Document 91kQyD5LJGzd1RG8b3kZdZEr3
AR226-3200
TRADE SECRET
Study Title H-24516: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproduction Evaluations
Volume 4 of 5
Laboratory Project ID: DuPont-5386
TEST GUIDELINES: U.S. EPA Health Effects Test Guidelines OPPTS 870.3100 (1998)
AUTHOR; Gregorys. Ladies, Ph.D., D.A.B.T. STUDY COMPLETED ON: December 3,2001
PERFORMING LABORATORY:
E.I. du Font de Nemours and Company Haskell Laboratory for Toxicology and Industrial Medicine
Elkton Road, P.O. Box 50 Newark, Delaware 19714-0050
WORK REQUEST NUMBER:|^Bfl
SERVICE CODE NUMBERa^JJV
SPONSOR STUDY NUMBER:!----------^IHF
Page 970 of 1500
Company Sanitized. Does not contain TSCA CB)
41.
H
H-24516: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproduction Evaluations____
INDIVIDUAL ANIMAL GROSS AMD MICROSCOPIC OBSERVATIONS
Dose Group : II -
Animal Ref
0 mg/kg/day Sex: Females Microscopic & Macroscopic Findings
643330
Terminal Sacrifice Killed on Day : 125
Exposure Group : ONE-MONTH RECOVERY
Animal is signed off from necropsy
Gross Pathology :
No Macroscopic Abnormality Observed :
LIVER, KIDNEYS, LUNGS, HEART, SKELETAL MUSCLE, SPLEEN, AORTA, BRAIN, SPINAL CORD, STOMACH, DUODENUM, JEJUNUM, ILEUM, PANCREAS, CECUM, COLON, RECTUM, MESENTERIC LYMPH NODE, SALIVARY GLANDS, MANDIBULAR LYMPH NODE, THYMUS, ADRENAL GLANDS, SCIATIC NERVE, PITUITARY GLAND,
THYROID GLAND, PARATHYROID GLANDS, TRACHEA, ESOPHAGUS,
. PHARYNX/LARYNX, EYE(S) WITH OPTIC NERVE, SKIN, MAMMARY GLAND (FEMALE), OVARIES, UTERUS, URINARY BLADDER, FEMUR/KNEE JOINT, STERNUM, NOSE, MANDIBLE
Histopathology :
LIVER : INFLAMMATION, SUBACUTE/CHRONIC, minimal.
KIDNEYS :
NEPHROPATHY, CHRONIC PROGRESSIVE, minimal.
: THYROID GLAND :
ALTERATION, COLLOID, minimal.
No Microscopic Abnormality Observed :
NOSE, MANDIBLE
971
.Company Sanitized. Does not contain
H
H-24516: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Geqeration Reproduction Evaluations___
INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS
Dose Group : II -
Animal Ref
0 nig/kg/day Sex: Females Microscopic & Macroscopic Findings
643336
Unscheduled Sacrifice Duration of dosing-days: 105.
Exposure Group : ONE-MONTH RECOVERY
Animal is signed off from necropsy
Gross Pathology :
KIDNEYS : CALCULUS\CALCULI,
URINARY BLADDER : CALCULUS\CALCULI,
BILATERAL,
severe.
severe.
No Macroscopic Abnormality Observed :
LIVER, LUNGS, HEART, SKELETAL MUSCLE. SPLEEN, AORTA, BRAIN,
"
SPINAL CORD, STOMACH, DUODENUM, JEJUNUM, ILEUM, PANCREAS, CECUM, COLON, RECTUM, MESENTERIC LYMPH NODE, SALIVARY GLANDS, MANDIBULAR LYMPH NODE, THYMUS, ADRENAL GLANDS,
SCIATIC MERVE, PITUITARY GLAND, THYROID GLAND,
PARATHYROID GLANDS, TRACHEA, ESOPHAGUS, PHARYNX/LARYNX,
EYE(S) WITH OPTIC NERVE, SKIN, MAMMARY GLAND (FEMALE), OVARIES, UTERUS, FEMUR/KNEE JOINT, STERNUM, NOSE
Histopathology :
643336
LIVER : INFLAMMATION, SUBACUTE/CHRONIC,
KIDNEYS :
MINERALIZATION, mild. NECROSIS, TUBULAR, mild.
HYPERPLASIA, TRANSITIONAL CELL,
INFLAMMATION, ACUTE, mild.
THYMUS :
ATROPHY, mild.
Continued on the next page ....
minimal. moderate,
972
Company Sanitized. Does not contain TS
H-24516: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproduction Evaluations
INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS
Dose Group : II -
Animal Ref
0 mg/kg/day Sex: Females Microscopic & Macroscopic Findings
643336
Continued from previous page
Histopathology :
URINARY BLADDER :
HYPERPLASIA, SIMPLE, TRANSITIONAL CELL,
INFLAMMATION, SUBACUTE/CHRONIC,
HEMORRHAGE, mild.
BONE MARROW :
mild.
HYPERPLASIA, GRANULOCYTIC, mild.
moderate.
No Microscopic Abnormality Observed :
LUNGS, HEART, SKELETAL MUSCLE, SPLEEN, AORTA, BRAIN, SPINAL
CORD, STOMACH, DUODENUM, JEJUNUM, ILEUM, PANCREAS, CECUM, - "COLON, RECTUM, MESENTERIC LYMPH NODE, SALIVARY GLANDS,
MANDIBULAR LYMPH NODE, ADRENAL GLANDS, SCIATIC NERVE, PITUITARY GLAND, THYROID GLAND, PARATHYROID GLANDS,
TRACHEA, ESOPHAGUS, PHARYNX/LARYNX,
EYE(S) .WITH OPTIC NERVE, SKIN, MAMMARY GLAND (FEMALE), OVARIES, UTERUS, FEMUR/KNEE JOINT, STERNUM, NOSE, MANDIBLE
643354
Terminal Sacrifice Killed on Day : 93
Exposure Group : 90-DAY EXPOSURE
Animal is signed off from necropsy
Gross Pathology ;
643354
No Macroscopic Abnormality Observed : LIVER, KIDNEYS, LUNGS, HEART, SKELETAL MUSCLE, SPLEEN,
AORTA. BRAIN, SPINAL CORD, STOMACH, DUODENUM, JEJUNUM, ILEUM, PANCREAS, CECUM, COLON, RECTUM, MESENTERIC LYMPH NODE, SALIVARY GLANDS, MANDIBULAR LYMPH NODE, THYMUS, ADRENAL GLANDS, SCIATIC NERVE, PITUITARY GLAND,
Continued on the next page ....
973
CompanySanitized. Does not conta
H-24516: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproduction Evaluations
INDIVIDUAL ANIMAL GROSS AMD MICROSCOPIC OBSERVATIONS
Dose Group : II - 0 mg/kg/day Sex: Females
Animal Ref
Microscopic & Macroscopic Findings
643354 .
Continued from previous page
Gross Pathology :
No Macroscopic Abnormality Observed :
THYROID GLAND, PARATHYROID GLANDS, TRACHEA, ESOPHAGUS,
PHARYNX/LARYNX, EYE(S) WITH OPTIC NERVE, SKIM, MAMMARY GLAND (FEMALE), OVARIES, UTERUS, URINARY BLADDER, FEMUR/KNEE JOINT, STERNUM, NOSE, MANDIBLE
Histopathology :
No Microscopic Abnormality Observed :
LIVER, KIDNEYS, LUNGS, HEART, SKELETAL MUSCLE. SPLEEN, AORTA, BRAIN, SPINAL CORD, STOMACH, DUODENUM, JEJUNUM, ILEUM, PANCREAS, CECUM, COLON, RECTUM, MESENTERIC LYMPH
'
NODE, SALIVARY GLANDS, MANDIBULAR LYMPH NODE, THYMUS, ADRENAL GLANDS, SCIATIC NERVE, PITUITARY GLAND,
THYROID GLAND, PARATHYROID GLANDS, TRACHEA, ESOPHAGUS,
PHARYNX/LARYNX, EYE(S) WITH OPTIC NERVE, SKIN, MAMMARY GLAND (FEMALE), OVARIES, UTERUS, URINARY BLADDER, FEMUR/KNEE JOINT, STERNUM, BONE MARROW, NOSE, MANDIBLE
643361
Terminal Sacrifice Killed on Day : 93
Exposure Group : 90-DAY EXPOSURE
Animal is signed off from necropsy
Gross Pathology :
643361
No Macroscopic Abnormality Observed : LIVER, KIDNEYS, LUNGS, HEART, SKELETAL MUSCLE, SPLEEN,
AORTA, BRAIN, SPINAL CORD, STOMACH, DUODENUM, JEJUNUM, ILEUM, PANCREAS, CECUM, COLON, RECTUM, MESENTERIC LYMPH NODE, SALIVARY GLANDS, MANDIBULAR LYMPH NODE, THYMUS,
ADRENAL GLANDS, SCIATIC NERVE, PITUITARY GLAND,
Continued on the next page ....
974
Company Sanitized. Does not contain
0
H-24516: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproduction Evaluations
INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS
Dose Group : II -
Animal Ref
0 mg/kg/day Sex: Females Microscopic & Macroscopic Findings
643361
Continued from previous page
Gross Pathology :
No Macroscopic Abnormality Observed :
THYROID GLAND, PARATHYROID GLANDS, TRACHBA, ESOPHAGUS,
PHARYNX/LARYNX, EYE(S) WITH OPTIC NERVE, SKIN, MAMMARY GLAND (FEMALE), OVARIES, UTERUS, URINARY BLADDER, FEMUR/KNEE JOINT, STERNUM, NOSE, MANDIBLE
Histopathology :
LIVER : INFLAMMATION,
PARATHYROID GLANDS NOT PRESENT.
SUBACUTE/CHRONIC,
:
minimal.
No Microscopic Abnormality Observed : KIDNEYS,'LUNGS, HEART, SKELETAL MUSCLE, SPLEEN, AORTA,
BRAIN, SPINAL CORD, STOMACH, DUODENUM, JEJUNUM, ILEUM, PANCREAS, CECUM, COLON, RECTUM, MESENTERIC LYMPH NODE,
SALIVARY GLANDS, MANDIBULAR LYMPH NODE, THYMUS, ADRENAL
GLAMDS, SCIATIC NERVE, PITUITARY GLAND, THYROID GLAND,
TRACHEA, ESOPHAGUS, PHARYNX/LARYNX, EYE(S) WITH OPTIC NERVE, SKIN, MAMMARY GLAND (FEMALE),
OVARIES, UTERUS, URINARY BLADDER, FEMUR/KNEE JOINT,
STERNUM, BONE MARROW, NOSE, MANDIBLE
975
. . 1 H-24516: Subchronic Toxicity
90-Day Gavage Study in Rats with One-Generation Reproduction Evaluations____
INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS
Dose Group : II - 0 mg/kg/day Sex: Females
Animal Ref
Microscopic & Macroscopic Findings
643362
Terminal Sacrifice Killed on Day : 93
Exposure Group : 90-DAY EXPOSURE
Animal is signed off from necropsy
Gross Pathology :
No Macroscopic Abnormality Observed : LIVER, KIDNEYS, LUNGS, HEART, SKELETAL MUSCLE, SPLEEN,
AORTA, BRAIN, SPINAL CORD, STOMACH, DUODENUM, JEJUNUM, ILEUM, PANCREAS, CECUM, COLON, RECTUM, MESENTERIC LYMPH NODE, SALIVARY GLANDS, MANDIBULAR LYMPH NODE, THYMUS,
ADRENAL GLANDS, SCIATIC NERVE, PITUITARY GLAND, THYROID GLAND, PARATHYROID GLANDS, TRACHEA, ESOPHAGUS,
.PHARYNX/LARYNX, EYE(S) WITH OPTIC NERVE, SKIN, MAMMARY GLAND (FEMALE), OVARIES, UTERUS, URINARY BLADDER, FEMUR/KNEE JOINT, STERNUM, NOSE, MANDIBLE
Histopathology :
LIVER :
NECROSIS, FOCAL, minimal.
INFLAMMATION, SUBACUTE/CHRONIC,
KIDNEYS :
minimal.
NEPHROPATHY, CHRONIC PROGRESSIVE, minimal.
HEART :
CARDIOMYOPATHY, minimal.
643362 Continued on the next page ....
976
Company Sanitized. Does not con
H-24516: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproduction Evaluations
INDIVIDUAL ANIMAL GROSS AMD MICROSCOPIC OBSERVATIONS
Dose Group : II -
Animal Ref
0 mg/kg/day Sex: Females Microscopic & Macroscopic Findings
643362
,
Continued from previous page
Histopathology :
No Microscopic Abnormality Observed :
LUNGS, SKELETAL MUSCLE, SPLEEN, AORTA, BRAIN, SPINAL CORD,
STOMACH, DUODENUM, JEJUNUM, ILEUM, PANCREAS, CECUM, COLON, RECTUM, MESENTERIC LYMPH NODE, SALIVARY GLANDS, MANDIBULAR LYMPH NODE, THYMUS, ADRENAL GLANDS, SCIATIC NERVE, PITUITARY GLAND, THYROID GLAND, PARATHYROID GLANDS,
TRACHEA, ESOPHAGUS, PHARYNX/LARYNX, EYE(S) WITH OPTIC NERVE, SKIN, MAMMARY GLAND (FEMALE), OVARIES, UTERUS, URINARY BLADDER, FEMUR/KNEE JOINT, STERNUM, BONE MARROW, NOSE, MANDIBLE
643374
Terminal Sacrifice Killed on Day : 93
Exposure Group : 90-DAY EXPOSURE
Animal is signed off from necropsy
Gross Pathology :
643374
No Macroscopic Abnormality Observed : LIVER, KIDNEYS, LUNGS, HEART, SKELETAL MUSCLE, SPLEEN,
AORTA, BRAIN, SPINAL CORD, STOMACH, DUODENUM, JEJUNUM, ILEUM, PANCREAS, CECUM, COLON, RECTUM, MESENTERIC LYMPH NODE. SALIVARY GLANDS. MANDIBULAR LYMPH NODE, THYMUS, ADRENAL GLANDS, SCIATIC NERVE, PITUITARY GLAND,
THYROID GLAND, PARATHYROID GLANDS, TRACHEA, ESOPHAGUS, PHARYNX/LARYNX, EYE(S) WITH OPTIC NERVE, SKIN, MAMMARY
GLAND (FEMALE), OVARIES, UTERUS, URINARY BLADDER, FEMUR/KNEE JOINT, STERNUM, NOSE, MANDIBLE
Continued on the next page ....
977
H-24516: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Gengration Reproduction Evaluations
INDIVIDUAL ANIMAL GROSS AMD MICROSCOPIC OBSERVATIONS
Dose Group : II - 0 mg/kg/day Sex: Females
Animal Ref
Microscopic & Macroscopic Findings
643374
.
Continued from previous page
Histopathology :
LIVER : FATTY CHANGE, INFLAMMATION,
MEDIAN CLEFT, mild. SUBACUTE/CHRONIC. minimal.
No Microscopic Abnormality Observed :
KIDNEYS, LUNGS, HEART, SKELETAL MUSCLE, SPLEEN, AORTA, BRAIN, SPINAL CORD, STOMACH, DUODENUM, JEJUNUM, ILEUM, PANCREAS, CECUM, COLON, RECTUM, MESENTERIC LYMPH NODE,
SALIVARY GLANDS, MANDIBULAR LYMPH NODE, THYMUS, ADRENAL
GLANDS, SCIATIC NERVE, PITUITARY GLAND, THYROID GLAND, "PARATHYROID GLANDS, TRACHEA, ESOPHAGUS, PHARYNX/LARYNX,
EYE(S) WITH OPTIC NERVE, SKIN, MAMMARY GLAND (FEMALE), OVARIES, UTERUS, URINARY BLADDER, FEMUR/KNEE JOINT, STERNUM, BONE MARROW, NOSE, MANDIBLE
643377
Terminal Sacrifice Killed on Day : 125
Exposure Group : ONE-MONTH RECOVERY
Animal is signed off from necropsy
Gross Pathology :
PITUITARY GLAND : LARGE.
643377 Continued on the next page
978
eompany Sanitized. Does not contain T
^
^
H-24516: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproduction Evaluations___
INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS
Dose Group : II - 0 mg/kg/day Sex: Females
Animal Ref
Microscopic & Macroscopic Findings
643377
Continued from previous page
Gross Pathology :
Mo Macroscopic Abnormality Observed :
LIVER, KIDNEYS, LUNGS, HEART, SKELETAL MUSCLE, SPLEEN, AORTA, BRAIN, SPINAL CORD, STOMACH, DUODENUM, JEJUNUM, ILEUM, PANCREAS, CECUM, COLON, RECTUM, MESENTERIC LYMPH NODE, SALIVARY GLANDS, MANDIBULAR LYMPH NODE, THYMUS, ADRENAL GLANDS, SCIATIC NERVE, THYROID GLAND, PARATHYROID GLANDS, TRACHEA, ESOPHAGUS, PHARYNX/LARYNX, EYE(S) WITH OPTIC NERVE, SKIN, MAMMARY GLAND (FEMALE), OVARIES, UTERUS, URINARY BLADDER, FEMUR/KNEE JOINT, STERNUM, NOSE, MANDIBLE
Histopathology :
LIVER : INFLAMMATION, SUBACUTE/CHRONIC, minimal.
KIDNEYS :
NEPHROPATHY. CHRONIC PROGRESSIVE, minimal.
THYROID GLAND :
ALTERATION. COLLOID, minimal.
