............................................
Clitoral Gland
---------------------------------------
Harderian Gland
------ - --------- -----------------
Lyaph Node
---------------------------------------
Lyeph Node (abdotinal)
---------------------------- - ------
Lyaph Node (thoracic)
..................... ........................
Nesentary
---------------------------------------
A + indicates that a diagnosis was aade. A - indicates that no diagnosis or coaaent was aade.
487
A c indicates only a nondiagnostic coaaent was aade. Please refer to the Single Tabulated Aniaal Report.
001972
Tissue Inventory Page: 296
Tissue Inventory (continued)
Riker Laboratories, Inc. 3N FH-3924: Two Year Oral Toxicity-Oncogenicity Study in Rats
Project Nuaber: 02B1CR0012 Species: Rat
Table: 4
Tissue Naae
Preputial Gland Skin Soft Tissues (abdoaen) Soft Tissues (head) Soft Tissues (leg) Soft Tissues (neck) Soft Tissues (thorax) Thyaus Unidentified Tissue General Coaaent
Dose Group Kate: FH-3924 100 ppi 1111111111111111111111111 RRRRRRRRRRRRRRRRRRRRRRRRR
Aniaal Nuabers - ------------------------------ ---------------- -- ------------3333333333333333333333333 7777777777777777777777777 3333334444444455555555556 0 145B90 12 34 569 0 123 45 678 90
Sex MH MMH H MH t t MH MMH H H t l K MH H MMMH
+- +
A + indicates that a diagnosis was aade. A - indicates that no diagnosis or coaaent nas aade.
488
A c indicates only a nondiagnostic coaaent as aade. Please refer to the Single Tabulated Aniaal Report.
0 0 1 9 7 3 Tissue Inventory Page: 297
Tissue Inventory (continue*1
Riker Laboratories, Inc. 3H FN-3924: Two Year Oral Toxicity-Oncogenicity Study in Rats
Project Nuaber: 0281CR0012 Species: Rat
Tibie: 4
Tissue Naae
Dose Group Naae: FN-3924 100 ppa 1111111111111111111111111 RRRRRRRRRRRRRRRRRRRRRRRRR
Aniaal Nuabers 4444444444444444444444444
7777777777777777777777777 5 5 56 6 6 G6 b 6 7 7 7 7 7 7 7 7 8 8 8 B 9 99
6 8 92 4 5 7 B 9 0 1 2 3 4 6 7 8 14 6 9 0 12
Sex F F FFF F FFF F F F F F F FF F FFF F F FF
Adrenal
+ + ++ + + + + + + + + + + + + + + + + + + C + +
Aorta
+ + ++ + + + + + + + + + + + + + + + + C + + + +
Bone Harrow
++++++++++++++++++++++++
Brain
+++++++++++++++++++++++
Esophagus Eye
+ C ++ C + + + + + + + + + + C + + + + + + C + + + C ++ + + + + + + + + + + + + C + + + + + + + +
Heart
+++++++++++++++++++++++++
Kidney
+++++++++++++++++++++++++
Large Intestine
+ C+ + + + + + + + + + + + + + + + + + + + + + +
Liver
++++++++++++++++++++++++
Lung
++++++*++++++++++++++++++
Lyaph Node (aesenteric)
+ C ++ + + + + + + + + C + + + + + + C + CC + +
Haaaary Gland
+ C ++ + + + + + + + + + + + + + + + + + + + + +
Ovary
+ C ++ + + + + + + + + + + + + + + + + + + C + +
Pancreas
+ + ++ + + + + + + + + + + + + + + + + + + C + +
Parathyroid
CC + + + C + CC + + + + + C + + + + C C C C + +
Pituitary
+ + + + + + + + + + + + + + + + + + + + + + C+ +
Prostate
Salivary Gland
+ C+ + + + + + + + + + + + + + + + + + + + C+ +
Snail Intestine
+C++++ ++ ++ ++ + ++ ++ ++ ++ + ++ +
Spinal Cord
+ + + + + + + + + + + + + + + + + + + + + + C+ +
Spleen
++ + +++++++++++++++++++++
Stoaach
+++++++++++++++++*++++++
Testis/Epididyais
Thyroid
C+ + + + + + + + + + + + + + + + + + + + C + +
Trachea
VV + + + + + + + + + + + + + + + + + + + + C + +
Urinary Bladder
++++++*++++++*+++++
Uterus
+ cr + + + + + + + + + + + + + + + + + + + c + +
-------------------------- jj,e following tissue^;' were not required by protocol
Bone ..............................................
Clitoral Gland
------------------- ------------------
Harderian Gland
----------- --------------------- - -
Lyaph Node
---------------------------------------
Lyaph Node (abdoainal)
------------------------- -- ----------
Lyaph Node (thoracic)
------------------------- ------------
Mesentary
---------------------- ----------------
A + indicates that a diagnosis was aade. A - indicates that no diagnosis or coaaent was wade.
489
A c indicates only a nondiagnostic coaaent was aade. Please refer to the Single Tabulated Aniaal Report.
001974
Tissue Inventory Page: 29G
Tissue Inventory (continued)
Riker Laboratories, Inc. 3H FN-3924: Two Year Oral Toxicity-Oncogenicity Study in Rats
Project Nuaber: 0281CR0012 Species: Rat
Table: 4
Tissue Naae
Preputial Gland Skin So-ft Tissues (abdoaen) Soft Tissues (head) Soft Tissues (leg) Soft Tissues (neck) Soft Tissues (thorax) Thyaus Unidentified Tissue General Coaaent
Dose Group Naae: FH-3924 100 pp* 1111111111111111111111111 RRRRRRRRRRRRRRRRRRRRRRRRR
Aniial Nuabers ---------------------------------------------------- - --------4444444444444444444444444 7777777777777777777777777 5554666666777777778888999 6892456789012346781469012
Sex F F F F F F F F F F F F F F F F F F F F F F F F F
---------------------- -- ------------- ---------------------------------------------------------------------------------------- ------------ ------------------------------------------------------------------------- - ---------------------- - ------------------------------------------------------ ---------- --------------------------------------------- - --------------------------------------------------------------------------------------- - -------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- - - - - -
A + indicates that a diagnosis Mas aade. A - indicates that no diagnosis or coaaent Mas aade.
490
A c indicates only a nondiagnostic coaaent uas aade. Please refer to the Single Tabulated Aniaal Report.
001975
Tissue Inventory Page: 299
Tissue Inventory (continued)
faker Laboratories, Inc. 3H FH-3924: Two Year Oral Toxicity-Oncogenicity Study in Rats
Project Nueber: 0261CR0012 Species: Rat
Table: 4
Tissue Naie
Dose 6roup Naie: FH-3924 100 ppa 1111111111111111111111111 RRRRRRRRRRRRRRRRRRRRRRRRR
Aniial Nuibers 4444444444444444444444444 777777B88B8BBB8B88BB888B8 9999990000000001111111112 4567890123457890123457890
Sex F F F F F F F F F F F F F F F F F F F F F F F F F
Adrenal
+++++++++++++++*+++++++
Aorta
+ + + + + + + + + + + + + C+ + + + + + + + + + C
Bone Narrow
+++++t+++++t++++++++++++
Brain
++++++++++++++++++++++++
Esophagus
+ C+ + + + + + + + + + C + + + C + + + + + + + +
Eye
+ + + + + + + + + + + C + + + ++ + + + + + + + C
Heart
Kidney
4- + + + + + + + + + + + + + + ++ + + + + + + + +
Large Intestine
+ + + + + + + + + + + + + + + ++ + + + + + 4 + C
Liver
t + + + + + + + + + + + + + + ++ + + + + + t + +
Lung
+ + + + + + + + + + t + + + ++ + + + + + + + + +
Lyiph Node (aesenteric)
+ + + + + c + c + + + c + c;+c + + + + + c + + c
Hanary 61and
+ + + + C + + + + + + + + + + ++ + + + + + + + C
Ovary
+ + + + + + + + + + + + + ++ + + + + + + +
Pancreas
+ + + + 4 + + + + + + + + + + ++ + + + + + + + C
Parathyroid
C + + + C C C + + + + CC + + + + C C C + + CC +
Pituitary
++++++++++++++++++++ +++++
Prostate
Salivary Gland
H H t [ M H H H H H C* * ( H
Snail Intestine
++ ++ ++++ +++++ +++++ +++ +++C
Spinal Cord
++4+++t +++e++++++++++++++
Spleen
+++++++++++++++++++++++ +
Stoiach
+ + 4- + + + + + + + + + + + + + + + + + + + + +
Testi s/Epi di dyii s
Thyroid
++ ++ ++ + + + + + + C+ ++ ++ + C+ ++ ++
Trachea
+ + + + + + + + + + + + C+ + + + + + + + + + + +
Urinary Bladder
4H H CH H 1C* H H + H H M [
Uterus
+ + + + + + + + + + < + + + + + + + + + + + + +
-------------------------- j(,e following tissue(s) were not required by protocol
Bone ------------------------- ----------
Clitoral Gland
---------------------------------------
Harder!an 61and
-------------- -- ---------------------
Lyiph Node
---------------------------------------
Lyiph Node (abdoiinal)
---------------------------- ----------
Lyiph Node (thoracic)
Hesentary
----------------- - - --------------
A + indicates that a diagnosis was aade. A - indicates that no diagnosis or conent was lade.
491
A c indicates only a nondiagnostic conent was wade. Please refer to the Single Tabulated Aniial Report.
001976
Tissue Inventory Page: 300
Tissue Inventory (continued)
Riker Laboratories, Inc. 3H FH-3924: Tuo Year Oral Toxicity-Oncogenicity Study in Rats
Project Hueber: 0281CR0012 Species: Rat
Table: 4
Tissue Naie
Preputial Bland Skin Soft Tissues (abdoien) Soft Tissues (head) Soft Tissues (leg) Soft Tissues (neck) Soft Tissues (thorax) Thyius Unidentified Tissue Seneral Conent
Dose 6roup Naie: FH-3924 100 ppa 1111111111111111111111111 RRRRRRRRRRRRRRRRRRRRRRRRR
Aniial Nuibers -------------------------------------------------------------------------4444444444444444444444444 7 7 7 7 7 7 B8 8 8 88 8 BB8 8 8 8 8 88 0 B8 9999990000000001111111112 4567890123457890123457890
Sex F F F F F F F F F F F F F F F F F F F F F F F F F
-------------------------------------------------------------- ------------------------------- ------------------+ ---------+ ----------------------------------------------------------------------------- - ----------------------------------------------------------------------- ------------------------------------ * ---------------------------------------------------------------------------------------- - ------------------- - ------------------------------- --------------------------------------------------------------------------------------------------------------------------------------------------------------------------
A + indicates that a diagnosis as lade. A - indicates that no diagnosis or conent uas eade.
492
A c indicates Qnly a nondiagnostic conent as aade. Please refer to the Single Tabulated Aniial Report.
001977
Tissue Inventory Page: 301
Tissue Inventory (continued)
Riker Laboratories, Inc. 3H FH-3924: Two Year Oral Toxicity-Oncogenicity Study in Rats
Project Nuaber: 0281CR0012 Species: Rat
Table: 4
Tissue Naae
Dose Broup Naee: FH-3924 30 ppa I 111111i 11111111111111111 R RR RR R RR RR RR RR RR RR RR RR RR R
Aniaal N ua b e rs---------- --------------------------- -----------------------------------3333333333333333333333333 7777777777777777777777777 6 6 6 6 6 6 6 6 6 7 77 77 7 7 7 7 7 B8 BB8 B 1234567890123456789012345
Sex M K H H H H H H M H H H N H H H H H H H H H H H H
Adrenal
4444444444444444444444444
Aorta
Bone Harrow
Brain
Esophagus Eye
C + + + C + + CCCCCC + + CCCCCCCCCC
------------------------------- ------------4 ---------------------------
Heart
4444444444444444444444444
Kidney
4444444444444444444444444
Large Intestine
Liver
4444444444444444444444444
Lung Lyaph Node (aesenteric)
4444444444444444444444444 --------------------------------- --- - - -------------------------------- 4 - - -
Haaaary Gland
Ovary
PancrEas
4444444444444444444444444
Parathyroid
C + C C C C C C C + C + C + + CC + + + CC + + +
P itu ita ry Prostate
444444444444444444C ++++++
H H M H tH [ M H *H H H H
Salivary Gland
C+ + + + + + + + + + C+ + + + + + + + + + C+ +
Seal 1 Intestine
Spinal Cord Spleen
+4++++++4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4
Stoaach
44444444 44444444 444444444
Testis/Epididyais
4444C + + + 44 4444 44 4 4 4 4 4 4 4 4 4
Thyroid
C4 4 4 4 C H 44444444 4 4 4444 444
Trachea
44444444 44444444 444444444
Urinary Bladder
44444444 444444C +444444444
Uterus
------------------------------ The follow ing tissue(s) were not required by protocol
Bone
------------------------------- ------------
C lito ra l Gland
--------------------- ---------------------
Harderian Biand
------------------------- ------------------
Lyaph Node
--------------------------------------------
Lyaph Node (abdoainal)
------------------- - ------- ------- -
Lyaph Node (thoracic)
---------------- - ----------------------
Hesentary
------------- --------------- - ----------
A 4 indicates that a diagnosis was aade. A - indicates that no diagnosis or coaaent was aade.
493
A c indicates only a nondiagnostic coaaent was aade. Please refer to the Single Tabulated Aniaal Report.
001978
tissue Inventory Page: 302
Tissue Inventory (continued)
Riker Laboratories, Inc. 3N FH-3924: Two Year Oral Toxicity-Oncogenicity Study in Rats
Project Nuaber: 0281CR0012 Species: Rat
Table: 4
Tissue Naae
Preputial Gland Skin So-ft Tissues (abdoaen) Soft Tissues (head) Soft Tissues (leg) Soft Tissues (neck) Soft Tissues (thorax! Thyaus Unidentified Tissue General Coaaent
Dose Group Naee: FH-3924 30 ppa 1111111111111111111111111 RRRRRRRRRRRRRRRRRRRRRRRRR
Aniaal Nuibers - ----------------------------------------------------------------------3333333333333333333333333 7777777777777777777777777 6666666667777777777888888 1234567890123456789012345
Sex H H H H H H H H H H H H H H H H H H H H H H H H H
- ---------------------------- * --------------- --------------------+ - - + - - + ................+ - + - - - - + + --------------------- --------------------------------------------------------------------------------------- * ------------------------------------------------------- ------- ----------------------------------------------------------- ------------------------- ---------------------------------------------------------- ------------- - .......................... ------ + --------------------------------------------------------------------------------------------------------------------------------------------------------- - -------------------------------------------
A + indicates that a diagnosis was Bade. A - indicates that no diagnosis or coaaent as aade.
494
A c indicates only a nondiagnostic coaaent was aade. Please refer to the Single Tabulated Aniaal Report.
001979
Tissue Inventory Page: 303
Tissue Inventory (continued)
Rifcer Laboratories, Inc. 3H FN-3924: Two Year Oral Toxicity-Oncogenicity Study in Rats
Project Nueber: 0281CR00I2 Species: Rat
Table: 4
Tissue Naae
Dose Group Naee: FH-3924 30 ppa 1111111111i 11111111111111 RRRRRRRRRRRRRRRRRRRRRRRRR
Aniaal Nuabers - - - -------------------------------------------------------
3333333333333333333333333
7 7 7 7 7 7 7 7 7 7 77 77 888B8BB8B88
8888999999999900000000001 789012345678901234567890 Sex H M M M H H M M M M r i H H f t M M M H I I M M M H M f t
Adrenal
++ ++ ++ ++ + ++ ++ +++ + + ++ ++ + C+
Aorta
----------------------------------------------------------------------------------------
Bone Harrow
---------------------------------------------------- ----------------------------------
Brain
------------------------------------------------ --- ------------------------------------
Esophagus
+cc+ccccc+++c++++++++++++
Eye Heart Kidney
--------------------------------------------------------------------------------- + -
4444444444444444444444444 4444444444444444444444444
Large Intestine Liver Lung
+ ---------------------
4444444444444444444444444 4444444444444444444444444
Lyiph Node (aesenteric)
-----------------------+ - - - --------------------------------------------------
Masaary Gland
----------------------------------------------------------- ---
Ovary
Pancreas Parathyroid Pituitary Prostate Salivary Gland
------------------------------ --- -------------------------------- --- ------------------
+ ++ + ++ ++ ++ +C ++ +++ ++ + + +++ + ++cc++c++cc++c+++c+++++c+ ++++++++ ++++ ++++C++++++++ + ++ ++ +++ 4+ ++ 4+ +C++ C+ ++ + ++ +4 ++ + + + + + + + + + + + ++ + + + C+ + + +
Stall Intestine
+ --------------------
Spinal Cord Spleen Stoaach
Test i s/Epi didyai s
Thyroid Trachea
------------------------------------------------------------------ --- ------------------
4444444444444444444444444 4444444444444444444444444 4444444444444444444444444 4444444444444444444444444 4444444444444444444444444
Urinary Bladder
44 44444444C ++++++++++++C+
Uterus
---------------------------------------------------------------------- --- --------------
------------------------------ The follow ing tissue(s) were not required by protocol -----------
Bone
------------------------- ------------------------------
C lito ra l Bland
--------------------------------------------------------
Harderian Bland
---------------------------- - ----------------------
Lyaph Node
---------------------- --------------------------- - -
Lyaph Node (abdoainal)
---------------------------------------------- + --
Lyaph Node (thoracic) Hesentary
---------------- ----------------------- ---------- ---------- --------------------------------- - - - 4
A 4 indicates that a diagnosis was aade. A - indicates that no diagnosis or coaaent was aade.
495
001980A c indicates only a nondiagnostic coaaent was aade. Please refer to the Single Tabulated Aniaal Report. Tissue Inventory Page: 304
Tissue Inventory (continued)
RiIter Laboratories, Inc. 3H FN-3924: To Year Oral Toxicity-Oncogenicity Study in Rats
Project Nueber: 0281CR0012 Species: Rat
Table: 4
Tissue Naae
Preputial SI and Skin Soft Tissues (abdoaen) Soft Tissues (head) Soft Tissues (leg) Soft Tissues (neck) Soft Tissues (thorax) Thyaus Unidentified Tissue General Consent
Dose Sroup Naae: FH-3924 30 ppe 1111111111111111111111111 RRRRRRRRRRRRRRRRRRRRRRRRR
Aniaal Nuabers ------- ------------------- ------------------------- - ------------3333333333333333333333333
7777777777777788888808088
8888999999999900000000001 6 789 0 123 45 67 89 0 12 3 45 67 B9 0 Sex H H H N H N N H H H N H H N M N H H H N H H H H M
------------------------- -----------------------------------------------.............................. - - + +
------------- --------------------------------------------- ------------------- ------------------------------ ------------------------ ------------------------------------------------------------------------------------------------- - ----------------------------------------------- ------------------------------- - ------------------------------------------------------- * --------------------------------------------------------------------------------------------------- ------------------------------------------------------ - --------------------------------------------
A + indicates that a diagnosis was aade. A - indicates that no diagnosis or coaaent as aade.
496
001981A c indicates only a nondiagnostic coaaent as aade. Please refer to the Single Tabulated Aniaal Report. Tissue Inventory Page: 305
Tissue Inventory (continued)
Riker Laboratories, Inc. 3H FH-3924: Two Year Oral Toxicity-Oncogenicity Study in Rats
Project Nueber: 02B1CR0012 Species: Rat
Table: 4
Tissue Naee
Dose Sroup Naee: FH-3924 30 ppa 11111111111! 1111111111111 RRRRRRRRRRRRRRRRRRRRRRRRR
Anisal Nuebers 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4
8B8B8B88888888B8B88B8B888 2222222223333333333444444
1234567890123456789012345
Sex F F F F F F F F F F F F F F F F F F F F F F F F F
Adrenal
Aorta
Bone Harrow
Brain
Esophagus Eye
4444C + + + + + +C+C + 4 4 4 4 4 4 4 4 4 4 - + ------------------- - - 4 ---------4 - 4 ---------------------
Heart
4444444444444444444444444
Kidney
4444444444444444444444444
Large Intestine
Liver
4444444444444444444444444
Lung
4444444444444444444444444
Lyaph Node (aesenteric)
---------------------------------------------+ - + - ------------4 4 ----------- +
Haaaary Gland
4444444444444444444c44444
Ovary
+ + + + + + + + ++ + + + + + 4 + ++ + +
Pancreas
4 4 4 C + + + + C+ + + + C C 4 4 C + + + + CCC
Parathyroid
+ + CC + + + C+ C + C + + + + + C C C + + CC +
P ituitary
4444444444444c*CC'*' + +C+ + + +
Prostate
Salivary Gland
+ + CCC + + + + + + C + + C + C + 4 4 4 4 C + +
Saall Intestine
-----------------------------------------------------+ ---------------------------------------
Spinal Cord
Spleen
4444444444444444444444444
Stoaach
4444444444444444444444C ++
Testi s/Epi di dyai s
Thyroid
+ + + C + + + C + + + C ++ + + + C + + + + C C 4
Trachea
4 4 4 4 4 4 4 4 4 4 4 C ++ + + + + + + + + C + +
Urinary Bladder
4 4 4 [ f 4 4 4 4 4 4 4 44 * [ c < [ 4 H * M
Uterus
C C M tH IH H M M M H fH M
The following tissue(s) were not required by protocol ----------------------------
Bone
C lito ra l Gland
Harderian Gland
Lyaph Node
Lyaph Node (abdoainal) Lyaph Node (thoracic) Hesentary
---------------------------- --------------------------- t .................. ---------------------- + ------------------------------------------------
A 4 indicates that a diagnosis was aade. A - indicates that no diagnosis or coaaent was aade.
497
A c indicates only a nondiagnostic coaaent was aade. Please refer to the Single Tabulated Aniaal Report.
0019S2 Tissue Inventory Page: 306
Tissue Inventory (continued)
Riiter Laboratories, Inc. 3H FH-3924: Two Year Oral Toxicity-Oncogenicity Study in Rats
Project Nueber: 0281CR0012 Species: Rat
Table: 4
Tissue Naie
Preputial Bland Skin Soft Tissues (abdoten) Soft Tissues (head) So-ft Tissues (leg) Soft Tissues (neck) Soft Tissues (thorax) Thyeus Unidentified Tissue General Coaeent
Dose Sroup Naie: Fh-3924 30 ppe 11111111111111111111I I 111 RRRRRRRRRRRRRRRRRRRRRRRRR
Ani sal M uabers------------------------- -----------------------------------------------4444M 4444444444444444444 8 B8 8 8 6 B8 B0 8 0 6 8 8 8 8 B8 BB8 B8 B 2222222223333333333444444 1234567890123456789012345
Sex F F F F F F F F F F F F F F F F F F F F F F F F F
-------------------------------------------------------------- -
------- + ------------+ ..................... +
+
---------------------------------- - ---------------------- -
------------------------------------- - - ---------------- -
---------------------------- ------------------------------------
---------------- --------------------------------- ---------------
------------------- -- ----------- ------------------------ - -
------------------------------------------- ---------------------
----------------------------------------------------- ----------
---------------- ------------------------------------------------
A indicates that a diagnosis Has eade. A - indicates that no diagnosis or coaeent aas aade.
498
A c indicates only a nondiagnostic coaaent was aade. Please refer to the Single Tabulated Aniaal Report.
0 0 1 Q R ' t Tissue Inventory Page: 307
Tissue Inventory (continued)
Riker Laboratories, Inc. 3H FH-3924: Two Year Oral Toxicity-Oncogenicity Study in Rats
Project Nuaber: 0281CR0012 Species: Rat
Table: 4
Tissue Naae
Dose Group Naae: FH-3924 30 ppi 1 1 1 1 1 1 1 1 1 11 1 M 1 1 1 1 1 1 1 11 1 1 RRRRRRRRRRRRRRRRRRRRRRRRR
4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4Aniaal N uabers------------------- -------------- ------------------------------------ ---
eB 8 8 8 8 6 B 8 B 8 8 8 8 8 B 8 8 B 8 8 B B B 8
444455555555556666AA66A67 678901234567B901234567890 Sex F F F F F F F F F F F F F F F F F F F F F F F F F
Adrenal
++c+++++++++++++++++*++++
Aorta
Bone Narrow Brain
--- --------------------------
Esophagus
+ +C+ + + + + ++ ++ + + + + + + + C+ + ++ +
Eye Heart Kidney Large Intestine
4444444444444444444444444
4444444444444444444444444 ----- -------- - + ------------- -----
Liver
+ + + + + + + + + + + + + + + + + + + + 4 + + +
Lung
4444444444444444444444444
Lyaph Node (aesenteric)
------------- + _ ----------- 4 4 4 - - - 4 ----------- - 4 ---------------
Naaaary Gland
4[4 4tH 44 44[4 4[tM H H IH
Ovary
4 4 C + + + + C+ ++ ++ ++ ++ ++ + + + ++ +
Pancreas
C C C C + + CC + ++ ++ ++ +C ++ + + + +C +
Parathyroid
+ + C + C + C + C + + C+ + C + + + + C C + + C 4
P itu ita ry
4 c H t H i H H H H M H M *4 t
Prostate
Salivary Gland
4 4 [ * 4 4 44 4 4 [ [ ( M 4 t 4 4 [ 4 4 4 4
Seal1 Intestine
Spinal Cord
Spleen
4444444444444444444444444
Stcaach
4444444444444444444444444
Testi s/Epi di dyai s
Thyroid
44C+C + + + C+ + + + + C+ + + + C + + + + C
Trachea
44C + + + + + + + + + + + + + + + + C + + + + +
Urinary Bladder
44C + 4 4 4 4 4 4 4 C + + 4 4 4 4 4 4 4 4 4 4 4
Uterus
4444444444444444444444444
------------------------------ jhe following tissue(s) were not required by protocol
Bone
.............................. .....................
C lito ra l Gland
-------------------------------------------
Harder! an Gland
------------------- ------------------------
Lyaph Node
------------------- -- --------------- - -
Lyaph Node (abdoainal)
---------- ---------------------------------
Lyaph Node (thoracic)
------- ---------------------------- - -
Hesentary
------------- ------------------ --- - - -
A 4 indicates that a diagnosis was aade. A - indicates that no diagnosis or coaaent was aade.
499
A c indicates only a nondiagnostic coaaent was aade. Please refer to the Single Tabulated Aniaal Report.
001984
Tissue Inventory Page: 308
Tissue Inventory (continued)
Riker Laboratories, Inc. 3H Flt-3924: Two Year Oral Toxicity-Oncogenicity Study in Rats
Project Nuaber: 02B1CR0012 Species: Rat
Table: 4
Tissue Naae
Preputial Sland Skin Soft Tissues (abdoaen) Soft Tissues (head) Soft Tissues (leg) Soft Tissues (neck) Soft Tissues (thorax) Thymus Unidentified Tissue General Coaaent
Dose Group Nate: FH-3924 30 ppe 1111111111111111111I 11111 RRRRRRRRRRRRRRRRRRRRRRRRR
Aniaal Nuabers ------- - ---------------------------------- - ---------------------4444444444444444444444444 8888888888688888888888688 4444555555555564668466647 6789012345678901234567890
Sex F F F F F F F F F F F F F F F F F F F F F F F F F
------- -- --------------------- -- ------------------------------ --------- - + - + + .......................... + - + ............................. ------- ------------- -------------------------------------------------------------------------------------------------------- -----------------...........................................................- ......................... ...................... ... .............................- ............................. ------------------------------------------------------------------------------------------------------------------------------------* --------------------------------- ---------------- - - - ------------. . . . ------------------- --------------------------------- ---------------- -
A + indicates that a diagnosis aas aade. A - indicates that no diagnosis or coaaent aas aade.
500
0 0 1 9 8 5A c indicates only a nondiagnostic coaaent as aade. Please refer to the Single Tabulated Aniaal Report. Tissue Inventory Page: 309
Tissue Inventory (continued)
Riker Laboratories, Inc. 3H FH-3924: Two Year Oral Toxicity-Oncogenicity Study in Rats
Project Nueber: 0281CR0012 Species: Rat
Table: 4
Tissue Naae
Dose 6roup Naae*. FH-3924 10 ppa 1111111111111111111111111 RRRRRRRRRRRRRRRRRRRRRRRRR
A niial Nuibers ---------------------------------- - ---------------- - ------------3333333333333333333333333 8 B8 BB8 BSB8 B8 B8 8 8 8 8 8 B8 B8 8 8 1111111112222222222333333 12 34 56 78 90 12 34 56 7B9 0 12 34 5
Sex H H H H H H H H H H H H H H K H H N N H H N H H H
Adrenal
+ + + + + + + + + + + + + + + + + + + + + +
Aorta
Bone Harrow
Brain
Esophagus Eye Heart Kidney
+ + C + + + + + *' + * + + + + + + + + + + + + + +
- ------------- ---------------------- --------------------+ - -
*- + + + + + t + + + + + + + + + + + t + + + + + +
++++++++++++++++++++++++
Large Intestine Liver Lung Lyaph Node (aesenteric)
++++++++++++++++++++++
t+++++t+++++++++++t+t++++ ------------------------------------------------- + ---------------------
Haaaary Gland
Ovary
Pancreas
+ + c + + + + + + + + + + + + + + + + + + + + ++
Parathyroid
+ + CC + + C + + CC + + CC + + C+ + + + + + +
P itu ita ry
+ + + + + + + + + + + + + + + C+ + + + + + + + +
Prostate
++++++++++++++++++*++++++
Salivary Gland
+ + C+ + + + + C+ + + + + C+ C+ + + + + + C+
Saall Intestine
Spinal Cord
Spleen
+++++++++++++++++++++++
Stonach
+ ++ +++ ++ +C++ ++ ++ ++ + +C+ +++
Testis/Epididyais
+++++++++++++++++++++++++
Thyroid
+ + C+ ++ ++ + + + + + + + + + + ++ + + + + +
Trachea
+ + + + + + + + + + + + + + + + + + + + + + +
Urinary Bladder
++++++++++++++++++++++++
Uterus
------------------------------The fo llo ttin g tissue(s) were not required by protocol
Bone
................................................ -
C lito ra l Gland
-------------------------------------------
Harder!an Gland
-------------------------------------------
Lyaph Node
.............................. ...................