No Microscopic Abnormality Observed :
NOSE, MANDIBLE
979
Company Sanitized. Does not contain TS
^
1
H-24516: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproduction Evaluations____
INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS
Dose Group : II - 0 ing/kg/day Sex: Females
Animal Ref
Microscopic & Macroscopic Findings
643383
Terminal Sacrifice Killed on Day : 181
Exposure Group : THREE-MONTH RECOVERY
Animal is signed off from necropsy
Gross Pathology :
No Macroscopic Abnormality Observed : LIVER, KIDNEYS, LUNGS, HEART, SKELETAL MUSCLE, SPLEEN,
AORTA, BRAIN, SPINAL CORD, STOMACH, DUODENUM, JEJUNUM, ILEUM, PANCREAS, CECUM, COLON, RECTUM, MESENTERIC LYMPH NODE, SALIVARY GLANDS, MANDIBULAR LYMPH NODE, THYMUS, ADRENAL GLANDS, SCIATIC NERVE, PITUITARY GLAND,
.THYROID GLAND, PARATHYROID GLANDS, TRACHEA, ESOPHAGUS, PHARYNX/LARYNX, EYE(S) WITH OPTIC NERVE, SKIN, MAMMARY GLAND (FEMALE), OVARIES, UTERUS, URINARY BLADDER,
FEMUR/KNEE JOINT, STERNUM, NOSE
Histopathology :
THYROID GLAND :
ALTERATION. COLLOID, mild.
NOSE :
INFLAMMATION, SUBACUTE/CHRONIC, minimal.
HYPERPLASIA/SQUAMOUS METAPLASIA, TRANSITIONAL
CELL,
mild.
980
Company Sanitized. Does not contain
1
H-24516: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproduction Evaluations____
INDIVIDUAL ANIMAL GROSS AMD MICROSCOPIC OBSERVATIONS
Dose Group : II -
Animal Ref
0 mg/kg/day Sex: Females Microscopic & Macroscopic Findings
643384
Terminal Sacrifice Killed on Day : 181
Exposure Group : THREE-MONTH RECOVERY
Animal is signed off from necropsy
Gross Pathology
No Macroscopic Abnormality Observed : LIVER, KIDNEYS, LUNGS, HEART, SKELETAL MUSCLE, SPLEEN,
AORTA, BRAIN, SPINAL CORD, STOMACH, DUODENUM, JEJUNUM, ILEUM, PANCREAS, CECUM, COLON, RECTUM, MESENTERIC LYMPH NODE, SALIVARY GLANDS, MANDIBULAR LYMPH NODE, THYMUS, ADRENAL GLANDS, SCIATIC NERVE, PITUITARY GLAND,
THYROID GLAND, PARATHYROID GLANDS, TRACHEA, ESOPHAGUS,
"PHARYNX/LARYNX, EYE(S) WITH OPTIC NERVE, SKIN, MAMMARY GLAND (FEMALE), OVARIES, UTERUS, URINARY BLADDER,
FEMUR/KNEE JOINT, STERNUM, NOSE
Histopathology :
THYROID GLAND :
ALTERATION, COLLOID, minimal.
No Microscopic Abnormality Observed :
NOSE
981
Company Sanitized. Does not con
'
^
H-24516: Subchronic Toxicity
90-Day Gavage Study in Rats with One-Generation Reproduction Evaluations___
INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS
Dose Group : II - 0 mg/kg/day Sex: Females
Animal Ref
Microscopic & Macroscopic Findings
643387
.
Terminal Sacrifice
Killed on Day : 125
Exposure Group : ONE-MONTH RECOVERY
Animal is signed off from necropsy
Gross Pathology :
No Macroscopic Abnormality Observed :
LIVER, KIDNEYS, LUNGS, HEART, SKELETAL MUSCLE, SPLEEN, AORTA, BRAIN, SPINAL CORD, STOMACH, DUODENUM, JEJUNUM, ILEUM, PANCREAS, CECUM, COLON, RECTUM, MESENTERIC LYMPH NODE, SALIVARY GLANDS, MANDIBULAR LYMPH NODE, THYMUS,
ADRENAL GLANDS, SCIATIC NERVE, PITUITARY GLAND,
THYROID GLAND. PARATHYROID GLANDS, TRACHEA, ESOPHAGUS,
-PHARYNX/LARYNX, EYE(S) WITH OPTIC NERVE, SKIN, MAMMARY GLAND (FEMALE), OVARIES, UTERUS, URINARY BLADDER, FEMUR/KNEE JOINT, STERNUM, NOSE, MANDIBLE
Histopathology :
LIVER : INFLAMMATION, SUBACUTE/CHRONIC, minimal.
No Microscopic Abnormality Observed :
KIDNEYS, THYROID GLAND, NOSE, MANDIBLE
982
Company Sanitized. Does not con
H-24516: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproduction Evaluations
INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS
Dose Group : II -
Animal Ref
0 mg/kg/day Sex: Females Microscopic & Macroscopic Findings
643398
Terminal Sacrifice Killed on Day : 93
Exposure Group : 90-DAY EXPOSURE
Animal is signed off from necropsy
Gross Pathology :
No Macroscopic Abnormality Observed : LIVER, KIDNEYS, LUNGS, HEART, SKELETAL MUSCLE, SPLEEN,
AORTA, BRAIN, SPINAL CORD, STOMACH, DUODENUM, JEJUNUM, ILEUM, PANCREAS, CECUM, COLON, RECTUM, MESENTERIC LYMPH NODE, SALIVARY GLANDS, MANDIBULAR LYMPH NODE, THYMUS, ADRENAL GLANDS, SCIATIC NERVE, PITUITARY GLAND, THYROID GLAND, PARATHYROID GLANDS, TRACHEA, ESOPHAGUS,
' PHARYNX/LARYNX, EYE(S) WITH OPTIC NERVE, SKIN, MAMMARY GLAND (FEMALE), OVARIES, UTERUS, URINARY BLADDER,
FEMUR/KNEE JOINT, STERNUM, NOSE. MANDIBLE
Histopathology :
LIVER : INFLAMMATION, SUBACUTE/CHRONIC, minimal.
PATTY CHANGE, MEDIAN CLEFT, mild.
KIDNEYS :
NEPHROPATHY, CHRONIC PROGRESSIVE, minimal.
HEART :
CARDIOMYOPATHY, minimal.
PARATHYROID GLANDS :
NOT PRESENT.
643398 Continued on the next page
983
Company Sanitized. Does not co
^
n
H-24516: Subchronic Toxicity
90-Day Gavage Study in Rats with One-Generation Reproduction Evaluations___
INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS
Dose Group : II -
Animal Ref
0 mg/kg/day Sex: Females Microscopic & Macroscopic Findings
643398
.
Continued from previous page
Histopathology :
No Microscopic Abnormality Observed :
LUNGS, SKELETAL MUSCLE, SPLEEN, AORTA, BRAIN, SPINAL CORD,
STOMACH, DUODENUM, JEJUNUM, ILEUM, PANCREAS, CECUM, COLON, RECTUM, MESENTERIC LYMPH NODE, SALIVARY GLANDS, MANDIBULAR
LYMPH NODE, THYMUS, ADRENAL GLANDS, SCIATIC NERVE, PITUITARY GLAMD, THYROID GLAND, TRACHEA, ESOPHAGUS,
PHARYNX/LARYNX, EYE(S) WITH OPTIC NERVE, SKIN, MAMMARY GLAND (FEMALE), OVARIES, UTERUS, URINARY BLADDER, FEMUR/KNEE JOINT, STERNUM, BONE MARROW, NOSE, MANDIBLE
643402
. Terminal Sacrifice Killed on Day : 181
Exposure Group : THREE-MONTH RECOVERY
Animal is signed off from necropsy
Gross Pathology :
No Macroscopic Abnormality Observed :
LIVER, KIDNEYS, LUNGS, HEART, SKELETAL MUSCLE, SPLEEN, AORTA, BRAIN, SPINAL CORD, STOMACH, DUODENUM, JEJUNUM, ILEUM, PANCREAS, CECUM, COLON, RECTUM, MESENTERIC LYMPH NODE, SALIVARY GLANDS, MANDIBULAR LYMPH NODE, THYMUS, ADRENAL GLANDS. SCIATIC NERVE, PITUITARY GLAND,
THYROID GLAND, PARATHYROID GLANDS, TRACHEA, ESOPHAGUS, PHARYNX/LARYNX, EYE(S) WITH OPTIC NERVE, SKIN, MAMMARY GLAND (FEMALE), OVARIES, UTERUS, URINARY BLADDER,
FEMUR/KNEE JOINT, STERNUM, NOSE
643402 Continued on the next page ....
984 Company Sanitized. Dees not conta
^
n
H-24516: Subchronic Toxicity
90-Day Gavage Study in Rats with One-Generation Reproduction Evaluations___
INDIVIDUAL ANIMAL GROSS AMD MICROSCOPIC OBSERVATIONS
Dose Group : II -
Animal Ref
0 nig/kg/day Sex: Females Microscopic & Macroscopic Findings
643402
Continued from previous page
Histopathology :
THYROID GLAND :
ALTERATION, COLLOID, minimal.
No Microscopic Abnormality Observed :
NOSE
643405
Terminal Sacrifice Killed on Day : 125
Exposure Group : ONE-MONTH RECOVERY
Animal is signed off from necropsy
Gross Pathology :
No Macroscopic Abnormality Observed : LIVER, KIDNEYS, LUNGS, HEART, SKELETAL MUSCLE, SPLEEN,
AORTA, BRAIN, SPINAL CORD, STOMACH, DUODENUM, JEJUNUM, ILEUM, PANCREAS, CECUM. COLON, RECTUM, MESENTERIC LYMPH NODE, SALIVARY GLANDS, MANDIBULAR LYMPH NODE, THYMUS.
ADRENAL GLANDS, SCIATIC NERVE, PITUITARY GLAND, THYROID GLAND, PARATHYROID GLANDS, TRACHEA, ESOPHAGUS, PHARYNX/LARYNX, EYE(S) WITH OPTIC NERVE, SKIN, MAMMARY GLAND (FEMALE), OVARIES, UTERUS, URINARY BLADDER, FEMUR/KNEE JOINT, STERNUM, NOSE, MANDIBLE
Histopathology :
643405
LIVER : INFLAMMATION, SUBACUTE/CHRONIC,
NECROSIS, FOCAL, minimal.
Continued on the next page ....
minimal.
985
company Sanitized. Does not conta
e . H-24516: Subchronic Toxicity
90-Day Gavage Study in Rats with One-Generation Reproduction Evaluations___
INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS
Dose Group : II - 0 mg/kg/day Sex: Females
Animal Ref
Microscopic & Macroscopic Findings
643405
.
Continued from previous page
Histopathology :
THYROID GLAND :
ALTERATION, COLLOID, minimal.
No Microscopic Abnormality Observed :
KIDNEYS, NOSE, MANDIBLE
643406
Terminal Sacrifice Killed on Day : 93
Exposure Group : 90-DAY EXPOSURE
Animal is signed off from necropsy
Gross Pathology :
No Macroscopic Abnormality Observed : LIVER, KIDNEYS, LUNGS, HEART, SKELETAL MUSCLE, SPLEEN,
AORTA, BRAIN, SPINAL CORD, STOMACH, DUODENUM, JEJUNUM, ILEUM, PANCREAS, CECUM, COLON, RECTUM, MESENTERIC LYMPH
NODE, SALIVARY GLANDS, MANDIBULAR LYMPH NODE, THYMUS,
ADRENAL GLANDS, SCIATIC NERVE, PITUITARY GLAND, THYROID GLAND, PARATHYROID GLANDS, TRACHEA, ESOPHAGUS,
PHARYNX/LARYNX, EYE(S) WITH OPTIC NERVE, SKIN, MAMMARY GLAND (FEMALE), OVARIES, UTERUS, URINARY BLADDER,
FEMUR/KNEE JOINT, STERNUM, NOSE, MANDIBLE
Histopathology :
643406
LIVER : INFLAMMATION, SUBACUTE/CHRONIC,
Continued on the next page ....
minimal.
986
Gwapmy Sanitized. Does no
H-24516: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproduction Evaluations
INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS
Dose Group : II - 0 mg/kg/day Sex: Females
Animal Ref
Microscopic & Macroscopic Findings
643406
Continued from previous page
Histopathology :
No Microscopic Abnormality Observed :
KIDNEYS, LUNGS, HEART, SKELETAL MUSCLE, SPLEEN, AORTA, BRAIN, SPINAL CORD, STOMACH, DUODENUM, JEJUNUM, ILEUM, PANCREAS, CECUM, COLON, RECTUM, MESENTERIC LYMPH NODE, SALIVARY GLANDS, MANDIBULAR LYMPH NODE, THYMUS, ADRENAL GLANDS, SCIATIC NERVE, PITUITARY GLAMD, THYROID GLAND, PARATHYROID GLANDS, TRACHEA, ESOPHAGUS, PHARYNX/LARYNX, EYE(S) WITH OPTIC NERVE, SKIN, MAMMARY GLAND (FEMALE), OVARIES, UTERUS, URINARY BLADDER, FEMUR/KNEE JOINT, STERNUM, BONE MARROW, NOSE, MANDIBLE
643415
Terminal Sacrifice Killed on Day : 125
Exposure Group : ONE-MONTH RECOVERY
Animal is signed off from necropsy
Gross Pathology :
PITUITARY GLAND :
LARGE.
No Macroscopic Abnormality Observed :
LIVER, KIDNEYS, LUNGS, HEART, SKELETAL MUSCLE, SPLEEN, AORTA, BRAIN, SPINAL CORD, STOMACH, DUODENUM, JEJUNUM, ILEUM. PANCREAS, CECUM, COLON, RECTUM, MESENTERIC LYMPH NODE, SALIVARY GLANDS, MANDIBULAR LYMPH NODE, THYMUS,
ADRENAL GLANDS, SCIATIC NERVE, THYROID GLAND,
643415 Continued on the next page ....
987
fiompanySanRbed. Does not c
H-24516: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproduction Evaluations
INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS
Dose Group : II -
Animal Ref
0 mg/kg/day Sex: Females Microscopic & Macroscopic Findings
643415
Continued from previous page
Gross Pathology :
No Macroscopic Abnormality Observed :
PARATHYROID GLANDS, TRACHEA, ESOPHAGUS, PHARYNX/LARYNX,
EYE(S) WITH OPTIC NERVE, SKIN, MAMMARY GLAND (FEMALE), OVARIES, UTERUS, URINARY BLADDER, FEMUR/KNEE JOINT, STERNUM, NOSE. MANDIBLE
Histopathology :
KIDNEYS :
NEPHROPATHY, CHRONIC PROGRESSIVE, minimal. PITUITARY GLAND :
HYPERPLASIA, DIFFUSE, mild.
NOSE :
SQUAMOUS HYPERPLASIA, NASOLACRIMAL DUCT, mild.
No Microscopic Abnormality Observed : LIVER, THYROID GLAND, MANDIBLE
643425
Terminal Sacrifice Killed on Day : 125
Exposure Group : ONE-MONTH RECOVERY
Animal is signed off from necropsy
Gross Pathology :
643425
No Macroscopic Abnormality Observed : LIVER, KIDNEYS, LUNGS, HEART, SKELETAL MUSCLE, SPLEEN,
AORTA. BRAIN. SPINAL CORD, STOMACH, DUODENUM, JEJUNUM, ILEUM, PANCREAS, CECUM, COLON, RECTUM, MESENTERIC LYMPH NODE, SALIVARY GLANDS, MANDIBULAR LYMPH NODE, THYMUS,
ADRENAL GLANDS, SCIATIC NERVE, PITUITARY GLAND,
Continued on the next page ....
988 Company Sanitized, Does not cont
'
H-24516: Subchronic Toxicity
90-Day Gavage Study in Rats with One-Generation Reproduction Evaluations
INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS
Dose Group : II -
Animal Ref
0 nig/kg/day Sex: Females Microscopic & Macroscopic Findings
643425
Continued from previous page
Gross Pathology :
No Macroscopic Abnormality Observed :
THYROID GLAND, PARATHYROID GLANDS, TRACHEA, ESOPHAGUS,
PHARYNX/LARYNX, EYE(S) WITH OPTIC NERVE, SKIN, MAMMARY GLAND (FEMALE), OVARIES, UTERUS, URINARY BLADDER, FEMUR/KNEE JOINT, STERNUM, NOSE, MANDIBLE
Histopathology :
LIVER : FATTY CHANGE, MEDIAN CLEFT, minimal.
KIDNEYS :
HYDRONEPHROSIS, BILATERAL, minimal.
THYROID GLAND :
ALTERATION, COLLOID, minimal.
No Microscopic Abnormality Observed :
NOSE, MANDIBLE
643426
. Terminal Sacrifice Killed on Day : 125
Exposure Group : ONE-MONTH RECOVERY
Animal is signed off from necropsy
Gross Pathology :
643426
No Macroscopic Abnormality Observed : LIVER, KIDNEYS, LUNGS, HEART, SKELETAL MUSCLE, SPLEEN,
AORTA, BRAIN, SPINAL CORD, STOMACH, DUODENUM, JEJUNUM,
ILEUM, PANCREAS, CECUM, COLON, RECTUM, MESENTERIC LYMPH
NODE, SALIVARY GLANDS, MANDIBULAR LYMPH NODE, THYMUS,
ADRENAL GLANDS, SCIATIC NERVE, PITUITARY GLAND,
Continued on the next page ....
989
'"^'^."o.^
1
H-24516: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproduction Evaluations
INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS
Dose Group : II - 0 mg/kg/day Sex: Females
Animal Ref
Microscopic & Macroscopic Findings
643426
Continued from previous page
Gross Pathology :
No Macroscopic Abnormality Observed :
THYROID GLAND, PARATHYROID GLANDS, TRACHEA, ESOPHAGUS,
PHARYNX/LARYNX, EYE(S) WITH OPTIC NERVE, SKIN, MAMMARY GLAND (FEMALE), OVARIES, UTERUS. URINARY BLADDER, FEMUR/KNEE JOINT, STERNUM, NOSE, MANDIBLE
Histopathology :
LIVER : INFLAMMATION, SUBACUTE/CHRONIC, minimal.
KIDNEYS :
NEPHROPATHY, CHRONIC PROGRESSIVE, minimal.
THYROID GLAND :
ALTERATION, COLLOID, minimal.