Lyaph Node (abdoainal!
------- ------------------------------------
Lyaph Node (thoracic)
------------------------------- - - - -
Hesentary
---------------------- ---------------------
A + indicates that a diagnosis was aade. A - indicates that no diagnosis or coaaent was aade.
A c indicates only a nondiagnostic coaaent was aade. Please refer to the Single Tabulated Aniaal Report.
001986
Tissue Inventory Page: 310
Tissue Inventory (continued)
Riker Laboratories, Inc. 3H FN-3924: Tot Year Oral Toxicity-Oncogenicity Study in Rats
Project Nuaber: 0281CR0012 Species: Rat
Table: 4
Tissue Naae
Preputial Bland Skin Soft Tissues (abdoaen) Soft Tissues (head) Soft Tissues (leg) Soft Tissues (neck) Soft Tissues (thorax) Thyaus Unidentified Tissue General Coaaent
Dose Group Naae: FH-3924 10 ppa 1111111111I 11111111111M 1 R RRR RR RR RR RR R RR R RR RR R R RR R
Aniaal N u a b e rs---------------------- ----------------- --------------------------------3333333333333333333333333 0 B8 8 B8 B8 B8 8 8 8 B8 8 BB8 8 8 8 B8 8 1111111112222222222333333 1234567090123456789012345
Sex N H H H N N H N H N H H H H H H N H N H N H M N H
------- ------------------------------------------ -- --------------------------- + - - + - + .........................+ - - - ------------------------------------------------ ---------- ---------------------------------------------------------- - ------- ------- ------------------- ------------------------------ ------------------------ ------------------------ ------------------------------ -- ------------------------ --------------------------------------------------- - ------- * ---------------- --------------------------- --- - - ---------------------------------------------------------- ---------------. . . . . --------- - -------------------------------------------------------------------
A + in d ica tes th a t a diagnosis was Bade. A - in d ica tes th a t no diagnosis or coaaent as aade. A c indicates only a nondiagnostic coaaent uas aade. Please refer to the Single Tabulated Aniaal Report
0 0 1 9 8 7 Tissue Inventory Page! 311
502
Tissue Inventory (continued)
Riker Laboratories, Inc. 3H FH-3924: Two Year Oral Toxicity-Oncogenicity Study in Rats
Project Nuaber: 0281CR0012 Species: Rat
Table: 4
Tissue Nate
Dose 6roup Naee: FH-3924 10 ppa 1111111111111111111111111 RRRRRRRRRRRRRRRRRRRRRRRRR
Aniaal Nuabers ----------------------------------------------------------------- ------33 33 33 33 333 33 33 33 333 33 33 3 8 B8 B8 B8 BB8 0 8 B8 B8 8 8 8 B8 8 B8 8 3333444444444455555555556 6 7 8 9 0 12 3 45 6 7 8 9 0 12 3 4 5 6 7 B9 0
Sex H H H H H H H M H H H H H H H H H H H H H H H H H
Adrenal
4444444444444444444444444
Aorta
Bone Harrou
Brain
Esophagus Eye
4 4 c + C + C + C + +' + + + + + + + + + + + + + +
+ + ---------- 4 - - ------------- + ---------------------
Heart
4444444444444444444444444
Kidney
4444444444444444444444444
Large Intestine
Liver
4444444444444444444444444
Lung
4444444444444444444444444
Lyaph Node (aesentenc)
Haaoary 61and
Ovary
Pancreas
+ + + + + + C+ + + + + + + + + + + ++ + + + + +
Parathyroid P itu ita ry
4 4 4 444 C + CC4C+CC + + + + C+ + + + +
f H *M cH H 4H H t
H M*
Prostate
444444C + +444444 4444444444
Salivary 61and
4 4 4 4 4 4 C 4 4 4 4 4 4 4 4 4 4 4 C + C + 444
Seal1 Intestine
Spinal Cord
Spleen
4444444444444444444444444
Stoaach
4444444444444444444444444
Testis/Epididyais
4444444444444444444444444
Thyroid
444444C + + + 4C4444444C ++ +++
Trachea
444444C + ++ ++ + + + + + + + + + + + + +
Urinary Bladder
444444C + + + ++ 444444444 444 4
Uterus
------------------------------ jhg following tissueis* aere not required by protocol
Bone
-------------------------- - + ---------
C lito ra l Bland
------------------------------------- - -
Harderian 61and
................... ... ..................- - -
Lyaph Node
---------------------------------- - -
Lyaph Node (abdoainal)
------------- ----------------------------
Lyaph Node (thoracic)
.......................... .............. - - -
Hesentary
------------------------------------- --- -
A 4 indicates that a diagnosis aas aade. A - indicates that no diagnosis or consent aas aade.
503
A c indicates only a nondiagnostic consent was aade. Please refer to the Single Tabulated Aniaal Report.
Tissue Inventory Page: 312
0013 8 8
Tissue Inventory (continued)
Riker Laboratories, Inc. 3N FH-3924: Two Year Oral Toxicity-Oncogenicity Study in Rats
Project Nueber: 02S1CR0012 Species: Rat
Table: 4
Tissue Naae
Preputial Bland Skin Soft Tissues (abdoaen) Soft Tissues (head) Soft Tissues (leg) Soft Tissues (neck) Soft Tissues (thorax) Thyaus Unidentified Tissue General Coaaent
Oose 6roup Naae: FM-3924 10 ppe 1 111 11 11 11 111 1 11 1 11 1 11 1 11 RRRRRRRRRRRRRRRRRRRRRRRRR
Aniaal Nuaber5----------- ------------ ------------------------------- -------3333333333333333333333333 8B8888B8B8B88888888BB8B88 3333444444444455555555556 6789012345678901234567890
Sex N H H M N N H M N N N N H H N N H R H N N M N H N
---------------- ------------------------------------------ ---------------
+ ---------- + ....................................................................
-------------------------------------------- - -------------------------
---------------------- - ----------------------------------------------
^ --------------------------------------------------------------------------
+ ---------------------------------------- ---------------------+
---------- +
-------------------------------------------
------------- ------------------------ ------------------------------------
--------------------------------------------------------------------------
+ ---------- -- ---------------------------------------
A + indicates that a diagnosis was aade. A - indicates that no diagnosis or coaaent was aade.
A c indicates only a nondiagnostic coaaent Nas/ifc. ^ ase r e f e r i o the Single Tabulated Aniaal Report, Tissue Inventory Page: 313
504
Tissue Inventor- '
Riker Laboratories, Inc. 3H FH-3924: Two Year Oral Toxicity-Oncogenicity Study in Rats
Project Mueber: 0281CR0012 Species: Rat
Table: 4
Tissue Nate
Dose Group Naie: FH-3924 10 ppe
1 11 11 11 11 1 11 11 11 1 11 11 111 I
RRRRRRRRRRRRRRRRRRRRRRRRR
Annal N u a b e rs------------------------- -- --------------------------------------------4444444444444444444444444
8 0 fl e B 0 8 8 6 8 8 8 6 8 8 B 8 B 8 B 8 8 B 8 B
7777777778888888888999999
1234567890123456789012345
Sex F F F F F F F F F F F F F F F F F F F F F F F F F
Adrenal
+ + + + + + + + + + + + + + + + + + + + + + + +
Aorta
Bone Harrow Brain
+-------------------------------------------------------------------------------. . . -------------------------- --------------------------
Esophagus Eye
+ + + C + + + + + ++ + + + + + C + + + + + + +
----- c -------------------------------
Heart
+++++++++++++++++++++++
Kidney Large Intestine
+++++++++++++++++++++++++ --------------------------------------------------------+ ---------------
Liver
+++++++++++++++++++++++
Lung
+++++++++++++++++++++++
Lyaph Node (tesenteric)
Hataary Gland
C+ ++ + + + + + + + + + + + + + + + + ++ ++ +
Ovary
+ + + + C+ + + + + + + C+ + + + + + + + + + + +
Pancreas
+ + + + C + + + CC + + + C + + + C+ + C + + + +
Parathyroid
+ C + + C + + + C + C + + + + + + C + + + + CC +
P itu ita ry
+ + + + C+ + + + + + + + C+ + + + + + + + + + +
Prostate
Salivary Gland
+ + + + C + C + + C + + CC+C + C + + + + + + +
Stall Intestine
Spinal Cord Spleen
+++++++++++++++++++++++++
Stoaach
++++++++++++++++++++++++
Testis/Epididyais
Thyroid
+ + + + C + + +C + + + + + + + + C+ + + + + + +
Trachea
4- + + + C + + + + + + + + + + + * C + + + + + + +
Urinary Bladder Uterus
+ + + + C + + ++ + + + + + + ++ + + + + + + + +
+ + + + t + + +f + + + + + + ++ c+ + + + + + +
------------------------------ The following tissue(s) were not required by protocol
Bone
------------------------------------- - -
C lito ra l Gland
---------------------------------------- +
Harden an Gland
-------------------------------------------
Lyaph Node
-------------------------------------------
Lyaph Node (abdoainal)
---------------------------------- - - -
Lyaph Node (thoracic)
-------------------------------------------
Hesentary
------------------------------------- ---
A + indicates that a diagnosis was aade. A - indicates that no diagnosis or coaaent was aade.
A c indicates only a nondiagnostic coaaent was aade. Please refer to the Single Tabulated Aniaal Report.
001990
Tissue Inventory Page! 314
505
Tissue Inventory (continued)
Riker Laboratories, Inc. 3M FH-3924: Tuo Year Oral Toxicity-Oncogenicity Study in Rats
Project Nueber: 0281CR0012 Species: Rat
Table: 4
Tissue Naie
Preputial Gland Skin SoFt Tissues (abdoaen) SoFt Tissues (head) Soft Tissues (leg) Soft Tissues (neck) Soft Tissues (thorax) Thyaus Unidentified Tissue General Coaeent
Dose Sroup Naae; FH-3924 10 ppi 1111111111111111111111111 RRRRRRRRRRRRRRRRRRRRRRRRR
Aniaal Nuabers - ------------------------------- ------------------------------ --------4444444444444444444444444 B8 0 BB8 B8 B8 8 8 8 8 8 8 8 8 8 8 B8 B8 B 777777777BB8888888B999999 1234567890123456789012345
Sex F F F F F F F F F F F F F F F F F F F F F F F F F
---------------------------------- ------- ---------------------------- + ................... + .............................+ - - + --------------------- --------------------------------------------------------------- - ---------------------------------------- - ---------------------------------- - ---------------- - ---------------------------------................................. ... .................................................. -------------------------------------------- - ----------------------------------------------------------------------------------------------- ----------------------------------------------------------------------------------------------- ---------------------------------------------------
'
A + indicates that a diagnosis was aade. A - indicates that no diagnosis or coaaent uas aade.
A c indicates only a nondiagnostic coaaent was aade. Please refer to the Single Tabulated Aniaal Report.
001991
Tissue Inventory Page: 315
506
Tissue Inventory (continued)
Riker Laboratories, Inc. 3H FH-3924: Tuo Year Oral Toxicity-Oncogenicity Study in Rats
Project Nuaber: 02B1CR0012 Species: Rat
Table: 4
Tissue Naae
Dose 6roup Naae: FH-3924 10 ppa 1111111111111111111111111 RRRRRRRRRRRRRRRRRRRRRRRRR
Aniaal Nuabers ---------------------------------------------- - ---------------------4444444444444444444444444 B8B8999999999999999999999 9999000000000011111111112 6 7 B9 0 12 3 4 5 6 7 8 9 0 12 3 4 5 6 7 8 9 0
Sex F F F F F F F F F F F F F F F F F F F F F F F F F
Adrenal
+ + + C+ ++ + + + + ++ + + + + + + + + + + ++
Aorta
Bone Harrox
Brain
- + ------------------------------------------- ----- - -----------------------------------------------------------
Esophagus Eye Heart Kidney Large Intestine Liver Lung Lyaph Node (aesenteric)
+ + + C+ + + + + + + + + + + + + + + C+ + C + +
------------- , --------------------------------------- + - + - -
+++++++++++++++++++++++ ++++++++++++++++*++++++ ------- - + + --------------------------------------------------------++++++++++++++++++++++++ ++++++++++++++++++++++++ ---------- + ------------------------------ ------------------------
Haiaary Gland
+ + + + C+ + + ++ + + + + + + + + + + + + ++ C
Ovary
+ + C+ ++ + + + + + + + + + + + + + + + + + + +
Pancreas
+++++c*++++++++++++c++c++
Parathyroid P itu ita ry
+ + + C + + + + C + + + C C + + + + + CC + + + +
H M H M H H c M H f C t M M
Prostate Salivary 61and
+ + + + + + + C + + + + + + + + C+ C+ + + + +
Saall Intestine
----------------------+ -------------------------------------------------------------------------------------------------------- . . . .
Spinal Cord Spleen Stoaach
++++++++++++++++++++++++ + + + + + + + + + + + < + + + + + + + + +
Testis/Epididyais Thyroid
M * [ M H M H H M t M [ M +* t
Trachea
++ +C++ ++ +++ + ++++++ +C++ +++
Urinary Bladder
+ + + C+ + + + + + + + + + + + + + + C + + + + +
Uterus
+ + + + + C+ + + + + + + + + + + + + + + + + + +
------------------------------j(,e holloaing tissueis) were not required by protocol -
Bone
------------------- ---------------------------
C lito ra l Gland
---------- - ---------------------------- +
Harderian Bland
..................................... ...
Lyaph Node
---------------------------------- ------------
Lyaph Node (abdoainal)
-----------------------------------------------
Lyaph Node (thoracic)
........... ................................ - - -
Hesentary
-----------------------------------------------
A + indicates that a diagnosis aas aade. A - indicates that no diagnosis or coaaent was aade.
507
001992A c indicates only a nondiagnostic coaaent was aade. Please refer to the Single Tabulated Aniaal Report. Tissue Inventory Page: 316
Tissue Inventory (continued)
Riker Laboratories, Inc. 3H FN-3924: Tho Year Oral Toxicity-Oncogenicity Study in Rats
Project Nueber! 02B1CR0012 Species: Rat
Tibie: 4
Tissue Naae
Preputial Gland Skin So-ft Tissues (abdoaen) Soft Tissues (head) Soft Tissues (leg) Soft Tissues (neck) Soft Tissues (thorax) Thyaus Unidentified Tissue Beneral Consent
Dose 6roup Naie: FM-3924 10 ppe 1111111111111111111111111 RRRRRRRRRRRRRRRRRRRRRRRRR
Aniaal N u a b e rs------------------------- --------------------- - - ------------------4444444444444444444444444 B8 8 8 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 99 99 9
9999000000000011111111112
6789012345678901234567890 Sex F F F F F F F F F F F F F F F F F F F F F F F F F
---------------------------- -- -----------------------------------------..................................+ ............................................... -------------------------------------------------------------------------------------------------------------- - ------------------------- - ------------------------------------------- - ------------------------------------------------- ------------------------------ ------------------------------------------------ ------- ------------------------------------------------------------- -- --------------------- --------------------------------------------------------- ----------------- --------------------------------------- -- ---------------------------------------------
A + indicates that a diagnosis was aade. A - indicates that no diagnosis or coaaent as aade.
508
A c indicates only a nondiagnostic coaaent was aade. Please refer to the Single Tabulated Aniaal Report.
001993
Tissue Inventory Page: 317
APPENDIX ITEM E STATISTICAL METHODS
1. For memo dated February 11, 1985; see Tables 12-18 2. For memo dated September 24, 1985; see Tables 19
and 20
001994
509
Internal Correspondence
Appendix Item E
To: Chuck F. Chesney - Riker Path and Tox - 270-3S-05 From: s a n y . McCarville - Riker Res Data Ops - 270-3A-01 Subject: statistical Analysis for FM-3924 in Rats Date: February 11, 1985
The laboratory values and organ weight data for the study of fluoro carbon FM-3924 in rats have been analyzed, and the results are presented in the attached tables. The statistical methods used to analyze the data are described in the following paragraphs.
Statistical Methods The means and standard deviations for percent organ weight to body weight ratios, organ weight to brain weight ratios, and labora tory data were determined separately for each sex and dose group. These data were analyzed using Bartlett's test for homogeneity of variance. If this test was not significant at a = 0.001, the data were further analyzed by comparing each treated group to the control group using a two-tailed Dunnett's test at the a = 0.05 significance level. The results of Dunnett's test have been indicated by asterisks on the mean tables. If Bartlett's test was significant at a = 0.001, the data were ranked and a two-tailed Dunnett's test was performed on the ranks. These results have been indicated by the pound sign (#) on the mean tables.
References Bartlett's Test
Anderson, V.L. and McLean, R.A. (1974), Design of Experiments: A Realistic Approach, New York: Marcel Dekker, Inc., 15-22.
Dunnett's Test Winer, B.J. (1971), Statistical Principles in Experimental Design, New York, McGraw-Hill Book Company, 201-204.
001995
Appendix Item E
Pcge 2 Statistical Analysis for FM-3924 in Rats SEMremr 02/11/85
Rank Transformations Conover, W.J., and Iman, R.L. (1981), "Rank Transformations as a Bridge Between Parametric and Nonparametric Statistics", The American Statistician, Vol.35, No. 3, 124-129. If you have any questions regarding the analyses, please let me know.
J i*. SEM :emr
Att.
c: Cathy E. Ludemann Len J. Sibinski MEE/RWH
001936
51 1
Internal Correspondence
APPENDIX ITEM E
To:
From:
Subject: Date:
L. Jr Slbtnskt - Riker Path and Tox - 270-3S-05`
S. E. McCarville - Riker Res Data Ops - 270-3A-01
Statistical Analysis of Microscopic Findings for FM-3924 in Rats September 24, 1985
The major microscopic findings of the Two Year Oral (Diet) Toxicity-Oncogenicity Study of Fluorocarbon FM-3924 in Rats were statistically analyzed. For each organ/lesion
classification the sexes were analyzed separately using a two-tailed Fisher's Exact Test comparing each treated
group to the controls. An a = 0.05 significance level with Bonferroni's adjustment for multiple comparisons was used within each organ/lesion/sex category. If the expected value of each cell was greater than 20, then Yates' corrected Chi-Square test was used. An asterisk on the summary tables
indicates a significant difference between the controls and the treated group.
References
Fisher's Exact Test:
Conover, W. J., (1971), Practical Nonparametric Statistics, New York, John Wiley and Sons Inc., 162-164.
Yates' Corrected Chi-Square:
Fleiss, Joseph L., (1973), Statistical Methods for Rates and Porportions, New York, John Wiley and Sons Inc., 14-15, 19-20.
S. E. McCarville :mjm
c: MEE/RWH
001997
512
APPENDIX ITEM F
GROUP MEAN BODY WEIGHTS, INDIVIDUAL BODY WEIGHTS AND FEED JAR WEIGHTS OF MALE
RATS RECEIVING FLUOROCHEMICAL FM-3924 IN DIET FOR TWO YEARS
NOTES:
Code 1 indicates a control group rat weight Code 4 indicates a FM-3924 - 100 ppm group rat weight Code 5 indicates a FM-3924 - 30 ppm group rat weight Code 6 indicates a FM-3924 - 10 ppm group rat weight Codes 11, 14, 15, 16 indicates the total feed jar weight for
the previous rat All weights are in grams
001998
i
Appendix Item F
Two Year Oral (Diet) Toxicity - Oncogenicity Study of Fluorocarbon FM-3924 in Rats
Group Mean Body Weights (g) _+ Standard Deviation Males
001999
Study Week
Control - 0 ppm Mean BW + SD (N) --
100 ppm Mean lBW + SD (N) --
30 ppm Mean BW + SD (N) *
10 ppm Mean BW + SD (N) 5.
0
165.3 + 10.5 (65)
168.2 + 10.1 (65)
169.1 + 12.5 (50)
165.6 + 11.1 (50)
2
270.9 + 16.4 (65)
*253.6 + 15.7 (65)
262.8 + 16.2 (50)
*258.3 + 16.2 (50)
4
334.0 + 25.1 (65)
*308.7 + 22.1 (65)
327.7 + 19.0 (50)
*321.3 + 22.5 (50)
6
390.7 + 31.0 (65)
*333.1 + 26.8 (65)
*361.6 + 25.1 (50)
*355.3 + 26.4 (50)
8
429.2 + 37.3 (65)
*369.8 + 29.4 (65)
*404.8 + 27.1 (50)
*394.5 + 27.2 (50)
10
456.2 + 42.7 (65)
*397.2 + 32.3 (65)
*433.8 + 29.2 (50)
*428.3 + 29.8 (50)
12
475.5 + 43.4 (65)
*417.1 + 35.2 (65)
*454.8 + 33.6 (50)
*453.2 + 31.5 (50)
14
493.2 + 47.7 (65)
*425.5 + 36.7 (64)
*464.7 + 35.9 (50)
*466.2 + 32.9 (50)
16
502*9 + 48.9 (65)
*442.4 + 37.3 (64)
485.0 + 40.4 (50)
484.2 + 34.4 (50)
18
515.3 + 48.7 (65)
*452.7 + 40.5 (64)
495.0 + 41.0 (50)
495.0 + 37.5 (50)
20
526.8 + 49.5 (65)
*465.0 + 41 .2 (64)
508.9 + 42.3 (50)
508.0 + 38.2 (50)
22
542.3 + 52.1 (65)
*474.6 + 40.5 (64)
522.5 + 44.2 (50)
521.1 4- 39.1 (50)
24
550.4 + 53.0 (65)
*483.7 + 41.6 (64)
532.1 + 43.6 (50)
531.9 + 41.2 (50)
26
561.0 + 54.3 (65)
*489.0 + 41.2 (64)
541.4 + 46.5 (50)
541.1 + 42.3 (50)
28
567.5 + 55.0 (65)
*500.1 + 43.1 (64)
552.4 + 45.9 (50)
553.0 + 43.9 (50)
30
576.3 + 56.7 (65)
*510.5 + 44.6 (64)
561.3 + 47.7 (50)
561.9 + 45.6 (50)
32
580.6 + 57.4 (65)
*515.9 + 44.8 (64)
569.2 + 47.0 (50)
570.1 + 46.7 (50)
34
582.9 + 62.5 (65)
*507.1 + 48.5 (64)
567.1 + 45.9 (50)
566.3 + 45.6 (50)
LT1 -- Number of animals weighed
* Significant difference from Control at the 5% level (Dunnett's t Test; cr= 0.05)
Appendix Itfm F Two Year Oral (Diet) Toxicity - Oncogenicity Study
of Fluorocarbon FM-3924 in Rats
Group Mean Body Weights (g) + Standard Deviation
Males
Study Week
Control - 0 ppm Mean BW + SD (N)~
100 ppm Mean BW + SD (N)-
36 38 _ 40 2- 42 n 44 o 46 O 48 o 50
52 54 56 58 60 62 64 66 68 70
591 .0 + 599.4 + 608.4 + 612.9 + 619.8 + 623.5 + 626.1 + 639.2 + 638.6 + 654.3 + 661.6 + 668.0 + 673.2 + 674.4 + 664.5 + 650.8 + 656.6 + 661.9 +
59.7 (64) 59.4 (64) 61.6 (64) 61.2 (64) 62.3 (64) 64.3 (64) 63.4 (64) 67.0 (64) 70.1 (64) 75.3 (49) 73.3 (48) 76.4 (48) 75.4 (48) 77.4 (48) 77.6 (47) 78.1 (47) 82.9 (47) 84.7 (47)
*518.8 + *524.9 + *530.4 + *536.5 + *541.7 + *548.8 f *552.3 + *559.9 + *566.7 + *573.4 + *579.0 + *583.6 + *584.5 + *589.2 + *589.5 + *591.0 + *592.9 + *601.2 +
45.4 (64) 47.7 (64) 48.5 (64) 49.0 (64) 51 .4 (64) 50.0 (63) 51.5 (63) 53.8 (63) 55.2 (62) 57.6 (47) 60.1 (47) 59.7 (47) 60.7 (47) 63.8 (46) 65.8 (46) 69.4 (46) 75.2 (45) 67.4 (44)
30 ppm Mean BW + SD (N) -
10 ppm Mean BW + SD
(N) i
576.8 + 578.2 + 586.8 + 592.0 + 598.8 + 604.8 + 611.0 + 619.1 + 623.8 + 627.3 + 633.5 + 634.6 + 637.3 + 640.3 + 641.7 4 644.7 4 646.2 + 650.5 +
48.7 (50) 49.0 (50) 51.4 (50) 51 .2 (50) 51.6 (50) 52.0 (50) 52.8 (50) 54.8 (50) 57.8 (50) 58.2 (50) 58.0 (50) 60.0 (50) 59.9 (50) 62.2 (50) 66.7 (50) 70.9 (50) 72.5 (50) 72.2 (49)
575.8 + 578.0 + 588.7 + 590.7 + 595.9 + 601.3 + 605.2 + 614.1 4 618.1 + 620.7 4 *625.7 4 635.2 4 639.4 + 641.2 + 642.8 4 646.0 4 650.6 + 650.5 +
47.0 (50) 47.5 (50) 47.9 (50) 49.5 (50) 50.1 (50) 52.7 (50) 54.2 (50) 56.1 (50) 57.7 (50) 62.5 (50) 69.9 (50) 62.0 (49) 62.6 (49) 63.4 (49) 63.5 (49) 65.8 (49) 70.3 (49) 69.5 (48)
a -- Number of animals weighed * Significant difference from Control at the 5% level (Dunnett's t Test; a = 0.05)
515
i
Appendix Item F Two Year Oral (Diet) Toxicity - Oncoqenicity Study
of Fluorocarbon FM-3924 in Rats Group Mean Body Weights (g) jf Standard Deviation
Males
CD
00 00 m
002001
Study Week
Control - 0 p p m _ Mean BW + SD (N)~
100 ppm
a
Mean 1BW SD <N)~
72
658.3 86.3 (47)
*592.1 + 69.2 (44)
74
660.8 + 81.7 (46)
*588.1 75.7 (44)
76
667.7 + 84.9 (46)
*600.2 + 68.7 (43)
78
668.8 + 83.8 (46)
*598.9 + 77.6 (42)
80
670.6 + 85.2 (46)
*607.2 + 70.9 (41)
82
663.1 + 85.5 (46)
*602.6 + 67.8 (40)
84
668.1 + 88.8 (45)
*612.3 + 68.3 (38)
86
675.6 + 86.8 (42)
*610.2 + 70.2 (38)
88
678.9 + 86.4 (41)
*613.4 + 69.8 (38)
90
690.0
93.9 (41)
*617.7 + 71.7 (38)
92
686.0 + 91.6 (40)
*610.9 + 71.0 (38)
94
678.3 + 90.3 (40)
*595.3. + 72.7 (35)
96
677.5 + 95.1 (38)
*592.6 + 74.5 (34)
98
675.7 + 98.6 (38)
*594.2 + 74.4 (33)
100
671.1 + 94.4 (37)
*594.7 + 74.8 (32)
102 665.9 + 101.2 (36)
+ 84.0 (32)
104
642.0 + 99.5 (35)
*568.6 + 97.0 (32)
30 ppm
a
Mean BW + SD (N) ~
640.5 + 638.7 + 651.9 + 654.8 + 656.5 + 657.5 + 657.3 + 653.4 + 648.2 + 646.9 + 644.7 + 634.3 + 630.9 + 627.6 + 630.0 + 629.0 + 628.9 +
73.4 (49) 76.9 (49) 68.3 (47) 77.2 (47) 67.5 (46) 64.8 (45) 67.5 (45) 66.3 (45) 70.9 (45) 77.5 (45) 79.4 (44) 09.1 (43) 91 .4 (42) 98.1 (41) 90.4 (39) 95.1 (37) 76.5 (35)
10 ppm Mean BW + SD
a (N) -
642.9 + 641.6 4 648.3 + 650.6 + 652.5 + 648.8 + 648.9 + 653.4 + 655.9 + 656.8 + 655.4 + 657.3 + 651.1 + 649.2 + 642.1 + 651.1 + 645.6 +
71.1 (48) 73.1 (48) 73.3 (47) 74.1 (47) 73.3 (47) 72.2 (47) 79.1 (46) 74.1 (44) 80.3 (43) 79.9 (43) R8.0 (43) 78.0 (42) 82.5 (42) 83.6 (42) 88.4 (41) 84.1 (39) 79.5 (39)
a -- Number of animals weighed (Jl * Significant difference from Control at the 5% level (Dunnett'a t Test? a = 0.05)
BEST COPY AVAILABLE
TWO YEAR O R A L <DIET > TOX-ONC ST UD Y OF FM -3924 & FC -1 42 IN RAT EXP. # 02 81 CR 0& 12
TE CH NI CI AN I N I T I A L S :S MH TO DAY'S D A T E :S 4/21/61 SEX OF RATS:S MALES ROOM NUMBER:S D-34 WEIGHT OF F U LL FOOD J A R :S 5 0 0G RA MS
WEEK 0
1R03516 01S 007101167. eo FOODJAR 11S 007201000. 0Q
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FOODJAR U S 013801000. 00
1R03548 G1S 013901152. 50 FOODJAR IIS 014001000. 00
1 11 1
11 1 11 1 11
1 11 1
11
1 11 1
11 1 11
1 11
1
11 1
11
1 11
1
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1
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1 11
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1
11 . 1 11 1
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167. & 8
162. 7 0 157 0 178. 7 0
168 0 157. 4
0
172. 9 0 169. 1
0 148 0 157. 6
0 159. 4
0 157. 6
0
173. 8 0 155. 2
0 180. 5
0. 1
160. 5 0
163. 1 0 178
0 162. 5 0
162. 8
0 156. 9 0
173. 2 0 164. 3 0 165. 1
0 152. 5 0
002002
best copy available
1R2541 01S 014101176. 90
FODJAR U S 014201000 00 1R02542 01S 014301160 10 FOODJAR U S 014401O00. 00
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1R02548 01S 015501176. 70
FODJAR IIS 015601000. 00
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1R0355O 01S 015901168. 40
FODJAR IIS 016001000. 00 1R03551 01S 016101149. 10 FODJAR U S 016201000. 00 1R62552 01S 016301162. 70 FODJAR IIS 016401000. 00 1R03553 01S 016581173. 60 FODJAR IIS 016601000. 00 1R03554 01S 016701147. 20
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FODJAR IIS 01720100O. 00 -R0355? 01S 017301171. 70
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FODJAR U S 017801000. 00 1R03560 01S 017901186. 50
FODJAR IIS 018001000. 00
1R03561 01S 018101155. 20 F O D JA R IIS 018201000. 0IJ-!