No Microscopic Abnormality Observed ;
NOSE, MANDIBLE
643436
Terminal Sacrifice Killed on Day : 93
Exposure Group : 90-DAY EXPOSURE
Animal is signed off from necropsy
Gross Pathology :
643436
No Macroscopic Abnormality Observed : LIVER. KIDNEYS, LUNGS, HEART, SKELETAL MUSCLE, SPLEEN,
AORTA, BRAIN, SPINAL CORD, STOMACH, DUODENUM, JEJUNUM, ILEUM, PANCREAS, CECUM, COLON, RECTUM, MESENTERIC LYMPH NODE, SALIVARY GLANDS, MANDIBULAR LYMPH NODE, THYMUS,
ADRENAL GLANDS, SCIATIC NERVE, PITUITARY GLAND,
Continued on the next page ....
555"
Does not contai
H-24516: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproduction Evaluations
INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS
Dose Group : II -
Animal Ref 643436
0 mg/kg/day Sex: Females Microscopic & Macroscopic Findings Continued from previous page
Gross Pathology :
No Macroscopic Abnormality Observed ;
THYROID GLAND, PARATHYROID GLANDS, TRACHEA, ESOPHAGUS,
PHARYNX/LARYNX, EYE(S) WITH OPTIC NERVE, SKIN, MAMMARY GLAND (FEMALE), OVARIES. UTERUS, URINARY BLADDER.
FEMUR/KNEE JOINT, STERNUM, NOSE, MANDIBLE
Histopathology :
LIVER : INFLAMMATION, SUBACUTE/CHRONIC,
KIDNEYS :
CYST, minimal.
HEART ;
CARDIOMYOPATHY, minimal.
minimal.
No Microscopic Abnormality Observed :
LUNGS, SKELETAL MUSCLE. SPLEEN, AORTA, BRAIN, SPINAL CORD,
STOMACH, DUODENUM, JEJUNUM, ILEUM, PANCREAS, CECUM, COLON, RECTUM, MESENTERIC LYMPH NODE, SALIVARY GLANDS, MAMDIBULAR LYMPH NODE, THYMUS, ADRENAL GLANDS, SCIATIC NERVE, PITUITARY GLAMD, THYROID GLAND, PARATHYROID GLANDS, TRACHEA, ESOPHAGUS, PHARYNX/LARYNX,
EYE(S) WITH OPTIC NERVE, SKIN, MAMMARY GLAND (FEMALE), OVARIES, UTERUS, URINARY BLADDER, FEMUR/KNEE JOINT, STERNUM, BONE MARROW, NOSE, MANDIBLE
991
Company Sanitized. Does not contain
^
_
^
H-24516: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproduction Evaluations___
INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS
Dose Group : II -
Animal Ref
0 mg/kg/day Sex: Females Microscopic & Macroscopic Findings
643448
Terminal Sacrifice Killed on Day : 125
Exposure Group : ONE-MONTH RECOVERY
Animal is signed off from necropsy
Gross Pathology :
No Macroscopic Abnormality Observed : LIVER, KIDNEYS, LUNGS, HEART, SKELETAL MUSCLE, SPLEEN,
AORTA, BRAIN, SPINAL CORD, STOMACH, DUODENUM, JEJUNUM,
ILEUM, PANCREAS, CECUM, COLON, RECTUM, MESENTERIC LYMPH NODE, SALIVARY GLANDS, MANDIBULAR LYMPH NODE, THYMUS,
ADRENAL GLANDS, SCIATIC NERVE, PITUITARY GLAND,
THYROID GLAND, PARATHYROID GLANDS, TRACHEA, ESOPHAGUS,
"PHARYNX/LARYNX, EYE(S) WITH OPTIC NERVE, SKIN, MAMMARY GLAND (FEMALE), OVARIES, UTERUS, URINARY BLADDER,
FEMUR/KNEE JOINT, STERNUM, NOSE, MANDIBLE
Histopathology :
LIVER : INFLAMMATION, SUBACUTE/CHRONIC, minimal.
No Microscopic Abnormality Observed :
KIDNEYS, THYROID GLAND, NOSE, MANDIBLE
992
Company Sanitized. Does not con
T-24516: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproduction Evaluations
INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS
Dose Group : II - 0 mg/kg/day Sex: Females
Animal Ref
Microscopic & Macroscopic Findings
643453
Terminal Sacrifice Killed on Day : 125
Exposure Group : ONE-MONTH RECOVERY
Animal is signed off from necropsy
Gross Pathology :
No Macroscopic Abnormality Observed : LIVER, KIDNEYS, LUNGS, HEART, SKELETAL MUSCLE, SPLEEN,
AORTA, BRAIN, SPINAL CORD, STOMACH, DUODENUM, JEJUNUM, ILEUM, PANCREAS, CECUM, COLON, RECTUM, MESENTERIC LYMPH NODE, SALIVARY GLANDS, MANDIBULAR LYMPH NODE, THYMUS,
ADRENAL GLANDS, SCIATIC NERVE, PITUITARY GLAND,
THYROID GLAND, PARATHYROID GLANDS, TRACHEA, ESOPHAGUS,
-PHARYNX/LARYNX, EYE(S) WITH OPTIC NERVE, SKIN, MAMMARY GLAND (FEMALE), OVARIES, UTERUS, URINARY BLADDER, FEMUR/KNEE JOINT, STERNUM, NOSE, MANDIBLE
Histopathology :
LIVER : INFLAMMATION, SUBACUTE/CHRONIC, minimal.
KIDNEYS :
NEPHROPATHY, CHRONIC PROGRESSIVE, minimal. CYST, minimal.
No Microscopic Abnormality Observed :
THYROID GLAND, NOSE, MANDIBLE
993
tBampwy SenRbed. Does
H-24516: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproduction Evaluations
INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS
Dose Group : II -
Animal Ref
0 mg/kg/day Sex: Females Microscopic & Macroscopic Findings
643463
Terminal Sacrifice Killed on Day : 93
Exposure Group : 90-DAY EXPOSURE
Animal is signed off from necropsy
Gross Pathology
No Macroscopic Abnormality Observed : LIVER, KIDNEYS, LUNGS, HEART, SKELETAL MUSCLE, SPLEEN,
AORTA, BRAIN, SPINAL CORD, STOMACH, DUODENUM, JEJUNUM, ILEUM, PANCREAS, CECUM, COLON, RECTUM, MESENTERIC LYMPH NODE, SALIVARY GLANDS, MANDIBULAR LYMPH NODE, THYMUS,
ADRENAL GLANDS, SCIATIC NERVE, PITUITARY GLAND, THYROID GLAND, PARATHYROID GLANDS, TRACHEA, ESOPHAGUS, -PHARYNX/LARYNX, EYE(S) WITH OPTIC NERVE, SKIN, MAMMARY GLAND (FEMALE), OVARIES, UTERUS, URINARY BLADDER, FEMUR/KNEE JOINT, STERNUM, NOSE, MANDIBLE
Histopathology
LIVER ; INFLAMMATION, SUBACUTE/CHRONIC,
LUNGS :
THROMBUS, minimal. EYE(S) WITH OPTIC NERVE :
OPTIC NERVE NOT PRESENT.
minimal.
643463
No Microscopic Abnormality Observed :
KIDNEYS, HEART, SKELETAL MUSCLE, SPLEEN, AORTA, BRAIN, SPINAL CORD, STOMACH, DUODENUM, JEJUNUM, ILEUM, PANCREAS, CECUM, COLON, RECTUM, MESENTERIC LYMPH NODE, SALIVARY GLANDS, MANDIBULAR LYMPH NODE, THYMUS, ADRENAL GLANDS, SCIATIC NERVE, PITUITARY GLAND, THYROID GLAND,
Continued on the next page
994
H-24516: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproduction Evaluations
INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS
Dose Group : II - 0 mg/kg/day Sex: Females
Animal Ref
Microscopic & Macroscopic Findings
643463
Continued from previous page
Histopathology :
No Microscopic Abnormality Observed :
PARATHYROID GLANDS, TRACHEA, ESOPHAGUS, PHARYNX/LARYNX,
EYE(S) WITH OPTIC NERVE, SKIN, MAMMARY GLAND (FEMALE), OVARIES, UTERUS, URINARY BLADDER, FEMUR/KNEE JOINT,
STERNUM, BONE MARROW, NOSE, MANDIBLE
643465
Terminal Sacrifice Killed on Day : 181
Exposure Group : THREE-MONTH RECOVERY
Animal is signed off from necropsy
Gross Pathology :
No Macroscopic Abnormality Observed :
LIVER, KIDNEYS, LUMGS, HEART, SKELETAL MUSCLE, SPLEEN, AORTA, BRAIN, SPINAL CORD, STOMACH, DUODENUM, JEJUNUM, ILEUM, PANCREAS, CECUM, COLON, RECTUM. MESENTERIC LYMPH NODE, SALIVARY GLANDS, MANDIBULAR LYMPH NODE, THYMUS,
ADRENAL GLANDS, SCIATIC NERVE, PITUITARY GLAND,
THYROID GLAND, PARATHYROID GLANDS, TRACHEA, ESOPHAGUS,
PHARYNX/LARYNX, EYE(S) WITH OPTIC NERVE, SKIN, MAMMARY GLAND (FEMALE), OVARIES, UTERUS, URINARY BLADDER,
FEMUR/KNEE JOINT, STERNUM, NOSE
Histopathology :
643465
THYROID GLAND : ALTERATION, COLLOID,
Continued on the next page ....
minimal.
995
Company Sanitized. Does not conta
/-H-N
i-24516: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproduction Evaluations
INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS
Dose Group : II -
Animal Ref
0 mg/kg/day Sex: Females Microscopic & Macroscopic Findings
643465
Continued from previous page
Histopathology :
NOSE
:
INFLAMMATION, SUBACUTE/CHRONIC, minimal.
HYPERPLASIA/SQUAMOUS METAPLASIA, TRANSITIONAL
CELL,
mild.
643477
Terminal Sacrifice Killed on Day : 93
Exposure Group : 90-DAY EXPOSURE
Animal is signed off from necropsy
Gross Pathology :
No Macroscopic Abnormality Observed : LIVER, KIDNEYS, LUNGS, HEART, SKELETAL MUSCLE, SPLEEN,
AORTA, ^BRAIN, SPINAL CORD, STOMACH, DUODENUM, JEJUNUM, ILEUM, PANCREAS, CECUM, COLON, RECTUM, MESENTERIC LYMPH NODE, SALIVARY GLANDS, MANDIBULAR LYMPH NODE, THYMUS,
ADRENAL GLANDS, SCIATIC NERVE, PITUITARY GLAND,
THYROID GLAND, PARATHYROID GLANDS, TRACHEA, ESOPHAGUS,
PHARYNX/LARYNX, EYE(S) WITH OPTIC NERVE, SKIN, MAMMARY GLAND (FEMALE), OVARIES, UTERUS, URINARY BLADDER, FEMUR/KNEE JOINT, STERNUM, NOSE, MANDIBLE
Histopathology :
643477
LIVER :
INFLAMMATION, SUBACUTE/CHRONIC, minimal.
KIDNEYS :
.... NEPHROPATHY, CHRONIC PROGRESSIVE, minimal.
Continued on the next page
996 Company SanKlzed. Does not contain
H-24516: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproduction Evaluations
INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS
Dose Group : II -
Animal Ref
0 mg/kg/day Sex: Females Microscopic & Macroscopic Findings
643477
Continued from previous page
Histopathology :
PARATHYROID GLANDS : NOT PRESENT.
EYE(S) WITH OPTIC NERVE : OPTIC NERVE NOT PRESENT.
No Microscopic Abnormality Observed :
LUNGS, HEART, SKELETAL MUSCLE, SPLEEN, AORTA, BRAIN, SPINAL CORD, STOMACH, DUODENUM, JEJUNUM, ILEUM, PANCREAS, CECUM, COLON, RECTUM, MESENTERIC LYMPH NODE, SALIVARY GLANDS, MANDIBULAR LYMPH NODE, THYMUS, ADRENAL GLANDS, SCIATIC
. NERVE, PITUITARY GLAND, THYROID GLAND, TRACHEA, ESOPHAGUS, PHARYNX/LARYNX, EYE(S) WITH OPTIC NERVE, SKIN, MAMMARY GLAND (FEMALE), OVARIES, UTERUS, URINARY BLADDER, FEMUR/KNEE JOINT. STERNUM, BONE MARROW, NOSE, MANDIBLE
643484
Terminal Sacrifice Killed on Day : 181
Exposure Group : THREE-MONTH RECOVERY
Animal is signed off from necropsy
Gross Pathology :
643484
No Macroscopic Abnormality Observed : LIVER, KIDNEYS, LUNGS, HEART, SKELETAL MUSCLE, SPLEEN,
AORTA, BRAIN, SPINAL CORD, STOMACH, DUODENUM, JEJUNUM, ILEUM, PANCREAS, CECUM, COLON, RECTUM, MESENTERIC LYMPH
NODE, SALIVARY GLANDS, MANDIBULAR LYMPH NODE, THYMUS, ADRENAL GLANDS, SCIATIC NERVE, PITUITARY GLAND,
Continued on the next page ....
997
Company Sanitized. Does not contain
H-24516: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproduction Evaluations
INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS
Dose Group : II -
Animal Ref
0 mg/kg/day Sex: Females Microscopic & Macroscopic Findings
643484
Continued from previous page
Gross Pathology :
No Macroscopic Abnormality Observed :
THYROID GLAND, PARATHYROID GLANDS, TRACHEA, ESOPHAGUS,
PHARYNX/LARYNX, EYE(S) WITH OPTIC NERVE, SKIN, MAMMARY GLAND (FEMALE), OVARIES, UTERUS, URINARY BLADDER,
FEMUR/KNEE JOINT, STERNUM, NOSE
Histopathology :
THYROID GLAND :
ALTERATION, COLLOID, minimal.
NOSE. ":
INFLAMMATION, SUBACUTE/CHRONIC, mild.
HYPERPIASIA/SQUAMOUS METAPLASIA, TRANSITIONAL
CELL,
mild.
643486
Terminal Sacrifice Killed on Day : 93
Exposure Group : 90-DAY EXPOSURE
Animal is signed off from necropsy
Gross Pathology :
No Macroscopic Abnormality Observed :
LIVER, KIDNEYS, LUNGS, HEART, SKELETAL MUSCLE, SPLEEN, AORTA, BRAIN, SPINAL CORD, STOMACH, DUODENUM. JEJUNUM, ILEUM, PANCREAS, CECUM, COLON, RECTUM, MESENTERIC LYMPH NODE, SALIVARY GLANDS, MANDIBULAR LYMPH NODE, THYMUS,
ADRENAL GLANDS, SCIATIC NERVE, PITUITARY GLAND,
643486 Continued on the next page ....
998
Company Sanitized. Does not con
H-24516: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproduction Evaluations
INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS
Dose Group : II -
Animal Ref 643486
0 nig/kg/day Sex: Females Microscopic & Macroscopic Findings Continued from previous page
Gross Pathology :
No Macroscopic Abnormality Observed :
THYROID GLAND, PARATHYROID GLANDS, TRACHEA, ESOPHAGUS,
PHARYNX/LARYNX, EYE(S) WITH OPTIC NERVE, SKIN, MAMMARY GLAND (FEMALE), OVARIES, UTERUS, URINARY BLADDER, FEMUR/KNEE JOINT, STERNUM, NOSE, MANDIBLE
Histopathology :
LIVER : INFLAMMATION, SUBACUTE/CHRONIC,
MESENTERIC LYMPH NODE : NOT PRESENT.
PARATHYROID GLANDS : NOT PRESENT.
minimal.
No Microscopic Abnormality Observed :
KIDNEYS, LUNGS, HEART, SKELETAL.MUSCLE, SPLEEN, AORTA.
BRAIN, SPINAL CORD, STOMACH, DUODENUM, JEJUNUM, ILEUM, PANCREAS, CECUM, COLON, RECTUM, SALIVARY GLANDS, MANDIBULAR
LYMPH NODE, THYMUS, ADRENAL GLANDS, SCIATIC NERVE,
PITUITARY GLAND, THYROID GLAND, TRACHEA, ESOPHAGUS, PHARYMX/LARYNX, EYE(S) WITH OPTIC NERVE, SKIN, MAMMARY GLAND (FEMALE), OVARIES, UTERUS, URINARY BLADDER, FEMUR/KNEE JOINT, STERNUM, BONE MARROW, NOSE, MANDIBLE
999 Company Sanitized. Does not cont
Bh.
H-24516: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproduction Evaluations
INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS
Dose Group : IV - 25 mg/kg/day Sex: Females
Animal Ref
Microscopic & Macroscopic Findings
643321
Unscheduled Sacrifice Duration of dosing-days: 29
Exposure Group : 90-DAY EXPOSURE
Animal is signed off from necropsy
Gross Pathology :
KIDNEYS :
DILATATION, BILATERAL, PELVIS, DISCOLORATION, TAN, BILATERAL, URINARY BLADDER :
DILATATION, severe. CALCULUS \ CALCULI, 7MM DIA.
moderate.
GRANULAR .
No.Macroscopic Abnormality Observed : LIVER, LUNGS, HEART, SKELETAL MUSCLE, SPLEEN, AORTA, BRAIN,
SPINAL CORD, STOMACH, DUODENUM, JEJUNUM, ILEUM, PANCREAS, CECUM, COLON, RECTUM, MESENTERIC LYMPH NODE, SALIVARY GLANDS, MANDIBULAR LYMPH NODE, THYMUS, ADRENAL GLANDS,
SCIATIC NERVE, PITUITARY GLAND, THYROID GLAND,
PARATHYROID GLANDS, TRACHEA, ESOPHAGUS, PHARYNX/LARYNX, EYE(S) WITH OPTIC NERVE, SKIN, MAMMARY GLAND (FEMALE), OVARIES, UTERUS, FEMUR/KNEE JOINT, STERNUM, NOSE
Histopathology :
643321
KIDNEYS :
HYDRONEPHROSIS, BILATERAL, mild. INFLAMMATION, ACUTE, moderate. HYPERPLASIA, TRANSITIONAL CELL, mild. NECROSIS, TUBULAR, moderate.
HEART :
CARDIOMYOPATHY, minimal.
Continued on the next page ....