1R03562 01S 018301147. 80 FO DJAR U S 018401000. 0G! 1R03562 01S 018501182. 40 FODJAR IIS 018601000. 00
1R03564 01S 018701144. 50 FODJAR IIS 018801000 00 1R03565 01S 018901174 7 FODJAR IIS 019001000. 00 1R02566 01S 01 9101153 4i.'
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FODJAR IIS 020201000 00 1R03572 eis 020301172. 40 FODJAR IIS 020401000 00 1R03573 0 1 S 020501181. i*0 FODJAR U S 020601000. O
1
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11
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1 11 1
11 1 11 1 11 1 11 1 11 1 11 1 11
1 11 1 11
1 11 1 11
1
11 1
11
1 11 1 11 1 11 1 11 1
11 1
11 1 11 1
11 1 11 1 11
1 11 1 11 1 11
176. 9
0 160 1
0
169. 7 0 167. 7 0 169. 3 0 149. 6 0
168. 5 0 176. 7 0
173 0 168. 4 0 149. 1 0 162. 7 0 172. 6 0 147. 2 0
154. 2 0 168. 6 0 171. 7 0 174. 9
0 161. 9
0 186. 5
0 155. 2 0 147. 8
0 182. 4 0 144. 5
0 174. 7
0 153. 4
0 163. 2 0 185. 4
0 157. 7
0 163. 6 0
159. 7 0 172. 4 0 181. 9 0
002003
1R02574 01S 020701177. 3Q FOODJAR IIS 020S010O0. 10 1*82575 01b 020901165. eo FOODJAR 11S 021001000. 3Q 1R03576 01S 021101168. 2Q FOODJAR 11S 021201000. 00 *R03577 01S 021301177. 20
OODJAR 11S 021401000. 00 1R02578 01S 021501183. 80
FOODJAR IIS 821601000. 00
1R02579 01S 02170114S. 90 FOODJAR 11S 021801000. 00
1R03580 01S 021901154. 00
FOODJAR 11S 022001000. 00
1 11 1 11 1 11 1
11 1
11 1
11 1 11
177. 3
0. 1 165. 8 8. 3 160. 2 0 177. 3
0 182. 8
0 149. 9 0 154
0
BEST COPY AVAILABLE
002004
519
BEST COPY AVAILABLE
TWO YEAR ORAL-::[>IET> TOX-ONC ST UD Y OF FM -3924 & FC-143 IN ROTS EXP. # 02 81 CR 60 12
TECHNICION INITIALS:S MH TODAY'S D A T E :S 4/22/81 SEX OF R A T S :S MALE ROOM NUMBER:S D-332 WEIGHT OF FULL FOOD J A R :S 500GRAMS
WEEK 8
1R03696 048 00/101168. 8Q FOODJAR 14S 007201000. IQ 1R03697 04S 007301171. SO.
FOODJAR 14S 007401000. 0Q 1R03698 04S 007501171. IQ FOODJAR 14S 007601000. IQ 1R03699 04S 007701171. 6Q FOODJAR 14S 007801000. IQ 1R03700 04S 007901170. IQ FOODJAR 14S 010001000. 0Q
1R03701 04S 010101156. 3Q FOODJAR 14S 010201000. 0Q 1R03702 04S 010301157. IQ
FOODJAR 14S 010401000. 0Q 1R03703 04S 010501176. 7Q FOODJAR 14S 010601000. 0Q
1R03704 04S 010701186. 5Q FOODJAR 14S 018801000. 0Q
03705 04S 010901169. 5Q
FOODJAR 14S 011001000. 0Q
1R03706 04S 011101169. 7Q
FOODJAR 14S 011201000. 0Q
1R03707 04S 011301156. 3Q
FOODJAR 14S 011401000. 0Q 1R03708 04S 011501154. 8Q
FOODJAR 14S 011601000. 0Q 1R03709 04 S 011701175. 6Q
FOODJAR 14S 011801000. 0Q
1R03710 04 S 011901181. 0Q FOODJAR 14S 012001000. 0Q 1R03711 04S 012101168. IQ
FOODJAR 14 S 012201000. 0Q 1R03712 04S 012301170. 7Q
FOODJAR 14S 012401000. 0Q 1R03713 04S 012501176. 9Q FOODJAR 14S 012601000. 0G
1R03714 04S 012701154. 7Q
FOODJAR 14S 012801000. 0Q 1R03715 04S 012901187. 6Q FOODJAR 14S 013001000. 0Q
1R03716 04S 013101158. 3Q FOODJAR 14S 013201000. 0Q 1R03717 04S 013301174. 0Q
" "ODJAR 14S 013401000. 0Q .03718 04S 013501157. 7Q
FOODJAR 14S 013601000. 0Q
1R03719 04S 013701176. 3Q FOODJAR 14S 013801000. 0Q 1R03720 04S 013901170. 0Q
FOODJAR 14S 014001000. 0Q 1R03721 04S 014101181. 3Q
4 14 4
14 4 14 4 14 4
14 4 14 4
14 4 14 4 14 4
14
4 14
4 14 4
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0. 1 171. 6
0. 1 170. 1 0
156. 3 0 157.1
0 176. 7 0
186. 5 0 169. 5
0
169. 7
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0
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0 170. 7
0
176. 9 0
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0
158. 3 0 174
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0
176. 3 0 170
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00200S
520
FOODJRR 145 014201800. 00 1R 03 72 2 04 014301180. 4Q FOODJRR 14S 014401000. 00 1R03723 04 014501169. 10 FOODJRR 14S 014601000. 00 1R03724 04S 014781178. 80 FOODJRR 14S 014801000. 00
33725 04S 014901174. 40 FOODJRR 145 015001000. 10 1R02726 04S 015101171. 90 FOODJRR 14S 015201008. 00 1R03727 04S 015301153. 10
FOODJRR 14S 015401000. 10 1R03728 04S 015501175. 80 FOODJRR 14 015601000. 00
1R03729 04S 015701172. 90 FOODJRR 14S 015801000. 00 1R03730 04S 015901160. 20 FOODJRR 14S 016001000. 00
1R03731 04S 016101163. 20
FOODJRR 14S 016201000. 00
1R03732 04S 016301177. 2Q
FOODJRR 14S 016401000. 10 1R03733 04S 016501142. 90
FOODJRR 14S 016601000. 00
1R03734 04S 016701166. 80
FOODJRR 14S 016801000. 00
1R03735 04S 016981169. 20
FOODJRR 14S 017001000. 10 1R03736 04S 017101155. 50
FOODJRR 14S 017201000. 00 1R03737 04S 017301178. 6Q
' ''ODJRR 14S 017401000. 00
*.<03728 04S 017501161. 20
FOODJRR 14S 017601000. 00 1R0373S 04S 017781141. 60
FOODJRR 14S 017801000. 00 1R03740 04S 017901152. 30
FOODJRR 14S 018001000. 10 1R03741 04S 018101167. 40
FOODJRR 14S 018201000. 10 1R03742 04S 018301174. 40
FOODJRR 14S 018401080. 00 1R03743 04S 018501157. 20
FOODJRR 14S 018601000. 00
1R03744 04S 018701184. 00 FOODJRR 14S 018801000. 00
1R02745 04 018901159. 50
FOODJRR 14 019001000. 10
1R03746 045 019101168. 30
FOODJRR 14 019201000. 10 1R03747 045 019301167. 60
FOODJRR 145 019401000. 00 1R0374S 045 019581185. 10
FOODJRR 14S 019681000. 00
1R03749 045 019701164. 50 FOODJRR 145 019801000. 00 <R03750 045 019901157. 00
ODJRR 145 020001000. 00 1R03751 045 020101176. 90 FOODJRR 145 020201000. 00 1R02752 045 020301165. 50 FOODJRR 145 020481000. 00
XR03753 045 020501172. 10 FOODJRR 145 020601000. 00 1R02754 045 020701163. 60
14 0 4 180. 4 14 0 4 169. 1 14 0 4 178. 8 14 0 4 174. 4 14 0. 1 4 171. 9 14 0 4 153. 1 14 0. 1 4 175. 8 14 0 4 172. 9 14 0 4 160. 2 14 0 4 163. 2 14 0 4 177. 2 14 0. 1 4 142. 9 14 0 4 166. 8 14 0 4 169. 2 14 0. 1 4 155. 5 14 0 4 178. 6 14 0 4 161. 2
14 0 4 141. 6 14 0 4 152. 3 14 0. 1 4 167. 4 14 0. 1 4 174. 4 14 0 4 157. 2 14 0 4 184 14 0 4 159. 5 14 0. 1 4 168. 3 14 0. 1 4 167. 6 14 0 4 185. 1 14 0 4 164. 5 14 0 4 157 14 0 4 176. 9 14 0 4 165. 5 14 0 4 172. 1 14 0 4 163. 6
002006
m CO
H cn>
C mX 9 F=
Jpw 09
Emh
521
FOODJRR 14 S 0208 01 00 0 0QL
iRO 37 55 FOODJRR 148 021001000. 00
1R03756 04 021101186. 30
FOODJflR 14S 021201000. 10 1R03757 04 021301163. 00 FOODJRR 14S 021401000. 00
'03758 04 021501164. 10
iJQDJRR 14 021601000. 10 1R03759 04 021701166. 30 FOODJHk 14 021801000. 00 1R03760 04 021901168. 70
FOODJRP 14 022001000. 00 1R03761 05 022101160. 80 FOODJRR 15S 022201000. 00 1R03762 05S 022301152. 00 FOODJflR 15S 022401000. 00 1R03763 05 022501187. 20
FOODJflR 15S 022601000. 10
1R03764 05S 022701193. 90 FOODJflR 15S 022801000. 00 1R03765 05S 022901154. 80 FOODJRR 15S 023001000. 00 1R03766 05S 023101178. 10
FOODJflR 15S 023201000. 00 1R02767 05S 023301177. 40 FOODJflR 15S 023401000. 00 1R03768 05S 023501169. 00
FOODJflR 15S 023601000. 00 1R03769 05S 023701187. 3Q FOODJflR 15S 023801000. 00 1R03770 05S 023901182. 20 FOODJflR 15S 024001000. 00
03771 05 024181150. 80
FOODJflR 15S 024201000. 00 1R03772 05S 024301148. 1Q FOODJflR 15S 024401000. 00
1R03773 05S 024501151. 40 FOODJflR 15S 024601000. 00 1R03774 05S 024701179. 40
FOODJflR 15S 024801000. 00 1R03775 05S 024901163. 80 FOODJflR 15S 025001000. 00
1R03776 05S 025101185. 00 FOODJflR 15S 025201000. 00 1R03777 05S 025301182. 2Q
FOODJRR 15S 025401000. 00 1R03778 05S 025501184. 40
FOODJflR 15S 025601000. 10 1R03779 05 S 025701160. 30
FOODJRR 15S 025801000. 00 1R03780 05S 025901171. 90 FOODJflR 15S 026001000. 00 1R03781 05S 026101193. 60
FOODJflR 15S 026201000. 10
1R03782 05S 026301175. 50 FOODJflR 15S 026401000. 10 1R03783 05S 026501181. 60 ''ODJflR 15S 026601000. 00 -.S03784 05S 026701171. 30 FOODJflR 15S 026801008. 00 1R03785 05S 026901161. 30 FOODJflR 15S 027001000. 00 1R03786 05S 027101168. 30 FOODJflR 15S 027201000. 00 1R02787 05S 027301152. 90
14 4 14
4 14 4 14 4 14 4 14 4
14 5 15 5
15 5
15 5 15 5 15 5
15
5 15 5 15 5 15 5 15 5
15 5 15 5
15 5
15 5 15
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15 5
15 5 15 5
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167. 1 0 186. 2
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0. 1 175. 5 0. 1 181. 6 0 171. 3 0 161. 3 0 168. 3 0 152. 9
002007
522
FOODJflR 158 O27401000. 3Q
1R03788 058 027501176. 00
FOODJflR 158 02 7601000 00 1R03789 05S 027701160. 0
FOODJflR 158 027801000. 00 1R03790 058 027901164. 40
FOODJflR 158 O28001000. 00
.37791 058 0281O1179. 70 FOODJflR 158 0282O1000. 00
IF'02792 058 028301157. 70
FOODJflR 152. 028401000. 00 IRO:793 058 028581153. 20 F OODJflR 158 028601000. 20 1R03794 058 026:701154. 90
FOODJflR 158 028801000. 00
1R03795 058 028901155. 60 FOODJflR 158 029001000. 00 1R03796 058 029101159. 80
FOODJflR 158 029201000. 00
1R03797 058 029301138. 20
FOODJflR 158 029401000. 20
1R03798 058 029501153. 40
FOODJflR 158 029601000. 00 1R03799 058 029701157. 60
FOODJflR 158 029801000. 00
1R03800 058 029901178. 30 FOODJflR 158 030001000. 00 1R03801 058 030101157. 10
FOODJflR 158 030201000. 00 IF:03 SO 2 058 030301174. 40
FOODJflR 158 030401000. 00
1R03803 058 030501171. 80 ''ODJflR 158 030601000. 00
-..<03804 058 030701175. 90
FOODJflR 158 0361801000. 00 1R03805 058 030901166. 4U
FOODJflR 158 031001000. 00 IF !613806 058 031101168. 10 FOODJflR 158 031201000. 20 1R038O7 058 031301167. 10
FOODJflR 158 0314Gil000. 00! 1R03808 058 031501158. 80!
FOODJflR 158 031601000. 00
1R03809 058 031701178. 50 FU ODJAR 158 031801000. 00! 1R03810 05S 031901171. 00!
FOODJflR 158 032001000. 00 1R03811 068 032101172. SO
FOODJflR 168 032201000. 0C1
1R03812 068 032301170. 20 FOODJflR 168 032401000. 00 1R03813 068 032501163. 60
FOODJflR 168 032601000. 00 1R03814 068 032701148. 00 FOODJflR 168 032801000. 00' 1R03815 068 032901150. 30 FOODJflR 168 033<001000. 00 iFii.j3.yl8 068 033101154. 20
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FOODJflR 168 033401000. 00' 1R03818 068 033501172. 00' FOODJflR 168 033601000. 00'
1R03819 6i6S 033701158. 40 FOODJflR 168 033801000. 00! 1R03820 068 033901180. 10
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15 5 15 5 15 5 15 5
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002008
elf AVAILABLE
*
523
FOODJRR 16S 0 3 4 0 0 1 0 0 0 0 1 P 8 3 S 2 1 0 6 S 0 3 4 1 0 1 1 7 8 . 0Q
FOODJRR 1 6 0 3 4 2 0 1 0 0 0 . 0 0 1R 03822 06 834301164. 20 FOODJRR 16S 0 2 4 4 0 1 0 0 0 . 0 0 1R03823 06S 024501182. 90 FOODJRR 16S 0 2 4 6 0 1 0 0 0 . 0 0
'0 3 8 2 4 0 6 0 2 4 7 0 1 1 4 2 . 9 0 i O0DJRR 1 6 0 2 4 8 0 1 0 0 0 . 0 0 1R03825 06 034901147. 40 FOOD JRF: 1 6 0 3 5 0 0 1 0 0 0 . 0 0 1R03826 06 025101150. 50 FOODJRR 1 6 0 2 5 2 0 1 0 0 0 . 0 0 1R 03827 06S 025301156. 40 FOODJRR 16S 0 3 5 4 0 1 0 0 0 . 0 0 1R03828 06S 035501174. 40 FOODJRR 1 6 0 3 5 6 0 1 0 0 0 . 0 0 1R 03829 0 6 0 2 5 7 0 1 1 8 0 . IQ FOODJRR 1 6 0 3 5 8 0 1 0 8 0 . 0 0 1R 03830 06S 025901187. 50 FOODJRR 1 6 0 3 6 0 0 1 0 0 0 . 0 0 1R 03831 06S 036101165. 80 FOODJRR 16S 0 3 6 2 0 1 0 0 0 . 0 0 1R03832 06 036301163. 40 FOODJRR 16S 0 3 6 4 0 1 0 0 0 . 0 0 1R03833 06 036501160. 40 FOODJRR 16S 0 3 6 6 0 1 0 0 0 . 0 0 1R 03834 06S 036701171. 40 FOODJRR 1 6 0 3 6 8 0 1 0 0 0 . 0 0 1R 03835 06 026901180. 80 FOODJRR 16S 0 3 7 0 0 1 0 0 8 . 0 0 1R 03836 06S 037101183. 60 FOODJRR 16S 0 3 7 2 0 1 0 8 0 . 0 0
03837 06S 037301152. 70 FOODJRR 16S 0 3 7 4 0 1 0 0 0 . 0 0 1R83838 06S 037501160. 60 FOODJRR 16S 0 3 7 6 0 1 0 0 0 . 0 0 1R03829 06 037701157. 80 FOODJRR! 1 6 S 8 2 7 8 0 1 0 0 0 . 0 0 1R03840 06S 037901176. 60 FOODJRR! 1 6 S 0 3 8 0 0 1 0 0 0 . 0 0 1R03841 06 038101173. 00 FOODJRR 16S 0 2 8 2 0 1 0 0 0 . 1 0 1 R 0 3 8 4 2 06S 0 3 -8 3 0 1 1 6 8 . 9 0 FOODJRR 16S 0 3 8 4 0 1 0 0 0 . 0 0 1R 03843 06S 038501166. 10 FOODJRR 16S 0 3 8 6 0 1 0 0 0 . 0 0 1R 03844 06S 0 3 8 7 0 1 1 7 5 . 7 0 FOODJRR 16S 0 3 8 8 0 1 0 0 0 . 1 0 1R 03845 06S 028901172. 40 FOODJRR 16S 0 3 9 0 0 1 0 0 0 . 0 0 1R 03846 06S 039101172. 20 FOODJRR 16S 0 3 9 2 0 1 0 0 0 . 0 0 1R03847 06S 029301166. 50 FOODJRR 16 S 0 3 9 4 0 1 0 0 0 . 1 0 1R03848 06S 039501149. 40 FOODJRR 1 6 0 3 9 6 0 1 0 0 0 . 0 0 1R03849 06S 039701172. 70 ' ODJRR 1 6 S 0 3 9 8 0 1 0 0 0 . 0 0
..6 38 50 0 6 S 0 3 9 9 0 1 1 5 1 . 0 0 FOODJRR 1 6 0 4 0 0 0 1 0 0 0 . 0 0 1R03851 06S 040101145. 80 FOODJRR 16S 0 4 0 2 0 1 0 0 0 . 0 0 1R03852 06S 040301176. 90 FOODJRR 16S 0 4 0 4 0 1 0 0 0 . 0 0 1R03853 06S 040501162. 20
16 0 6 178 16 0 6 164. 2 16 0 6 182. 9 16 0 6 142. 9 16 0 6 147. 4 16 0 6 150. 5 16 0 6 156. 4 16 0 6 174. 4 16 0 6 180. 1 16 0 6 187. 5 16 0 6 165. 8 16 0 6 162. 4 16 0 6 160. 4 16 0 6 171. 4 16 0 6 180. 8 16 0 6 183. 6 16 0 6 152. 7 16 0 6 160. 6 16 0 6 157. 8 16 0 6 176. 6 16 0 6 173 16 0. 1 6 168. 9 16 0 6 166. 1 16 0 6 175. 7 1 6 0. 1 6 172. 4 16 0 6 172. 2 16 0 6 166. 5 1 6 0. 1 6 149. 4 16 0 6 172. 7 16 0 6 151 16 0 6 145. 8 16 0 6 176. 9 16 0 6 162. 2
002009
524
FOODJRR 16S 1R 03854 06S FOODJRR 16S 1R03855 065 FOODJRR 1 6 5 1R03856 06S FOODJRR 1 6 S
385? 06S FOODJRR 16S 1R03858 06S FOODJRR 16S 1R03859 06S FOODJRR 16S 1R03860 065 FOODJRR 16S 9999999999
040601000. 040701154. 048801000. 040901160. 041001000. 041101171. 041201161. 041301161. 041401000. 041501171. 041601000. 041701168. 041801000. 041901161.
042001000. 99
0Q 6Q 0Q 6Q 0Q 9Q 3Q IQ 0Q 9Q 1G 3Q 0Q 8Q 0Q
16 6 16 6 16 6 16 6 16 6 16 6 16 6 16 0
0 154. 8 0 160. 6 0 171. 9 0 161. 1 0 171. 9 0. 1 168. 3 0 161. 8 0
1 S T COPY AVAILABLE
00201&
525
1 S T COPY AVAILABLE
TWO
YEAR
O R H L <.D I E T > T O X -O N C S T U D Y O F F M - 3 9 2 4 & F C - 1 4 3 I N RFlTS EXP. # 0 2 81 C R 0 01 2
T E C H N IC IA N I N I T I A L S : S MH TODAY S D A TE : S 4 /2 8 /8 1 SEX OF R A T S : S MALE ROOM N U M B E R :S D - 3 4 0 W E I G H T OF F U L L FOOD -JAR : S 5 0 OOP AMS
WEEK 1
1RQ3516 01S 010000218. 7Q FOODJAR IIS 01O100338. 9Q 1R03517 01S 010200216. 60
FOODJAR 11S 010300349. IQ
1P.03518 01S 010400211. IQ
FOODJAR IIS 010500345. 4Q 1RQ3519 OIS 010600234. 6Q
FOODJAR IIS 010700324. 6Q 1R03520 01S 010800220. 6Q FUODJAR IIS 010900339. 6Q 1R03521 01S O11000204. 9Q FOODJAR 11S 011100354. 7Q 1R03522 OIS 011200219. 8Q F UUDJ AR! IIS 011300341. 0Q 1R03523 01S 011408214. 5Q F UUD J AR! U S 011500358. 2Q 1R03524 01S 011600199. 6Q FOODJAR IIS 011700364. 7Q
.03525 01S 011800206. 8Q FOODJAR IIS 011900359. 8Q 1R03528 01S O12000207. 4Q FOODJAR! IIS 012100341. 0Q
1R03527 01S 012200215. IQ FOOD JAR! IIS 012300344. 9Q 1R03528 01S 012400226. 4Q
FOODJAR! IIS 012500339. IQ 1R03529 01S 01260G213. IQ FOODJAR U S 012700338. 8Q 1R03530 01S 012800230. 0Q FOODJAR! IIS 012900344. 9Q
1R03531 01S 013000211. 4Q
FOODJAR U S 013100348 2Q 1R03532 01S 013200215. 7Q
FOODJAR U S 013300342. 2Q
1R03533 01S 013400234. 6Q FOODJAR U S 013500325. 4Q 1R03534 01S 013600215. 9Q
FOODJAR U S 013700344. 3Q 1R03535 01S 013800198. 5Q FOODJAR 11S 013900369. 4Q
1R83536 01S 014000197N0Q FOODJAR 11S 014100362. IQ 1R03537 OIS 014200226. 2Q
'ODJAR U S 014300342. 9Q 03538 01S 014400220. 9Q FOOT1JAR! U S 014500340. 0Q
1R03539 01S 014600210. 4Q FOODJAR U S 014700355. 5Q 1R03548 OIS 014800203. IQ FOODJAR! U S 014900352. 7Q 1R03541 01S 015000227. 3Q
1 11 1
11 1 11 1
11 1
11 1 11 1
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218. 7 338. 9 216. 6
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324. 6 220. 6 339. 6 204. 9 354. 7 219. 8 341 214. 5 358. r> 199. 6
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211. 4 348. coL 215. 7 342. 2 234. 6 325. 4 215 9 344. 198. 5 369. 4 197 362. 1 226. 2 342. 9 220. 9 34 210. 4 355. 5 203. 1 352. 7 227. 3
002011
526
FOODJRP lis 0 15100348 40
1R03542 01S 0152O0215 50 FODJRR 11S 0153;00325 80 1R83543 01S 015400223. 60 FOODJRR 11S 015500220. #0 1R03544 01S 0156010216. 80 FODDJRR 11S 015700340. 90
03545 OIS 131580101230. 10 FOOD JRR 11S 015900348. 00 1R02546 0 1 S 0116010102017. 40 FOODJRR 11S 016100345. 60 1R02547 0 1 S 01162010222. 00
FODJFtF! 11S 0163010329. 90 1R83548 01S 0164010235. 00 FOODJRR 11S 0165010336. 40
1R03549 OIS 0116600223. 30 F OODJ FlR 11S 016700252. 70 1R03550 OIS 01168001219. 40 FOODJRR 11S 016900350. 00 1R02551 01S 017000183. 20 FOODJRR 11S 017100374. 20 1R02552 01S 017200216. 10
FOODJRR 11S 0117300336. 90 1R03553 01S 0117400228. 30 FOODJRR 11S 0117500324. 70 1R03554 HUS 0U7600192. 60 FOODJRR IIS 0U7700357. 40 1R02555 CUS 0U7800204. 80
FOODJRR 11S 017900354. 40 1P.03556 01S 0118000226. 6Q FOODJRR 11S 018100329. 10
1R03557 01S 018200233. 20 "'ODJ RR 11S 018200234. 80
-- i< 0 3 5 5 3 01S 018400217. 70
FOODJRR 11S 018500351. 10 1R03559 01S 018600218. 70
FOODJRR: .15 1R 03560 01S 0188001234. 10 FOODJRR 11S 0189 0346. 90 1R02561 01S 019000212. 60
FOODJRR 11S 019100228. 00 1R3562 01S 019200192. 60 FOODJRR 11S 019300370. 00 1R03562 eUS 0119400237. 60 FOODJRR 11S 019500338. 70 1R03564 01S 0119600197. 80
FOODJRR 11S 019700362. 50 1R03565 CUS 019800227. 10
FOODJRR IIS 0U9900351. 10
1R03566 01S 020000205. 30 FOODJRR 11S 020100356. 80 1R03567 01S 020200221. 30
FOODJRR 11S 020300340. 80 1R83568 01S 020400247. 10
FOODJRR U S 020500328. 70 1R03569 01S 020600219. 90 FOODJRR 11S 020700345. 80 1R03570 01S 020800218. 8 0
'ODJRR 11S 020900328. 60 1R03571 01S 0121000217. 80
FOODJRR 11S 021100336. 80 1R02572 01S 021200219. 30 FOODJRR 11S 021300345. 00
1R03573 01S 02140101234. 20 FOODJRR 11S 0215001334. 90 1R02574 0115 021600237. 40
11 348. 4 1 215 5
11 335. 8 1 2J-. C' 11 330 1 216. 8 11 340. 9 1 238. 1 11 348 1 207. 4 11 345. 6 1 222 11 329. 9 1 235 11 336. 4 1 223. 3 11 352. 7 1 219. 4 11 358
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1 216. 1 11 336. 9 1 228. 3
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1 192. 6 11 357. 4 1 204. 8
11 354. 4 1 226. 6 11 339. 1
1 233. 2 11 334. 8 1 217. 7 11 351. 1 1 218. 7
11 339.5 1 234. 1 11 346. 9
1 212. 6 11 338 1 192. 6 11 370 1 237. 6 11 338. 7 1 197. 8
11 362. 5 1 227. 1 11 351. 1 1 205. 3 11 356. 8 1 221. 3 11 340. 8 1 247. 1 11 328. 7 1 219. 9 11 345. 8 1 218 11 320. 6 1 217. 8 11 336. 8 1 219. 3 11 345 1 234. 2 11 334. 9 1 237. 4
002012
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TE CH NI CI AN INITIALS::S MH TODAY'S D A T E :S 4/29/81 SEX OF R A T S :S MALE R O OM N U M B E R :S D-332 WEIGHT OF FULL FOOD JAR::S 500G RR MS
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TWO
'YEAR
ORAL<DIET> TOX-OMC STUDY OF FM-S924 & FC-143 IN RATS
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TECHNICIAN INITIALS:S MH
TODAY S D A T E . S 5 /1 2 /0 1 S E X OF RATS : S MALE
ROOM NUM BER : S 0 -3 4 0 0 -3 .2 0 W EIGH T OF F U L L FOOD J A R : S 500GRAM S
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TWO
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T E C H N I C I A N I N I T I A L S : ? MH
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002046
561
1 WO YEAR' ORAL 'DIET/1 TOX-ONC STUDY OF FM-3924 FC-143 IN RATS EXP. # 0 2 81C R 0012
TECHNICIAN INITIALS:S MH T O D A Y 'S D A T E :S 5/26/81 SEX OF R A T S :S MALE ROOM N U M B E R :S D- 3 4 0 , 0-238 HEIGHT OF FULL FOOD J A R :S 550GRAMS
WEEK. 5
1R03516 01S W07000388. 6Q FOOD1JAR U S 00 ?100358. 0Q 1R03517 01S 06 '208357. 2Q
FOOD1JAR: U S 007300386. 80 1R03518 0 1 S 107400355. 70 FOOD1JAR U S 007500389. 60 1R03519 CHS 007600389. 8Q
FOODJ AR U S 007780361. 8Q 1R03520 01S 0O7800382. 5Q FOODJAR U S 007900364. 2Q 1R03521 01S 010000345. 9Q FOuD-JAR U S 010100335. 7Q 1R03522 CIS 010200354. 9Q
FOOD1JAR U S 010300394. 2Q 1R03523 01S 0:10400388 7Q FOODJAR U S 010500377. 4Q 1R83524 01S 010600340. 90
FOODJAR U S 010700385. 80 1 525 01S 010800357. 60 FOODJAR US. 010900377. 30 1R63526 01 011080353. 50
FOOD JAR U S 011100383. 60
1R03527 CHS 011200361. 70
FOODJAR U S 0113002:89. 90 1R03528 01S 011400379. 20
FOODJAR U S 011500378. 70 1R03529 CHS 011600365. 60 FOODJAR U S 011700376. 10
1RO3530 CHS 011800377. 30 FOOD1JAR: U S 011900377. 00 1R03531 CHS 012000353. 80 FOODJAR U S CH2100392. 40 1R03532 CHS 0122002:63. 80 FOODJAR U S 012300363. 70 1R03533 01S CH2400370. 40 FOODJAR: U S CH2500382. 20 1R03534 01S CH2600396. 90
FOOD-JAR: U S 012700360. 10 1R03535 01S 012800320. 00 FOOD JAR U S 012900350. 70 1R03536 CHS 013000339. 30 FOODJAR: U S 013100398. 80 1R03537 CHS 013280325. 70 F D.JAR U S 013300369. 80 1K03538 CHS 813400386. 40
FOODJAR: U S 013500375. 20
1R03539 01S 012600295. 80 FOODJAR U S GH2700407. 00 1RO3540 01S 013800339. 20 FUUDJAR U S 012:900384. 50 1R02541 CHS 0140002:69. 70
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F OOD-JAF' IIS 015100272. 60 1R02547 01.9 0:15200373. 70
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FOOD-JAR U S 0165010355. 10
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FOODJAR U S 016900390. 90 1R02556 OIS 017000386. 30 FOODJAR U S 017100381. 30
1R02557 OIS 017200247. 40 F OOD-JAF: U S 017300400. 00 1 2558 01S 017400308. 50
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1R03580 OIS 0178O0341. 60! FOOD-JAR U S 017900396. 40! 1R02561 01S 018000399. 80!