1000
Company Sanitized. Dom not contain
^
^
H-24516: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproduction Evaluations
INDIVIDUAL ANIMAL GROSS AMD MICROSCOPIC OBSERVATIONS
Dose Group : IV - 25 mg/kg/day Sex: Females
Animal Ref
Microscopic & Macroscopic Findings
643321
Continued from previous page
Histopathology :
SPLEEN :
DEPLETION, LYMPHOID,
THYMUS :
ATROPHY, moderate.
URINARY BLADDER : HYPERPLASIA, SIMPLE,
BONE MARROW :
ATROPHY, mild.
MANDIBLE : .NOT PRESENT.
moderate. TRANSITIONAL
CELL,
moderate.
No Microscopic Abnormality Observed : LIVER, LUNGS, SKELETAL MUSCLE, AORTA, BRAIN, SPINAL CORD,
STOMACH, DUODENUM, JEJUNUM, ILEUM, PANCREAS, CECUM, COLON, RECTUM, MESENTERIC LYMPH NODE, SALIVARY GLANDS, MANDIBULAR LYMPH NODE, ADRENAL GLANDS, SCIATIC NERVE, PITUITARY GLAND, THYROID GLAND, PARATHYROID GLANDS. TRACHEA, ESOPHAGUS,
PHARYNX/LARYNX, EYE(S) WITH OPTIC NERVE, SKIN, MAMMARY GLAND (FEMALE), OVARIES, UTERUS, FEMUR/KNEE JOINT, STERNUM,
NOSE
1001
Company Sanitized. Ooe not conta
^
1
H-24516: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproduction Evaluations
INDIVIDUAL ANIMAL GROSS AMD MICROSCOPIC OBSERVATIONS
Dose Group : IV - 25 mg/kg/day Sex: Females
Animal Ref
Microscopic & Macroscopic Findings
643324
Terminal Sacrifice Killed on Day : 93
Exposure Group : 90-DAY EXPOSURE
Animal is signed off from necropsy
Gross Pathology :
No Macroscopic Abnormality Observed : LIVER, KIDNEYS, LUNGS, HEART, SKELETAL MUSCLE, SPLEEN,
AORTA, BRAIN, SPINAL CORD, STOMACH, DUODENUM, JEJUNUM, ILEUM, PANCREAS, CECUM, COLON, RECTUM, MESENTERIC LYMPH NODE, SALIVARY GLANDS, MANDIBULAR LYMPH NODE, THYMUS,
ADRENAL GLANDS, SCIATIC NERVE, PITUITARY GLAND,
- -THYROID GLAND, PARATHYROID GLANDS, TRACHEA, ESOPHAGUS, PHARYNX/LARYNX, EYE(S) WITH OPTIC NERVE, SKIN, MAMMARY GLAND (FEMALE), OVARIES, UTERUS, URINARY BLADDER,
FEMUR/KNEE JOINT, STERNUM, NOSE, MANDIBLE
Histopathology :
LIVER : INFLAMMATION, SUBACUTE/CHRONIC,
THYROID GLAND :
ALTERATION, COLLOID, minimal.
minimal.
No Microscopic Abnormality Observed :
KIDNEYS, NOSE, MANDIBLE
1002
Company Sanitized. Does not contain
H-24516: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproduction Evaluations___
INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS
Dose Group : IV - 25 mg/kg/day Sex: Females
Animal Ref
Microscopic & Macroscopic Findings
643364
Terminal Sacrifice Killed on Day : 93
Exposure Group : 90-DAY EXPOSURE
Animal is signed off from necropsy
Gross Pathology :
No Macroscopic Abnormality Observed : LIVER, KIDNEYS, LUNGS, HEART, SKELETAL MUSCLE, SPLEEN,
AORTA, BRAIN, SPINAL CORD, STOMACH, DUODENUM, JEJUNUM, ILEUM, PANCREAS, CECUM, COLON, RECTUM, MESENTERIC LYMPH NODE, SALIVARY GLANDS, MANDIBULAR LYMPH NODE, THYMUS,
ADRENAL GLANDS, SCIATIC NERVE, PITUITARY GLAND,
.THYROID GLAND, PARATHYROID GLANDS, TRACHEA, ESOPHAGUS, PHARYNX/LARYNX, EYE(S) WITH OPTIC NERVE, SKIN, MAMMARY GLAND (FEMALE), OVARIES, UTERUS, URINARY BLADDER, FEMUR/KNEE JOINT, STERNUM, NOSE, MANDIBLE
Histopathology :
LIVER : INFLAMMATION, SUBACUTE/CHRONIC, minimal.
KIDNEYS :
NEPHROPATHY, CHRONIC PROGRESSIVE, minimal.
No Microscopic Abnormality Observed :
THYROID GLAND, NOSE, MANDIBLE
1003
Company Sanitized. Does not co
H-24516: Subchronic Toxicnty 90-Day Gavage Study in Rats with One-Generation Reproduction Evaluations
INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS
Dose Group : IV - 25 ing/kg/day Sex: Females
Animal Ref 643379
Microscopic & Macroscopic Findings
Terminal Sacrifice Killed on Day : 181
Exposure Group : THREE-MONTH RECOVERY
Animal is signed off from necropsy
Gross Pathology
No Macroscopic Abnormality Observed : LIVER, KIDNEYS, LUNGS, HEART, SKELETAL MUSCLE, SPLEEN,
AORTA, BRAIN, SPINAL CORD, STOMACH, DUODENUM, JEJUNUM, ILEUM, PANCREAS, CECUM, COLON, RECTUM, MESENTERIC LYMPH NODE, SALIVARY GLANDS, MANDIBULAR LYMPH NODE, THYMUS, ADRENAL GLANDS, SCIATIC NERVE, PITUITARY GLAND, THYROID GLAND, PARATHYROID GLANDS, TRACHEA, ESOPHAGUS, PHARYNX/LARYNX, EYE(S) WITH OPTIC NERVE, SKIN, MAMMARY
- -GLAND (FEMALE), OVARIES, UTERUS, URINARY BLADDER,
FEMUR/KMEE JOINT, STERNUM, NOSE
Histopathology :
THYROID GLAND :
ALTERATION, COLLOID, minimal.
643380
Terminal Sacrifice Killed on Day : 93
Exposure Group : 90-DAY EXPOSURE
Animal is signed off from necropsy
Gross Pathology :
643380
No Macroscopic Abnormality Observed : LIVER, KIDNEYS, LUNGS, HEART, SKELETAL MUSCLE, SPLEEN,
AORTA, BRAIN, SPINAL CORD, STOMACH, DUODENUM, JEJUNUM, ILEUM, PANCREAS, CECUM, COLON, RECTUM, MESENTERIC LYMPH NODE, SALIVARY GLANDS, MANDIBULAR LYMPH NODE, THYMUS,
ADRENAL GLANDS, SCIATIC NERVE, PITUITARY GLAND,
Continued on the next page ....
1004
Company Sanitized. Does not con
H-24516: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproduction Evaluations
INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS
Dose Group : IV - 25 mg/kg/day Sex: Females
Animal Ref
Microscopic & Macroscopic Findings
643380
Continued from previous page
Gross Pathology :
No Macroscopic Abnormality Observed :
THYROID GLAND, PARATHYROID GLANDS, TRACHEA, ESOPHAGUS,
PHARYNX/LARYNX, EYE(S) WITH OPTIC NERVE, SKIN, MAMMARY GLAND (FEMALE), OVARIES, UTERUS, URINARY BLADDER, FEMUR/KNEE JOINT, STERNUM, NOSE, MANDIBLE
Histopathology :
LIVER : -INFLAMMATION, SUBACUTE/CHRONIC,
THYROID GLAND :
ALTERATION, COLLOID, minimal.
minimal.
No Microscopic Abnormality Observed :
KIDNEYS, NOSE, MANDIBLE
643389
Terminal Sacrifice Killed on Day : 93
Exposure Group : 90-DAY EXPOSURE
Animal is signed off from necropsy
Gross Pathology :
643389
No Macroscopic Abnormality Observed : LIVER, KIDNEYS, LUNGS, HEART, SKELETAL MUSCLE, SPLEEN,
AORTA, BRAIN, SPINAL CORD, STOMACH, DUODENUM, JEJUNUM, ILEUM, PANCREAS, CECUM, COLON, RECTUM, MESENTERIC LYMPH NODE, SALIVARY GLANDS, MANDIBULAR LYMPH NODE, THYMUS,
ADRENAL GLANDS, SCIATIC NERVE, PITUITARY GLAND,
Continued on the next page ....
^
"Ml contai
H-24516: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproduction Evaluations
INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS
Dose Group : IV - 25 mg/kg/day Sex; Females
Animal Ref
Microscopic & Macroscopic Findings
643389 .
Continued from previous page
Gross Pathology
No Macroscopic Abnormality Observed :
THYROID GLAND, PARATHYROID GLANDS, TRACHEA, ESOPHAGUS,
PHARYNX/LARYNX, EYE(S) WITH OPTIC NERVE, SKIN. MAMMARY GLAND (FEMALE), OVARIES, UTERUS, URINARY BLADDER,
FEMUR/KNEE JOINT, STERNUM, NOSE, MANDIBLE
Histopathology :
LIVER : INFLAMMATION, SUBACUTE/CHRONIC, minimal.
. THYROID GLAMD :
.ALTERATION, COLLOID, minimal.
NOSE :
INFLAMMATION, SUBACUTE/CHRONIC, mild.
FRACTURE/CALLUS, TOOTH.
No Microscopic Abnormality Observed :
KIDNEYS, MANDIBLE
643390
Terminal Sacrifice Killed on Day : 93
Exposure Group : 90-DAY EXPOSURE
Animal is signed off from necropsy
Gross Pathology :
643390
No Macroscopic Abnormality Observed :
LIVER, KIDNEYS, LUNGS, HEART, SKELETAL MUSCLE, SPLEEN, AORTA, BRAIN, SPINAL CORD, STOMACH, DUODENUM, JEJUNUM, ILEUM, PANCREAS, CECUM, COLON, RECTUM, MESENTERIC LYMPH NODE, SALIVARY GLANDS, MANDIBULAR LYMPH NODE, THYMUS, ADRENAL GLANDS, SCIATIC NERVE, PITUITARY GLAMD,
Continued on the next page ....
1006
t not contai
^
A
H-24516: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproduction Evaluations____
INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS
Dose Group : IV - 25 mg/kg/day Sex: Females
Animal Ref 643390
Microscopic & Macroscopic Findings Continued from previous page
Gross Pathology :
No Macroscopic Abnormality Observed :
THYROID GLAND, PARATHYROID GLANDS, TRACHEA, ESOPHAGUS,
PHARYNX/LARYNX, EYE(S) WITH OPTIC NERVE, SKIN, MAMMARY GLAND (FEMALE), OVARIES, UTERUS, URINARY BLADDER, FEMUR/KNEE JOINT, STERNUM, NOSE, MANDIBLE
Histopatholo9y :
LIVER : . -INFLAMMATION, SUBACUTE/CHRONIC, minimal.
No Microscopic Abnormality Observed :
KIDNEYS, THYROID GLAND, NOSE, MANDIBLE
643391
Terminal Sacrifice Killed on Day : 181
Exposure Group : THREE-MONTH RECOVERY
Animal is signed off from necropsy
Gross Pathology :
No Macroscopic Abnormality Observed : LIVER, KIDNEYS, LUNGS, HEART. SKELETAL MUSCLE, SPLEEN,
AORTA, BRAIN, SPINAL CORD, STOMACH, DUODENUM, JEJUNUM, ILEUM, PANCREAS, CECUM, COLON, RECTUM, MESENTERIC LYMPH NODE, SALIVARY GLANDS, MANDIBULAR LYMPH NODE, THYMUS, ADRENAL GLANDS, SCIATIC NERVE, PITUITARY GLAND,
643391 Continued on the next page ....
1007
'"otcon
H-24516: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproduction Evaluations____
INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS
Dose Group : IV - 25 mg/kg/day Sex: Females
Animal Ref
Microscopic & Macroscopic Findings
643391
Continued from previous page
Gross Pathology :
No Macroscopic Abnormality Observed :
THYROID GLAND, PARATHYROID GLANDS, TRACHEA, ESOPHAGUS,
PHARYNX/LARYNX, EYE(S) WITH OPTIC NERVE, SKIN, MAMMARY GLAND (FEMALE), OVARIES,.UTERUS, URINARY BLADDER, FEMUR/KNEE JOINT, STERNUM, NOSE
Histopathology :
THYROID GLAND :
-ALTERATION, COLLOID, minimal.
643396
Terminal Sacrifice Killed on Day : 93
Exposure Group : 90-DAY EXPOSURE
Animal is signed off from necropsy
Gross Pathology :
643396
No Macroscopic Abnormality Observed : LIVER, KIDNEYS, LUNGS, HEART, SKELETAL MUSCLE, SPLEEN,
AORTA, BRAIN, SPINAL CORD, STOMACH, DUODENUM, JEJUNUM, ILEUM, PANCREAS, CECUM, COLON, RECTUM, MESENTERIC LYMPH NODE, SALIVARY GLANDS, MANDIBULAR LYMPH NODE, THYMUS, ADRENAL GLANDS, SCIATIC NERVE, PITUITARY GLAND,
THYROID GLAND, PARATHYROID GLANDS, TRACHEA, ESOPHAGUS, PHARYNX/LARYNX, EYE(S) WITH OPTIC NERVE, SKIN, MAMMARY GLAND (FEMALE). OVARIES, UTERUS, URINARY BLADDER, FEMUR/KNEE JOINT, STERNUM, NOSE, MANDIBLE
Continued on the next page ....
1008
euvwswwwi'^"^<M,r
H-24516: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproduction Evaluations
INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS
Dose Group : IV - 25 nig/kg/day Sex: Females
Animal Ref
Microscopic & Macroscopic Findings
643396
. .
Continued from previous page
Histopathology :
LIVER : INFLAMMATION, SUBACUTE/CHRONIC, minimal.
KIDNEYS :
NEPHROPATHY, CHRONIC PROGRESSIVE, minimal.
No Microscopic Abnormality Observed :
THYROID GLAND, NOSE, MANDIBLE
643410
Terminal Sacrifice Killed on Day : 93
- "Exposure Group : 90-DAY EXPOSURE
Animal is signed off from necropsy
Gross Pathology :
No Macroscopic Abnormality Observed : LIVER, KIDNEYS, LUNGS, HEART, SKELETAL MUSCLE, SPLEEN,
AORTA, BRAIN, SPINAL CORD, STOMACH, DUODENUM, JEJUNUM, ILEUM, PANCREAS, CECUM, COLON, RECTUM, MESENTERIC LYMPH NODE, SALIVARY GLANDS, MANDIBULAR LYMPH NODE, THYMUS, ADRENAL GLANDS, SCIATIC NERVE, PITUITARY GLAND, . THYROID GLAND, PARATHYROID GLANDS, TRACHEA, ESOPHAGUS,
PHARYNX/LARYNX. EYE(S) WITH OPTIC NERVE, SKIN, MAMMARY
GLAND (FEMALE), OVARIES, UTERUS, URINARY BLADDER,
FEMUR/KNEE JOINT, STERNUM, NOSE, MANDIBLE
643410 Continued on the next page
1009
"ot con
H-24516: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproduction Evaluations
INDIVIDUAL ANIMAL GROSS AMD MICROSCOPIC OBSERVATIONS
Dose Group : IV - 25 mg/kg/day Sex: Females
Animal Ref
Microscopic & Macroscopic Findings
643410
Continued from previous page
Histopathology :
LIVER : INFLAMMATION, SUBACUTE/CHRONIC,
THYROID GLAND :
ALTERATION, COLLOID, minimal.
minimal.
No Microscopic Abnormality Observed :
KIDNEYS, NOSE, MANDIBLE
643433
Terminal Sacrifice Killed on Day : 93
"Exposure Group : 90-DAY EXPOSURE
Animal is signed off from necropsy
Gross Pathology :
No Macroscopic Abnormality Observed : LIVER, KIDNEYS, LUNGS, HEART, SKELETAL MUSCLE, SPLEEN,
AORTA, BRAIN, SPINAL CORD, STOMACH, DUODENUM, JEJUNUM, ILEUM, PANCREAS, CECUM, COLON, RECTUM, MESENTERIC LYMPH NODE, SALIVARY GLANDS, MANDIBULAR LYMPH NODE, THYMUS, ADRENAL GLANDS, SCIATIC NERVE, PITUITARY GLAND, THYROID GLAND, PARATHYROID GLANDS, TRACHEA, ESOPHAGUS, PHARYNX/LARYNX, EYE(S) WITH OPTIC NERVE, SKIN, MAMMARY
GLAND (FEMALE), OVARIES, UTERUS, URINARY BLADDER,
FEMUR/KNEE JOINT, STERNUM, NOSE, MANDIBLE
643433 Continued on the next page ....
1010
Company SanRfzed. Does not
1
H-24516: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproduction Evaluations___
INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS
Dose Group : IV - 25 nig/kg/day Sex: Females
Animal Ref
Microscopic & Macroscopic Findings
643433
Continued from previous page
Histopathology :
LIVER : INFLAMMATION, SUBACUTE/CHRONIC,
THYROID GLAND :
ALTERATION, COLLOID, minimal.
minimal.
No Microscopic Abnormality Observed :
KIDNEYS, NOSE, MANDIBLE
643437
Terminal Sacrifice -Killed on Day : 181
" Exposure Group : THREE-MONTH RECOVERY
Animal is signed off from necropsy
Gross Pathology :
No Macroscopic Abnormality Observed : LIVER, KIDNEYS, LUNGS, HEART, SKELETAL MUSCLE, SPLEEN,
AORTA, BRAIN, SPINAL CORD, STOMACH, DUODENUM, JEJUNUM, ILEUM, PANCREAS, CECUM, COLON, RECTUM, MESENTERIC LYMPH NODE, SALIVARY GLANDS, MANDIBULAR LYMPH NODE, THYMUS, ADRENAL GLANDS, SCIATIC NERVE, PITUITARY GLAND,
THYROID GLAND, PARATHYROID GLANDS, TRACHEA, ESOPHAGUS,
PHARYNX/LARYNX, EYE(S) WITH OPTIC NERVE, SKIN, MAMMARY GLAND (FEMALE), OVARIES, UTERUS, URINARY BLADDER,
FEMUR/KNEE JOINT, STERNUM, NOSE
643437 Continued on the next page ....
1011
Company SanRlzed. Does not co
H-24516: Subchronic Toxicity
'
90-Day Gavage Study in Rats with One-Generation Reproduction Evaluations___
INDIVIDUAL ANIMAL GROSS AMD MICROSCOPIC OBSERVATIONS
Dose Group : IV - 25 mg/kg/day Sex: Females
Animal Ref 643437
Microscopic & Macroscopic Findings Continued from previous page
Histopathology :
THYROID GLAND :
ALTERATION, COLLOID, minimal.
643458
Terminal Sacrifice Killed on Day : 93
Exposure Group : 90-DAY EXPOSURE
Animal is si9ned off from necropsy
Gross Pathology :
No Macroscopic Abnormality Observed : LIVER, KIDNEYS, LUNGS. HEART, SKELETAL MUSCLE, SPLEEN,
AORTA. BRAIN, SPINAL CORD, STOMACH, DUODENUM, JEJUNUM, ILEUM, PANCREAS, CECUM, COLON, RECTUM, MESENTERIC LYMPH NODE, SALIVARY GLANDS, MANDIBULAR LYMPH NODE, THYMUS, ADRENAL GLANDS, SCIATIC NERVE, PITUITARY GLAMD,
THYROID GLAND, PARATHYROID GLANDS, TRACHEA, ESOPHAGUS,
PHARYNX/LARYNX, EYE(S) WITH OPTIC NERVE, SKIN, MAMMARY GLAMD (FEMALE), OVARIES, UTERUS, URINARY BLADDER,
FEMUR/KNEE JOINT, STERNUM, NOSE, MANDIBLE
Histopathology :
643458
LIVER : INFLAMMATION, SUBACUTE/CHRONIC, minimal. FATTY CHANGE, MEDIAN CLEFT, minimal.
THYROID GLAMD :
ALTERATION, COLLOID, minimal.
Continued on the next page ....
1012
Company Sanitized. Does not co
H-24516: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproduction Evaluations
INDIVIDUAL ANIMAL GROSS AMD MICROSCOPIC OBSERVATIONS
Dose Group : IV - 25 nig/kg/day Sex: Females
Animal Ref
643458
Microscopic & Macroscopic Findings Continued from previous page
Histopathology :
No Microscopic Abnormality Observed :
KIDNEYS, NOSE, MANDIBLE
643483
Terminal Sacrifice Killed on Day : 181
Exposure Group : THREE-MONTH RECOVERY
Animal is signed off from necropsy
Gross Pathology :
No Macroscopic Abnormality Observed : LIVER, KIDNEYS, LUNGS, HEART, SKELETAL MUSCLE, SPLEEN,
AORTA, BRAIN. SPINAL CORD, STOMACH, DUODENUM. JEJUNUM, ILEUM, PANCREAS, CECUM, COLON, RECTUM, MESENTERIC LYMPH NODE, SALIVARY GLANDS, MANDIBULAR LYMPH NODE, THYMUS, ADRENAL GLANDS, SCIATIC NERVE, PITUITARY GLAND,
THYROID GLAMD, PARATHYROID GLANDS, TRACHEA, ESOPHAGUS,
PHARYNX/LARYNX, EYE(S) WITH OPTIC NERVE, SKIN, MAMMARY GLAND (FEMALE), OVARIES, UTERUS. URINARY BLADDER, FEMUR/KNEE JOINT, STERNUM, NOSE
Histopathology :
THYROID GLAND :
ALTERATION, COLLOID, moderate.
1013
Company Sanitized. Does no
^
n
H-24516: Subchronic Toxicity
90-Day Gavage Study in Rats with One-Generation Reproduction Evaluations___
INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS
Dose Group : VI -
Animal Ref 643322
100 mg/kg/day Sex: Females Microscopic & Macroscopic Findings
Terminal Sacrifice Killed on Day : 93
Exposure Group : 90-DAY EXPOSURE
Animal is signed off from necropsy
Gross Pathology :
No Macroscopic Abnormality Observed : LIVER, KIDNEYS, LUNGS, HEART, SKELETAL MUSCLE, SPLEEN,
AORTA, BRAIN, SPINAL CORD, STOMACH, DUODENUM, JEJUNUM, ILEUM, PANCREAS, CECUM, COLON, RECTUM, MESENTERIC LYMPH NODE, SALIVARY GLANDS, MANDIBULAR LYMPH NODE, THYMUS, ADRENAL GLANDS, SCIATIC NERVE, PITUITARY GLAND,
-.THYROID GLAND, PARATHYROID GLANDS, TRACHEA, ESOPHAGUS, PHARYNX/LARYNX, EYE(S) WITH OPTIC NERVE, SKIN, MAMMARY GLAND (FEMALE), OVARIES, UTERUS. URINARY BLADDER, FEMUR/KNEE JOINT, STERNUM, NOSE, MANDIBLE
Histopathology :
NOSE :
DEGENERATION, AMELOBLASTS, minimal.
No Microscopic Abnormality Observed : LIVER, KIDNEYS, THYROID GLAND, MANDIBLE
1014
Company Sanitized. Does no
e
H-24516: Subchronic Toxicity
90-Day Gavage Study in Rats with One-Generation Reproduction Evaluations___
INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS
Dose Group : VI - 100 mg/kg/day Sex; Females
Animal Ref
Microscopic & Macroscopic Findings
643323
Terminal Sacrifice Killed on Day : 93
Exposure Group : 90-DAY EXPOSURE
Animal is signed off from necropsy
Gross Pathology :
No Macroscopic Abnormality Observed : LIVER, KIDNEYS, LUNGS, HEART, SKELETAL MUSCLE, SPLEEN,
AORTA, BRAIN, SPINAL CORD, STOMACH, DUODENUM, JEJUNUM, ILEUM, PANCREAS, CECUM, COLON, RECTUM, MESENTERIC LYMPH NODE, SALIVARY GLANDS, MANDIBULAR LYMPH NODE, THYMUS, ADRENAL GLANDS, SCIATIC NERVE, PITUITARY GLAMD,
-THYROID GLAND, PARATHYROID GLANDS, TRACHEA, ESOPHAGUS,
PHARYMX/LARYNX, EYE(S) WITH OPTIC NERVE, SKIN, MAMMARY GLAND (FEMALE), OVARIES, UTERUS, URINARY BLADDER, FEMUR/KNEE JOINT, STERNUM, NOSE, MANDIBLE
Histopathology :
LIVER : INFLAMMATION, SUBACUTE/CHRONIC, minimal.
KIDNEYS :
NEPHROPATHY, CHRONIC PROGRESSIVE, minimal.
No Microscopic Abnormality Observed :
THYROID GLAND, NOSE, MANDIBLE
1015
Company Sanitized. Doe not co
H-24516: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproduction Evaluations
INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS
Dose Group : VI - 100 mg/kg/day Sex: Females
Animal Ref
Microscopic & Macroscopic Findings
643360
Terminal Sacrifice Killed on Day : 181
Exposure Group : THREE-MONTH RECOVERY
Animal is signed off from necropsy
Gross Pathology :
No Macroscopic Abnormality Observed :
LIVER, KIDNEYS, LUNGS, HEART, SKELETAL MUSCLE, SPLEEN, AORTA, BRAIN, SPINAL CORD, STOMACH, DUODENUM, JEJUNUM, ILEUM, PANCREAS, CECUM, COLON, RECTUM, MESENTERIC LYMPH NODE, SALIVARY GLANDS, MANDIBULAR LYMPH NODE, THYMUS,
ADRENAL GLANDS, SCIATIC NERVE, PITUITARY GLAND,
.THYROID GLAND, PARATHYROID GLANDS, TRACHEA, ESOPHAGUS, PHARYNX/LARYNX, EYE(S) WITH OPTIC NERVE, SKIN, MAMMARY GLAND (FEMALE), OVARIES, UTERUS, URINARY BLADDER,
FEMUR/KNEE JOINT, STERNUM, NOSE
Histopathology :
THYROID GLAND :
ALTERATION, COLLOID, minimal.
NOSE :
INFLAMMATION, SUBACUTE/CHRONIC, minimal.
HYPERPLASIA/SQUAMOUS METAPLASIA, TRANSITIONAL
CELL,
mild.
1016
company sanlHzed- 0<x "ot con
0
H
H-24516: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproduction Evaluations
INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS
Dose Group : VI - 100 mg/kg/day Sex: Females
Animal Ref
Microscopic & Macroscopic Findings
643366
Terminal Sacrifice Killed on Day : 93
Exposure Group : 90-DAY EXPOSURE
Animal is signed off from necropsy
Gross Pathology :
No Macroscopic Abnormality Observed : LIVER, KIDNEYS, LUNGS, HEART, SKELETAL MUSCLE, SPLEEN,
AORTA, BRAIN, SPINAL CORD, STOMACH, DUODENUM, JEJUNUM,
ILEUM, PANCREAS, CECUM, COLON, RECTUM, MESENTERIC LYMPH NODE, SALIVARY GLANDS, MANDIBULAR LYMPH NODE, THYMUS,
ADRENAL GLANDS. SCIATIC NERVE, PITUITARY GLAND,
- .THYROID GLAND, PARATHYROID GLANDS, TRACHEA, ESOPHAGUS, PHARYNX/LARYNX, EYE(S) WITH OPTIC NERVE, SKIN, MAMMARY
GLAND (FEMALE), OVARIES, UTERUS, URINARY BLADDER,
FEMUR/KNEE JOINT, STERNUM, NOSE, MANDIBLE
Histopathology :
LIVER : INFLAMMATION, SUBACUTE/CHRONIC, minimal.
THYROID GLAND :
ALTERATION, COLLOID, moderate.
NOSE :
DEGENERATION, AMELOBLASTS, minimal.
No Microscopic Abnormality Observed :
KIDNEYS, MANDIBLE
1017
Company Sanitized. Does not conta
I
H-24516: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproduction Evaluations___
INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS
Dose Group : VI - 100 mg/kg/day Sex: Females
Animal Ref
Microscopic & Macroscopic Findings
643367
Terminal Sacrifice Killed on Day : 93
Exposure Group : 90-DAY EXPOSURE
Animal is signed off from necropsy
Gross Pathology :
No Macroscopic Abnormality Observed : LIVER, KIDNEYS, LUNGS, HEART, SKELETAL MUSCLE, SPLEEN,
AORTA, BRAIN, SPINAL CORD, STOMACH, DUODENUM, JEJUNUM, ILEUM, PANCREAS, CECUM, COLON, RECTUM, MESENTERIC LYMPH NODE, SALIVARY GLANDS, MANDIBULAR LYMPH NODE, THYMUS,
ADRENAL GLANDS, SCIATIC NERVE, PITUITARY GLAND,
.THYROID GLAND, PARATHYROID GLANDS, TRACHEA, ESOPHAGUS, " PHARYNX/LARYNX, EYE(S) WITH OPTIC NERVE, SKIN, MAMMARY
GLAND (FEMALE), OVARIES, UTERUS, URINARY BLADDER,
FEMUR/KNEE JOINT, STERNUM, NOSE, MANDIBLE
Histopathology :
LIVER : INFLAMMATION,
NOSE :
DEGENERATION,
SUBACUTE/CHRONIC, minimal. AMELOBLASTS, minimal.
No Microscopic Abnormality Observed :
KIDNEYS, THYROID GLAND, MANDIBLE
1018
Company Sanitized. Does not con
H
H-24516: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproduction Evaluations
INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS
Dose Group : VI - 100 mg/kg/day Sex: Females
Animal Ref
Microscopic & Macroscopic Findings
643373
Terminal Sacrifice Killed on Day : 181
Exposure Group : THREE-MONTH RECOVERY
Animal is signed off from necropsy
Gross Pathology :
No Macroscopic Abnormality Observed : LIVER, KIDNEYS, LUNGS, HEART. SKELETAL MUSCLE, SPLEEN,
AORTA, BRAIN, SPINAL CORD, STOMACH, DUODENUM, JEJUNUM, ILEUM, PANCREAS, CECUM, COLON. RECTUM, MESENTERIC LYMPH NODE, SALIVARY GLANDS, MANDIBULAR LYMPH NODE, THYMUS, ADRENAL GLANDS, SCIATIC NERVE, PITUITARY GLAND,
THYROID GLAND, PARATHYROID GLANDS, TRACHEA, ESOPHAGUS,
"PHARYNX/LARYNX, EYE(S) WITH OPTIC NERVE, SKIN, MAMMARY GLAND (FEMALE), OVARIES, UTERUS, URINARY BLADDER, FEMUR/KNEE JOINT, STERNUM, NOSE
Histopathology :
THYROID GLAND :
ALTERATION, COLLOID, mild.
No Microscopic Abnormality Observed :
NOSE
1019
Company Sanitized. Does not co
H-24516: Subchronic Toxicity
^^ 90-Day Gavage Study in Rats with One-Generation Reproduction Evaluations
INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC
OBSERVATIONS
Dose Group : VI - 100 mg/kg/day Sex: Females
Animal Ref 643381
Microscopic & Macroscopic Findings Terminal Sacrifice
Killed on Day : 181
Exposure Group : THREE-MONTH RECOVERY
Animal is signed off from necropsy
Gross Pathology :
No Macroscopic Abnormality Observed : LIVER, KIDNEYS, LUNGS, HEART, SKELETAL MUSCLE, SPLEEN,
AORTA, BRAIN, SPINAL CORD, STOMACH, DUODENUM, JEJUNUM, ILEUM, PANCREAS, CECUM, COLON, RECTUM, MESENTERIC LYMPH NODE, SALIVARY GLANDS, MANDIBULAR LYMPH NODE, THYMUS,
ADRENAL GLANDS, SCIATIC NERVE, PITUITARY GLAND, THYROID GLAND, PARATHYROID GLANDS, TRACHEA, ESOPHAGUS,
" "PHARYNX/LARYNX, EYE(S) WITH OPTIC NERVE, SKIN, MAMMARY GLAND (FEMALE), OVARIES, UTERUS, URINARY BLADDER,
FEMUR/KNEE JOINT, STERNUM, NOSE
Histopathology :
THYROID GLAND :
ALTERATION, COLLOID, minimal.
NOSE :
INFLAMMATION, SUBACUTE/CHRONIC, minimal. HYPERPLASIA/SQUAMOUS METAPLASIA, TRANSITIONAL
minimal.
CELL,
1020
Company Sanitized. Does not contain T
^
^
H-24516: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproduction Evaluations
^^
INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC
OBSERVATIONS
Dose Group : VI - 100 mg/kg/day Sex: Females
Animal Ref
Microscopic & Macroscopic Findings
643382
Terminal Sacrifice Killed on Day : 181
Exposure Group : THREE-MONTH RECOVERY
Animal is signed off from necropsy
Gross Pathology ;
No Macroscopic Abnormality Observed : LIVER, KIDNEYS, LUNGS, HEART, SKELETAL MUSCLE, SPLEEN,
AORTA, BRAIN, SPINAL CORD, STOMACH, DUODENUM, JEJUNUM,
ILEUM, PANCREAS, CECUM, COLON, RECTUM, MESENTERIC LYMPH NODE, SALIVARY GLANDS, MANDIBULAR LYMPH NODE, THYMUS,
ADRENAL GLANDS, SCIATIC NERVE, PITUITARY GLAND,
.THYROID GLAMD, PARATHYROID GLANDS. TRACHEA, ESOPHAGUS,
PHARYNX/LARYNX, EYE(S) WITH OPTIC NERVE, SKIN, MAMMARY GLAND (FEMALE), OVARIES, UTERUS, URINARY BLADDER, FEMUR/KNEE JOINT, STERNUM, NOSE
Histopathology : No Microscopic Abnormality Observed :
THYROID GLAND, NOSE
643392
Terminal Sacrifice Killed on Day : 93
Exposure Group : 90-DAY EXPOSURE
Animal is signed off from necropsy
Gross Pathology :
643392
LUNGS : DISCOLORATION,
Continued on the next page
DARK.
....
1021
Company SanMzed. Does not contai
1
H-24516: Subchronic Toxicity
90-Day Gavage Study in Rats with One-Generation Reproduction Evaluations___
INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS
Dose Group : VI - 100 mg/kg/day Sex: Females
Animal Ref
Microscopic & Macroscopic Findings
643392
Continued from previous page
Gross Pathology :
No Macroscopic Abnormality Observed : LIVER, KIDNEYS, HEART, SKELETAL MUSCLE, SPLEEN, AORTA,
BRAIN, SPINAL CORD, STOMACH, DUODENUM, JEJUNUM, ILEUM, PANCREAS, CECUM, COLON, RECTUM, MESENTERIC LYMPH NODE,
SALIVARY GLANDS, MANDIBULAR LYMPH NODE, THYMUS, ADRENAL GLANDS, SCIATIC NERVE, PITUITARY GLAND, THYROID GLAND,
PARATHYROID GLANDS, TRACHEA, ESOPHAGUS, PHARYNX/LARYNX,
EYE(S) WITH OPTIC NERVE, SKIN, MAMMARY GLAND (FEMALE), OVARIES, UTERUS, URINARY BLADDER, FEMUR/KNEE JOINT, . .STERNUM, NOSE, MANDIBLE
Histopathology :
LIVER :
INFLAMMATION, SUBACUTE/CHRONIC. minimal.
KIDNEYS :
NEPHROPATHY, CHRONIC PROGRESSIVE, minimal.