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1R3563 01S 018400343. 50! f o o d JAF' U S 018500389. 60!
1R03564 OIS 1318680338. 00
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IF:03566 01S 0190 00 34 5 50' FOOD-JAR U S 019108383. 40 1R03567 01S 0192001390 20
FOOC>JAF: 11S 019300359. 10' 1R03563 01S 019400375. 20! FOOD JAF: 11S 0il950'i3394. 70'
1R03569 OHS 019600377. 40 F o o d JAF: U S 019700373. 30 1R03570 GilS 0198010278. 70'
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00204
564
TWO YEAR ORALCDIET) TX-GNC STUDY OF FM-3924 & FC-142 IN RATS EXP. 02S1CR0012
( TECHNICIAN INITIALS:S MH TODAY'S DATE-.S 5/27/81 SEX OF R A T S :S MALE ROOM NUMBER:S D-322 WEIGHT OF FULL FOOD JAR:S 550GRAMS
WEEK 5
1R03696 04S 007100237. 3Q
4
FOODJAR 14S 007200389. 50 : 14
1R02697 04S 007300228. 40
4
FOODJAR 14S 007400403. 60
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FOODJAR 14S 007600297. 80
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1RG3701 04S 010100327. 60
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1R03702 04S 010300219. 90
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FOODJAR 14 S 010400396. 50
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1R03703 04S 010500358. 20
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FOODJAR 14S 0106G0387. 60
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1R02704 4S 010700256. 20
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FOODJAR 14S 010800382. 00
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1R02705 04S 010900227. 40
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FOODJAR 14S 011000399. 70
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1R02706 04S 011100340. 00
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FOODJAR 14S 011200390. 30
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1R02707 04S 011300211. 80
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1R03708 04S 011500225. 20
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FOODJAR 14S 011600384. 80
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FOODJAR 14S 012400395. 50
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1R03714 04S 012700222. 4Q
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FOODJAR 14S 012800395. 10
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1R03730 04S 015900229. 60 FOODJftR 14S 016000287. 50 1R03731 045 016100370. 30 FOODJftR 14S 016200256. 70 1R03732 04S 016300300. 80 FOODJftR 14S 016400466. 10 1R03732 04S 016500217. 80 FOODJftR 145 016600294. 00 1R03734 04S 016700250. 30 FOODJftR 14S 016800372. 40
1R02725 04S 016900290. 90 FOODJftR 14S 017000411. 60
1RB3736 04S 017100279. 60 FOODJftR 14S 017200299. 70 1R03737 04S 017200329. 50
FOODJftR 14S 017400391. 20 1R0373S 04S 017500205. 80! FOODJftR 14 S 017600388. 90 1R0372S1 045 017700254. 80 FOODJftR 145 017800414. 70 1R3740 04b 017900322. 10
FOODJftR 145 018000393. 90
1R03741 045 018100243. 90! FOODJftR 14S 018200384. 50 1R03742 045 018300361. 60
FOODJftR 14S 018400283. 20 1R03743 045 018500226. 70
FOODJftR 145 018600290. 50 1R02744 04S 018700232. 10
FOODJftR 14S 018800291. 40
1R03745 04S 018900260. 50 FOODJftR 145 019000409. 10 1R02746 04S 019100321. 50
FOODJftR 14S 019200394. 20 1R02747 04S 019300324. 40 FOODJftR 145 019400396. 60
1R02746 04S 019500355. 80
FOODJftR 14S 019600389. 80 1R02749 04S 019700326. DO
FOODJftR 145 019800400. 40
i 32756 04S 019900300. 70 FOODJftR 14S 020000297. 10 1R02751 045 020100275. 20 FOODJftR 14S 020200270. 60 1R03752 045 020200283. 10
FOODJftR 14S 020400412. 30 1R 03752 045 020500362. 20<
FOODJftR 145 020600374. 30
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1R02754 04S 020700227. 40 FO ODJRR 14S 020800283. 50. 1R02755 04 020900368. 70 FOODJRR 14 021000378. 00 1R03736 04 021100328. 90 FOODJRR 14S 021200373. 10 )03757 04 021300312. 80 { JDJrtR 14 021400387. 20 1R03758 04 021500323. 10
FOODJRR 14 021600293. 20 1RG3759 04 021700255. 10 FOODJRR 14 021800276. 90
1R03760 045 021900301. 10 FOODJRR 145 022000382. 60 1R02761 055 022100235. 50
FOODJRR 155 022200293. 10
1R02762 055 022300210. 10 FOODJRR 155 022400406. 80 1R03762 055 022500370. 10 FOODJRR 155 022600367. 8Q 1R03764 05S 022700379. 2Q FOODJRR 155 022800377. 50 1R03765 055 022900341. 60 FOODJRR 155 023000368. 90
1R03766 05S 023108366. 50
FOODJRR 155 022200378. 50 1R03767 055 023300377. 00
FOODJRR 15S 023400372. 00 1R02768 055 023508261. 90 FOODJRR 155 023600357. 40 1R02769 055 022700338. 20 FOODJRR 155 022800365. 80 1R03770 055 23900394. 50
FOODJRR 155 024000360. 80
1R02771 05S 024100344. 20
FOODJRR 15S 024200372. 00 1R03772 055 024300214. 20
FOODJRR 155 02440039G. 40 1R03773 055 024500332. 10
FOODJRR 155 0246G0270. 50 1R03774 05S 024700241. 50
FOODJRR 155 24800394. 20
1R03775 055 024900369. IQ FOODJRR 155 02500O360. 0Q
1R02776 055 025100395. 8Q
FOODJRR 155 025200329. IQ 1R03777 05S 025300324. 10
FOODJRR 155 025400412. 00 1R03778 05S 025500366. 30
FOODJRR 15S 025400273. 10
1R03779 05S 025700248. 20
FOODJRR 155 025860381. 20 1R03780 OSS 025900330. 2Q FOODJRR 15S 026000390. 10
1R03781 05S 026100372. 7Q FOODJRR 15S 026200372. 3Q 1R037S2 05S 026300375. 0Q FOODJRR 155 026400360. 40
l 33783 055 026500322. 50 FOODJRR 15S 026600385. 20 1R03784 055 026700364. IQ FOODJRR 15S 026800365. 60 1R03785 05S 026900371. 0Q
FOODJRR 15S 027000360. 2Q 1R03786 OSS 027100361. 6Q FOODJRR 15S 02?0028&-8Q
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002052
227. 4
282. 5
268. 7
278
228. 9
272. 1
212. 8
287. 2
222 1
292. 2
255. 1
376. 9
381. 1
382. 6
325. 5
293. 1
310. 1
406. 8
370. 1
367. 8
379. 2
377. 5
341. 6
368. 9
366. 5
378. 5
377
373
361. 9
257. 4
238. 2
365. 8
294. 5
360. 8
344.
372 314.
J$F
COPY AW ill ABIE
390.
333. 1
370. 5
341. 5
394. 2
369. 1
360
395. 8
329. 1
324. 1
412
366. 2
372. 1
348. 2
381. 2
330. 2
290. 1
372. 7
372. 3
275
360. 4
222. 5
385. 2
364. 1
365. 6
271
360. 2
361. 6
382. 8 ______
567
1R3787 05 02730O312. 10
5
FO OD JR R 15S 02740405. 30*
15
1R037S8 05S 027500353. 90
5
FOODJRR 15S 027600282. 5Q 1R02789 05S 027700330. 5Q
15 5
FOODJRR 15S 027800279. 60
15
; '>37$ 0 05S 027900227. 20
5
JDJRR 155 028600266. 60 1R03791 05S 028100296 90
15 5
FOODJRR 155 028200240. 90
15
1R03792 055 026300217. 2Q
5
FOODJRR 155 028400292. 20
15
1R03792 05S 028500222. 50
5
FOODJRR 155 028600287. 60
15
1R03794 055 028700275. 90
5
FOODJRR 155 026800240. eo
15
1R03795 055 028900343. 10
5
FOODJRR 155 029006386. 70
15
1R03796 055 029100341. 60
5
FOODJRR 155 029200368. 90
15
1R03797 05S 029300363. 2Q
5
FOODJRR A5S 029460380. 50
15
1R03798 05S 029500353. 00
5
FOODJRR 15S 029600380. 4Q
15
1R03799 05S 029700354. 2Q
5
FOODJRR 155 029800371. 20
15
1R03800 055 029966374. 90
5
FOODJRR 155 030000376. 60
15
1R03801 05S 030100358. 80
5
FOODJRR 155 030206365. IQ
15
1R03802 05S 030360385. 40
5,
FOODJRR 15S 030400332. 60
15
1R03803 055 030500381. 10
5
FOODJRR 155 030600375. 10
15
1R03804 055 020700347. 80
5
FOODJRR 155 030800383. 50
15
1R03805 055 030900325. 50
5
FOODJRR 155 031000386. 90 1R03806 055 .31100378. 60
15 5
FOODJRR 155 031200352. 40
15
1R03807 055 031300347. 30
5
FOODJRR 155 031400361. 80
15
1R03S08 055 021500258. 6Q
5
FOODJRR 155 031606366. 70
15
1R03S09 055 031700359. 6Q
5
FOODJRR 155 031800372. 10
15
1R03810 055 031900366. 70
5
FOODJRR 15S 032000361. 50
15
1R03811 06S 032100376 50
6
FOODJRR 16S 032206266. 60
16
1R03812 065 032360396. 00
6
FOODJRR 16S 032400357. 20
16
1R03813 06S 022500259 80
6
FOODJRR 165 022600370. 7Q
16
1R03814 06S 032700335. 8Q
6
FOODJRR 16S 032600386. 00
16
1R03815 06S 032900237. 30
6
c
F^ODJAR 16S 033000366. 30 i 33816 06S 033100333. 80
16 6
FOODJRR 16S 033200387. 40
16
1R03817 06S 033300330 70
6
FOODJRR 165 033400401. 90
16
1R03818 065 033500348 60
6
FOODJRR 16S 033600381. 90
16
1R03819 065 033700365. IQ
6
FO OD JR R 16S 033800365. 70 S. 16
002053
312. 1
405. 3 353. 9
382. 5 330. 5 379. 6 337. 2 368. 6 396. 9
340. 9 317. 2 392. 2
332. 5 387. 6 375. 9
340. 8
343. 1 386. 7
341. 6
366. 9 363. 2
360. 5
353 380. 4 354. 2 371. 2 374. 9
378. 6
358. 8 365. 1 385. 4 332. 6 381. 1
375. 1 347. 8 382. 5
325. 5 386. 9 378. 6 352. 4 347. 2 361. 8
358. 6 366. 7 359. 6
372. 1 366. 7
361. 5
370. 5 360. 8 396
357. 2 359. 8 370. 7
335. 8 388 337. 3
366. 3
333. 8 387. 4 330. 7 401. 9 348. 6 381. 9 365. 1
365. 7
BEST COPY AM il ABLE
568
1R 03S2O 08 S 03.1900392. 5*Cl FOODJRR 16S 024000256. 00
1R02S21 68S 0241002 57. 70 FOODJRR 165 034200282 10
1R03S22 06S 034300255. 10 FOODJRR 16S 034400367. 60 ? '03823 08 034500288. 80 ; JD JRR 165 0246003-64 90 1R03824 065 034700334. 20
FOODJRR 18 S 034800389. 00 1R03S25 065 034900223. 30 FO ODJRR 18S 0250002.83. 80 1R62826 08S 035100206. 40 F O OD JRF: 16 035200292. 60 1R03827 065 035300247. 70
FOODJRR 18 S 025400277. 00 1R03828 065 025500368. 00 FOODJRR 165 025600389. 80 1R03829 06S 035700346. 80
FOODJRR 16S 035800383. 10 1R0382O 06S 035900267. 90
FOODJRR 16S 026000382. 80 1R03831 06S 036100342. 70 FOODJRR 165 036200261. 50
1R03832 08S 036300380. 00 FOODJRR 16S 036400365. 40 1R03333 06S 036500295. 10
FOODJRR 16S 02'6600398. 70
1R03834 065 036700343. 50
FOODJRR 16S 036800388. 80
1R03825 065 036900334. 10 FOODJRR 16S 037000384. 30 1R03836 06S 027100274. 30 FOODJRR 165 027200365. 80
1R02837 065 037300299. 20 FOODJRR 165 02740042. 70 1R03838 06S 037500327. 80
FO ODJRR 165 037600386. 5C!
1R03839 065 037700299. 20
FOODJRR 165 037800407. 10. 1R03840 065 037900361. 70
FOODJRR 165 038000365. 10
1R03841 06S 028100257. 90 FOODJRR 165 038200382. 50
1R03842 065 038300322. 10
FOODJRR 165 038400383. 20
1R03843 065 038500343. 70 FOODJRR 16S 038600386. 90
1R02844 06S 038700245. 60 FOODJRR 165 028800384. 90 1R03845 06S 038900340. 40
FOODJRR 16S 039000363. 40 1R03846 06S 039100367. 80 FOODJRR 165 039200272. 70
1R03847 065 029200402. 30 FOODJRR 16S 029400244. 70 1R02848 06S 039500225. 20 FOODJRR 165 029600400. 30
. J3849 06S 039700369. 00
FOODJRR 16S 039800369. 30 1R03850 065 029900214. 10 FOODJRR 165 040000297. 10 1R02851 06S 040100228. 30
FOODJRR 165 040200288. 60 1R03852 065 040300300. 60 FOODJRR 165 040400414 30
6 16 6
16 6 16 6 16 6
16 6 16 6 16 6 16 6 16
6 16 6
16 6 16
6 16 6 16
6 16
6 16 6 16 6 16 6 16 6
16 6 16
6 16 6
16
6 16 6 16 6
16 6 16
6 16 6 16
6 16 6 16 6
16 6 16
002054
292. 9 256 257. 7
282. 1 355. 1 267. 6
288, 8 264. 9 234. 2
289 222, 2 282. 8 306. 4 392. 6 247. 7
377
368 389. 8
346. 8
382. 1 367. 9
382. 8
243. 7 361. 5
380 265. 4 295. 1
298. 7
343. 5 388. 8
224. 1 384. 2 374. 2
365. 8
299. 3 402. 7 327. 8
286. 5 299. 2
407. 1
361. 7 365. 1
357. 9 382. 5
222. 1
383. 2
243. 7 386. 9
345. 6 384. 9
340. 4
262. 4 367. 8 272. 7
402. 3 344. 7 325. 2 408. 3
369
269. 3 214. 1
397. 1 228. 2
388. 6 300. 6 414. 3
BEST COPY AVAU ABLE
569
1R02852 065 04050252. 10
ie sFOODJAR
040600280. IQ
t'll*1R02854
040700222. 20
ie sF00JAR
040800278. 50.
1R03855 065 040800256. 20
FOODJAR 165 041000267. 00
* ''03856 065 041100380. 20
. JE-'JAF: 16S 041200276. 40
1R03857 065 041300342. 60
FOODJAR 165 041400372. 70
1R03858 065 041500362. 10
F OODJ AF: 165 041600281. 30
1R03859 065 . 41700322;. 60
FOODJAR 165 041800382. 60
1R03S6 065 041800357. 30
FOOD JAF: 165 042000378. 80
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16 6
616
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16 6 16
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352. 1
290. 1 323. 2
3278. 9
356. 367 380. 2 376. 4 342. 6 372. 7
362. 1 381. 3 222. 6
3382. 6
257. 278. 9
BEST COPY AVAIIABLE
570
TWO YEAR ORRL<DIET> TOX-ONC STUDY OF FM-3924 & FC-143 IN RRTS EXP. 0281CR0012
TECHNICIRN INITIRLS.S MH TO DA Y' S D R T E :S 6/2/61 SE X OF R R T S :S MRLE R O OM N U M B E R :S D-348, D-336 WEIGHT OF FULL FOOD JRR.S 550GRAMS
WEEK 6
1R03516 01S 000000421. 3G FOODJfiR U S 000100352. 60 1R03517 01S 000200387. 8Q FOODJRR U S 000300365. 90
1R03518 01S 000400385. 7Q FOODJRR 11S 000500369. 80 1R03519 01S 000606421. 0Q
FOODJRR U S 000700358. 30 1R03520 01S 000800410. 10 FOODJRR U S 000900366. 40
1R03521 01S 001000376. 30 FOODJRR U S 001100372. 60 1R03522 01S 00120G375. 90
FOODJRR 11S 001308392. 80
1R03523 01S 001400426. 30 FOODJRR U S 001500318. 60
1R02524 01S 001600363. 90 FOODJRR U S 001700385. 30
3 3525 01S 001800461. 10
FuoDJflR U S 001900252. IQ 1R03526 01S 002000384. 80 FOODJRR 11S 002108363. 50
1R03527 01S 002280389. 80 FOODJRR 11S 002300378. 90 1R03526 01S 002400414. 50
FOODJRR 11S 002500360. 0Q 1R03529 01S 002600389. 10
FOODJRR U S 002700329. 30
1R03530 01S 002800396. 30 FOODJRR U S 002900372. 20 1R03531 01S 003000386. 90
FOODJRR 11S 003100371. 20
1R03532 01S 003200390. 00
FOODJRR 11S 003300365. 70
1R03533 01S 003400409. 00 FOODJRR 11S 003500376. 6Q 1R03534 01S 003600432. 8Q
FOODJRR 11S 003700347. 70 1R03535 01S 003800341. 2Q FOODJRR U S 003900393. IQ
1R03536 01S 004000370. 70 FOODJRR IIS 004100386. 10 1R03537 01S 004200350. 2Q
FP^DJRR 11S 004300366. 3Q 1. 3538 01 S 004400425. 6Q FOODJRR 11S 004508350. 10
1R03539 01S 004600323 9Q FOODJRR 11S 004700392. 60 1R03540 01S 004808364. 60
FOODJRR U S 004900375. 2Q 1R03541 01S 005000412. 50
1 421. 3
11 352. 6
1 387. 8
11 365. 9
1 385. 7
11 369. 8
1 421
11 358. 3
1 410. 1
11 360. 4
1 376. 3
11 372. 6
1 375. 9
11 392. 8
1 426. 3
11 318. 6
1 363. 9
11 385. 3
1 401. 1
11 352. 1
1 384. 8
11 363. 5
1 11
iE S BEST COPY AVAII ABLE
1 414. 5
11 360
1 389. 1
11 329. 3
1 396. 3
11 372. 2
1 386. 9
11 371. 2
1 390
11 365. 7
1 409
11 376 6
1 432. 8
11 347. 7
1 341. 2
11 393. 1
1 370. 7
11 386. 1
1 350. 2
11 366. 3
1 425. 6
11 350. 1
1 323. 9
11 392. 6
1 364. 6
11 375. 2
1 412. 5
002056
571
FOODJRR 11S 005100328. 5Q 1R03542 01S 005200397. 20 FOODJRR 11S 005300365. 20 1R03543 01S 005400443. 80 FOODJRR lis 005500335. 20 1R03544 01S 005600384. 60 FOHDJRR 11S 005700367. 00
1. 3545 01S 005800422. 10 FOODJRR 11S 005900359. 6Q 1R03546 01S 006000420. 20
FOODJRR 11S 006100371. 10 1R03547 01S 006200407. 10 FOODJRR 11S 006300347. 00 1R03548 01S 006400441. 10 FOODJRR 11S 006500359. 4Q 1R83549 01S 006600371. 00 FOODJRR 11S 006700382. 30 1R03550 01S 006800382. 1Q FOODJRR 11S 006900379. 70
1R03551 01S 007000301. 10 FOODJRR 11S 007100408. 80 1R03552 01S 007200403. 2Q
FOODJRR 11S 007300363. 9Q 1R03553 01S 007400442. 70
FOODJRR lis 007500348. 90 1R03554 01S 007600329. 80 FOODJRR u s 007700385. 00 1R03555 01S 007800374. 00
FOODJRR 11S 007908385. 90 1R03556 01S 008000421. 00 FOODJRR lis 008100380. 00 1R03557 01S 008200383. 50
DJRR lis 008300392. 7Q lh.03558 01S 008400326. 90
FOODJRR lis 1R03559 01S 008600409. 10 FOODJRR u s 008700372. 40 1R03560 01S 008800374. 20 FNNDJ0R 00R 008900379. 60 1R03561 01S 009000435. 80 FOODJRR lis 009100348. 3Q 1R03562 01S 009200329. 70 FOODJRR lis 009300397. 30
1R03563 01S 009400368. 90 FOODJRR lis 009500385. 60 1R03564 01S 009600364. 70 FOODJRR lis 009700374. 00 1R03565 01S 009800398. 7Q FOODJRR lis 009900346. 80 1R03566 01S 010000361. 3Q FOODJRR iis;
10 3567 FOODJRR u s 010300358. 1Q 1R03568 01S 010400404. 90 FOODJRR lis 010500388. 7Q
1R03569 01S 010600409. 0Q
FOODJRR u s 010700362. 20 303570 01S 010800414. 20 1 JDJRR lis 010900319. 0Q 1R03571 01S 011000424. 60 FOODJRR lis 011100340. 0Q 1R03572 01S 011200396. 7Q FOODJRR lis 011300350. 9Q 1R03573 01S 011400398. 50 FOODJRR lis 011500368. 10 1R03574 01S 011600407. 40
11 1 11 1 11 1 11
1 11
1
11 1
11 1 11 1 11 1 11
1 11 1 11 1 11
1 11 1
11 1 11 1 11 1 11 1 11 1
11 1
11 1 11 1 11 1 11 1 11
1 11
1 11 1 11 1 11 1 11 1 11 1 11 1 11 1
002057
3b. O 397. 2 365. 2 443. 8 335. 2 384. 6 367
422. 1 359. 6 420. 2
371. 1 407. 1 347 441. 1 359. 4 371
382. 3 382. 1 379. 7
301. 1 408. 8 403. 2
363. 9 442. 7 348. 9 329. 8 385 374
385. 9 421 380 383. 5 392. 7 326. 9
410. 1 409. 1 372. 4 374. 2 379. 6 435. 8 348. 3 329. 7 397. 3
368. 9 385. 6 364. 7 374 398. 7 346. 8
361. 3 397. 2
427. 0 358. 1 404. 9 388. 7 409 362. 2 414. 2 319 424. 6 340 396. 7 350. 9 398. 5 368. 1 407. 4
SEST COPY AVAII ABLE
572
l-UUDJHK lib 011700217. 8
1R03575 01S 011800358. 3Q
FOODJfiR U S 01190035. IQ 1R03576 01S 012000387. 4Q
FOODJfiR 11S 012100373. 4Q 1R02577 01S 012200405. 10 FOODJfiR U S 012300361. 50 3r'02578 015 012400276. 4G i JDJRR 115 012500352. 3G 1R03579 01S 012600372. 7Q FOODJfiR 115 012700374. IQ 0R03580 015 012800366. 3Q FOODJfiR 11S 012900368. 3G
11
1
11 1
11 1 11
1 11 1 11 1 11
317. 8
358. 3
356. 1 387. 4
373. 4 405. 1 361. 5 376. 4 352. 3 372. 7 374. 1 366. 3 368. 3
BEST COPVAVAB ABLE
002058
573
TWO VEAF: 0RHL'L'1ET> TOX-ONC STUDV OF FM-3924 * FC-142 IN RATS EXP. ft 0281CR0012
TECHNICIAN INITIALS:S MH TODA V /S D A T E :S 6/3/81 SEX OF R A T S :S MALE ROOM NUMBER:S D-232 WEIGHT OF FULL F O OD J A R :S 550GRAMS
WEEK 6
1R03696 04S 00 7100355. 00 FOODJAR 14 S 007200389. 70 1R03697 04 S 00 7300320. 00 FOODJAR 14S 007400422. 40
1R03698 04S 007500348. 50 FOODJAR 14S 807600397. 60 1R03699 04S 007700321. 70 FOODJAR 14S 007800419. 50 1R03700 04S 00 7900377. 70
FOODJAR 14S 010000387. 70
1R03701 045 010100347. 30
FOODJAR 14S 010200383. 30 1R037O2 04 10300214. 30 FOODJAR 1 4 S> 010400424. 10 1RO3703 045 010500352. 60 FOODJAR 145 010600480. 60
1RO3704 045 010700349. 10 BOODJAR 145 010800425. 80
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576
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FOODJRR 165 040600400 9Q
1R03854 06S 040700315. 3Q
FOODJRR 165 040800423. 4Q
1R03855 065 040900351. 90
FOODJRR 165 041000360. 0Q
1R03856 06S 041100377. 80
FOODJRR 16S 041200406. 20
1 5857 06S 041300369. 0Q
FOODJR 16S 041400381. 90
1R03858 065 041500362. 90
FOODJRR 165 041600413. 50
1R03S59 065 041700326. 00
FOODJRR 165 041800403. 3Q
1R03860 065 041900372. 00
FOODJRR 165 042000385. 50
9999999999
99
16 6 16 6 16 6 16 6 16 6
16 6 16 6 16 0
400. 9 315. 3
423. 4
351. 9
360 377. 8 406. 2
369 381. 9 362. 9
413. 5 326
403. 3 372 385. 5
EST COPY AVAU ABLE
002064
579
TWO
VEAR
ORAL tDIET :> TOX-ONC STUDY OF FM-2924 FC-143 IN RATS EXE. # 0281CR0012
T E C H N IC IO N I N I T I A L S : MH
TODAV S DATE : S 6 /9 /8 1 S E X OF RA TS : S MALE ROOM NUM BER : S [>-340, 0 - 3 2 8 W E IG H T OF F U L L FOOD -JAR : S 550G RA M S
WEEK ?
1R03 518 01S 0O2100434. 70
FOOC J A R I I S 0 0 ?2 O 0 3 4 8 . 80 1P.03 517 0 1 S 00?300410. 00
FOOt JAR I I S 007 400361 . 0
i r o : :518 0 1 S 007500399. 60
FOOt JAR I I S ' 007 600347 . 50
1R03'519 0 1 S 00770O434. 70
FOOt JAR U S 0078O 0353. 60
1R03 :520 0 1 S 0O7900420. 20
FOOL JAR U S 0 1 0 0 0 0 3 4 8 . 30
1R03 '521 0 1 S 010100380. 80
FOOt JAR U S 010 280276 . 00
1R03 :522 0 1 S 0103003:92. 00
FOOt JAR U S 01040G378. 60
1R03 :523 0 1 S 0 1 0 5 0 0 4 4 2 10
FOOt JAR U S 010608230. 20
1R03:524 015 010700382. 60
FOOD JA R U S 010800371. 40
1 ::525 01 0 1 0 9 0 0 3 7 8 . 00
FOOt JAR U S 011000315. 80
1R0Z 528 01S 011100399. 30
FUUDJftR U S 011200221. 20
1R03 527 0 1S 011300401. 90
FOODJAR U S 011400378. 10
1R0Z :528 0 1S 0115G0424. 70
FOOC JAR U S 0 1 1 6 0 0 2 2 4 . 00
1R03529 01S 011700299. 80
FUUD JFlF: U S 011 800268 . 30
1R0Z .530 0 1 S 011900413. 60
FOOt JAR U S 012 000356 . 70
1R0Z '521 01S 012100402. 00
FOOt JAR U S 012200263. 80 1R0Zc r -- ~.i 0 1 S 0 1 2 2 0 0 4 1 1 . 20
FOOt JAR U S 012400263:.' 20
1R0Z :533 0 1 S 012500427. 90
FOOOJfiR U S 012600362. 50
1R0Z 534 0 1 S 012700445. 80
F U U D J HFs U S 0 1 2 8 0 0 2 4 3 . 30 1R0Z .525 0 1 S 012900356. 00
F OODJHR U S 012000392. 50
1R0Z :536 0 1 S 013108375. 00
FOOt JAR U S 013:200393:. 20
1R0Z
0 iS 013300260. 30
p - -T JAR U S 0134003:89. 50
1 , -z:528 IS 013500447. 20
FOOt JAR U S 012 600252. 70 1R0Z :539 0 1 S 812700342. 90
FOOt JAR U S 013 800284. 90
IROZ 540 0 1 S 012900380. 30
FOOt JAR U S 01400O371. 80
1 R0Z 541 0 1 S 0 1 4 1 0 0 4 2 8 . 30
FOODJAR U S 014200360. 60
1 11 1 11 1 11 1 11 1 11 1 11 1 11 1 11 1 11 1 11 1 11 1 11 1 11
1
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11
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1
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346. 8 400 361. 2
399. 6 347. 5 434. 7
353. 6 420. 2 348. 3 380. 8 376 392
338. 6 442. 1 230. 2 382. 6 371. 4 "^7*5-!