No Microscopic Abnormality Observed :
LUNGS, THYROID GLAND, NOSE, MANDIBLE
1022
Company SanHteed. Does not conta
^
H-24516: Subchronic 90-Day Gavage Study
Toxicity in Rats with
One-Generation Reproduction Evaluations
^^
INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC
OBSERVATIONS
Dose Group : VI - 100 mg/kg/day Sex: Females
Animal Ref 643409
Microscopic & Macroscopic Findings
Terminal Sacrifice Killed on Day : 93
Exposure Group : 90-DAY EXPOSURE
Animal is signed off from necropsy
Gross Pathology :
No Macroscopic Abnormality Observed : LIVER, KIDNEYS, LUNGS, HEART, SKELETAL MUSCLE, SPLEEN,
AORTA, BRAIN, SPINAL CORD, STOMACH, DUODENUM, JEJUNUM, ILEUM, PANCREAS, CECUM, COLON, RECTUM, MESENTERIC LYMPH NODE, SALIVARY GLANDS, MANDIBULAR LYMPH NODE, THYMUS,
ADRENAL GLANDS, SCIATIC NERVE, PITUITARY GLAND,
.THYROID GLAND, PARATHYROID GLANDS, TRACHEA, ESOPHAGUS, - PHARYNX/LARYNX, EYE(S) WITH OPTIC NERVE, SKIN, MAMMARY
GLAND (FEMALE), OVARIES, UTERUS, URINARY BLADDER, FEMUR/KNEE JOINT, STERNUM, NOSE, MANDIBLE
Histopathology :
LIVER : INFLAMMATION,
NOSE :
DEGENERATION,
SUBACUTE/CHRONIC, minimal. AMELOBLASTS, minimal.
No Microscopic Abnormality Observed :
KIDNEYS, THYROID GLAND, MANDIBLE
1023
Company Sanitized. Does not conta
H-24516: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproduction Evaluations
INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS
Dose Group : VI - 100 mg/kg/day Sex: Females
Animal Ref
Microscopic & Macroscopic Findings
643412
Terminal Sacrifice Killed on Day : 181
Exposure Group : THREE-MONTH RECOVERY
Animal is signed off from necropsy
Gross Pathology :
No Macroscopic Abnormality Observed : LIVER, KIDNEYS, LUNGS, HEART, SKELETAL MUSCLE, SPLEEN,
AORTA, BRAIN, SPINAL CORD, STOMACH, DUODENUM, JEJUNUM, ILEUM, PANCREAS, CECUM, COLON, RECTUM, MESENTERIC LYMPH NODE. SALIVARY GLANDS, MANDIBULAR LYMPH NODE, THYMUS,
ADRENAL GLANDS, SCIATIC NERVE, PITUITARY GLAND,
. THYROID GLAND, PARATHYROID GLANDS, TRACHEA, ESOPHAGUS, "PHARYNX/LARYNX, EYE(S) WITH OPTIC NERVE, SKIN, MAMMARY GLAND (FEMALE), OVARIES, UTERUS, URINARY BLADDER,
FEMUR/KNEE JOINT, STERNUM, NOSE
Histopathology :
THYROID GLAND :
ALTERATION, COLLOID, minimal.
No Microscopic Abnormality Observed :
NOSE
1024
Company Sanitized. Does not conta
^
^,
H-24516: Subchronic Toxicity
90-Day Gavage Study in Rats with One-Generation Reproduction Evaluations____
INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS
Dose Group : VI - 100 nig/kg/day Sex: Females
Animal Ref
Microscopic & Macroscopic Findings
643461
Terminal Sacrifice Killed on Day : 93
Exposure Group : 90-DAY EXPOSURE
Animal is signed off from necropsy
Gross Pathology :
No Macroscopic Abnormality Observed : LIVER, KIDNEYS, LUNGS, HEART, SKELETAL MUSCLE, SPLEEN,
AORTA, BRAIN, SPINAL CORD, STOMACH, DUODENUM, JEJUNUM, ILEUM, PANCREAS, CECUM, COLON, RECTUM, MESENTERIC LYMPH NODE, SALIVARY GLANDS, MANDIBULAR LYMPH NODE, THYMUS,
ADRENAL GLANDS, SCIATIC NERVE, PITUITARY GLAND,
.THYROID GLAND, PARATHYROID GLANDS, TRACHEA, ESOPHAGUS,
PHARYNX/LARYNX, EYE(S) WITH OPTIC NERVE, SKIN, MAMMARY GLAND (FEMALE), OVARIES, UTERUS, URINARY BLADDER,
FEMUR/KNEE JOINT, STERNUM, NOSE
Histopathology :
LIVER : INFLAMMATION, SUBACUTE/CHRONIC, minimal.
THYROID GLAND :
ALTERATION, COLLOID, minimal.
NOSE :
DEGENERATION, AMELOBLASTS, minimal.
No Microscopic Abnormality Observed :
KIDNEYS, MANDIBLE
1025
Company Sanitized. Does not conte!n T
'
H-24516: Subchronic ToKicity 90-Day Gavage Study in Rats with One-Generation Reproduction Evaluations
INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS
Dose Group : VI - 100 ing/kg/day Sex: Females
Animal Ref
Microscopic & Macroscopic Findings
643462
Terminal Sacrifice Killed on Day : 93
Exposure Group : 90-DAY EXPOSURE
Animal is signed off from necropsy
Gross Pathology :
No Macroscopic Abnormality Observed : LIVER, KIDNEYS, LUNGS, HEART, SKELETAL MUSCLE, SPLEEN,
AORTA. BRAIN, SPINAL CORD, STOMACH, DUODENUM, JEJUNUM, ILEUM, PANCREAS, CECUM, COLON, RECTUM, MESENTERIC LYMPH NODE, SALIVARY GLANDS, MANDIBULAR LYMPH NODE, THYMUS, ADRENAL GLANDS, SCIATIC NERVE, PITUITARY GLAND,
THYROID GLAND, PARATHYROID GLANDS, TRACHEA, ESOPHAGUS,
PHARYNX/LARYNX, EYE(S) WITH OPTIC NERVE, SKIN, MAMMARY
"
"GLAND (FEMALE), OVARIES, UTERUS, URINARY BLADDER,
FEMUR/KNEE JOINT, STERNUM, NOSE, MANDIBLE
Histopathology :
LIVER : INFLAMMATION, SUBACUTE/CHRONIC,.minimal.
THYROID GLAND :
ALTERATION, COLLOID, minimal.
No Microscopic Abnormality Observed :
KIDNEYS, NOSE, MANDIBLE
1026
Company Sanitized. Does not contain
H-24516: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproduction Evaluations
INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS
Dose Group : VI - 100 mg/kg/day Sex: Females
Animal Ref
Microscopic & Macroscopic Findings
643472
Terminal Sacrifice Killed on Day : 93
Exposure Group : 90-DAY EXPOSURE
Animal is signed off from necropsy
Gross Pathology :
No Macroscopic Abnormality Observed : LIVER, KIDNEYS, LUNGS, HEART, SKELETAL MUSCLE, SPLEEN,
AORTA, BRAIN, SPINAL CORD, STOMACH, DUODENUM, JEJUNUM,
ILEUM, PANCREAS, CECUM, COLON, RECTUM, MESENTERIC LYMPH NODE, SALIVARY GLANDS, MANDIBULAR LYMPH NODE, THYMUS, ADRENAL GLANDS, SCIATIC MERVE, PITUITARY GLAND,
THYROID GLAND, PARATHYROID GLANDS, TRACHEA, ESOPHAGUS, " PHARYNX/LARYNX, EYE(S) WITH OPTIC NERVE, SKIN, MAMMARY
GLAND (FEMALE), OVARIES, UTERUS, URINARY BLADDER. FEMUR/KNEE JOINT, STERNUM, NOSE, MANDIBLE
Histopathology :
LIVER : INFLAMMATION,
NOSE :
DEGENERATION,
SUBACUTE/CHRONIC, minimal. AMELOBLASTS, minimal.
No Microscopic Abnormality Observed :
KIDNEYS, THYROID GLAND, MANDIBLE
1027
H-24516: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproduction Evaluations
INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS
Dose Group : VI - 100 mg/kg/day Sex: Females
Animal Ref
Microscopic & Macroscopic Findings
643489
Terminal Sacrifice Killed on Day : 93
Exposure Group : 90-DAY EXPOSURE
Animal is signed off from necropsy
Gross Pathology :
No Macroscopic Abnormality Observed : LIVER, KIDNEYS, LUNGS, HEART, SKELETAL MUSCLE, SPLEEN, AORTA, BRAIN,.SPINAL CORD, STOMACH, DUODENUM, JEJUNUM,
ILEUM, PANCREAS, CECUM, COLON, RECTUM, MESENTERIC LYMPH NODE, SALIVARY GLANDS, MANDIBULAR LYMPH NODE, THYMUS,
ADRENAL GLANDS, SCIATIC NERVE, PITUITARY GLAND,
THYROID GLAND, PARATHYROID GLANDS, TRACHEA, ESOPHAGUS,
' PHARYNX/LARYNX, EYE(S) WITH OPTIC NERVE, SKIN, MAMMARY GLAND (FEMALE), OVARIES, UTERUS, URINARY BLADDER,
FEMUR/KNEE JOINT, STERNUM, NOSE, MANDIBLE
Histopathology :
LIVER : INFLAMMATION, SUBACUTE/CHRONIC, minimal.
NECROSIS, FOCAL, minimal.
KIDNEYS :
NEPHROPATHY, CHRONIC PROGRESSIVE, minimal.
THYROID GLAND :
ALTERATION, COLLOID, minimal.
No Microscopic Abnormality Observed :
NOSE, MANDIBLE
1028
'CompanySanitized. Does not conta
^^ .
^
_
H-24516: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproduction Evaluations
INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS
Dose Group : VIII - 250 mg/kg/day Sex: Females
Animal Ref
Microscopic & Macroscopic Findings
643329
Terminal Sacrifice Killed on Day : 181
Exposure Group : THREE-MONTH RECOVERY
Animal is signed off from necropsy
Gross Pathology :
No Macroscopic Abnormality Observed : LIVER, KIDNEYS, LUNGS, HEART, SKELETAL MUSCLE, SPLEEN,
AORTA, BRAIN, SPINAL CORD, STOMACH, DUODENUM, JEJUNUM, ILEUM, PANCREAS, CECUM, COLON, RECTUM, MESENTERIC LYMPH NODE, SALIVARY GLANDS, MANDIBULAR LYMPH NODE, THYMUS,
ADRENAL GLANDS, SCIATIC NERVE, PITUITARY GLAND,
THYROID GLAND, PARATHYROID GLANDS, TRACHEA, ESOPHAGUS,
"
"PHARYNX/LARYNX, EYE(S) WITH OPTIC NERVE, SKIN, MAMMARY GLAND (FEMALE), OVARIES, UTERUS, URINARY BLADDER, FEMUR/KNEE JOINT, STERNUM, NOSE
Histopathology :
THYROID GLAND :
ALTERATION, COLLOID, mild.
NOSE :
DEGENERATION, AMELOBLASTS,
minimal.
1029
Company-SanBhed.Does not con
- H-24516: Subchronic Toxicity
90-Day Gavage Study in Rats with One-Generation Reproduction Evaluations
INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS
Dose Group : VIII - 250 mg/kg/day Sex: Females
Animal Ref
Microscopic & Macroscopic Findings
643332
.
Terminal Sacrifice
Killed on Day : 93
Exposure Group : 90-DAY EXPOSURE
Animal is signed off from necropsy
Gross Pathology :
No Macroscopic Abnormality Observed : LIVER, KIDNEYS, LUNGS, HEART, SKELETAL MUSCLE, SPLEEN,
AORTA, BRAIN, SPINAL CORD, STOMACH, DUODENUM, JEJUNUM, ILEUM, PANCREAS, CECUM, COLON, RECTUM, MESENTERIC LYMPH NODE, SALIVARY GLANDS, MANDIBULAR LYMPH NODE, THYMUS,
ADRENAL GLANDS, SCIATIC NERVE, PITUITARY GLAND,
THYROID GLAND, PARATHYROID GLANDS, TRACHEA, ESOPHAGUS,
- PHARYNX/LARYNX, EYE(S) WITH OPTIC NERVE, SKIN, MAMMARY GLAND (FEMALE), OVARIES, UTERUS, URINARY BLADDER,
FEMUR/KNEE JOINT, STERNUM, NOSE, MANDIBLE
Histopathology :
.
LIVER : HYPERTROPHY, HEPATOCYTE, CENTRILOBULAR,
THYROID GLAND :
ALTERATION, COLLOID, minimal.
UTERUS ;
DILATATION, LUMEN, mild.
NOSE :
DEGENERATION, AMELOBLASTS, mild.
MANDIBLE :
DEGENERATION, AMELOBLASTS, mild.
mild.
643332 Continued on the next page ....
1030
CompanySanfflared. Does not cont
H-24516: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproduction Evaluations
INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS
Dose Group : VIII - 250 mg/kg/day Sex: Females
Animal Ref
Microscopic & Macroscopic Findings
Animal Ref .
Microscopic & Macroscopic Findings
643332
Continued from previous page
Histopathology :
No Microscopic Abnormality Observed :
KIDNEYS, LUNGS, HEART, SKELETAL MUSCLE, SPLEEN, AORTA, BRAIN, SPINAL CORD, STOMACH, DUODENUM, JEJUNUM, ILEUM, PANCREAS, CECUM, COLON, RECTUM, MESENTERIC LYMPH MODE,
SALIVARY GLANDS, MANDIBULAR LYMPH NODE, THYMUS, ADRENAL GLAMDS, SCIATIC NERVE, PITUITARY GLAND, PARATHYROID GLANDS,
TRACHEA, ESOPHAGUS, PHARYNX/LARYNX,
EYE(S) WITH OPTIC NERVE, SKIN, MAMMARY GLAND (FEMALE),
"
OVARIES, URINARY BLADDER, FEMUR/KNEE JOINT, STERNUM, BONE
MARROW
643340
Found Dead
Duration of dosing-days: 69
Exposure Group : 90-DAY EXPOSURE
Animal is signed off from necropsy
Gross Pathology :
ADRENAL GLANDS :
LARGE, BILATERAL, moderate.
WHOLE BODY :
Autolysis: tissues taken, severe.
643340
No Macroscopic Abnormality Observed :
LIVER, KIDNEYS, LUNGS, HEART, SKELETAL MUSCLE, SPLEEN, AORTA, BRAIN, SPINAL CORD, STOMACH, DUODENUM, JEJUNUM, ILEUM, PANCREAS, CECUM, COLON, RECTUM, MESENTERIC LYMPH
NODE, SALIVARY GLANDS, MANDIBULAR LYMPH NODE, THYMUS,
SCIATIC NERVE, PITUITARY GLAND, THYROID GLAND,
Continued on the next page ....
^-
Does not
H-24516: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproduction Evaluations___
INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS
Dose Group : VIII - 250 mg/kg/day Sex: Females
Animal Ref
Microscopic & Macroscopic Findings
643340
Continued from previous page
Gross Pathology :
No Macroscopic Abnormality Observed :
PARATHYROID GLANDS, TRACHEA, ESOPHAGUS, PHARYNX/LARYNX, EYE(S) WITH OPTIC NERVE, SKIN, MAMMARY GLAND (FEMALE), OVARIES, UTERUS, URINARY BLADDER, FEMUR/KNEE JOINT, STERNUM, NOSE
Histopathology :
SPLEEN :
DEPLETION, LYMPHOID, mild.
JEJUNUM :
AUTOLYSIS: NECROPSY AND HISTOLOGY PERFORMED,
THYMUS :
ATROPHY, severe.
PARATHYROID GLANDS :
NOT PRESENT.
EYE(S) WITH OPTIC NERVE : AUTOLYSIS: NECROPSY AND HISTOLOGY PERFORMED,
NOSE :
INFLAMMATION, DEGENERATION, MANDIBLE :
SUBACUTE/CHRONIC, minimal. AMELOBLASTS, mild.
NOT PRESENT.
moderate. mild.
643340 Continued on the next page ....
1032
CompanySanitized. Does not
^
n
H-24516: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproduction Evaluations___
INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS
Dose Group : VIII - 250 mg/kg/day Sex: Females
Animal Ref
Microscopic & Macroscopic Findings
643340
Continued from previous page
Histopathology :
No Microscopic Abnormality Observed : LIVER, KIDNEYS, LUNGS, HEART, SKELETAL MUSCLE, AORTA,
BRAIN, SPINAL CORD, STOMACH, DUODENUM, JEJUNUM, ILEUM, PANCREAS, CECUM, COLON, RECTUM, MESENTERIC LYMPH NODE,
SALIVARY GLANDS, MANDIBULAR LYMPH NODE, ADRENAL GLANDS,
SCIATIC NERVE, PITUITARY GLAND, THYROID GLAND, TRACHEA, ESOPHAGUS, PHARYNX/LARYNX, . EYE(S) WITH OPTIC NERVE, SKIN, MAMMARY GLAND (FEMALE), OVARIES, UTERUS, URINARY BLADDER,
FEMUR/KNEE JOINT, STERNUM, BONE MARROW
643341
- "Terminal Sacrifice Killed on Day : 93
Exposure Group : 90-DAY EXPOSURE
Animal is signed off from necropsy
Gross Pathology :
No Macroscopic Abnormality Observed : LIVER, KIDNEYS, LUNGS, HEART, SKELETAL MUSCLE, SPLEEN,
AORTA, BRAIN, SPINAL CORD, STOMACH, DUODENUM, JEJUNUM, ILEUM, PANCREAS, CECUM, COLON, RECTUM, MESENTERIC LYMPH NODE, SALIVARY GLANDS, MANDIBULAR LYMPH NODE, THYMUS, ADRENAL GLANDS, SCIATIC NERVE, PITUITARY GLAND,
THYROID GLAND, PARATHYROID GLANDS, TRACHEA, ESOPHAGUS,
PHARYNX/LARYMX, EYE(S) WITH OPTIC NERVE, SKIN, MAMMARY GLAND (FEMALE), OVARIES, UTERUS, URINARY BLADDER,
FEMUR/KNEE JOINT, STERNUM, NOSE, MANDIBLE
643341 Continued on the next page ....
1033
Company Sanitized. Does no
H-24516: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproduction Evaluations
INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS
Dose Group : VIII - 250 mg/kg/day Sex: Females
Animal Ref
Microscopic & Macroscopic Findings
643341
Continued from previous page
Histopathology :
LIVER : HYPERTROPHY, HEPATOCYTE, CENTRILOBUIAR,
SPLEEM :
NOT PRESENT. THYROID GLAND :
ALTERATION, COLLOID, minimal.