315. 8 399. 3 321. 2 401. 9 378. 1 424. 7 334 399. 8 3*SS*. s 413. 6 356. 7 402 363. 8 411. 2 363 427. 9 362. 5 445. 8 343. 3 356 292. 5 375 2:92:. 2 360. 3 369. 5 447. 2 352. 7 342. 9 384. 9 380. 3 271. 8 428. 2 3643. 6
BEST COPY AVAIf ABLE
580
IF-'*.'. 54 8 018 0.14 200408 00
F UUL1JHR Ilf. l 4 4 0 O 260. 8*_1 1R02542 OIS O.l42'00452 20 FOC*L'JRF' 118 014600*226. 40 1R02544 0112 01147 0101402. 20 F OOL'JFlF: 118 014800262. 70
1' 3545 0*18 011480101422. 50 F.. _.0JRF: 118 011500101256. 2*0 1K03546 0i18 011510i0142 4 8Cl F OOL'JFlF' 112. 01520102701. 00 1F:Ci3547 0118 0115200426. 50 FOOL'JRF: 118 015400212. 60 1R02548 0*18 01.55010457. 60 FOOL'JRF' IIS 015600228. 20 I R Q 3549 018 01157001284. 00 F DOL'JFlF: 118 0*1580101288. 20 IF:02:55 0118 011580101298. 00 FOOL'JRF: 112 011601001266. 70 IF:02 551 012 016100212. 20 FOOD JFiF: 112 016200408. 50 IF:02 55 2 012 0*16200416. 20
FOOL'JFlF' 112 01640*0255. 2*0 1R02552 0*12 0116500*456. 90! FOUDJRF' 112 0166010217. 40
IF'02554 012 01167010*222. 90
FOOL'JRF: 112 011680*0252. 80 IF'02555 0*12 0*1690*02:90*. 20
FOOL'JRF: IIS 01170*00*255. 90! 1R03556 OIS 017100427. 20 FOOL'JRF: 112 011720*0*212. 60
1RQ3557 012 6117200297. 40 FOOL'JRF' IIS 01740*0284. 60
1 2558 CHS 017500228. 70
FOOL'JRF: 11S 817600*268. IG! IF:02:55 8 0*12 017700*422. 40 FOOL'JRF: 11S 017800272. 60
IRC*3566* 0 1 S 0*17900280. 40 FOOL'JRF: 11S 011800*0*277. 60 IF:02561 0i12 011810*0*452. 90
FOOL'JRF' 112 018200227. 40
1R02562 012 0*18200242. 90 FOOL1JRF: 11S 0118400289. 50
1R02562 01S 018500279. 10 FOOD JRF: 11S 01866*6*282. 00) 1R02564 0 1 S 0118700*272. 90!
FOOL'JRF' 11S 018800251. 10 IF:02565 01S 0189610412. 0*0 FOOL'JRF: 11S 019000272. 70
1RQ3566 01S 0*1910*0272. 20 FOOL'JRF: 11S 0192010*275. 70! 1R02567 01S 01930101434. 30
FOODJRR IIS 0H9400353. 80 1R02568 01S 019500428. 40!
FOOL'JRF: 11S 0*196001361. 90! 1R02569 01S 019700421. 30 F OOL1JRF: 11S 0*198001354. 20! 1R02:570 012 0119900*432. 20!
F'" "D.JRR 11S 0*2010001325. 60 1. .--2571 C*1'S Ci20i10iC'445. 50! FOOL'JRF: 11S 0*20200*342 00!
IF:02572 CHS 020300414. 80
F'OOC'JRR 11S 0126*4010*353. 10! IF:02572 012 0180*5010*421. 50! FOOL'JRF: 11S 01206010*361. 30! I R 02574 012 0120*7010*417. 90 FOOL'JRF: 11S 0*20*8061313. 30!
1
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11 1 11 1 11 1 11 1 11 1 11 1
11 1 11 1 11 1
11 1 11 1 11 1
11 1 11 1 11 1 11 1 11 1 11 1
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11 1 11 1 11 1
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002066
408
360* 9
453 2
22t. 4 402. 2 262. 7 432. 5 356. 2 434. 9 3701 426. 5 312. 6
457. 6 228. 3 384
388. 3 399 366. 7
312. 2 408. 5 416. 2
255. 3 456. 9 217. 4
233. 9 3:52. 8 390. 2
355. 9 4 ^ \ s 312. 6 397. 4 384. 6 338. 7 368. 1 422. 4 373. 6 380. 4 277. 6 452. 9
227. 4 343. 9 2:89. 5
379. 1 382 373. 9
351. 1 412 273. 7 273. 2 375. 7 434. 2
353. 8 428. 4
361. 9 421. 2 254. 2
432. 2 325. 6 445. 5 342 414. 8 352. 1 421. 5 361. 2 417. 9 213. 2
BEST COPY AVAU ABLE
581
1R03575 01 020900175. 70 FOODJAR U S 021000314. 00 1R03576 01S 021100399. 80
FOODJAR U S 021200331. 70 1R03577 01S 021300423. 50 FOODJflR U S 021400350. 10 J r "1-578 0 1 S 821500384. 60 F._ ..D-JRR 11S 021600354. 90 1R03579 01S 021700387. 60
FOODJAR 11S 021800362. 50
1R03580 01 0219003-79 30
FOOD-JAR 11 0220003-69. 90
1 11 1
11 1 11 1 11 1
11 1 11
3 75. 334 399. o
331. ' 423. 5 350. 1
384. 6 354. Q
j-;"7 6
362. 5
379. 369. Ci
BEST COPY AVAII ABLE
002067
582
TWn VEHR O R A L - D I E T > TGX-ONC STUDY OF FM-2924 * FC-142 IN RATS EXP. # 0281CR0012
TECHNICIAN I N I T I A L S : MH TODAY "'S D A T E :S 6/10/81 SEX OF R H T S :S MALE ROOM NUMBER:S D-232 WEIGHT OF FULL FOOT' JAR:S 550GRAMS
WEEK ?
1R:02696 04S. 007100369. 90 FOOD JAR 14S 00720040. 5Q 1R02697 04S 00?300334. IQ FOODJAR 14S O0 ?4004C'0, 30
1R03698 04S 0075QQ3&2. 4Q
FOODJAR 14S 00?600272. 20 1R02699 04S 00770032b. 9Q FOODJAR 14S 007800381. 0Q 1R03700 04S .07900276. 5Q FOODJAR 14S 010000397. 90
1R03701 04S 010100340. 10 FOODJAR 1 4 S' 010200425 90 1R 62702 042. 010300222. 90
FOODJAR 14S 010400394. 20 IF:02 703 04S 010500370. 60 FuODJAR 14S 01060O380. 10
1R03704 04S 010700280. 60
FOODJAR 14S 010800369. 30 1 2705 04S 010900241. 80 FOODJAR 14S 011000271. 10
1R03706 04S 011100255. 20 FOODJAR 14S 011200386. 80
1R03707 04S 011200349. 00 FOODJAR 14S 011400384. 50 1R0J i0 o 04S 011500211. 10
FOODJAR 14S 011600432. 80 1R037O9 04S .11700252. 80 FOODJAR 14 S 011800381. 10
1R 02710 04S 011900272. 30! FOODJAR 14S 012O00396. 40 1R02711 04S 012100229. 60
FOOD*JAR 14S 012200297. 90 1R 02712 04S 012200352. 60' FOOD'JAR! 14S 012400288. 80
1R03712 04S 012500291. 30: FOODJAR 14S 012600376. 70 1R02714 04S .12700222. 20
FOODJAR 14S 012800385. 50 1R02715 04S 012900402. 10 FOODJAR 14S 013000357. 70
1R 03 71 6 04S 013100364. 20' FOODJAR: 1 4 S 013200389. 10 1R03717 04S 013300318. 70 F DJAR 1 4 S- 012400401. 80 1 k o 3718 04S. 013500359. 5 O' FOODJAR: 14S 013600398. 60'
1R02719 04S 013700251. 20 FOODJAR 14S 012800291. 70 1R02720 04S 012900232. 00 FOODJAR 14S 014000418. 10 1R 02721 0 4 S. 014100278. 30 FOODJAR 14S 014200297. 20
4 14 4 14 4 14 4 14 4 14 4 14 4 14 4 14 4 14 4 14 4 14 4 14 4 14 4 14 4 14 4 14 4 14 4 14 4 14 4 14 4 14 4 14 4 14 4 14 4 14 4 14
002068
369. 9
406. 5 234. 1 400. 3
362. 4 373. 3 326. 9 281 376. 5 297. 9 340. 1
425. 9 322. 9
294. 2 270. 6 380. 1
280. 6 269. 2
341. 8
271. 1 255. 2 386. 8
249
I284. 5
211. 1 433. 8 253. 8 381. 1
372. 2 296. 4 329. 6 397. 9
252. 6 388. 8
391. 2 376. 7 322. 3
385. 5 403. 1 257. 7
364. 3 389. 1
218. 7 401. 8
259. 5 298. 6
351. 2 291. 7 332 418. 1 378. 2 297. 2
BEST COPY AVAR ABLE
583
1R03722 045 014200358. 00 FOOL* TRF' 14S O 1 4 4 0O 4O 0 20 1R03723 04 S .14500376. 20 F OODJflR 145 014600298. 50 IF:03 724 04S 014700373. 80 FOODJflR 14S 014800383. 90 1P R 2 7 2 5 45 149O0274. 20 F DJRR 149 01500O277. 70 1R02726 04S 015100236. 60 FOOL'JH R 14 015200282. 90 IF:0 3 2 7 04 015300359. 40 FOODJRR 145 015400395 00 1.R03 728 04S 0155OO216. 50 F 001'JflR 14S 015600414. 20 1R02729 045 015700344. 20 FOODJflR 14S 015800399. 60 1RO3720 04S 015900351. 40 FOODJRR 14S 016006403. 60
1R03731 04 5 016100000. 20
FOODJRR 145 016200379. 40 1R02732 04S 016200312. 60 FOODJRR 14S 01640O402. 30 1R03722 045 .16500316. 50 FOODJRR 145 0166O0413. 10 1R02734 045 016700260. 60 FOODJRR 145 016800290. 30
IRC'3725 045 816900299. 70 FOODJRR 145 017000409. 80 1F:03726 045 017100294. 30
FOODJRR 145 01720O424. 30
1R02727 045 017300358. 20 F DJRR 145 017400372. 20 1F.03738 045 017500322. 80 FOODJRR 145 017600406. 10 1R02729 04S 017700263. 60
FOODJflR 145 017800427. 70 1R O2 74 0 45 17900322. 40 FOODJRR 145 018008401. 50 1R03741 045 018100363. 10 FOODJRR 145 O18200401. 90 1R02742 045 018300276. 30
FOODJRR 145 018400291. 80 1R03743 04S 018500257. 60 FOOD JRF: 145 018600401. 40 1R02744 045 018700340. 60
FOODJflR 145 018800411. 20 1R02745 045 018900266. 60
FOODJRR 145 019000412. 70 1R03746 045 019108326. 80
FOODJflR 145 019200413. 30
1R02747 045 019280350. 00 FOODJRR 145 019400408. 50 1R03748 04S 019500262. 00 FOODJflR 145 019600395. 90 1R02749 045 019700215. 10 FOODJRR 145 019800298. 50
l p"''2750 045 019900313. 80 F DJRR 145 020000388. 70 1R02751 045 020100280. 10 FOODJRR 145 020200401. 90 1R02752 045 02O300285. 60 FOODJflR 145 020400429. 70 1R02753 045 020500382. 70 FOODJRR 145 020600297. 10 1R02754 045 020700335. 30
4 3:56*
14 400. 2 4 B76. 14 398. 5 4 273. 8 14 282. 9 4 274. 3 14 377. 7 4 2 6 -- 6. 14 382.9 4 359. 4 14
4 216. 5 14 414. 2 4 344. 2 14 399. 6 4 351 4 14 403. 6
4 386.5
14 379. 4
4 312. 6 14 402. 3 4 316. 5
14 413. 1 4 360. 6 14 390. 3
4 299. 7 14 409. 8 4 294. 2 14 424. 3 4 358. 2 14 272. 2 4 322. 8 14 406. 1 4 263. 6 14 427. 7 4 222. 4 14 401. 5
4 362, 1 14 401. 9 4 276. 3 14 291. 8 4 357. 6 14 401. 4 4 340. 6 14 411. 2 4 266. 6 14 413. 7 4 226. 8 14 413. 3 4 35 14 408. 5 4 262 14 395. 9 4 315. 1 14 398. 5 4 312. 8 14 388. 7 4 380. 1 14 401. 9 4 285. 6 14 429. 7 4 282 7 14 297. 1 4 235. 2
002069
BEST COPY AVAII ABLE
584
F L ' HF: 14S -'0800402 70 1R 03 75 5 043 '0900379. 00 F ODJHR 14S 021000393. 7Q
1F:03 756 04 S 021100350. 60 FODJftR 14S 021200265. 50
1R02757 04S 021300316. 50
F DJ h F: 14S 021400430. 00 lKc'2 758 04S 021500359. 50 FOOL1JftF 14S 021600267. 40
1R03759 46 021700349. 0Q FCiDJftF: 14S 021800404. 70 1R0276O 043 021900321. 10
F O D D JftF 143 022000382. 30
1R02761 05S 022100371. 80 FOODJftR 153 022200282. 50 1R03762 053 02230*3223. 90 FODJftR 153 322430415. 80 IF?2.762 053 022500374. 00
F 00 DJ flF: 153 02260025?. 50 1R02764 05S 0227002S2. 30 FOODJftR 153 022800411. 20 1R02765 053 022900234. 90 FOODJftR 153 023008421. 20 1F:02766 353 022100382. 60 FOODJftR 153 023200280. 00 1R33767 353 023300422. 50 FOOD JftF: 153 323400383. 10
1R02768 053 023580394. 80 FOOD JftF: 153 023600384. 90 1F:02 765* 353 023700357. 40
FOODJftR 153 022800287. 00
1R 02770 *353 02390*3422. 20 F DJftF: 153 624000247. 40
1F02771 353 324133382. 90 FOOL1JftF: 153 024200394. 20 1R02772 053 02430252. 20 FOODJftR 153 3244*304*32. 40 1R03773 053 024500363. 60 FOODJftR 153 024600366. 20
1R02774 053 024700232. 0 FOOL"JftF: 153 624800422. 60 1R02775 053 024900398. 10
F O O D JftF: 153 025000255. 80 1R 03776 053 02510*3417. 70 FOODJftR 153 025200346. 70
1R0J. r'7 {' 053 025200381. 70 F O OD JftF: 15S 25400346. 60 1R02778 053 025500404. 10
FOODJftR 153 025600382. 90 1R03779 853 025700365. 40 FODJftR 153 025800290. 70
1R02780 053 025900341. 50 FOODJftR 153 026000401. 40 1R03781 053 026100372. 70
FOODJftR 153 026200397. 10
1R03782 053 026300384. 60 FOODJftR 153 026400371. 50 d 3782 053 026500342. 30 Fo'JDJftR 153 026600401. 80
1R03784 053 026700384. 60 FOODJftR 153 026800367. 30 1R 02 78 5 053 326900293. 40 F OO D JftF: 153 027000380. 20
1R03786 053 027100377. 90 FOODJftR 153 627200392. 70 1R02787 05S 027300225. 30
14 402. 7 4 279 14 293. ? 4 256. 6 14 365. 5 4 316. 5 14 430 4 359. 5 14 367. 4
4 349 14 404. 7 4 321. 1 14 382. 3 5 371. 8 15 382. 5 5 323. 9 15 415. 8 5 374 15 357. 5 5 382. 3 15 411. 2
5 334. 9 15 421. 2 5 382. 6 15 380 5 422. 5 15 383. 1 5 394. 8 15 384. 9 5 357. 4 15 387 5 422. 2 15 347. 4 Bj 382. 9 15 394. 2 5 352. 2 15 402. 4 5 363. 6 15 366. 3 5 222.8 15 422. 6 5 398. 1 15 355. 8 5 417. 7 15 346. 7 5 381. 7 15 346. 6 5 404. 1 15 382. 9 5 365. 4 15 390. 7 5 341. 5 15 401. 4 5 372. 7 15 397. 1 5 384. 6 15 371. 5 5 342. 3 15 401. 8 5 384. 6 15 367. 3 5 393. 4 15 380. 2 5 377. 9 15 392. 7 5 325. 3
002070
K r COPYAVAII4BLE
585
F UD JRF: 108 027400414. 70
iktij 78s OOS 0 2 7 0 00 36 2 70 F O O D JRF 15S 2 7600394. 70 1F:02789 OOS 027700345. 00 FOODJRR 15S 02780O383. 90 1R0279O 05S 02790O264. 70 F'-''DJRR 15S 02S00O385. 10 1 791 05S O28100429. 80 FOODJRR 15S 028200373. 90 1R03792 05S 028300336. 70 FOODJRR: 15S 028400392. 30 1R03792 05S 028500341. 90 F 001'-JRF: 15S O28600403. 90 1R02794 05S 02870O425. 40 FOOD JRF: 15S 02880O362. 20 1R02795 05S O28900253. 70 FOOD JRF: 15S 029000362. 20 1R03796 05S 029100363. 10 F O OD JRF' 15S 829200406. 70 1R03797 05S 029300294. 40 FOOD JRF: 15S 029400384. 20
1R0379S 05S 029500374. 50 FOODJRF 15S 02960O377. 90
1R03799 05S 029760375. 10
FOO-JRR 15S O29800374. 40 1R03S00 05S 029900399. 40 FOODJRR 15S 030000357. 60
1R03801 85S 030100288. 90 FOODJRR 15S 030200361. 30 1R03802 05S O30300422. 00
FOODJRR 15S 030400251. 70 1R03802 05S 0305O0408. 10 F D-JRR 15S 030608370. 80
1K03804 85S 03070363. 20 FOODJRR 15S 030800391. 10 1R 02 80 5 05S 0309O0329. 3Gf FOODJRR 15S 031000418. 60 IR03806 05S O31100406. 60 FOODJRR 15S 021200390. 10
1R03807 05S 021300278. 10 FOODJRR 15S 031400279. 00 1R03808 05S 031500391. 70
F OODJRR 15S 031600271. 6G! 1R03809 05S 021700362. 50 FOODJRR 15S 031800383. 40
1R03810 05S 031900362. 10 FOODJRR 15S 032000380. 00 1R03811 06S 03-2100390. 10
FO OD JR R 16S 032200368. 30.
1R03812 06S 032200413. 40 FOODJRR 16S 032400339. 10
1R03813 06S 022500282. 30 FOODJRR 16S 0326O0370. 50 1R03814 06S 032700343. 30 FOODJRR 16S O22800372. 80 1R03815 06S 022900266. 30 FOODJRR 16S 022000251. 50
1^-R3816 06S 023100268. 40 F DJRR 16S 03320O275. 20 1R02817 06S 032300258. 40
FOODJRR 16S 033400410. 60 1R03818 06S O32500362. 00 FOODJRR 16S 032600406. 50 1R03S19 06 823700377. 80 F O OD JRF: 1 6 S 023800392. 20 1R03820 06S 033900404. 80
15 C*
15 5
15 5 15 5
15 5 15 5
15 5 15 5 15 5 15 5 15
5 15 5
15 5 15
5 15 5 15 5 15 5
15 5 15 5
15 5 15 5 15 5 15 5 15 6
16 6 16 6 16 6 16 6 16 6 16 6
16 6 16 6 16 6
002071
414. 7
262. 7 294. 7
345 383. 9 364. 7 285. 1 429. 8 372. 9 336. 7 292. 2 341. 9 402. 9 425. 4 362. 2 353. 7 362. 2 363. 1
406. 7 394. 4 384. 2 374. 5 377. 9 375. 1 274. 4 299. 4 357. 6
388. 9 361. 3 422
351. 7 408. 1 370. 8
362. 291. 1 229. 2 418. 6 406 6 390. 1 378. 1
391. 7
271. 6 262. 5 383. 4 362. 1 280 390. 1
368. 7. 413. 4 339. 1 282. 2 370. 5 343. " 372. 8 366. 7F 351. 5 368. 4 375. 2 258. 4 410. 6 362 406. 5 277. 8 292. 2 404 8
BEST copy AVAII ABLE
586
FOOL'.UHR It'S 024000287. 10 1F'S821 0tS 0 J 4100250 80 F j C'Jh R 10S O24200285. 70
1R03822 06S 0^4200277. 70 FOOL'J HR 1 6 S 024400280. 70 1R03822 06S 024500392. 50 F L'JHR 16S 024600415. 80 1k o 2824 06S O24700260. 20 FOOL'JHR 1 6 S' 024800407. 60
1R02825 06S 024900256. 50 FOOL'JHR 16S 025000290. 80 1R03S26 06 025100327. 30 FOOL'JHR 16S O25200367. 20
IF!02 82 7 06s> 035300275. 00 FOOL'JHR 16S 025400373. 40
1R02828 06S 035500404. 40 FOOL'JHR 16S 035600400. 70 1R02829 06S 035700361. 30 FOOL'JHR 16S 035800377. 50
IRQ3820 06S 35900384. 60 FOOL'JHR. 16S 036000395. 40
1R02821 06S 036100347. 60 FOOL'JHR 168 36200399. 80 1R02822 06S 836300416. 90
FOOL'JHR 16S 026400374. 50
1 F!0.iS'J:S 06 036500320. 10 FOOL'JHR 16S 036600392. 40
1R03824 06S 036700354. 20 FOOL'JHR 16S 036800410. 00 1R02825 06S 036900340. 40 FOOL'JHR 16S 037000409. 30 1R03826 06S 037100408. 50 F L'JHR 16S 637200274. 70
1R02827 06S 027300222. 10 FOOL'JHR 16S 037400407. 60 IF:02828 06S 037500355. 00 FOOL'JHF: 16S 037600405. 00 1R02829 06S 037700212. 30 FOODJHR 168 027800412. 00
1F:0840 065 03-7900366. 50 FOOL'JHR 165 038000366. 90 1R02S41 065 038100402. 30
FOOL'JHR 165 038200386. 70
1R02S42 065 028300337. 70 F OOL1JHR 165 038400395. 10
1R02843 065 038500373. 00 FOOL'JHR 165 038600395. 80 1R02844 065 038700373. 40 FOOL'JHR 165 038800376. 10 1R02845 065 038960355. 30 FOOL'JHR 165 039000292. 40
1R03846 065 029100396. 20 FOOL'JHR 16S 039200393. 40 1R0284? 065 039200415. 50 FOOL'JHR 165 039400261. 40 1R0284S 065 029500241. 10 FOOL'JHR 165 039660420. 60 i 2849 065 039700385. 20 F l..j E'JHR 165 029800377. 10 1RO2850 065 029900244. 20 FOOL'JHR 165 040000296. 60 1R03851 065 040100255. 70 FOOL'JHR 165 04020040. 10
1R02852 065 040200204. 00 FOOL'JHR: 168 046400422. 40
16 -E:7. 1
6 256. 8
16 285. 7
6 s77. 7
16 280. 7
6 292. 5
16 415. e
6 260. 2
16 467. 6
6
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16 290. 8
6 Ji-CL i. 2
16 267. 2
6 275
16 373. 4
6 404. 4
16 400. 7 6 361. 5
16 377. 5
6 384. 6
16 395. 4
6 347. 6
16 399. 8
6 416. 9
16 374. 5
6 220. 1
16 392. 4
6 354. 2
16 410
6 340. 4
16 409.
6 16
408. 374.
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6 222.1
16 407. 6
6 355
16 405
6 213. 3'
16 412
6 366. 5
16 366. 9
s 402. 2
16 386. 7
6 237. 7
16 295. 1
6 372
16 395. 8
6 373. 4
16 376. 1
6 355. 3
16 292. 4
6 396. 2
16 293. 4
6 415. 5
16 361. 4
6 341. 1
16 420. 6
6 285. 2
16 377. 1
6 244. 3
16 396. 6
6 255. 7
16 400. 1
6 304
16 422. 4
002072
BEST COPY AVAU S l
587
1R03853 06S 040560373. 0Q
FOODJRR 16S 040600407. 4Q
1R03854 06S 040700326. 90 FOODJRR 16S 040800407. 80
1R02855 06S 040900366. 40 FOODJRR 165 041000384. 40 1R 03 85 6 06S 041100389. 20 F '-'-'DJftR 165 041200374. 70 1. 3857 06S 04120363. 6Q FOODJRR 16S 041400386. 80 1R0385S 065 041580378. 40 FO ODJRR 165 041600400. 00 1R 02859 06S 041700349. 20
FOODJRR 165 041800374. 80 1R03860 06S 041900376. 70 FOODHRR 16S 042000396. 40
989999998880042000396. 40
6
16
6 16 6 16 6 16 6
16 6 16 6 16 6 16 9
--'l'J-
407. 4
326. 9 407. 8
366. 4 384. 4 389. 2 374. 7
363. 6 386. 8 378. 4 408 349. 2 374. 8 376. 7 396. 4 396. 4
BEST COPY AVAII ABLE
002073
588
TWO VERR ORRL<DIET> TOX-ONC STUDV OF FM-2924 & FC-143 IN RFlTS EXP. # 0281CR0012
TECHNICIRN INITIRLS:S MH TO DRV'S D R T E :S 6/16/81 SE X OF R R T S :S MALE ROOM NU MB ER :S D-340.- D-328 WEIGHT OF FULL FOOD J R R :S 550G RR MS
WEEK 8
1R03516 01S 007100463. 90 FOODJRR 11S 00?200358. 00 1R03517 01S 007200426. 20 FOODJRR 11S 007400376. 20 1R02518 01S 007500419. 00 FOODJRR IIS 007608366. 90 1R03519 01S 007700455. 60 FOODJRR IIS 007800272. 40 1R02520 01S 007900437. 9Q FOODJRR U S 010000380. 20
1R03521 01S 010100400. 80 FOODJRR 11S 010200374. 30 1R02522 01S 010300408. 20 FOODJRR u s 010400387. 5Q 1R03523 01S 010500472. 70 FOODJRR lis 010600267. 60 1R02524 01S 010700412. 50 FOODJRR lis 010800271. 70 3( 3525 01S 010900422. 40 FuuDJRR lis 011000252. 20 1R03526 01S 011100428. 7Q FOODJRR u s 011200363. 80 1R03527 01S 011300420. 10 FOODJRR lis 011400382. 60 1R02528 01S 011500451. 70 FOODJRR lis 011600358. 50 1R03529 01S 011700419. 30 FOODJRR lis 011800363. 10 1R02530 01S 011900444. 90 FOODJRR lis 012080360. 20 1 R 0 3 5 2 1 '01S 012100427. 90
FOODJRR lis 012200271. 60 1R03532 01S 012300422 eo FOODJRR lis 012400278. 20 1R02523 01S 012500464. 80 FOODJRR lis 012600352. 10 1R02524 01S 012700477. 40 FOODJRR lis 012800341. 30 1R02525 01S 012900380. 00 FOODJRR lis .13000381. 00 1R02536 01S 013100393. 00 FOODJRR lis 012200397. 30 1R03527 01S 0133003/4. 40
Fv .JRR lis 013400377. 90 1R03536 01S 013500485. 90 FOODJRR lis 013600343. 7Q 1R03539 01S 012700363. 40 FOODJRR lis 013800386. 0Q 1R03540 01S 013900398. 10 FOODJRR lis 014000371. 80 1R02541 01S 014100455. 70
1 463. 9
11 358
1 426. 2
11 376. 2
1 419
11 366. 9
1 455. 6
11 372. 4
1 427. 9
11 380. 2
1 408. 8
11 274. 3
1 408. 2
11 387. 5
1 472. 7
11 267. 6
1 412. 5
11 371. 7
1 422. 4
11 352. 2
1 428. 7
11 262. 8
1 11
Z k i BEST COPY AVAII ABLE
1 451. 7
11 258. 5
1 419. 3
11 362. 1
1 444. 9
11 260. 2
1 427. 9
11 371. 6
1 422. 8
11 378. 2
1 464. 8
11 352. 1
1 477. 4
11 341. 3
1 380
11 381
1 393
11 397. 2
1 374.4
11 377. 9 1 485. 9
11 343. 7 1 362. 4 11 386 1 398. 1 11 371. 8 1 455. 7
002074
589
FOODJRR 115 014200358. 20 1R02542 015 014300426 70 FOODJRR 11S 014400367. 80 1R03542 IS 014500484. 90 FOODJRR 11S 014600231. 50 1R02544 01S 014700434. 70 F' '*>JRR 11S 014800232. 4Q ltw3545 01S 014900463. 30
FOODJRR U S 015000346. 10 1R03546 01S 015100457. 60 FOODJRR 11S 015200247. 10 1R03547 01S 015308457. 90
FOODJRR 11S 015400337. 80
1R03548 01S 015500487. 30 FOODJRR U S 015600351. 40
1R03545 01 015700403 40 FOODJRR 11S 015800398. 20 1R03550 01S 015900417. 50
FOODJRR 11S 016000375. 50
1R03551 01S 016100326. 00 FOODJRR U S 016200410. 80
1R03552 015 016300447. 10 FOODJRR 115 016400351. 60 1R03552 01S 016500494. 20
FOODJRR 115 016600332. 00
1R02554 015 016700253. 60 FOODJRR 115 016800393. 60
1R03555 015
FOODJRR 115 017000378. 80 1R03556 015 017100467. 10
FOODJRR U S 017200364. 80 1R02557 01S 017200422. 60 R DJRR 11S 017400380. 90
1R02558 01S 017500359. 40 FOODJRR 115 017600384. 00
1R03559 01S 017700453. 70
FOODJRR U S 017800369. 40 1R03560 01S 017900395. 50 FOODJRR 115 018000385. 60
1R03561 01S 018100480. 00 FOODJRR 11S 018200329. 90 1R03562 01S 018300350. 80
FOODJRR 11S 018400395. 10
1R02563 015 018500400. 10 FOODJRR 11S 018600271. 50
1R62564 015 018700400. 30 FOODJRR 115 018800356. 80 1R03565 015 018900437. 20
FOODJRR 115 019000274. 40 1R03566 015 019100296. 40 FOODJRR 115 019200291. 00
1R02567 015 019300464. 60 FOODJRR U S 019400364. 76
1R03568 01S 019500459. 70
FOODJRR U S 019600361. 20
1R03569 01S 019700447. 70 FOODJRR 115 019800359. 70
? >3570 015 019900457. 60 R wJDJRR 11S 020000344. 60 1R03571 01S 020108481. 80
FOODJRR U S 020200346. 90 1R03572 015 020300421. 60 FOODJRR 115 020400366. 00
1R03573 015 020500447. 50 FOODJRR U S 020600358. 60 1R03574 015 820700462. 50
11 1 11 1 11 1 11 1 11 1 11 1 11 1 11 1 11 1 11 1 11 1 11 1 11 1 11 1 11 1 11 1 11 1 11 1 11 1 11 1 11 1
11 1 11 1 11 1 11 1 11 1 11 1 11 1 11 1 11 1
11 1 11 1 11 1
002075
358. 2 436. 7 367. 8 484. 9 331. 5 434. 7 332. 4 462. 3 346. 1
457. 6 347. 1
457. 9 337. 8 487. 3 351. 4
403. 4 390. 2 417. 5
375. 5
326 410. 8
447. 1 351. 6 494. 2
333 353. 6 393. 6 409.3
378. 8 467. 1 364. 8 422. 6 380. 9 359. 4 384 453. 7
369. 4 395. 5 385. 6
480 329. 9 350. 8
395. 1
400. 1 371. 5 400. 3 356. 8 437. 2 374. 4 396. 4 391 464. 6 364. 7 459. 7
361. 2 447. 7 359. 7 457. 6 244. 6 481. 8
346. 9 421. 6 366 447. 5 358. 6 462. 5
EST COPY AVAIl ABLE
590
FOODJfiR U S 020800318 60
1R03575 01S 020900389. 50
FOODJfiR IIS 021000337. 70
1R02576 01S 021100428 60 FOODJfiR U S 021200373. 40 1R03577 01S 021300452. 10
F'-ODJfiR lis 021400349. 20 1 j2578 01S 021500397. 70 FOODJfiR lis 021600370. 40
1R03579 eis 021700410. 50 FOODJfiR u s 021800368. 50
1R03580 01S 021980403. 70
FOODJfiR u s 022000269. 70
11
1
11 1 11 1 11 1 11
1 11 1
11
318. 6
389. 5 337. 7
428. 6 373. 4 452. 1 349. 2 397. 7 370. 4
410. 5
368. 5
403. 7
369. 7
S COPYMUMBLE
002076
591
TWii YEAR ORAL vDIET> TOX-ONC STUDV OF FM-3924 FC-142 IN RATS EXP. * 0261CR0012
TECHNICIAN INITIALS:S MH TODAY S D A T E :S 6/ 17/61 SEX OF RAT :S MALE ROOM NUMBER:S D-322 HEIGHT OF FULL FOOD J A R :S 5 5 0G RA MS
WEEK B
1R02696 04S OO ''100276. 70 FOODJAR 14S 00 7200403. IQ 1R02697 04S 007300367. 7Q FOODJAR 14S 0O740O391. 5Q
IR'03698 04S 0O750O386. 60 FOODJAR 14S 007600394. 20 1R03699 04S 00770O351. 30
FOODJAR 14 S 007800382. 10 1R02700 04S OO790O410. 90 FOODJAR 14S 01O0OO362. OQ
1R 03701 0 4 S 010100281. 20 FOODJAR 14S 010200380. 60 1R03702 04S 610300354. 10 FOODJAR 14 01040O381. 70 1R037O2 04S 010500398. 20 FOODJAR 14 S 01O60O369. 30 1RO2704 04S 0107O0399. 10 FOODJAR 14S 01080O365. 30 i 1705 04S O1090O373. 00
FUUDJAR 14S 0H000269. 00 1R01706- 04 011100262. 70
FOOD JAR 14S 0112OO294. 50
1R01707 04S O112O0356. 90
FOOL1JAR 14 O1140O396. 70
1R03708 04 O1150O261. 90
FOUDJAR 14S O1160O358. 30 1R02709 04S O1170O374. 80
FOODJAR 14S 011800368. 60
1R02710 04S 011900391. 70 FOOL1JAR 14S 01200O358. 60 1R01711 04S O12100256. 90 FOOL'JAR 14S O12200392. 40 1R02712 04 O12200377. 40 FOOL* JAR 14 012400383. 70 1R03712 04 O12500418. 60 FOOD1JAR 14 O1260O353. 60 1R02714 04S 01270O354. 00
FOOL'JAR 14S 012880381. 50 1R02715 04 01290O428. 20 FOODJAR: 14S 013000350. 30 1R02716 04S 013100387. 00 F OOL'JAF: 14 01220G371. 20 1R01717 04 012200341. 80
F ` *'DJAR 14 013400391. 40 1. .'3-718 04 O13500278. 50 FOODJAR 14 013600391. 40
1R02719 04 012700268. 20 FOODJAR 14 O128O0391. 30 1RO3720 04 012900349. 80 FOODJAR 14S 0140004O1. 80 1R02721 04 0141O0393. 00
4 376. 7 14 402. 1 4 367. 7 14 391. 5 4 386. 6 14 394. 2 4 351. 3 14 382. 1 4 410. 9 14 363 4 281. 2 14 380. 6 4 354. 1 14 381. 7 4 298. 2 14 369. 3 4 299. l 14 365. 2 4 _>*3 14 369 4 362. 7 14 394. 5 4 356. 9 14 396. 7 4 261. 9 14 358. 3 4 374. 8 14 368. 6
4 391. 7 14 358. 6 4 356. 9 14 392. 4 4 377. 4 14 382. 7 4 418. 6 14 353. 6 4 354 14 381. 5 4 428. 2 14 350. 3 4 287 14 271. 2 4 341. 8 14 291. 4 4 378. 5 14 391. 4 4 368. 2 14 391. 3 4 349. 8 14 401. 8 4 293
002077
COPY AVAIl ABLE
592
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002082
597
TWO YEAR ORAL<DIET> TOX-ONC STUDY OF FM -3 92 4 & FC-143 IN RATS EXP. # U2 81 CR 00 12
TECHNICIflN INITIFlLS :S MH TO DAY'S DATE :S 6/23/81 SEX OF R A T S :S MALE ROOM N U M B E R :S D-240, D-338 WEIGHT OF FULL FOOD J A R :S 550GRAMS
WEEK 9
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1 485. 7 11 257 1 438. 5 11 368. 4 1 436. 4 11 367. 6 1 481. 4 11 354. 1 1 466. 3 11 368. 3 1 414. 8 11 373. 4 1 420 11 382. 7 1 491. 2 11 369. 1 1 432. 2 11 370. 5 1 434. 8 11 379 1 444. 8 11 367 1 429 11 386 1 469. 7 11 257. 9 1 434. 2 11 369. 2 1 462. 8 11 369. 3 1 437. 2 11 389. 4 1 437. 4 11 375. 8 1 476. 2 11 362. 1 1 504. 2 11 337. 6 1 396. 1 11 387. 8 1 405. 9 11 298. 5 1 271. 6 11 390. 4 1 581 11 349 1 366. 2 11 395> 1 416. 1 11 380. 5
002083
COPY AVAILABLE
598
1*03541 018 014100476. 20
FUDJR 11S 014200268. 00 1R03542 01S 014300454. 00 F OOC'Jh F' 11S 114400261. 60
IF'03543 01S 014500497. 10! FOODJfiR 11S 014600237. 60 1R03544 01S 014700454. 20!
! JDJfiR lis 014800253. 10! 1*63545 01s 014900484. 00 FODJR 11S 015000347. 60
1R02546 01S 015100479. 40! FOODJR lis 015200248. 80) 1R03547 01S 015300481. 60!
FOODJR lis 015400216. 40! 1R63548 01S 015500499. 60!
FOODJR lis 015600357. 00 1R03549 01S 015700414. 80
FOODJR lis 015800395. 10!
1R03550 01S 015900428. 50! FOODJR lis 016000382. 30
1R02551 01S 016100236. 00
FOODJfiR lis 016200412. 20 1R02552 01S 016300461. 30 FOODJfiR lis 016400247. 90 1R03553 01S 016500511. 70
FOODJR lis 016600276. 90 1R03554 01S 016700363. 504 FOODJfiR lis 016800397. 40
1R02555 01S 016900419. 80
FOODJfiR lis 1R03556 01S 017100480. 20
FOODJfiR lis 017200370. 30 *- 03557 01S 017300427. 20
1-_ODJfiR lis 017400285. 70 1R03558 01S 017500364. 40 FOODJfiR lis 017600368. 40! 1R0 2:559 01S 017700461. 40
FOODJfiR lis 017800377. 90 1R03560 01S 017900398. 20
FOODJfiR lis 018000407. 30
1R03561 01S 018100491. 60 FOODJfiR lis 018200232. 20! 1R03562 01S 018300347. 10
FOODJfiR U S 018400411. 20 1R02563 01S 018500407. 80 FOODJfiR lis 018600384. 90
1R02564 01S 018700417. 60 FOODJfiR U S 018800363. 30 1R03565 01S 018900457. 20
FOODJfiR U S 019000368. 50 1R03566 01S 819100406. 80! FOODJfiR U S 019200371. 00
1R03567 01S 019300473. 40 FOODJfiR U S 019400371. 80 1R03568 01S 019500468. 30
FOODJfiR U S 019600263. 60 1R03569 01S 019700455. 20 FOODJfiR U S 019800368. 20
. .13570 01S 019906467. 90) FOODJR U S 020000246. 70
1R03571 01S 020100492. 50
FOODJR U S 020200250. 00 1R02572 01S 020400436. 60
FOODJfiR U S 0204O0373. 80 1R03573 0-1S 020500465. 00 FOODJfiR U S 020600363. 50!
1 4 7fc. 3 11 368 1 454 11 361. 6 1 497. 1 11 227. 6 1 454. 2 11 352. 1 1 484 11 347. 6 1 479. 4 11 348. 8 1 481. 6 11 216. 4 1 499. 6 11 357 1 414. 8 11 295. 1 1 428. 5 11 383. 3 1 336 11 412. 2 1 461. 3 11 247. 9 1 511. 7 11 376. 9 1 363. 5 11 397. 4 1 419. 8 11 371.1 1 480. 2 11 370. 3 1 427. 2 11 285. 7 1 264. 4 1 11 268. 4 1 461. 4 11 377. 9 1 298. 2 11 407. 2 1 491. 6 11 333. 2 1 347. 1 11 411. 2 1 407. 8 11 284. 9 1 417. 6 11 363. 3 1 457. 2 11 268. 5 1 406. 8 11 371 1 472. 4 11 371. 8 1 468. 2 11 363. 6 1 455. 2 11 268. 2 1 467. 9 11 346. 7 1 492. 5 11 350 1 436. 6 11 373. 8 1 465 11 362. 5
002084
599
1R2574 OI S 8207*0495. _ a .|
FOODJR 11S 020800405. 1R03575 OIS 0209004O4. F OOD-J Flft 11S 021000346. 1Q 1R3576 01S 021100438. Q FOODJR 11S 021200275. 2-Q 1R03577 01S 021300460. 60
F ODJR 11S 021400358. 70 X . . 0 3 5 7 0 OI S 021500405. so. FOODJR 11S 021600376. 5Q
1R03579 OIS 021700423. 70 FODJftF: 11S 021800369. 20
1R03580 OIS 021900412. 0 FOODJftF; 11S 022000366. 6Q
i
il i il
i il i
il i il i
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495. s 405 IT 404 C' 346. 1 438. C t 375. 3460. t. 358. 1405. 8
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4 cLS. 7 *
269.
412
266. 8
002085
600
TWO VEAR ORAL' DIET > TOX-ONC STUDY OF FM-2924 6. FC-143 IN RFITS EXP. # 0281CR0012
TECHNICIAN I N I T I A L S : MH TODAY S DATE :S 6/24/61 SEX OF RAT S :S MALE ROOM NUHBEF::S D-232 WEIGHT OF FULL FOOD J A R :S 550GRAMS
WEEK 9
IRC*2696 C'4S .0 7100390. 60 F OOD JAR 14S 07200392. 50 IRC'2697 04S C'C'7200390. 50 FOODJAR 14S 007400373. 60 1R02698 04S 007500406. 00 F001'JAR 14S 007600261. 40
1R02699 04S 007700367. 60 FOODJAR 14S 007800378. 00 1R02700 04S C'C'7900422. 50
F00t>JAR 14S 810000372. 80 1R02701 C'4S 010100294. 50 FOOL'JAR 1 4 S 010200373. 40
1R 03702 C'4S 010300377. 50 FOODJAR 14S 010400377. 50 1R.02702 04S 018500409. 40 FOODJAR 14S 010600372. 60 1R02704 C'4S 010700410. 30 F DJAR 14S 010800268. 90 1RO2705 04S C'IC'900387. 80 FOODJAR 14S 011000376. 30 1RO2706 64S 011100282. 70 FOOL'JAR 14S C'11200376. 70 1R02707 C'4S 011200374. 10
FO ODJAR 14S C'11400407. 80
1R02708 04S 011500270. 90 FOOD JAF: 14S 011600270. 40 1R027O9 C'4S 011700290. 70 FOODJAR 14S 0118:00379. 80 1R02710 04S 011900397. 00
FOODJAR 14S 012000369. 10 1 R 0 2 7 U 64S 012100273. 50 FOODJAR 14 S 012200395. 90 1R02712 04 S 012200102. 60
FOOt'JAR 14S 012400372. 10 1R02712 04S 012500426. 30 FOODJAR 14S 012600376. 20 1R02714 04S 012700369. 90 FOODJAR 14S 012800391. 80 IRC'3715 04S 012900449. 60 F00t>JAR 14S 013000357. 90 IRC'2716 C'4S 013100412. 70 FOOt'JAR 14S 012200352. 40 J -3717 04S 012300352. 30 F .....DJAR 14S 013400405. 50 1R03718 04 013500295. 60 F OODJAR 14'S 012600278. 70 IRC'2719 04S 0127003:84. 40 FOODJAR 14S 012800287. 20 1R 03720 C'4S 013900361. 20 FOODJAR 14S 014000400. 40
4 396. 6 14 292. 5
4 390. 5
14 372. 6
4 406
14 381. 4
4 367. 6
14 378
4 432. 5
14 372. 8
4 394. 5
14 272. 4
4 277. 5
14 377. 5
4 409. 4
14 272. 6 4 410. 3
14 4
368. 9 387. 8
1 S T COPY fiVAII ABLE
14 276. 2'
4 382. 7
14 276. 7
4 274. 1
14 407. 8
4 270. 9
14 270. 4
4 396. 7
14 379. 8 4 397
14 369. 1
4 373. 5
14 395. 9
4 395.6
14 372. 1
4 426. 3
14 376. 2
4 369. 9
14 391. 8
4 449. 6
14 357. 9
4 412. 7
14 352. 4
4 352. 3
14 405. 5
4 395. 6
14 278. 7
4 284. 4
14 S8r'. 2
4 261. 2
14 400 4
002086
601
i m -<;.721 04b 0i410ti411 50
F ijuL'JHF- 14b 014200270. 90 042- 0142 0 O 3 9 2. 90
F O u L'Jh P 1 4 S 014400282. 50 1 R 02723 04b 01450O408. 10 FOOL-JAR 14b 014600275. 20 R02724 04b 014700407. 20 F DJh F' 14b 014800274. 50
1F:03 725 04 b 014900413. 20 H.iOL'-Im K 14b 015000275. 90 Rti_ 726 04b 01 5100377 80 FOul* JflF: 143- 0152010370. 00
1RJ-72V 04b 015200292. 00 FOOL'JAF: 14S 015400376. 30
1R3728 04b 815500370. 60 FOOC'Jh F: 14b 015600278. 50 1RCi3 729 04b 015700403. 50 F 00L>JflF: 14b 015800366. 70
1R02730 04b 015900407. 10 FOOL'JAF: 14 016000373. 60 1R03721 04 016100445. 70 FOOOJh R 14 016200345. 80
1R02722 04 016300342. 90 FOOL'JAF: 14 016400384. 60 1R03722 04 016500372. 50 FOODJflF: 14b 016600387. 00 1R02724 04 016700400. 30 FOOC'JHP 14b 016800277. 40
IF:03 7 3 5 04 016900341. 60 FOOL1JFlF: 14 017000320. 40 1R03 726 04 017100331. 80 FOOL'JFlF: 14 017200384. 80 ir 13727 04b 017200391. 70
F .-DJAF 14 017400273. 60
1R 02728 04 0175010261. 60 F OOC1JR F: 14 017600261. 00 1R03729 014 0177010296. 40 FOOL'J AF: 14 01780101405. 40 1R03740 04 017900372. 40 FOODJflF: 14 01180100385. 60
1R03741 04 0181001296. 50! FOODJflF: 14b 018200293. 50 1R 02742 014 018300411. 80
F OOD JFlF: 14 018400371. 80 IF:02 74 2: 0i4 011850101391. 40 FOODJflF: 14 0186010373. 60
1F02744 014 0116700379. 00 FOODJflF: 14b 018800278. 20
1R03745 04S 018900215. 70 FOODJflF: 14 019000389. 80 1R02746 04 0191001374. 70 FOODJflF: 1 4 S 019200391. 20
1R03747 04 019300386. 60
FOODJflF: 14 019400369. 70 1R02748 04S 019500419. 30
FOODJAR 14S 019600374. 20 1R02749 04S 019700359. 30 FOODJflF: 1 4 S 019800376. 50 1 2750 04 019900362. 20 F OODJflR 14 020000403. 30 1R03751 04 020100433. 90 FOOL'JFlF: 14 020200359. 00! 1R 02 75 2 04S 020300218. 00! FOODJflF: 14 020401-1407. 20!
1R07752 04 020500432. 30 F OOC* JFlF: 14 020600340. 70!
4
14 4 14 4 14 4 14 4 14 4 14
4 14 4 14 4 14 4
14 4 14
4 14 4
14 4 14
4 14 4
14 4 14 4 14 4 14 4 14
4 14 4
14 4 14 4 14 4 14 4 14
4 14 4 14 4 14 4 14 4
14 4 14 4 14
002087
411. 5
278 9 292'. 9 282. 5 408. 1 375. 3 407. 2 274. 5
412. 2 375. 9
t' , &
370
292
376. 3 370 278. 5 402. 5 366. 7 407. 1
372. 6 445. 7 245. 8 342. 9 384. 6
372. 5 387 400. 3 277. 4 241. 6
320. 4 221. 8 384. 8 291. 7 272. 6 361. 6 261 296. 4
405. 4 373. 4 285. 6
296. 5 393. 5 411. 8 371. 8 291. 4 272. 6 379 378. 2 315. 7 289. 8 274. 7 391. 2 386. 6 369. 7 419. 3 374. 2 259. 3 376. 5 263. 2 403. 2 432. 9 359 318 407. 2
432. 2 340. 7
BEST COPY A V M ABI
602
iFu2754 0 4 'r- 02*07063 8?. 70 F i.iOL IHF 143- 02080035?. 00 1R60 755 04 -- 020800431. 70 FOOD JRF: 14S 021O00368. 10 1R6i 3756 04 S 021100388. 40 FOOL'JRF: 1 4 S 6121200340. 40 1R02757 04 021300363. 20 F 0,1HR 14 021461037?. ?Q
1 1,.(3758 0 4 S 021500397. 60 F OOL*J Hr' 14 U2l66iti404. 20
1R027 00 6i4 61217 00396. 10 FOOD Jm F' 14 0218610366. 00 IF!03 760 04 61219610344. 90 F uOL' .1RF 14S 0226i6'6i3:?9. 30 IF'2761 0bS 022100398. 60 FOODJRR 15S 022200393. 0
1R02762 5S 22300363. 60 FOOt1JFlF: 15S 02240O392. 40 IRtG 7 62 05 02250043:1. 00
F O OD JRF: 15 022600343. 90 1R03764 05S 022708432. 60 FOOD JFlR 15S 022800355. 20
1R 03765 05S 61229610412. 10 FOOt`JFlF 158 023061613.26-. 20 IF:03 76 6 05S 0231061435. 76.
FOut'JRF: 15S 6i2'326'6i360. 20 1R0 3-767 05 6123300469. 60 FOOD' JRF: 15S 6123400385. 90 1F:03768 05 02356i6i441. 40 FOOD JRF: 1 5 0 2 3 6 61036-5. 0Q 1F:03 76? 5S 6i23700392. 60 FOOL'JRF: 15 023800400. 00
1R R2 77 0 615 023900457. 20 F D JRF: 158 0240610358. 00
1R03771 58 024100417. 20
FOOD JRF: 1 5 0242 00 32 0 80 1R0 3-772 053- 024306396. 80 FOOL1JRF: 15S 024406i357. 90 IF:03:77 3' 6'53- 024500405. 50 FOOD JRF: 15 6124600354. 90
1R03774 05 024700375. 80 FOOD JRF: 15S 024808393. 80 1R03775 053- 6124900440. 60 F OOL'JRF' 15 02561003861. 80 1F:6>3776 053- 025100462. 70 FOOL-JRF: 15S 025200346. 70
1R03777 05S 025300420. 20 FOOD JRF: 15S 02546i6i375. 60 1R 03 77 8 0 5 S 0255610446. 2c FOOL'JRF: 15S 0256061341. 20 1R0377? 053- 6257 00 41 8 5C' FOOD-JRF: 15S 6125800348. 20
1R03780 65S 02590O390. 80 FOOL-JRF: 153- 026000379. 60 1R03781 05S 626100412. 90
FOOL'JRF: 15 S 02620i3?l. 40 1R037S2 05S 026300433. 60 FOOD-JRF: 15S 026400368. 40 1 3-783 05 0265610403 60 F.--JOJRF: 15S 0266061347. 80 1R 03784 5 0267061437. 30
FOOD JRF: 15S 026800361. 50 1R03 78-* 053- 61269610431. 00
F OOL1JRR 153- 02700036?. 0 1R03786 05 027100414. 70 FOOL'JRR 153- 027200402. 50
4 389 7
14 35?
NH
4 431. 7
14 368. 1
4 388. 4
V tN <Ti 'it 0(1 H
14 346. 4
4 363. 2
14 379. 9
4 39?. 6
14 46i4. 2
4 396. 1
14 3-66
J i r l 'it 'it r t 01 (M H l \ l N CM 'it 0 1 't
4 344. 9
14 379. 3 5 398. 6
15 393-
5 363. 6
15 392. 4 5 431
15 343. 9
5 432. 6
15 355. 2
5 412. 1
15 326. 2 5 435. 7
15 366. 2
5 469. 6
15 385. 9
5 441 4
15 365
'it ill OJ CD CD 1J 1 ID 01 CD 00 CD 00 N (- 0(1 'it r i C\| ID (M 00 'it 'T> ^ Oil 'it 09 lv l ID
5 392. 6
15 400
5 457. 2
15 358
5 417. 2
15 320. 8
Cj 396. 8
15 357. 9
5 405. 5
15 354. 9
5 375. 8
1e5
393. 8 440. 6
15 380. 8 5 462. 7
15 346. 7
5 420. 2
15 375. 6
crt 446. 3
15 341. 2 c 418. 5
15 348. 2
5 390. 8
15 379. 6
C ( 412.*9
15 371. 4
5 423, 8
15 268. 4
5 402. 6
15 347. 8
C 437. 3
15 361. 5
cr . 431
15 367. 1
5 414. 7
15 402. 5
002088
1F1V
Ut<2 02. OOtVt'.". OU
F*H_I[ITRF 103 0 2 7 4 00 40 9 80
1R02788 fciOS 02/50407. 00
FuOl'JRR 108 02 78-00288. 80
1R03 789 Obb 027700287. 80
FOOL'JRR 102 027800271. 60
lF:ti37S<0 0 `2'2 027 9002 99. 60
F '.'JRR It'S 028OO367. 50
lR0279i 059 O281O0488 20
FOOL'JRR 152 028200351. 60
1R0:;792 052 028200377. 60
FOOL1.1HR' 152 028400287. 10
IF:00 79 2 052 028500390. 60
FOOL'JRR 152 028600375. 10
lftei3?94 652 028700474. 20
FOOL'Jh F: 152 028800229. 40
1R02795 052 028900127. 00
FOOL'JRR 152 O29O00288. 00
1R02796 052 O29100410. 60
FOOL'JRR 152 029200263. 30
1R013797 05S 02930O438. 00
FOOL'JRR 152 0294O0366. 10
1R02798 052 02950416. 50
FOOL'JHF: 152 029600386. 90
1R02799 052 O2970O419. 90
FOOL'Jh F 152 029800377. 20
1RO 2-800 052 02990t'445. 90
FOOL'JFtR 152 030000367. 70
1R03881 052 020100425. 00
FuOL> JFtR 152 0302610344. 70
1R 03S02 0152 02013O0461. 10
FOOL'JFlR 1 5 S' 0201400349. 90!
l r 3802 052 030500454. 10
F, ,l'JRR 152' 013016010355'. 80
1R02-S04 052 030700396. 20!
F'OOL'JRF: 152 01380101295. 50!
1R 02-305 052 0i30i900389. 20!
FOOL'JRR 152 021000393. 70
1R02806 052 021100441. 10
FOOL'JRR 152 0212001366. 00
1R02807 052 021200406. 20
FOOL'JRR 152 021400362. 80
1R02808 .052 0215001448. 40!
FOOL'JRR 152 031600246. 60
1R 02 80 9 05S 012170O4019. SO.
FOOL'JRR 152 031800262. 20
1RO3810 0152 02190101431 80!
FOOL'JRR 152 01220010354. 50!
1R02811 062 02210O438. 10
FOOL'JRR 162 032200349. 70
1R03812 062 0322010471. 00!
FOOL'JRR 162 022400252. 30
1R03813 062 0325010451. 30!
FOOLJRR 162 022600341. 50
1R03814 062 022700386. 7G(
FOOL1JRR 162 032800381. 70
IF:02815 062 0i22900'299. 60!
FOOL'JRR: 162 023010101356. 80
1 2818 062 03210101409. 70.'
FOOL'JRR 162 0i22200i232. 40!
1R0281V 062 01322010412. 70
FOOL'JRR 162 022400377. 90!
1R 02818 0.62 0'2 250104011. 90!
FOOL'Jh F: 162 0*236010361. SO
1R 03819 062 0337001426. 50!
FOOL'JRR 162 03380101366. 90
267
15 409. 6
5 407
15 382. 8
5 3 7. 8
15 371. 6
5 399. 6
15 367. 5
5 488. 2
15 351. 6
5 377. 6
15 387. 1 5 390. 6
15 375. 1 5 474. 2
15 229. 4
5 385.5
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15 362. 3
438
15 366. 1
5 416. 5
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15 377. 3
5 445. 9
15 267. 7
5 425
15 344. 7
5 461. 1
15 349. 9
5 454. 1
15 5
255. 8 296. 2
BEST COPY AVAR ABLE
15 395. 5
5 389.
15 392. 7 5 441. 1
15 366 r 406. 2
15 363. 8
5 448. 4
15 346. 6
5 409. 9
15 362. 3
5 431. 8
15 254. 5
1$ 438. 1
16 349. 7
6 471
16 352. 2
6 451. 3
16 341. 5
6 386. 7
16 381. 7
399
16 356. 8
6 409. 7
16 232. 4
6 413. 7
16 377. 9
6 401. 9
16 361. 9
6 436. 5
16 366. 9
0020S9
604
sZ'\y OF S 0 2 : 9 0 0 4 5 7 . 30
F COL .1AF: 1C.8 0 1 4 0 0 0 2 5 1 2u
1R02 021 0 8 S 0 1 4 1 0 0 4 1 8 90
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1R02 il.-- 065. 0 2 4 9 0 0 4 5 9 . 90
F J a f : 162. 0 2 4 6 0 0 3 7 7 . 70
ii,.< : 024 0 6 S 0 : 47 004 15. 0G*
F Out 1JA F 16-9 0 3 4 8 0 0 3 7 5 . 10
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FOOL 'JA F ' 16-9 02-5000377. 00
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F 00D J OF: 1 6 9 02-5200388. 20 i r o : >!d '' 0 6 9 0 3 5 3 0 0 4 2 1 . 6 0
FOOL JAR 1 6 9 0 3 5 4 0 0 3 7 4 . 60
i r o : <f'i=l8 0 6 9 0 3 5 5 0 0 4 3 4 . 90
FOOL JAR 1 6 9 0 3 5 6 0 0 3 9 6 . 70
IF : OL'8 2 9 0 6 S 0 3 5 7 0 0 4 0 4 . 20
FOOL JAR 1 6 S 0358O04OO. 20
IF : 02
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FOOL JAR X C S 0_>60 0 0 >89 L-!
1 F:02 831 0 6 S 0 3 6 1 6 0 4 0 8 . 80
F OOCJAR 1 6 9 0 3 6 2 0 0 3 6 7 . 10
IF : 02 O--ci 062. 0 3 6 3 0 0 4 5 1 . 30
FOODJAk 169 036400365. 00 i r o : J-; s." 0 6 S O 36 5O 035 8. 50
FOOD-JAR 1 6 S 0 2 6 6 0 0 3 7 0 . 5Q
i r o : 824 0 6 S 0 3 6 7 6 0 3 8 8 . 60
FOOL '.JAR 1 6 S 036 800385 . 40
i r o : C`Ji-2.' 0 6 9 O 36 9O 037 7. 20
FOOL JAR 169 O37OOO390. 60
i r o : ;026 0 6 S 0 3 7 1 0 0 4 6 0 . 30
f : JAR 165 0 3 7 2 0 0 3 6 9 . 20
ir o : ;
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FOUL JAR 165 037 400378 . 40
i r o : O_2!* 0 6 9 0 3 7 5 0 0 3 8 2 . 40
FOOL JAR 169 0 3 7 6 6 0 3 9 6 . 30
i r o : 839 0 6 3 @ 3 770038 0. 3:Q
F O O D JA R 1 6 9 0 3 7 8 0 0 3 8 6 . 4G!
ir o : 840 089 @7900417. 4u
FOOL JAR 1 6 8 0 3 8 0 0 0 3 6 5 . 00
i r o : 84 1 0 6 9 0 3 8 1 0 0 4 3 9 . 5G!