UTERUS :
DILATATION, LUMEN, minimal.
NOSE :
DEGENERATION, AMELOBLASTS, mild.
MANDIBLE :
DEGENERATION, AMELOBLASTS, mild.
mild.
No Microscopic Abnormality Observed :
KIDNEYS,- LUNGS, HEART, SKELETAL MUSCLE, AORTA, BRAIN, SPINAL CORD, STOMACH, DUODENUM, JEJUNUM, ILEUM, PANCREAS, CECUM, COLON, RECTUM, MESENTERIC LYMPH NODE, SALIVARY
GLANDS, MANDIBULAR LYMPH NODE, THYMUS, ADRENAL GLANDS,
SCIATIC NERVE, PITUITARY GLAND, PARATHYROID GLANDS,
TRACHEA, ESOPHAGUS, PHARYNX/LARYNX,
EYE(S) WITH OPTIC NERVE, SKIN, MAMMARY GLAND (FEMALE), OVARIES, URINARY BLADDER, FEMUR/KNEE JOINT, STERNUM, BONE
MARROW
1034
Company SanRbed. Does not c
.. _
_
H-24516: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproduction Evaluations___
INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS
Dose Group : VIII - 250 mg/kg/day Sex: Females
Animal Ref
Microscopic & Macroscopic Findings
643345
Terminal Sacrifice Killed on Day : 125
Exposure Group : ONE-MONTH RECOVERY
Animal is signed off from necropsy
Gross Pathology :
No Macroscopic Abnormality Observed :
LIVER, KIDNEYS. LUNGS, HEART, SKELETAL MUSCLE, SPLEEN, AORTA, BRAIN, SPINAL CORD, STOMACH, DUODENUM, JEJUNUM, ILEUM, PANCREAS, CECUM, COLON, RECTUM, MESENTERIC LYMPH .NODE, SALIVARY GLANDS. MANDIBUIAR LYMPH NODE, THYMUS, ADRENAL GLANDS, SCIATIC NERVE, PITUITARY GLAND,
THYROID GLAND, PARATHYROID GLANDS, TRACHEA, ESOPHAGUS,
-"PHARYNX/LARYNX, EYE(S) WITH OPTIC NERVE, SKIN, MAMMARY GLAND (FEMALE), OVARIES, UTERUS, URINARY BLADDER,
FEMUR/KNEE JOINT, STERNUM, NOSE, MANDIBLE
Histopathology :
LIVER :
INFLAMMATION, SUBACUTE/CHRONIC, minimal.
THYROID GLAND :
ALTERATION, COLLOID, minimal.
NOSE :
DEGENERATION, AMELOBLASTS, mild.
No Microscopic Abnormality Observed :
KIDNEYS, MANDIBLE
1035
Company SanRIzed. Does pet caw
^
1
H-24516: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproduction Evaluations
INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS
Dose Group : VIII - 250 mg/kg/day Sex: Females
Animal Ref
Microscopic & Macroscopic Findings
643347
Terminal Sacrifice Killed on Day : 125
Exposure Group : ONE-MONTH RECOVERY
Animal is signed off from necropsy
Gross Pathology :
No Macroscopic Abnormality Observed : LIVER, KIDNEYS, LUNGS, HEART, SKELETAL MUSCLE, SPLEEN,
AORTA, BRAIN, SPINAL CORD, STOMACH, DUODENUM, JEJUNUM, ILEUM, PANCREAS, CECUM, COLON, RECTUM, MESENTERIC LYMPH NODE, SALIVARY GLANDS, MANDIBULAR LYMPH NODE, THYMUS,
ADRENAL GLANDS, SCIATIC NERVE, PITUITARY GLAND,
THYROID GLAND, PARATHYROID GLANDS, TRACHEA, ESOPHAGUS,
" -PHARYNX/LARYNX, EYE(S) WITH OPTIC NERVE, SKIN, MAMMARY GLAND (FEMALE), OVARIES, UTERUS, URINARY BLADDER, FEMUR/KNEE JOINT, STERNUM, NOSE, MANDIBLE
Histopathology :
LIVER : INFLAMMATION,
NOSE :
DEGENERATION,
SUBACUTE/CHRONIC, minimal. AMELOBLASTS, minimal.
No Microscopic Abnormality Observed :
KIDNEYS, THYROID GLAND, MANDIBLE
1036
CompanySanitized. Doe* not
T-24516: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproduction Evaluations
INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS
Dose Group : VIII - 250 mg/kg/day Sex: Females
Animal Ref
Microscopic & Macroscopic Findings
643351
Terminal Sacrifice Killed on Day : 125
Exposure Group : ONE-MONTH RECOVERY
Animal is signed off from necropsy
Gross Pathology :
No Macroscopic Abnormality Observed : LIVER, KIDNEYS, LUNGS, HEART, SKELETAL MUSCLE, SPLEEN,
AORTA, BRAIN, SPINAL CORD, STOMACH, DUODENUM, JEJUNUM, ILEUM, PANCREAS, CECUM, COLON, RECTUM, MESENTERIC LYMPH NODE. SALIVARY GLANDS, MANDIBULAR LYMPH NODE, THYMUS,
ADRENAL GLANDS, SCIATIC NERVE, PITUITARY GLAND,
THYROID GLAND, PARATHYROID GLANDS, TRACHEA, ESOPHAGUS,
- -PHARYNX/LARYNX, EYE(S) WITH OPTIC NERVE, SKIN, MAMMARY GLAMD (FEMALE), OVARIES, UTERUS, URINARY BLADDER, FEMUR/KNEE JOINT, STERNUM, NOSE, MANDIBLE
Histopathology :
THYROID GLAND :
ALTERATION, COLLOID, minimal.
No Microscopic Abnormality Observed :
LIVER, KIDNEYS, NOSE, MANDIBLE
1037
Qompany Sanft'zed. Does not co
'
d
H-24516: Subchronic Toxicity
90-Day Gavage Study in Rats with One-Generation Reproduction Evaluations
INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS
Dose Group : VIII - 250 mg/kg/day Sex: Females
Animal Ref
Microscopic & Macroscopic Findings
643356
Terminal Sacrifice Killed on Day : 181
Exposure Group : THREE-MONTH RECOVERY
Animal is signed off from necropsy
Gross Pathology :
No Macroscopic Abnormality Observed : LIVER, KIDNEYS, LUNGS, HEART, SKELETAL MUSCLE, SPLEEN,
AORTA, BRAIN, SPINAL CORD, STOMACH, DUODENUM, JEJUNUM,
ILEUM, PANCREAS, CECUM, COLON, RECTUM, MESENTERIC LYMPH NODE, SALIVARY GLANDS. MANDIBULAR LYMPH NODE, THYMUS,
ADRENAL GLANDS, SCIATIC NERVE, PITUITARY GLAND, THYROID GLAND, PARATHYROID GLANDS, TRACHEA, ESOPHAGUS,
" "PHARYNX/LARYNX, EYE(S) WITH OPTIC NERVE, SKIN, MAMMARY GLAND (FEMALE), OVARIES, UTERUS, URINARY BLADDER,
FEMUR/KNEE JOINT, STERNUM, NOSE
Histopathology :
THYROID GLAND :
ALTERATION, COLLOID, moderate.
NOSE :
INFLAMMATION, SUBACUTE/CHRONIC, mild. DEGENERATION, AMELOBLASTS, minimal.
HYPERPLASIA/SQUAMOUS METAPLASIA, TRANSITIONAL
CELL,
mild.
1038
Company Sanitized. Does not con
H-24516: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproduction Evaluations
INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS
Dose Group : VIII - 250 mg/kg/day Sex: Females
Animal Ref
Microscopic & Macroscopic Findings
643358
Terminal Sacrifice Killed on Day : 125
Exposure Group : ONE-MONTH RECOVERY
Animal is signed off from necropsy
Gross Pathology :
No Macroscopic Abnormality Observed : LIVER, KIDNEYS, LUNGS, HEART, SKELETAL MUSCLE, SPLEEN,
AORTA, BRAIN, SPINAL CORD, STOMACH, DUODENUM, JEJUNUM, ILEUM, PANCREAS, CECUM, COLON, RECTUM, MESENTERIC LYMPH NODE, SALIVARY GLANDS, MANDIBULAR LYMPH NODE, THYMUS,
ADRENAL GLANDS, SCIATIC NERVE, PITUITARY GLAND,
THYROID GLAND, PARATHYROID GLANDS, TRACHEA, ESOPHAGUS,
-PHARYNX/LARYNX, EYE(S) WITH OPTIC NERVE, SKIN, MAMMARY GLAND (FEMALE), OVARIES, UTERUS, URINARY BLADDER,
FEMUR/KNEE JOINT, STERNUM, NOSE, MANDIBLE
Histopathology :
LIVER : INFLAMMATION, SUBACUTE/CHRONIC, minimal.
KIDNEYS :
NEPHROPATHY, CHRONIC PROGRESSIVE, minimal.
THYROID GLAND :
ALTERATION, COLLOID, minimal.
NOSE :
DEGENERATION, AMELOBLASTS, mild.
No Microscopic Abnormality Observed :
MANDIBLE
1039
Compsmy Sa'r't'red. Does not con
H-24516: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproduction Evaluations
INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS
Dose Group : VIII - 250 nig/kg/day Sex: Females
Animal Ref
Microscopic & Macroscopic Findings
643359
Terminal Sacrifice Killed on Day : 93
Exposure Group : 90-DAY EXPOSURE
Animal is signed off from necropsy
Gross Pathology :
No Macroscopic Abnormality Observed : LIVER, KIDNEYS, LUNGS, HEART, SKELETAL MUSCLE, SPLEEN,
AORTA, BRAIN, SPINAL CORD, STOMACH, DUODENUM, JEJUNUM, ILEUM, PANCREAS, CECUM, COLON, RECTUM, MESENTERIC LYMPH NODE, SALIVARY GLANDS, MANDIBULAR LYMPH NODE, THYMUS,
ADRENAL GLANDS, SCIATIC NERVE, PITUITARY GLAND,
THYROID GLAND, PARATHYROID GLANDS, TRACHEA, ESOPHAGUS, - -PHARYNX/LARYNX, EYE(S) WITH OPTIC NERVE, SKIN, MAMMARY
GLAND (FEMALE), OVARIES, UTERUS, URINARY BLADDER, FEMUR/KNEE JOINT, STERNUM, NOSE, MANDIBLE
Histopathology :
643359
LIVER : HYPERTROPHY, HEPATOCYTE, CENTRILOBULAR, minimal. INFLAMMATION. SUBACUTE/CHRONIC, minimal.
THYROID GLAND :
HYPERTROPHY, FOLLICULAR, minimal. ALTERATION, COLLOID, minimal.
PARATHYROID GLANDS :
NOT PRESENT.
NOSE :
DEGENERATION, AMELOBLASTS, mild.
MANDIBLE :
DEGENERATION, AMELOBLASTS, mild.
Continued on the next page ....
1040
Company SanWzed. Does not
H-24516: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproduction Evaluations
INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS
Dose Group : VIII - 250 mg/kg/day Sex: Females
Animal Ref
Microscopic & Macroscopic Findings
643359
Continued from previous page
Histopathology :
No Microscopic Abnormality Observed :
KIDNEYS, LUNGS, HEART, SKELETAL MUSCLE, SPLEEN, AORTA,
BRAIN, SPINAL CORD, STOMACH, DUODENUM, JEJUNUM, ILEUM, PANCREAS, CECUM, COLON, RECTUM, MESENTERIC LYMPH NODE, SALIVARY GLANDS, MANDIBULAR LYMPH NODE, THYMUS, ADRENAL
GLANDS, SCIATIC NERVE, PITUITARY GLAND, TRACHEA, ESOPHAGUS, PHARYNX/LARYNX, EYE(S) WITH OPTIC NERVE, SKIN, MAMMARY GLAND (FEMALE), OVARIES, UTERUS, URINARY BLADDER, FEMUR/KNEE JOINT, STERNUM, BONE MARROW
643368
" Accidentally Killed
Duration of dosing-days: 53
Exposure Group : REPRODUCTION
Animal is signed off from necropsy
Gross Pathology :
ESOPHAGUS :
PUNCTURE, GAVAGE SKIN :
STAIN. RED, PERINEUM.
ERROR.
643368
No Macroscopic Abnormality Observed :
LIVER, KIDNEYS, LUNGS, HEART, SKELETAL MUSCLE, SPLEEN, AORTA, BRAIN, SPINAL CORD, STOMACH, DUODENUM, JEJUNUM, ILEUM, PANCREAS, CECUM, COLON, RECTUM, MESENTERIC LYMPH NODE, SALIVARY GLANDS, MANDIBULAR LYMPH NODE, THYMUS, ADRENAL GLANDS, SCIATIC NERVE, PITUITARY GLAND,
Continued on the next page ....
1041
Company Sanitized. Does not con
e
H-24516: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproduction Evaluations
INDIVIDUAL ANIMAL GROSS AMD MICROSCOPIC OBSERVATIONS
Dose Group : VIII - 250 mg/kg/day Sex: Females
Animal Ref
Microscopic & Macroscopic Findings
643368
Continued from previous page
Gross Pathology :
No Macroscopic Abnormality Observed :
THYROID GLAND, PARATHYROID GLANDS, TRACHEA, PHARYNX/LARYNX,
EYE(S) WITH OPTIC NERVE, MAMMARY GLAND (FEMALE), OVARIES,
UTERUS, URINARY BLADDER, FEMUR/KNEE JOINT, STERNUM, NOSE
Histopathology :
KIDNEYS : AUTOLYSIS: NECROPSY AND HISTOLOGY PERFORMED,
SPLEEN :
- -DEPLETION, LYMPHOID, mild.
JEJUNUM : AUTOLYSIS: NECROPSY AND HISTOLOGY PERFORMED,
THYMUS :
ATROPHY, severe.
ESOPHAGUS :
INFLAMMATION, SUBACUTE/CHRONIC, severe.
BONE MARROW :
HYPERPLASIA, GRANULOCYTIC, severe.
NOSE :
DEGENERATION. AMELOBLASTS, mild.
MANDIBLE : NOT PRESENT.
mild. moderate.
643368 Continued on the next page ....
1042
Company Sanitized. Does not co
H-24516: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproduction Evaluations
INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS
Dose Group : VIII - 250 mg/kg/day Sex: Females
Animal Ref
Microscopic & Macroscopic Findings
643368
Continued from previous page
Histopathology :
No Microscopic Abnormality observed : LIVER, KIDNEYS, LUNGS, HEART, SKELETAL MUSCLE, AORTA,
BRAIN, SPINAL CORD, STOMACH, DUODENUM, JEJUNUM, ILEUM, PANCREAS, CECUM, COLON, RECTUM, MESENTERIC LYMPH NODE,
SALIVARY GLANDS, MANDIBULAR LYMPH NODE, ADRENAL GLANDS,
SCIATIC NERVE, PITUITARY GLAND, THYROID GLAND, PARATHYROID GLANDS, TRACHEA, PHARYNX/LARYNX, EYE(S) WITH OPTIC NERVE, SKIN, MAMMARY GLAND (FEMALE), OVARIES, UTERUS, URINARY BLADDER, FEMUR/KNEE JOINT, STERNUM
643370
""Terminal Sacrifice Killed on Day : 93
Exposure Group : 90-DAY EXPOSURE
Animal is signed off from necropsy
, Gross Pathology :
No Macroscopic Abnormality Observed : LIVER, KIDNEYS, LUNGS, HEART, SKELETAL MUSCLE, SPLEEN,
AORTA, BRAIN, SPINAL CORD, STOMACH, DUODENUM, JEJUNUM, ILEUM, PANCREAS, CECUM, COLON, RECTUM, MESENTERIC LYMPH NODE, SALIVARY GLANDS, MANDIBULAR LYMPH NODE, THYMUS, ADRENAL GLANDS, SCIATIC NERVE, PITUITARY GLAND,
THYROID GLAND, PARATHYROID GLANDS, TRACHEA, ESOPHAGUS,
PHARYNX/LARYNX, EYE(S) WITH OPTIC NERVE, SKIN, MAMMARY GLAND (FEMALE), OVARIES, UTERUS, URINARY BLADDER,
FEMUR/KNEE JOINT, STERNUM, NOSE, MANDIBLE
643370 Continued on the next page ....
1043
Company Sanitized. Does not cont
H-24516: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproduction Evaluations
INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS
Dose Group : VIII - 250 mg/kg/day Sex: Females
Animal Ref
Microscopic & Macroscopic Findings
643370
Continued from previous page
Histopathology :
LIVER :
HYPERTROPHY, HEPATOCYTE, CENTRILOBULAR, mild. INFLAMMATION, SUBACUTE/CHRONIC, minimal.
KIDNEYS :
INPARCT, minimal.
NEPHROPATHY, CHRONIC MESENTERIC LYMPH NODE :
PROGRESSIVE,
minimal.
NOT PRESENT.
PARATHYROID GLANDS :
NOT PRESENT.
EYE-(S) WITH OPTIC NERVE : OPTIC NERVE NOT PRESENT.
NOSE :
DEGENERATION. AMELOBLASTS, mild.
MANDIBLE :
DEGENERATION, AMELOBLASTS, mild.