FOOL1J A R 1 6 3 0 3 8 2 0 0 3 7 8 . 9G!
i r o : :842 063 0 3 8 3 0 0 3 7 4 . 10
FOOL JAR 1 6 3 0 3 8 4 0 0 3 9 9 . 70
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F OODJAR 168 038600380. 10
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FOOL'JAR 1 6 8 0 3 9 0 0 0 3 6 8 . 60
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FOOL JAR 1 6 3 0 3 9 2 0 0 3 7 4 . 40
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FOOL JAR 165 039 400338 . 50
i r o : :848 069 @39500390. 90
FOOL JAR 165 0 2 9 600392 . 60
r : -849 0 6 5 0 3 9 7 0 8 4 2 4 9 0
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FOOL TAR 1 6 8 0 4 0 0 0 0 3 7 3 50
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FOOL' J AR 165 040 200383 . 80
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6 404. 2
16 4O0. 2
6 430. 6
16 389. 8
6 408. 8
16 367. 1
6 451. 3
16 365
6 358. 5
16 370. 5
6 388. 6
16 385. 4
6 377. 2
16 290. 6
6 460. 3
16 369. 2
6 385. 4
16 378. 4
6 382. 4
16 396. 3
6 380. 3
16 386. 4
6 417. 4
16 365
6 439. 5
16 378. 9
6 374. 1
16 399. 7
6 415. 9
16 380. 1
6 418 2
16 368. 4
6 398. 8
16 368. 6
6 445. 2
16 374. 4
6 476. 6
16 338. 5
6 390. 9
16 292. 6
6 424. 9 16 S&7. 6 291. 7
16 373. 5 t. 400. 7
16 282. 8
6 257. 9
16 397. 7
002090
EST COPY A IM ABLE
605
iK0385.i Ubb 0 4 0 5 0 0 4 0 3 . 4 0
FOODJftR: 16S 040680412. 8Q
1R03854 06 040700381. 80
FOODJftR 16S 040800378. 60
1R03855 06S 040980429. 10
FOODJftR 16S 041000362. 90
1R03856 06S 041100435. 70
F XTftR 16S 041200375. 90
1R0385? 06S 041300422. 20
FOODJftR 16S 041400345. 60
1R02858 06 041500423. 40
FOODJftR 16 041600373. 50
1R03859 06S 041700401. 40
FOODJftR 16 041800363. 30
1R03860 06 041900438 00
FOODJftR 16 042000347. 9Q
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403. 4
412. 8
381. 8
378. 6 429. 1 362. 9 435. 7
375. 9 422. 2 345. 6 423. 4 373. 5 401. 4
363. 2 438
347. 9
BEST COPY AVA ABLE
002091
606
TWO YEAR ORAL(DIET) TOX-ONC STUDV OF FM-2924 A FC-143 IN RATS EXF. # 0281CR0012
TECHNICIAN INITIALS:S MH TO DA Y' S D A T E :S 6/30/81 SEX OF R A T S :S MALE R O OM N U M B E R :S D-240, D-238 WEIGHT OF FULL FOOD JAR:S 550GRAMS
WEEK 10
1R03516 01S 00?190507. 00 FOODJAR 11S 007290357. 4Q 1R0251? 01S 007390457. 80
FOODJAR 11S 007490370. 40 1R03518 01S 007590444. 70 FOODJAR 11S 007690386. 00
1R03519 01S 007790491. 9Q FOODJAR U S 007890369. 20 1R03520 01S 807990472. 40
FOODJAR 11S 01009038?. 00 1R03521 01S 810190431. 30 FOODJAR 11S 010290271. 40
1R03522 01S 010390430. 20
FOODJAR U S 010490398. 50
1R02523 01S 010590501. 60
FOODJAR U S 010690336. 90 1 P `,|3524 01S 010790427. 00
F DJAR 11S 010890392. 90
1R02525 01S 010998448. 30 FOODJAR 11S 011090285. 40
1R03526 01S 01119O454. 80
FOODJAR U S 011290379. 20
1R02527 01S 011390427. 80 FOODJAR 11S 011490394. 80
1R03528 01S 011590489. 50 FOODJAR 11S 011690364. 30
1R62529 01S 011790443. 50
FOODJAR 11S 011890353. 70 1R03520 01S 011990473. 20 FOODJAR 11S 012090383. 50
1R02521 01S 012190450. 50 FOODJAR 11S 012290374. 30 1R03532 015 012390444. 00
FOODJAR U S 012490386. 60
1R03533 015 012590491. 50 FOODJAR U S 012690250. 5Q 1R03534 01S 012790517. 50
FOODJAR U S 012890358. 60 1R03535 01S 012990398. 4Q
FOODJAR 11S 013090403. 20 1R03536 01S 013190416. 00
FOODJAR U S 013290411. 10 1 353? 01S 013390388. 00 FuuDJAR 11S 013490398. 40 1R03538 01S 013590520. 40
FOODJAR 115 013690365. 60 1R03529 01S 013798378. 70 FOODJAR 115 013898410. 90
1R03540 015 012990423. 90 FOODJAR 11S 014090398. 80
1 11 1
11 1 11
1 11 1
11 1 11
1 11 1
11 1
11 1 11 1
11 1
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1 11 1
11 1 11
1 11 1 11 1 11 1 11 1 11 1 11 1 11 1
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11 1 11
507 357. 4 457. 8 370. 4 444. 7 386
491. 9 369. 2 473. 4
387 431. 3 371. 4
430. 2 398. 5 501. 6 236. 9 437
392. 9 448. 2 285. 4 454. 8 379. 2 427. 8 294. 8
489. 5 364. 3
443. 5
353. 7 472. 2 382. 5
450. 5 374. 3 444
386. 6 491. 5
350. 5 517. 5 358. 6 398. 4 402. 3 416 411. 1 388 398. 4 520. 4
365. 6 278. 7 410. 9 423. 9 398. 8
002092
607
lKfci^b41 01S 014190477. bO
FOODJRR U S 014290277. 40 1R03542 01S 014390466. 50 FOODJRR U S 014490374. 0D 1R03542 01S 014590511. 90 FOODJRR IIS 014690346. 6Q 1R02544 01S 014790471. 3Q F DJRR IIS 014890360. 50 1K03545 01S 014990499. 80 FOODJRR IIS 015090347. 70 1R02546 01S 015190496. 40 FOODJRR 11S 015290387. 20 1R03547 01S 015390498. 80
FOODJRR 11S 015490352. 50 1R03548 01S 015590519. 10
FOODJRR 11S 015690366. 00 1R02549 01S 015790430. 00 FOODJRR l i s 015890396. 60
1R02550 01S 015990443. 80
FOODJRR 11S 016090378. 50 1R02551 01S 016190341. 30 FOODJRR 11S 016290420. 10
1R03552 01S 016390485. 4Q FOODJRR 11S 016490361. 7Q
1R63553 01S 016590526. 50 FOODJRR 11S 016690355. 40
1R03554 01S 016790271. 70 FOODJRR l i s 016890406. 70
1R03555 01S 016990429. 50 FOODJRR l i s 017090397. 70 1R03556 01S 017190499. 90 FOODJRR l i s 017290284. 80 1Pi3557 01S 017390442. 80
R OJRR u s 017490401. 10
1R02558 01S 017590377. 60 FOODJRR l i s 017690406. 40 1R03559 01S 017790473. 40
FOODJRR l i s 017890387. 00 1R02560 01S 017990418. 1Q FOODJRR l i s 018090394. 50
1R02561 01S 018190513. 40 FOODJRR l i s 018290245. 50 1R03562 01S 018390367. 40
FOODJRR u s 018490406. 50 1R02563 01S 018590418. 70 FOODJRR l i s 018690397. 70
1R02564 01S 018790432. 00 FOODJRR l i s 018890382. 50
1R02565 01S 018990469. 80
FOODJRR l i s 019090356. 00 1R03566 01S 019190415. 10 FOODJRR l i s 019290404. 70
1R03567 01S 019390499. 20 FOODJRR u s 019490373. 10 1R02568 01S 019590484. 10
FOODJRR l i s 019690375. 40 1R02569 01S 019790481. 60 FOODJRR l i s 019890354. 50
1 3570 01S 019990488. 10 FOODJRR l i s 020090351. 50 1R03571 01S 020190497. 50
FOODJRR l i s 020290275. 10 1R03572 01S 020390451 10
FOODJRR l i s 020490282. 90
1R03573 01S 020590474. 40 FOODJRR l i s 020690380. 20
1 4 rV. b
11 377. 4
1 466. 5
11 274
1 511. 9
11 246. 6
1 471. 2
11 260. 5
1 499. 8
11 247. 7
1 496. 4
11 287. 2
1 498. 8
11 352. 5
1 519. 1
11 266
1 430
11 396. 6
1 443. 8
11 378. 5
1 241. 3
11 420. 1
1 485. 4
11 261. 7
1 526. 5
11 355. 4
1 271. 7
11 406. 7
1 429. 5
11 397. 7
1 499. 9
11 384. 8
1 11
iESTCOPYAVAILABLE
1
11 406. 4
1 473. 4
11 387
1 418. 1
11 394. 5
1 513. 4
11 345. 5
1 367. 4
11 406. 5
1 418 7
11 397. 7
1 432
11 382. 5
1 469. 8
11 356
1 415. 1
11 404. 7
1 499. 2
11 273. 1
1 484. 1
11 375. 4
1 481. 6
11 354. 5
1 488. 1
11 351. 5
1 497. 5
11 375. 1
1 451. 1
11 382. 9
1 474. 4
11 380. 2
002093
608
1RP2574 01S 02079O51S 40
FOODJAR 11S 020890345. 10 1R03575 01S 020990413. 80
FOOt'JRR 11S 021096363. 10 1 R 0 3 5 76 01S 021190444. 40 FGDJRR 11S 021290397. 90 1R03577 01S 021390466. 00 F DJ RR lis 021490387. 80 1K83578 01S .21590424. 20 FOODJRR lis 021690372. 30
1R03579 01S 021790442. 50 FOODJRR lis 021890380. 30 1R62580 01S 021990428. 40 FOODJRR lis 022690389. 50
1 11 1
11 1 11 1
11 1 11 1
11
1 11
518 4
345. 1 413. 8 363. 1
444. 4 397. 9 466 387. 8 424. 2
372. 442. 5 380. 2
428. 4 389. 5
EST CP AVAlUiLE
002094
609
TWO VF HH ORh L'.DIET > TOK-ONC S T U D V OF FM-3924 . FC-142 IN RATS E/R. # 0281CRB012
TECHNICIAN I N I T I A L S : MH T L'HV S DATE: S 7/1/81 SE/ DF RATS:S MALE ROOM NUMBER :S D -222 WEICHT OF FULL FOOD JAR :S 55 RR HS
WEEK 10
IF:DSC SC 04 S 00V100411 0 FOODJHR 1 4S 00?200380.20 1Ro36 9 7 04 S 00 ''300403. 20
FO ODJAR 14S 00 ?400382. 10 IF:02698 04 S 00 S 0 0415. 60
FODDJAR 14S 003600381. 50
1R02699 04 S 003700378. 20 FOOD TAF: 14S 0O3800380. 10 1R2700 04 S 003900453 40 FOOL'JAR 14S 010000264. 20 1R03701 04 S 010100400. 60
FOODJAR 14S 010200382. 90
1R02702 04 S 010200290 40
FOODJAR 14S 010400386. 30 1R02782 04 S 010500412. 20
F UUDJ AF: 14 S 010600389. 40 l r '3:704 04 S 010700418. 60
F'._-DJAF: 14S 010800285. 60 IPOS 700 04 S 0109O0402. 30 FOOL1JAR 14S 011000272. 40
1R027O6 04 S 011100391. 50
F OOL'JAR 14 S 011200297. 60 IF.'02 7'07 04S 011300287. 40
F OOL1JAF: 14S 011400383. 70
1R02708 04 S 011500381. 00 FOOL-JAR 14 S 011600369. 30 1R02 70S 04 S 011700404. 20
FOuDJAF: 14S 011800281. 00 1R0K710 04 S 011900299. 50 FOODJAR 14S 012000371 70 1R02711 04 S 012100390. 40
FOODJAR 14S 012200290. 40 1R02712 04 S 012200410. 00
FOODJAR 14S 012400378. 70 1R03712 04 S 012500439. 90
FOODJAR 14S 012600275 30
1R02714 04 S 012700278. 20
FOODJAR 14S 012800396. 60 1R02715 04 S 012900471. 20 FOODJAR 14S 012000354 80 IF"03:718 04 S 013100432. 20
F OOD JAF: 14 S 012200256. 00 3717 04 S 013.3002:65. 20
F uuD JAF: 14S 0124003.83. 40 1R03718 04 S 012500416. 30 FOODJAR 14S 012600269 80 1R 62 71 9 04 S 0127003 98. 10 F OOD JAF' 14 S 0128002 82. 40
1R03720 04 S 013900270. 80 F OOL1JAF: 14S 014000408. 60
4 14 4 14 4 14 4 14 4 14 4 14 4 14 4 14 4 14 4 14 4 14 4 14 4 14 4 14 4 14 4 14 4 14 4 14 4 14 4 14 4 14 4 14 4
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002095
411. 280. 2 402. 2
"'82 1 415. 6 281. 5
378. 2 380. 1 453. 4 264. Ci 400. S 38`2. 9 390. 4 386. 412.
389. 4 418. 6 2 F:5 6
402. 3-72. 4 291. 5
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j-.'c'o '-. 7 281 369. J;. 404. 2
281 399 5 271. 7 290. 4 390. 4 410
"J?2; T
439. 9
7 7 K ; "
BEST COPY AVAII ABLE
378. 2! 396. 6 471. 2
354. S 432. 2 256
265. 2 282. 4 416. S 369. 6 398. 1
382. 4 270. 8 408.
610
1F'61_ .21 041. 014 300418. SO.
F O'OI 'JRF: 14b 0142003 82. 20 IF'U. 722 04 S 01 4300396 90 f-UOt'JHK 14 b 014400386 90 J FiJ3 723 04 b 014 '..00408. 10 (-OODJRF 14b 014600402. 50 iRi.*2724 '4S 0147610414 50 F D.1RF 14 b 0148003 80. 40 1, -372';. 04 b 0149610424. 60 FOOD JRF 14b U.lOOO03 84. 70 lF:G3 72t 04 b 01 si 003 79. 20 f o o d j r f ' 14 b O1S26103 86. 50 IF:03 7 2'7 04b 6i:tS3O0406 40 FO OIORF 14S 0154OO3 76. 80 1F03728 04b 0155610374 40
FOODJRF 14b 015600396. 10 1 R 03-72S' 04b O1570O416. 60 F OOC JRF' 14S il580Ci375. 10 IF:03 7 30 04 S 0159OO411. 00
F OGD-TftR 14S 016O00386. 70 1R03731 04 S 016100463. 10 FOODJRF 14S O1620035O. 80 1R03722 04b 01630O347. 50
FOOL1JRF: 14b 016400393. 70 I F 0373:3 04b 61165610389. 30
FOOL1.1RF: 14 b 01666*0384. 70 1F0273 4 04 b 61167061415 70
F uuD JRF: 14 b 01680G385. 30
1F03735 04 b 0169610355. 50
FOODJRF 14b 01.70610381. 70 IF:03:73 6 04 b 017100342. 10
F UO D JRF: 14S il72610392. 60 1R02737 04 b 17300403. 30 F D JRF, 14 b 017400385. 70 1F03 730 04 b Oi 7500372. 30 FO ODJRF 14b Gil766ii377. 30
1F03739 04 b 617700305. 50 FO OD JR F 14 b O17800404. 80! JF:03 740 04 b 6U 79O0383. 00 F GOD JRF' 14S 611861061396. 00! I F 03 74 J 041 018100413. 20. FOODJRF: 14b 01820O346. 60 1F03 742 04 b 01830O424. 00! FO ODJRF 14b 0184610372. 30
1F07743 04 b 6*18500403: 50 F ODDJRF 14S 118600383. 80 JF03744 04 b *18700283. 00! FOODJRF 14b 013800397. 70
1F 03745 04 b 0189061319. 80
F OOC-JRF 14b 6*19000394. 40 1.F03 746 04 b 0191610377. 10
F OODTRF 14 b 019200398. 3'0 1R 03747 04b 0193061388. 80 FOODJRF: 14b 019400400. 50 I F 03748 04b 019506*425. 10
FOOL1JRF 14 b 6*1960i3:85. 70 1F0374S1 04 b 019706-1364 10 FO ODJRF 14 b 6*198004 6*6. 60 lr 2750 04 b 6*19906*3-68. 70! F ..-D JRF 14 b 020O00383. 40 1R 02 75 1 04 b 026*100445. 90 FOOL-JRF 14 S 026*26161357. 30( 1F 03702 04 b 0203 00321. 70 F OOC'JRF: 14 b '26146*0417. 40 1F 03 75 3 04 b 0 2 1506*445. 30!
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4166 s
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FOOL*JRk 153 022200294. 00
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FOC JRF: 153 022409395. IQ
ike: 763 053 022500448. 40
F Ot'JRR 153 022600357. 7Q
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FOOL JRF: 153 022800269. 30
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FOC JRF: 158. 023:000330. 20
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FOOt JRF: 153 23200259. 60
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FOOt'JRk 15S 022400238. 00
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FOOt `JRR 153 622800366. 10
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FOOt JRF: 153 024200266. 70
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FOOt'JRk 153 024400381. 30
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FOOt'JRk 153 024800285. 20
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FOOt 'JRk 153 025600252. 90
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FOOt'JRk 153 025800360. 50
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FOOt'JMk i53 026400370. 90 i :;7 053 0265'00417. 20
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6 465. 4
16 263. 3
6 272. 1
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16 392. 5
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6 401. 5
16 268
6 405. 9
16 380. 9
6 397. 9
16 389. 2
6 440. 3
16 362. 1
6 447. 7
16 383. 9
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002099
' 614
lKtC<853 068 040500415*. 60
F00DJAF: 168 040600289. 20
1R03854 06 S 040700390. 90
FODJAR 16S 046800384. 20
1R03855 06S 040900444. 20
FODJAR 16S 041000358 30
1R03856 06S 041100446 00
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1. -.3857 06b 041300433. 80
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1R63S58 06S 041500435. 20
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1R03859 06S 041700414. 00
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1R03860 06S 041900454. 20
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IESIMHVAKE
002100
615
TWO YEAR 0RAL<D1ET> TOX-ONC STUDY OF FM-3924 & FC-142 IN RATS EXP. # 0281CR0612
TECHNICIFIN INITIALS .S MH TO D A Y ' S D A T E .S 7 / 7 / 6 1 SEX OF RATS.S MALE ROOM NUMBER:.S D-34G, D-338 WEIGHT OF FULL FOOD J A R :S 5 5 0 GRAMS
WEEK. 1 1
1R02516 01S 007100516. 4G FOODJAR IIS 007200360. 3Q 1R03517 01S 007300461. 9Q
FOODJAR 11S 007400274. 20 1R03518 IS 007580456. 80 FOODJAR U S 007600381. 00
1R03519 01S 007700505. 30 FOODJAR 11S 007800271. 70 1R03526 01S 007900483. 70
FOODJAR 11S 010000377. 50 1R03521 01S 010100436. 40 FOODJAR 11S 010200379. 20
1R03522 01S 010300445. 10 FOODJAR 11S 010400385. 90 1R03523 01S 010500522. 30
FOODJAR 11S 010600368. 50 1P02524 01S F OJAR 11S 01080O3S4. 80 1R03525 01S 010900458. 90 FOODJAR 11S 011000387. 70 1R03526 eis 011100465. 10 FOODJAR 11S 011200377. 20 1R02527 01S 011300450. 30 FOODJAR U S 011400383. 50 1R03528 01S 011500498. 20 FOODJAR 115 011600372. 70
1R02529 01S 011700462. 70
FOODJAR 11S 011800372. 70 1R03520 01S 011900491. 20
FOODJAR 11S 012000272. 00
1R03521 01S 012100462. 20 FOODJAR IIS 012200382. 00
1R03532 015 012300460. 70 FOODJAR U S 012400376. 40 1R03533 015 012500505. 90 FOODJAR 11S 012600367. 20 1R03534 01S 012700521. 40
FOODJAR 11S 012800355. 40 1R02535 01S 012900404. 50
FOODJAR 11S 013000405. 50
1R03536 01S 012100417. 60
FOODJAR 11S 013200414. 60 lr '3537 01S 013300391. 00 F<- ^DJAR 11S 013400398. 00
1R03538 01S 013500534. 20
FOODJAR U S 013600359. 10 1R03529 01S 013700385. 80
FOODJAR 11S 013880402. 50 1R03540 01S 012900441. 70 FOODJAR 11S 014000388. 40
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BEST COPY AVAI1ABLE
002101
616
1R02541 01S 01410W498. 20
FOODJAR lis 014200385. 30
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1R03552 01S 016300503. 00 FOODJAR lis 016400254. 30 1R03553 01S 016500556. 80 FOODJAR lis 016600246. 50 1R03554 01S 016700382. 50 FOODJAR lis 016800400. 60!
1R03555 01S 016900447. 60 FOODJAR lis 817000287. 30 1R03556 01S 017100511. 20
FOODJAR lis 017200377. 10 1f -'3515? 01S 017300451. 00 f ._..d j a r lis 017400392. 90
1R03558 01S 017500385. 00 FOODJAR U S 017600296. 80 1R03559 01S 017700485. 50 FOODJAR U S 017800384. 10 1R83560 01S 017900430. 50 FOODJAR lis 018000390. 50
1R03561 01S 018100530. 90 FOODJAR U S 018200335. 80
1R03562 01S 018200388. 9Q
FOODJAR U S 018400382. 40 1R02562 01S 018500428. 70 FOODJAR lis 018600290. 20
1R02564 01S 018700447. 80 FOODJAR lis 018800347. 10 1R035S5 01S 018900490. 50
FOODJAR U S 019000368. 20
1R02566 01S 019180420. 70 FOODJAR lis 019200297. 80 1R02567 01S 019200503. 30 FOODJAR lis 019400275. 70 1R0356S 01S 019500491. 60 FOODJAR lis 019600275. 50
1R03569 01S 019700485. 30 FOODJAR lis 019800366. 40
1 3570 01S 019900509. 70 FOODJAR lis 020000345. 60 1R02571 01S 020100508. 80 FOODJAR lis 020200263. 70 1R02572 01S 020300464. 20 FOODJAR lis 020400270. 70 1R03573 01S 020500464. 00 FOODJAR lis 020606384. 30
1 498. 3
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IF'02074 OIS 0 2 0 7 0 0 0 1 7 t)0
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F' `DJFIR lis 02 1400371 50 1..-.3578 01S 0215 00 44 2 60 FODJHFl lis 0216O264. 40
1R02578 01S 021700450 70 F0DJF1F: lis 021600281. 50
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0Z103
6 18
TWO VEAR ORAL<DIET> TOX-ONC STUDY OF FM-3924 # FC-143 IN RATS EXR. 0281CR0012
TECHNIC INN INITIALS:S MH T O D A Y ' S D A T E :S 7 / 8/81 SEX OF RA1S:S MALE R O O M NU M B E R : S fr-232 WEIGHT OF F U LL F O O D J A R :S 550CiRAMS
WEEK 11
1R02696 04 S 007100426. 50 FOODJAR 14S 007200295. 20
1R82697 04 S 007200414 00
FOODJAR 14S 007400285. 60 1R02698 04 S 007500428. 90 FOODJAR 14S 007600385. 90 1R03699 04S 007700388. 50 FOODJAR 14S 0O7800389. 40 1R03700 04S 007900481. 60
FOODJAR 14 S 610000261. 60
1R02701 04 S 010100422. 20 FOODJAR 14S 010200287. 90
1R03762 04 S 010200409. 90 FOODJAR 14 S 010400285. 10 1R037G2 04S 010560420. 00
FOODJAR 14 S 010600285 00 1RA3704 04 S 010700437. 90 F DJAR 14S 010800373. 40
1RO3705 04S 010900433. 50 FOODJAR 14 S 011000271. 20 1R0370S 04 S 011100414. 30 FOODJAR 14S 011200284. 70 1R02707 04 S 011200295. 40
FOODJAR 14S 011400286. 90
1R0270S 04S 011500278. 30 FOODJAR 14S 011600397. 20
1R02709 04S 011700420. 10
FOODJAR 14S 011800385. 60 1R02710 04S 011900416. 90
FOODJAR 14S 012000273 50
1R02711 04 S 012100410 90 FOODJAR 14S 01220038 7 40
1R02712 04S 012300429. 90
FOODJAR 14S 012400280 50 1R02713 04S 012500457. 30 FOODJAR 14S 012600278. 70
1R03714 04S 012700382. 60 FOODJAR 14S 012800404. 90
1R03715 04S 012900490. 30 FOODJAR 14S 013000361. 00 1R02716 04 S 013100448 40 FOODJAR 14S 013200252. 20 a 3717 04 S 013300267. 80 FwoDJAR 14S 013400295. 60 1R02718 04S 013500438. 60
FOODJAR 14S 012600277. 20 1R02719 04S 013700412 80 FOODJAR 14S 013800379. 10
1R02720 04 S 013900281. 50 FOODJAR 14S 014000408 70
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BEST I I P ! AVAIUB
61
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FOODJAR 145 015000390. 90 1R02726 045 015100386. 10 FOOD JAR 145 015200289. 10 1R'0372? 04 S 015300421. 00 FOODJAR 14S 015400382. 50 1R0372S 045 015500376. 90
FOODJAR 145 015600408. 30
1R03729 045 015700433. 80 FOODJAR 145 015800375. 20 1R03720 04S 015900424. 20 FOODJAR 14S 016000387. 30
1R03731 045 016100489. 60 FOODJAR 14S 016200356. 70 1R03732 845 016300366. 60
FOODJAR 14S 016400391. 60 1R83F32 045 016500404. 40
FOODJAR 145 016600387. 90 1R03724 045 016700433. 20
FOODJAR; 145 016800380. 40 1R02735 045 016900367. 90
FOODJAR 145 017000286. 90 1R03736 04 017100358. 10
FOODJAR: 145 017200388. 10 1R",|3737 045 017200417. 90
F DJAR 145 017400285. 90 1R03738 045 017500383. 00
FOODJAR 145 017600386. 90 1R03739 045 017700317. 70
FOODJAR 145 017800410. 00 1R03740 045 017900294. 50 FOODJAR 145 018800398. 10
1R03741 045 018100431. 80 FOODJAR 145 018200367. 70
1R03742 045 018300435. 70
FOODJAR 14 S 018400278. 00 1R03743 045 018500422. 40
FOODJAR 145 018600379. 30 1R03744 045 018708389. 60
FOODJAR 145 018800391. 50 1R03745 045 018900329. 40
FOODJAR 145 019000298. 90 1R02746 045 019100399. 80 FOODJAR 145 019200292. 00
1R63747 045 019200410. 10 FOODJAR 14S 019400394. 90 1R02748 045 019500426. 20
FOODJAR 14 S 019600289. 10 1R03749 045 019700381. 20 FOODJAR 145 019800400. 40 1 3750 045 019900283. 10 FuuE>JAR 14S 020000382. 50 1R03751 04S 020100462. 00 FOODJAR 14S 020200375. 70 1R03752 045 020300325. 70
FOODJAR 145 020400420. 80 1R02?53 045 020500452. 30 FOODJAR 14S 020600277. 80
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- 620
1R03754 04S 020700422 00
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002109
624
TWO YEAR ORALa-IET. TOX-ONC STUDY OF FM-2924 & FC -1 43 IN RATS EXP. # 0281CR00X2
TECHNICIAN INITIALS:S MH TODAY S D A T E :S 7/14/01 SEX OF RATS.S MALE ROOM NUMBER::S 0-240, D-338 WEIGHT OF FULL F O OD J A R :S 550GRAMS
WEEK 12
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BEST COPY V1I ABLE
2112
627
TWO
YEAR
O R A L < D I E T ) TOX-ONC STUDY OF FM-3924 & FC-143 IN RATS EXP. # 02 81 CR 00 12
T E C H N IC IA N I N I T I A L S : S MH T O D A Y 'S D A T E : S 7 / 1 5 / 8 1
S E X OF R A T S : S M ALE ROOM N U M B E R :S D - 3 2 2
W EIG HT OF F U L L FOOD J A R : S 550G RA M S
WEEK 1 2
1R 03696 FOODJAR 1R 02697 FOODJAR 1R 03698 FOODJAR 1R 03699 FOODJAR 1R 037O 0 FOODJAR 1R 037O 1 FOODJAR 1R 03702 FOODJAR 1R O 3703 FOODJAR 1R 03704 F DJAR 1R O 3705 FOODJAR 1R 03706 FOODJAR 1R O 3707 FOODJAR 1RO370S FOODJAR: 1R 63709 FOODJAR 1R 03710 FOODJAR 1R 03711 FOODJAR. 1R 03712 FOODJAR 1R 03713 FOODJAR 1R 03714 FOODJAR 1R 03715 FOODJAR 1R 03716 FOODJAR 1 3717 F l o DJAR 1R 03718 FOODJAR 1R 03719 FOODJAR 1R 03720 FOODJAR
64 S 14S 04S 14S 04S 14S 04S 14S 04S 14S 04S 14S 04S 14S 04S 14S 04 S 14 S 04S 14 S 04S 14S 04S 14S 04 S 14S 04 S 14S 04 S 14S 04S 14S 04S 14S 04 S 14S 04 S 14S 04 S 14S 04S 14S 04S 14S 04 S 14S 04 S 14S 04 S 14S
007180425. 70 007200403. 70 007300410. 90 007400401. 40 007500423. 60 007600384. 30 007700398. 60 007800390. 20 007900482. 40 010000356. 20 010100434. 50 010200386. 70 10300416. 40 010408391. 70 010500426. 90 010600381. 50 010700444. 60 010800382. 70 010900431. 90 011000375. 70 011100427. 00 011200388. 50 011300396. 60 011400398. 00 011500391. 40 011600376. 00 011700418. 20 011800394. 50 011900416. 90 012000379. 00 012100417. 00 012200390. 70 012300436. 60 012400387. 50 012580461. 50 012600374. 50 012700388. 50 012800403. 60 012900495. 20 013000364. 70 013100454. 00 013200370. 40 0 1 3 3 0 0 3 7 0 . 5>0 013400405. 00 013500447. 80 013600388. 80 013700419. 50 013800394. 40 013900392. 80 014080406. 40
4 14 4 14 4 14 4 14 4 14 4 14 4 14 4 14 4 14 4 14 4 14 4 14 4 14 4 14 4 14 4 14 4 14 4 14 4 14 4 14 4 14 4 14 4 14 4 14 4 14
002113
425. 7 403. 7 410. 9 401. 4 423. 8 384. 3 398. 6 390. 2 482. 4 356. 2 434. 5 386. 7 416. 4 391. 7 426. 9 381. 5 444. 6 382. 7 431. 9 375. 7 427 388. 5 396 6 398 291. 4 376 418. 2 394. 5 416. 9 379 417 390. 7 436. 6 387. 5 461. 5 374. 5 388. 5 403. 6 495. 2 364. 7 454 270. 4 270. 5 405 447. 8 388. 8 419. 5 294. 4 292. 8 406. 4
BEST COPY AVAII ABLE
628
1 P G 3 7 2 1 0 4 0 1 4 1 0 0 4 2 7 . 4 G! FGG DJflR 1 4 5 0 1 4 2 0 0 3 8 9 . 4 0 1 R 0 2 7 2 2 0 4 5 0 1 4 3 0 0 4 1 0 . ?Q FGGOJflF: 1 4 5 0 1 4 4 0 0 2 9 0 6 0 1R 03723 04S 014500441. 00 FG G DJflR 1 4 S 0 1 4 6 0 0 3 9 5 . 0 0 1R02724 045 014700429. 90 F XTflR 1 4 S 0 1 4 8 0 0 2 8 4 . 8 0 1RU3725 04 S 014900438. 80 FG G DJflR 1 4 5 0 1 5 0 0 0 3 4 9 . 3 0 1R 02726 04 015100397. 80 FGG DJflR 1 4 S 0 1 5 2 0 0 3 8 1 . 6 0 1R03727 04 015200430. 20 FGG DJflR 1 4 0 1 5 4 0 0 3 8 5 . 8 0 1F:02728 04 S 0 1 5 5 0 0 2 8 1 . 8 0
FGG DJflR 1 4 0 1 5 6 0 0 3 9 6 . 9 0 1R 02729 04 S 015700427. 70 FGG DJflR 1 4 S 0 1 5 8 0 0 3 7 7 . 7 0 1R03730 045 015900421. 90 FGG DJflR 1 4 S 0 1 6 0 0 0 3 8 6 . 8 0 1R03731 045 016100491. 90 FGG DJflR 1 4 5 0 1 6 2 0 0 2 7 0 . 3 0 1R02722 045 016300367. 00 FG G DJflR 1 4 S 0 1 6 4 0 0 3 9 7 . 4 0 1R 03732 04S 016500409. 70 FG G DJflR 1 4 5 0 1 6 6 0 0 3 9 0 . 5 0 1R 02724 04 S 016700433 60 FGG DJflR 1 4 S 0 1 6 S 0 0 3 7 9 . 3 0 1R 03735 045 016900356. 90 FG G DJflR 1 4 S 0 1 7 0 0 0 4 2 3 . 1 0 1R03736 045 017100355. 50 FG G DJflR 1 4 5 0 1 7 2 0 0 4 1 6 . 0 0 l r `* 3 7 2 7 0 4 5 0 1 7 3 0 0 4 3 1 . 8 0 F . j DJAR 1 4 5 0 1 7 4 0 0 3 6 3 . 2 0 1RG3738 045 017500382. 80 FGG DJflR 1 4 5 0 1 7 6 0 0 3 7 5 . 8 0 1RG2739 04S 017700225. 80 FGG DJflR 1 4 5 0 1 7 8 0 0 4 1 0 . 4 0 1 R 0 3 7 4 6 0 4 5 0 1 7 9 0 0 3 9 3 . 9CJ FG G DJflR 1 4 5 0 1 8 0 0 0 4 0 6 . 3 0 1R03741 045 018100441. 20 FG G DJflR 1 4 5 0 1 8 2 0 0 3 6 7 . 9 0 1R03742 045 018300429. 70 FG G DJflR 1 4 5 0 1 8 4 0 0 3 6 5 . 4 0 1R03743 045 018500438. 70 FG G DJflR 1 4 5 0 1 8 6 0 0 2 7 2 4 0 1R 03744 04S 018700399. 70 FG G DJflR 1 4 S 0 1 8 8 0 0 3 9 4 . 8 0 1R03745 045 018900348. 40 FGG DJflR 1 4 S 0 1 9 0 0 8 3 9 9 . 5 0 1R 02746 04 019100399. 00
FG G DJflR 1 4 S 0 1 9 2 0 0 3 9 8 . 8 0 1R 03747 04S 019208424. 30 F G G D J flR 1 4 5 0 1 9 4 0 0 3 7 6 . 4G* 1R03748 045 019500426. 50 FG G DJflR 1 4 S 0 1 9 6 0 0 3 8 2 . 1 0 1R03749 045 019700288. 50 FG G DJflR 1 4 5 0 1 9 8 0 0 2 9 6 . 0 0
1 3750 045 019900380. 70
FG G DJflR 1 4 5 0 2 0 0 0 0 3 9 7 . 3 0 1R03751 045 020100469. 40 FG G DJflR 1 4 5 0 2 0 2 0 0 3 6 6 . 9 0 1R 02752 045 028300224. 50 FG G DJflR 1 4 5 0 2 0 4 0 0 4 1 4 . 0 0 1R 03753 045 020500461 20 FGG DJflR 1 4 5 0 2 0 6 0 0 3 8 4 . 5 0
4 14 4 14 4 14 4 14 4 14 4 14 4 14 4 14 4 14 4 14 4 14 4 14 4 14 4 14 4 14 4 14 4 14 4 14 4 14 4 14 4 14 4 14 4 14 4 14 4 14 4 14 4 14 4 14 4 14 4 14 4 14 4 14 4 14
002114
427. 4 389. 4 410. 7 390. 6 441 395 429. 9 384. 8 438. 8 349. 2 397. 8 381. 6 430. 2 285. 8 381. 8 396. 9 437. 7 377. 7 431. 9 386. 8 491. 9 370. 3 267 397. 4 409. 7
390. 5 432. 6 379. 2 356. 9 423. 1 355. 5 416 431. 8 363. 2 382. 8 375. 8 325. 8 410. 4 393. 9 406. 3 441. 2 367. 9 439. 7 365. 4 438. 7 372. 4 399. 7 394. 8 248. 4 399. 5 399 398. 8 424. 3 376. 4 426. 5 382. 1 288. 5
2se
380. 7 397. 3 469. 4 266. 9 234. 5 414 461. 2 384. 5
EST COPY AVAI1 ABLE
629
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1R83813 FO O D JRF: 1R83814 FO O D JR F 1R63815 FO O D JR R d 3816 FO O D JR F 1R03817 FO O D JRF: 1R03818 FO O D JRF: 1F03819 FO O D JRF:
05S 15S 055 155 055 155 05 S 155 055 155
05S 15 058 15S 05S 155 055 155 055 155 05S 15S 055 155 055 155 055 155 055 155 055 155 055 155 055 155 055 155 05S 155 055 155 055 15S 05S 155 055 155 065 16S 065 165 065 165 065 16S 06S 165 065 165
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5
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002116
387. Ci 417. 1 440. 4
383. 7 408 8 369. 1 438. 5
252. 2 500 5 316. 2 384. 5 411. 4 445 . s> 364. 9 511
340. 4 409. 4 84. 9 466. 4 334. 468. 4 378 441. 7 397. 2 466. 5
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331. 9 53S. 3 347
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8ESTCOPYAVAII ABLE
' 631
1R03820
FO O D JftR 1R02821 FO O D JftR 1R03822 FO O D JftR 1R03823 F D JftR lr*0 2 8 2 4 F OD Jh R 1R02S25 FO O D JftR 1R03826 FO O D JftR 1R03827 FO O D JFlR 1R03828 FO O D JftR 1R02829 FO O D JftR 1R03830 FO O D JftR 1R03831 FO O D JftR 1R63832 FO O D JftR
1R02823 FO O D JftR 1R03834 FO O D JftR 1R62835 FO O D JftR 1R03836 F D JftR
1R02837 FO O D JftR 1R02838 FO O D JftR 1R03839 FO O D JftR 1R03840 FO O D JftR 1R03841 FO O D JftR 1R03842 FO O D JftR 1R03843 FO O D JftR 1R02S44
FO O D JftR 1R03845 FO O D JftR 1R02846 FO O D JftR 1R03847 FO O D JftR 1R03848 FO O D JftR 1' 3849 FL'.j D J h R 1R03850 FO O D JftR 1R03851 FO O D JftR 1R02852 FO O D JftR
065
165 06S 16S 06 S 165 06S 165 08 S 165 08 S 165 08S 16S 08S 16S 08S 165 08S 165 06S 16S 06S 165 06S 165
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6
16 6 16 6 16 6 16 6 16 6 16 6 16 6 16 6 16 6 16 6 16 6 16 6 16 6
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02117
488. 5
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423. 8 285. 2 412 285. 2 515. 4 247. 7 424. 8 374. 1 440. 1 384. 8 406. 8 432. 8 460. 9 272. 4 473. 2 374. 2 424. 6 324. 1 453 364. 1 467. 1 361. 7 407. 5 377 484. 7 371. 8 513 322. 1 433. 5 384. 8 467. 8 375. 9 425. 6 376. 5 452. 3 362. 8 395. 2 397. 5
EST COPY AVAII ABLE
632
1R63853 06S 040560436. 10
FO O D JftR le s 046 6 0 0 3 9 7 . 20
1R03854 e e s 040760420. 90
FO O D JH R e s 040 8 0 0 2 8 2 . 70
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TWO
VEAF:
ORMLOD1ET> TGX-ONC STUD V OF FM -3924 & FC -1 4 2 IN RA T S EXP. # 02S1CR8012
T E C H N IC IA N I N I T I A L S : S MH T O D A Y 'S D A TE : S 7 / 2 2 / 8 1 S E X OF R A J 8 .8 H A LE ROOI'1 NUM BER : S D -2 2 2 W EIG H T OF F U L L FOOD J A R : S 550G RA M S
WEEK 12
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645
TWO
VEAF:
O R A L C D IE T ) TGX-ONC STUDV OF FM -2924 FC -1 4 2 IN R A T S EXP. # 0281CR0012
T E C H N IC IA N I N I T I A L S : ? HH T OC-'AV ' S D A I t : S 7 / 2 9 / 8 1 S E X OF R A T S .'S M ALE ROOM N U M B E R : S D -2 2 2 W EIG H T OF F U L L FOOD J A R : S 550G RA M S
WEEK 14
1R03 696 FO O D JA R lF'Q j-6 9 7 FO O D JA R 1R03698 FO O D JA R 1R03699 FO O D JA R IF : 03 780
FOOD JA Fl 1R027Q1 FO O D JA R
1R02702 FO O D JA R 1 RO B 703FOOD JA F: 1RA27G4 F D-JAR 1 ROB: 70 5 FOOL'JA R 1R0B706 FOOD JA R 1R03707
FO O D JA R 1R0B708 FO O D JA R 1R037O9 FO O D JA R 1R03710 FO O D JA R 1R0B711 FO O D JA R 1R02712 FO O D JA R 1R0B713 FO O D JA R 1P.03 714 FO O D JA R 1R03715 FO O D JA R 1P.03 716 FO O D JA R 1 3717 F l..j D JA R 1R037O8 FO O D JA R 1R02719 FO O D JA R 1RO3720 FO O D JA R
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010600292. 60 01070O464. 20 0108O0385. 30 0109O0441. 90 01100O387. 70 011100424. 70
0 1 1 2 0 O 4 0 5 . OO 0113004O 4. 70 011400397. 10 O11500401. 90 01160O381. 80 011700427. 60
011800399. 90 011900432. 20 012000377. 70 012100418. 40 012200395. 90 0 1 2 3 0 0 4 4 7 . GO 012400394. 50 012500473. 40 812600379. 20 012700388. 10 012800403. 30 0 1 2 9 0 0 5 0 1 . 30. 012000378. 70 013100469. 60 013200370. 40 013380284. 00 013400405. 80 012500449. 50 0 1 2 6 0 0 4 0 7 . OO 0127O0428. 20 013800402. 20 012900401. 00 014000414. 60
4 14 4 14 4 14 4 14 4 14 4 14 4 14 4 14 4 14 4 14 4 4 4 14 4 14 4 14 4 14 4 14 4 14 4 14 4 14 4 14 4 14 4 14 4 14 4 14 4 14
002131
425. 4 409. 2 430. 4 393. 4 430 402. 2 405. 2 394 499. 9
270. 7 447 390. 2 436. 7 386. 2 444. 2
392. 6 464. 2 385. 3 441. 9 387. 7 424. 7 405 404. 7 397. 1 401. 9 381. 8 427. 6 399. 9 432. 2 377. 7 418. 4 395. 9 447 294. 5 472. 4 279. 2 288. 1 403. 3 501. 2 378. 7 469. 6 370. 4 384 405. 8 449. 5 4G7 428. 2 402. 2 401 414. 6
!E$T COPY AVAI1ABLE
646
1R03721 64 S FO O D JflR 1 4 S 1R02722 048 F OOD JflR 1 4 S 1R02722 64 S FO O D JflR 1 4 S 1R03724 04S F D JflF: 1 4 S 1R03725 64 S FOOD JflR 1 4 S 1R02726 64 S FO O D JflR 1 4 S 1 F 0 i'' C - I'- 6 4 S F O O D JflR 1 4 S lR0^.:'7.'b* 6 4 S FO O D JflR 1 4 S 1R03729 64 S FO O D JflR 1 4 S 1R03-730 64 S FO O D JflR 1 4 S 1R03721 64S FO O D JflR 1 4 S 1R03732 64 S FO O D JflR 1 4 S 1R02723 64 S
FO O D JA R 145 1R03734 045 FOOD-JFIR 1 4 5 1R02735 045 FO O D JflR 145 1R03736 045 FO O D JflR 145 1 "*-2727 0 4 5 F . _.D Jf lR 1 4 5 1R02738 645 FO O t1Jf lR 1 4 5 1R02739 045 F O O D JflR 1 4 5 1R03740 045 F O O D JflR 1 45 1R03 741 045 FO O D JflR 145 1R03742 045 FOOD-JFIR 1 4 5 1R03743 045 FOOD-JflR 1 4 5 1R03744 045 FOOt-'-JflR 1 4 5 1R03745 645 R flT # FOOD-JAR 1 4 5 1R03746 645 FO O D JflR 145 1R03747 645 FO O D JflR 1 4 S 1R02748 64S FO O D JflR 1 4 S 1R03749 045 F D JflR 145 1R03750 045 FO O D JflR 145 1R02751 04 S FO O D JflR 145 1R03752 04S FO O D JflR 145 1R03752 64 S
0 1 4 1 0 0 4 4 8 5*0
014200282. 60 014200425. 00 014400288 10 014500452. 30 01460029c-. 00 014700441 10 014800295. 50 014900457. 00 015000385. 20 0 1 5 1 0 0 4 0 1 . c-0 015200294. 50 015300442. 60 015400395. 60 015500391. 60 015600401. 80 015700447. 80 015800392. 20 015900439. 10 016000398. 10 016100500. 90 016200371. 80 016300354. 60 016400422. 60 016500411. 70
016600407. 00 0167G0429. 60 016800298. 20 016900249. 70 017000420. 40 017100360. 80 017200415. 20 017300437. 90 017400390. 40 017500398. 20 017600389. 40
017700230. 20 017800417, 80 017900390 20 018000417. 40 018100411. 70 01S200446. 90 018200445. 80 018400395. 60 618500437. 40 018600401. 70 018700398. 90 618800407. 50 018900000. 00
1R03745 64S 019000006. 60 019100404. 50 019200403. 90 019300437. 60 019406393. 40 019500437. 00 019600404. 80 019700390. 70 019800412. 40 019900297. 80 020000296. 10 020100472. 20 020200286. 80 020200241. 20 020400410. 20 0 2 0 5 0 0 4 7 2 . 2-0.
4 14 4 14 4 14 4
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002132
446. 5
382. 6
425
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452, 2
296
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295. 6
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360. 8
415. 2
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290. 4
398. 3
289. 4
330. 2
417. 8
290. 2
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411. 7
446. 9
445. 8
395. 6 437. 4
ST COPY AVAU ABLE
401. 7
298. 9
407. 5
0
NOT ON ST U D Y
0
404. 5
403. 9
437. 6
393. 4
427
404. 8
390. 7
412. 4
297. 8
290. 1
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280. 8
341. 3
410. 2
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647
F D U D JA R
1R03754 FOOD JA F: 1R03755 FO O D .JAR IF :03756
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F O JA R 1 4 S 007100391. 90 lr\c*3757 04 0 O 7 2 0 0 3 9 7 . 60 F OOD J AR 1 4 S 0 0 7 3 0 0 4 0 1 . 90 1R03758 04 S 007400438. 90 FOOD-JAR 1 4 S 0 0 7 5 0 0 4 1 1 . 60 1R03759 04S 007600446. 80 FOOD J AF; 14 0 0 7 7 0 0 3 7 9 . 0 1 R 0 3 7 6 6 04 0 0 7 8 0 0 3 8 4 . 3 FO O D JA R 14 007 9 0 0 3 9 9 . 10 1R03761 05 010000442. 60 FOOD*JA R 1 5 S 0 1 0 1 0 0 3 9 3 . 20 1R03762 05S 010200397. 90
FO O D 'JA R 1 5 S 0 1 0 3 0 6 4 1 0 . 60 1R03763 05 010400464. 80 FO O D JA R 15 010 5 0 0 3 8 3 . 10 1R03764 05 010600489. 20 FO O D JA R 15 010 7 0 0 3 6 4 . 40 1R03-765 05 010800482. 60 FO O D JA R 1 5 S 0 10 900341 . 60 1R03766 0 5 S 011000483. 90 F ODJAR 15 011100388. 80 1R02767 05 011200529. 10 FO O D JA R 15 011 3 0 0 3 8 1 . 00 1R0376S 05S 011400489. 20 FO O D JA R 1 5 S 0 11 500376 . 90 1PA3769 05 011600418. 00 F D JA R 15S 011700398. 50 1R01770 05 011800523. 30 FO U L1JA R 1 5 0 1 1 9 0 0 3 5 4 . 70 1R03771 05 012000469. 00
FO O D JA R 1 5 S 012100388 . 10 1R03772 05 S 012200448. 50 FO O D 'JA R 15 0 1 2 3 0 0 3 8 4 . 70 1R.02773 0 5 0 1 2 4 0 0 4 6 5 . 30. FOOD1JA R 1 5 0 1 2 5 0 0 3 8 4 . 50 1R02774 05S 012600419. 00 FO O D JA R 1 5 S 012 7 0 0 4 0 9 . 70 1R03775 05 012800497. 50 FO O D JA R 1 5 S 0 1 2 9 0 0 3 5 7 . 70 1R03776 05S 013000504. 30 F O O D JA R 1 5 S 0 1 3 1 0 0 3 6 9 . 2'.' 1R03777 05 013200472. 60
FO O D JA R 1 5 S 013 3 0 0 3 8 9 . 40 1R0377S 05 13400487. 60
FO O D JA R 15 0 1 3 5 0 0 3 8 0 . 70 1RG3779 05 013600475. 80 FO O D JA R 1 5 S 0 1 3 7 0 0 3 7 9 . 00 1R03780 05 013800419. 90 FO O D JA R 1 5 S 0 13 900407 . 10 1R03781 05S 014000456. 80 FO O D JA R 15 0 1 4 1 0 0 3 8 3 . 40 1 3782 05 014200479. 60 F l -o D JA R 1 5 0 1 4 3 0 0 3 8 3 . 50 1R03782 05 014400448. 80 FO O D JA R 15 014 500384 . 40 1R03784 05 014600491. 50 F O O D JA R 1 5 0 1 4 7 0 0 3 6 3 . 0*0
1R02785 05 014800487. 40 FO O D JA R 15 014 900371 . 80
14 4 14 4 14 4
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BEST COPY AVAII ABLE
648
IF : 2786 FO O D JA R lR 0 i2 7 8 ? F O O D J AF'
1R03788 FO O D JA R 1R03789 F D JA R 1R013790 FO O D JA R 1R02791 FOOD JA R 1R02792 FO O D JA R 1R03793 FO O D JA R 1R02794 FO O D JA R 1R03795 FO O D JA R
05S
158 058 15S 05S 15S 058 158 058 158 058 15S 058 158 058 158 058 158 058 158
015000457 20 015*100299 60 01520O286. 20 015*200425 20 015400452. 40 015500282. 40 015600416. 10 0157010297. 60 015800448. 60 015*900272. 50 0166100512. 40
016100371. 70 016200367. 30 01620044?. 20 0164061465. 90 016500375. 80 016600528. 20 16700244. 00 01680042?. 90 0 1 6 9 2. 20
1R03796 FOOD JA F : 158 0 1 7 1 0 0 4 1 2 . 70 1R03797 058 017200481. 40 FOOC1JA F: 158 0 1 7 3 0 0 3 7 1 . 00 1R02798 058 017400445. 10 FO O D JA R 158 017 5 0 0 4 1 2 . 60 1R02799 058 017600474. 80 F OOD JA F : 158 0 1 7 7 0 0 3 7 9 . SO IF :02860 058 017800491. 70 FOOD JA F: 158 017900375 . 10 1RO2801 058 018000476. 20 F r "'D JA R 158 018 1 0 0 3 7 2 . 20 1, .-2802 058 0 1 8 2 0 0 4 9 5 . 30 F O u t1JA R 1 5 8 0 1 8 2 0 0 2 7 2 . 30 1R028O2 058 018400496. 60 FOOD JA F: 158 0 1 8 5 0 0 2 7 1 . 60 1R02804 058 018600432. 90 FO O D JA R 158 018 7 0 0 3 9 0 . 10 1RO2805 058 018800428. 70 F OOD JA F: 158 0 1 8 9 0 0 2 8 5 . 90 1R028O6 058 019000479. 90 FO O D JA R 158 0 1 9 1 0 0 2 9 6 . 70 1F:02:807 058 0 1 9 2 0 0 4 4 4 . 40 FO O D JA R 158 019 2 0 0 2 8 0 . 60 IF '0 2 8 0 8 058 0 1 9 4 0 0 5 2 1 . 70 FO O D JA R 158 0 1 9 5 0 0 3 5 8 . 40 1F:02809 058 0 1 9 6 0 0 4 3 1 . 80 FOOC1JA R 1 5 8 0 1 9 7 0 0 2 9 6 . 20 1R02810 058 19800472. 40 FOOD JA F: 158 0 19 900365 . 30 1R02811 088 020000500. 30 FO O D JA R 1 6 8 2010 0288. 0 1 R 0 2 8 1 2 068 0202005*49. 20 FO O D JA R 168 020300367 . 70 1R02813 068 020400509. 80 FO O D JA R 168 020 5 0 0 3 6 6 . 40 1 R 0 2 8 1 4 068 20600436. 0 F D JA R 168 020700392. 90 1R02815 068 02080044O. 50 FO O D JA R 168 0 2 0 9 0 0 2 6 7 . 60 1 R 0 2 8 1 6 0 6 8 0 2 1 0 0 0 4 6 7 . 3Gl FO O D JA R 168 0 2 1 1 0 0 3 7 4 . 80 1R02817 068 021200443. 90 FO O D JA R 168 21300401. 20 1 R 0 2 8 1 8 0 6 8 0 2 1 4 0 0 4 4 6 . 60!
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002134
457. 2 2-99. 6 286. 2 425. 3 452 4 382. 4 416. 1 397. 6 448. 6 372. 5 512. 4 271. 7 267. 2 447. 2 465. 9 375. 8 528. 2 344 427. 9 3 8 7 .2
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BEST COPY AVAIlABU
649
FOOD-.THF: It 'S 021500392 4L! RG2819 G88 021800482 30 FOODJBF 16S G21700283. 90 1R382 08 021800510. 10 FOODJRF: 18S 021900359. 40 1RG2821 08S 02200G482. 60 FOODJHR 168 022100278. 40 1 3.822 G8 02220047G. 30! FL..JDJRR 18S 0223G0287. 70 1RG2823 G8 022400503. 80 FDJRk 16 22500385. 70 1R03824 68 22800452. 90! FOODJRF: 18S 622700394. 90 1RG2825 08S 22800457. 50! FOOD JHF: e s 022900377. 30 1F:02820 08S 023000419. 00 FOODJRF: 18S 023100395. 50 1R03827 0t' 023200472. 10 FOODJRF: 16S 023300382. 20 1RG3828 06S 023400483. 10 FOODJRR 16S 022500399. 40 1RG2829 G8S 022600449. 70 FOODJRF: 18S 023700382. 20 1RG2830 08S 022800485. G! FOODJRF: 18S 22900290. 20! 1RG3821 08S 24000440. 10 FOODJRF: les 024100297. 20 1RG3832 G8S 24200490. 20 FOODJRF: es 024300386. 00 1RG3833 08S 24400405. 10 FOODJRF: ies 024500281. 20 1R03834 0t.8 024600418. 30 FOODJRF: les 024700412. 20 1 3835 Ges 024800428. 10 FOODJRF: es 24900295. 60 1R03826 08.S 025000538. 90 FOODJRF: ies 025100373. 30 1R0382? 08S 025200433. 90 FOODJRF: ies 025200383. 80 1R03838 08S 0254001449. 20! FOODJRF: les 0255004G2. 60 1R03839 08S 025600443. 50! FOODJRF: es 25700380. 80 1R03848 0eS 025800466. 40! FOODJRF: 16S 0259G0392. 00! 1R03S41 es 02600G482. 40 FOODJRF: les 026100392:. 50 1R03842 es 026200428. 70 FOODJRF: es 026300350. 70 1RG2843 es 028400465. 30 FOODJRF: les 026500382. 00! 1RG2844 es 26600494. 50! FOODJRF: les 026700272. 70! 1R03845 es 26800430. G! FOODJRF: les 026900386. 40 1RG2846 G8 s 027000507. 50 FOODJRF: l e s 027100374. 50! 1R03847 es 027200512. 40 F DJRR es 0273004G6. 80 lr.^ 3 8 4 8 es 02740G450. 50 FOODJRF: les 027500291. 70 1RG3849 088 02760G484. 50! FOODJRF: ies 02770G378. 4L! 1RG2850 es G27800449. 60) FOODJRF: les 027900387. O 1RG2851 es 028000454. 60
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00213g
6 51
BEST COPY AM U ABIE
1 YEAR O R A LG D IE T> TO X-O N C STUDV OF F M -3 9 2 4 & F C -1 4 3 IN RATS EXP. # 0281C R 0012
T E C H N IC IA N I N I T I A L S : S MH T O D A Y 'S DATE : S 8 / 4 / 8 1 SEX OF R A T S : S MALE ROOM N U M B E R :S D - 3 4 0 , D - 3 3 8 W EIG H T OF F U L L FOOD J A R : S 550G R A M S
WEEK 1 5
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002137
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1R02527 0 1 S 011400468. 50
FOODJAR 1 1 S 0 1 1 5 0 0 3 7 9 . 5 0
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1K03521 0 1 S 012200500 80
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BEST COPY AVAIIABLE
002139
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' i V E HF: O RA L .D IET ' TS-O UC ST U D V OF FM -3 9 2 4 & F C - 1 4 2 IN R O T S ESP. # 2 81 CR 00 12
1 E C H U 1C IH N I N l l I f t L S : S MH, 1 ODRV D A T E :S B /5 /8 1 S E S DP P h T S . S I1HLE ROOM NUHfc-ER.S D -2 2 2 W EIG H T DF P U L L FuO D J HP: S 550RAM S
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TECHNICIAN I N I T I A L S :S MH TO L'AVS L>ATE:S 8/18/81 SEX OF F A T S :S MALE ROOM NUMBER :S L-240, D-S38 WEIGHT OF FULL FOOL' J A R :S 550GRAMS
WEEK 17
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002157
TWO VEAR ORAL DIET} TOX-ONC STUDV OF FM-3924 &. FC-143 IN RATS EXP. # 0281CR0012
TECHNICIAN INITIALS:S MH TODAY'S D A T E :S 6/19/81 SE X OF RAT S :S MALE
ROOM NUMBER :S D-332 WEIGHT OF FULL FOOD J A R :S 550G RA MS
WEEK 17
i
1R03696 64S 007100445. 50
FOODJAR 14S 007200414. 60
i, 1R 03697 64S 007300446. 30 FOODJAR 14S 007400386. 00
1R03698 04 S .07500433. 00
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1R03699 04S 007700408. 30
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1R03702 04 S 010300456. 90
FOODJAR 14S 010400395. 70
1R63703 04S 010500458. 70
FOODJAR 14S 016600394. 80
1R037O4 04 S 010700476. 30
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1 3705 04S 010900462. 00
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FOODJAR 14S 11200416. 30
1R03707 04 S 0113010418 60
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1R03708 04S 01150@4o2. 5Q
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1R63709 04S 011700442. 80
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1R03714 04 S 012708413. 90
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1R63722 04S 014300447. 80
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1R03724 045 016800467. 20
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FO O D JA R 145 0 0 1 2 0 0 4 0 7 . 40
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1R03749 045 002200410. 90
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1R03762 055 004808411. 10 FO O D JR R 1 5 S 0 0 4 9 0 0 4 1 1 . 00 1R03762 05S 005008481. 20
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1R03771 055 006600512. 60 FO O D JR R 155 .006700258. 80 1R02772 055 006800475. 50 FO O D JR R 155 006900382 . 90
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