No Microscopic Abnormality Observed :
LUNGS, HEART, SKELETAL MUSCLE, SPLEEN, AORTA, BRAIN, SPINAL
CORD, STOMACH, DUODENUM, JEJUNUM, ILEUM, PANCREAS, CECUM, COLON, RECTUM, SALIVARY GLANDS, MANDIBULAR LYMPH NODE, THYMUS, ADRENAL GLANDS, SCIATIC NERVE, PITUITARY GLAND, THYROID GLAND, TRACHEA, ESOPHAGUS, PHARYNX/LARYNX,
EYE(S) WITH OPTIC NERVE, SKIN, MAMMARY GLAND (FEMALE), OVARIES, UTERUS, URINARY BLADDER, FEMUR/KNEE JOINT, STERNUM, BONE MARROW
1044
'fcuiqpdilySanitized. Does not cont
24516: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproduction Evaluations
INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS
Dose Group : VIII - 250 mg/kg/day Sex: Females
Animal Ref
Microscopic & Macroscopic Findings
643388
Terminal Sacrifice . Killed on Day : 181
Exposure Group : THREE-MONTH RECOVERY
Animal is signed off from necropsy
Gross Pathology
No Macroscopic Abnormality Observed :
LIVER, KIDNEYS, LUNGS, HEART, SKELETAL MUSCLE, SPLEEN, AORTA, BRAIN, SPINAL CORD, STOMACH, DUODENUM, JEJUNUM, ILEUM, PANCREAS, CECUM, COLON, RECTUM, MESENTERIC LYMPH NODE, SALIVARY GLANDS, MANDIBULAR LYMPH NODE, THYMUS, ADRENAL GLANDS, SCIATIC NERVE, PITUITARY GLAND, THYROID GLAND, PARATHYROID GLANDS, TRACHEA, ESOPHAGUS,
. "PHARYNX/LARYNX, EYE(S) WITH OPTIC NERVE, SKIN, MAMMARY GLAND (FEMALE), OVARIES, UTERUS, URINARY BLADDER, FEMUR/KNEE JOINT, STERNUM, NOSE
Histopathology :
THYROID GLAND : ALTERATION, COLLOID,
NOSE : HYPERPLASIA/SQUAMOUS
minimal.
mild.
METAPLASIA,
TRANSITIONAL CELL,
1045
Company Sanitized. Does not con
H-24516: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproduction Evaluations
INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS
Dose Group : VIII - 250 mg/kg/day Sex: Females
Animal Ref
Microscopic & Macroscopic Findings
643404
Terminal Sacrifice Killed on Day : 93
Exposure Group : 90-DAY EXPOSURE
Animal is signed off from necropsy
Gross Pathology :
No Macroscopic Abnormality Observed : LIVER, - KIDNEYS, LUNGS, HEART, SKELETAL MUSCLE, SPLEEN,
AORTA, BRAIN, SPINAL CORD, STOMACH, DUODENUM, JEJUNUM, ILEUM, PANCREAS, CECUM, COLON, RECTUM, MESENTERIC LYMPH NODE, SALIVARY GLANDS, MANDIBULAR LYMPH NODE, THYMUS,
ADRENAL GLANDS, SCIATIC NERVE, PITUITARY GLAND, THYROID GLAND, PARATHYROID GLANDS, TRACHEA, ESOPHAGUS,
--PHARYNX/LARYNX, EYE(S) WITH OPTIC NERVE, SKIN, MAMMARY GLAND (FEMALE), OVARIES, UTERUS. URINARY BLADDER,
FEMUR/KNEE JOINT, STERNUM, NOSE, MANDIBLE
Histopathology :
LIVER :
HYPERTROPHY, HEPATOCYTE, CENTRILOBULAR, mild. INFLAMMATION, SUBACUTE/CHRONIC, minimal.
KIDNEYS :
NEPHROPATHY, CHRONIC PROGRESSIVE, moderate.
THYROID GLAND :
HYPERTROPHY, FOLLICULAR, minimal.
NOSE :
DEGENERATION, AMELOBLASTS, mild.
643404 Continued on the next page
1046
Company Sanitized. Does not co
-24516: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproduction Evaluations
INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS
Dose Group : VIII - 250 mg/kg/day Sex: Females
Animal Ref
Microscopic & Macroscopic Findings
643404
Continued from previous page
Histopathology :
No Microscopic Abnormality Observed :
LUMGS, HEART, SKELETAL MUSCLE, SPLEEN, AORTA, BRAIN, SPINAL
CORD, STOMACH, DUODENUM, JEJUNUM, ILEUM, PANCREAS, CECUM, COLON, RECTUM, MESENTERIC LYMPH NODE, SALIVARY GLANDS, MANDIBULAR LYMPH NODE, THYMUS, ADRENAL GLANDS, SCIATIC
NERVE, PITUITARY GLAND, PARATHYROID GLANDS, TRACHEA, ESOPHAGUS, PHARYNX/LARYNX, EYE(S) WITH OPTIC NERVE, SKIN, MAMMARY GLAND (FEMALE), OVARIES, UTERUS, URINARY BLADDER, FEMUR/KNEE JOINT, STERNUM, BONE MARROW, MANDIBLE
643408
-"Terminal Sacrifice Killed on Day : 93
Exposure Group : 90-DAY EXPOSURE
Animal is signed off from necropsy
Gross Pathology :
No Macroscopic Abnormality Observed : LIVER, KIDNEYS, LUNGS, HEART, SKELETAL MUSCLE. SPLEEN,
AORTA, BRAIN, SPINAL CORD, STOMACH, DUODENUM, JEJUNUM, ILEUM, PANCREAS, CECUM, COLON, RECTUM, MESENTERIC LYMPH NODE, SALIVARY GLANDS, MANDIBULAR LYMPH NODE, THYMUS, ADRENAL GLANDS, SCIATIC NERVE, PITUITARY GLAND,
THYROID GLAND, PARATHYROID GLANDS, TRACHEA, ESOPHAGUS,
PHARYNX/LARYNX, EYE(S) WITH OPTIC NERVE, SKIN, MAMMARY GLAND (FEMALE), OVARIES, UTERUS, URINARY BLADDER,
FEMUR/KNEE JOINT, STERNUM, NOSE
643408 Continued on the next page ....
1047
1 H-24516: SubchronicToxicity
90-Day Gavage Study in Rats with One-Generation Reproduction Evaluations
INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS
Dose Group : VIII - 250 mg/kg/day Sex: Females
Animal Ref
Microscopic & Macroscopic Findings
643408
Continued from previous page
Histopathology :
LIVER : HYPERTROPHY, HEPATOCYTE, CENTRILOBULAR, minimal. INFLAMMATION, SUBACUTE/CHRONIC, minimal.
KIDNEYS :
NEPHROPATHY, CHRONIC PROGRESSIVE, minimal.
THYROID GLAND :
HYPERTROPHY, FOLLICULAR, minimal. ALTERATION, COLLOID, minimal.
NOSE :
DEGENERATION, AMELOBLASTS, mild.
MANDIBLE :
NOT PRESENT.
No Microscopic Abnormality Observed ;
LUNGS, HEART, SKELETAL MUSCLE, SPLEEN, AORTA. BRAIN, SPINAL
CORD, STOMACH, DUODENUM, JEJUNUM, ILEUM, PANCREAS, CECUM, COLON, RECTUM, MESENTERIC LYMPH NODE, SALIVARY GLANDS, MANDIBULAR LYMPH NODE, THYMUS, ADRENAL GLANDS, SCIATIC
NERVE, PITUITARY GLAND, PARATHYROID GLAMDS, TRACHEA, ESOPHAGUS, PHARYNX/LARYNX, EYE(S) WITH OPTIC NERVE, SKIN, MAMMARY GLAND (FEMALE), OVARIES, UTERUS, URINARY BLADDER, FEMUR/KNEE JOINT, STERNUM, BONE MARROW
1048
------s^.o-----
H-24516: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproduction Evaluations
INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS
Dose Group : VIII - 250 mg/kg/day Sex: Females
Animal Ref
Microscopic & Macroscopic Findings
643423
Terminal Sacrifice Killed on Day : 125
Exposure Group : ONE-MONTH RECOVERY
Animal is signed off from necropsy
Gross Pathology :
No Macroscopic Abnormality Observed : LIVER, KIDNEYS, LUNGS, HEART, SKELETAL MUSCLE, SPLEEN,
AORTA, BRAIM, SPINAL CORD, STOMACH, DUODENUM, JEJUNUM, ILEUM, PANCREAS, CECUM, COLON, RECTUM, MESENTERIC LYMPH NODE, SALIVARY GLANDS, MANDIBULAR LYMPH NODE, THYMUS, ADRENAL GLANDS, SCIATIC NERVE, PITUITARY GLAND,
THYROID GLAND, PARATHYROID GLANDS, TRACHEA, ESOPHAGUS,
--PHARYNX/LARYNX, EYE(S) WITH OPTIC NERVE, SKIN, MAMMARY GLAND (FEMALE), OVARIES, UTERUS, URINARY BLADDER, FEMUR/KNEE JOINT, STERNUM, NOSE, MANDIBLE
Histopathology :
LIVER : INFLAMMATION, SUBACUTE/CHRONIC, minimal.
KIDNEYS :
NEPHROPATHY, CHRONIC PROGRESSIVE, minimal.
THYROID GLAND :
ALTERATION, COLLOID, minimal.
No Microscopic Abnormality Observed :
NOSE, MANDIBLE
1049
,^,,^.-----rt-"T
H-24516: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproduction Evaluations
INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS
Dose Group : VIII - 250 mg/kg/day Sex: Females
Animal Ref
Microscopic & Macroscopic Findings
643435
Terminal Sacrifice Killed on Day : 93
Exposure Group : 90-DAY EXPOSURE
Animal is signed off from necropsy
Gross Pathology :
No Macroscopic Abnormality Observed : LIVER, KIDNEYS, LUNGS, HEART, SKELETAL MUSCLE, SPLEEN,
AORTA, BRAIN, SPINAL CORD, STOMACH, DUODENUM, JEJUNUM, ILEUM, PANCREAS, CECUM, COLON, RECTUM, MESENTERIC LYMPH NODE, SALIVARY GLANDS, MANDIBULAR LYMPH NODE, THYMUS,
ADRENAL GLANDS, SCIATIC NERVE, PITUITARY GLAMD,
THYROID GLAND, PARATHYROID GLANDS, TRACHEA, ESOPHAGUS,
PHARYNX/LARYNX, EYE(S) WITH OPTIC NERVE, SKIN, MAMMARY - GLAND (FEMALE), OVARIES, UTERUS, URINARY BLADDER,
FEMUR/KNEE JOINT, STERNUM, NOSE, MANDIBLE
Histopathology :
:
643435
LIVER :
HYPERTROPHY, HEPATOCYTE, CENTRILOBULAR, mild. INFLAMMATION, SUBACUTE/CHRONIC, minimal.
PANCREAS :
ATROPHY, minimal.
THYROID GLAND :
HYPERTROPHY, FOLLICULAR, minimal. ALTERATION, COLLOID, minimal.
UTERUS :
DILATATION, LUMEN, minimal.
URINARY BLADDER : NOT PRESENT.
Continued on the next page ....
1050
Company Sanitized. Does not contain
^
H-24516: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproduction Evaluations
INDIVIDUAL ANIMAL GROSS AMD MICROSCOPIC OBSERVATIONS
Dose Group : VIII - 250 mg/kg/day Sex: Females
Animal Ref
Microscopic & Macroscopic Findings
643435
Continued from previous page
Histopathology :
NOSE : DEGENERATION,
MANDIBLE : DEGENERATION,
AMELOBLASTS, AMELOBLASTS,
mild. minimal.
No Microscopic Abnormality Observed :
KIDNEYS, LUNGS, HEART, SKELETAL MUSCLE, SPLEEN, AORTA, BRAIN. SPINAL CORD, STOMACH, DUODENUM, JEJUNUM, ILEUM, CECUM, COLON, RECTUM, MESENTERIC LYMPH NODE, SALIVARY
GLANDS, MANDIBULAR LYMPH NODE, THYMUS, ADRENAL GLANDS,
SCIATIC NERVE, PITUITARY GLAND, PARATHYROID GLANDS,
TRACHEA, ESOPHAGUS, PHARYNX/LARYNX,
EYE(S) WITH OPTIC NERVE, SKIN, MAMMARY GLAND (FEMALE), OVARIES, FEMUR/KNEE JOINT, STERNUM, BONE MARROW
643441
Terminal Sacrifice Killed on Day : 125
Exposure Group : ONE-MONTH RECOVERY
Animal is signed off from necropsy
Gross Pathology :
643441
No Macroscopic Abnormality Observed : LIVER, KIDNEYS, LUNGS, HEART, SKELETAL MUSCLE, SPLEEN,
AORTA, BRAIN, SPINAL CORD, STOMACH, DUODENUM, JEJUNUM, ILEUM, PANCREAS, CECUM, COLON, RECTUM, MESENTERIC LYMPH NODE, SALIVARY GLANDS, MANDIBULAR LYMPH NODE, THYMUS,
ADRENAL GLANDS, SCIATIC NERVE, PITUITARY GLAND,
Continued on the next page ....
1051
Company Sanitized. Does not
^
H-24516: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproduction Evaluations
INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS
Dose Group : VIII - 250 mg/kg/day Sex: Females
Animal Ref
Microscopic & Macroscopic Findings
643441
Continued from previous page
Gross Pathology :
No Macroscopic Abnormality Observed :
THYROID GLAND, PARATHYROID GLANDS, TRACHEA, ESOPHAGUS,
PHARYNX/LARYNX, EYE(S) WITH OPTIC NERVE, SKIN, MAMMARY GLAND (FEMALE), OVARIES, UTERUS, URINARY BLADDER, FEMUR/KNEE JOINT, STERNUM, NOSE, MANDIBLE
Histopathology :
LIVER :
INFLAMMATION, -- FATTY CHANGE,
KIDNEYS :
SUBACUTE/CHRONIC, minimal. MEDIAN CLEFT, minimal.
NEPHROPATHY, CHRONIC PROGRESSIVE, minimal.
THYROID GLAND :
ALTERATION, COLLOID, minimal.
NOSE :
DEGENERATION, AMELOBLASTS, minimal.
No Microscopic Abnormality Observed :
MANDIBLE
1052
Company Sanitized. Does not c
/r^r'^'i.
H-24516: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproduction Evaluations
INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS
Dose Group : VIII - 250 mg/kg/day Sex: Females
Animal Ref
Microscopic & Macroscopic Findings
643444
Terminal Sacrifice Killed on Day : 125
Exposure Group : ONE-MONTH RECOVERY
Animal is signed off from necropsy
Gross Pathology :
No Macroscopic Abnormality.Observed : LIVER, KIDNEYS, LUNGS, HEART, SKELETAL MUSCLE, SPLEEN,
AORTA, BRAIN, SPINAL CORD, STOMACH, DUODENUM, JEJUNUM, ILEUM, PANCREAS, CECUM, COLON. RECTUM, MESEMTERIC LYMPH NODE, SALIVARY GLANDS, MANDIBULAR LYMPH NODE, THYMUS,
ADRENAL GLANDS, SCIATIC NERVE, PITUITARY GLAND,
THYROID GLAND, PARATHYROID GLANDS, TRACHEA, ESOPHAGUS,
.. PHARYNX/LARYNX, EYE(S) WITH OPTIC NERVE, SKIN, MAMMARY GLAND (FEMALE), OVARIES, UTERUS, URINARY BLADDER, FEMUR/KNEE JOINT, STERNUM, NOSE, MANDIBLE
Histopathology :
LIVER :
INFLAMMATION, SUBACUTE/CHRONIC, minimal.
NECROSIS, FOCAL, minimal.
:
KIDNEYS :
NEPHROPATHY, CHRONIC PROGRESSIVE, minimal.
THYROID GLAND :
ALTERATION, COLLOID, minimal.
NOSE :
DEGENERATION, AMELOBLASTS, minimal.
No Microscopic Abnormality Observed :
MAMDIBLE
1053
Company Sanitized. Does
H-24516: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproduction Evaluations
INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS
Dose Group : VIII - 250 mg/kg/day Sex: Females
Animal Ref
Microscopic & Macroscopic Findings
643446
Terminal Sacrifice Killed on Day : 93
Exposure Group : 90-DAY EXPOSURE
Animal is signed off from necropsy
Gross Pathology :
No Macroscopic Abnormality Observed : LIVER, KIDNEYS, LUNGS, HEART, SKELETAL MUSCLE, SPLEEN,
AORTA, BRAIN, SPINAL CORD, STOMACH, DUODENUM, JEJUNUM, ILEUM, PANCREAS, CECUM, COLON, RECTUM, MESENTERIC LYMPH NODE, SALIVARY GLANDS, MANDIBULAR LYMPH NODE, THYMUS,
ADRENAL GLANDS, SCIATIC NERVE, PITUITARY GLAND,
THYROID GLAND, PARATHYROID GLANDS, TRACHEA, ESOPHAGUS,
"
PHARYNX/LARYNX, EYE(S) WITH OPTIC NERVE, SKIN, MAMMARY GLAND (FEMALE), OVARIES, UTERUS, URINARY BLADDER,
FEMUR/KNEE JOINT, STERNUM, NOSE, MANDIBLE
Histopathology :
643446
LIVER : HYPERTROPHY, HEPATOCYTE, CENTRILOBULAR, minimal.
INFLAMMATION, SUBACUTE/CHRONIC, minimal.
PANCREAS :
ATROPHY, minimal.
THYROID GLAND :
HYPERTROPHY, FOLLICULAR, minimal. ALTERATION, COLLOID, mild.
PARATHYROID GLANDS :
NOT PRESENT. EYE(S) WITH OPTIC NERVE :
OPTIC NERVE NOT PRESENT.
Continued on the next page ....
1054
Company Sanitized. Does not con
H-24516: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproduction Evaluations
INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS
Dose Group : VIII - 250 ing/kg/day Sex: Females
Animal Ref
Microscopic & Macroscopic Findings
643446 .
Continued from previous page
Histopathology ;
NOSE : DEGENERATION.
MANDIBLE : DEGENERATION,
AMELOBLASTS, AMELOBLASTS,
mild. minimal.
No Microscopic Abnormality Observed :
KIDNEYS, LUNGS, HEART, SKELETAL MUSCLE. SPLEEN, AORTA, BRAIN, SPINAL CORD, STOMACH, DUODENUM, JEJUNUM, ILEUM, CECUM, COLON, RECTUM, MESENTERIC LYMPH NODE, SALIVARY
GLANDS, MANDIBULAR LYMPH NODE, THYMUS, ADRENAL GLANDS,
-" SCIATIC NERVE, PITUITARY GLAND, TRACHEA, ESOPHAGUS, PHARYNX/LARYNX, EYE(S) WITH OPTIC NERVE, SKIN, MAMMARY GLAND (FEMALE), OVARIES, UTERUS, URINARY BLADDER, FEMUR/KNEE JOINT, STERNUM, BONE MARROW
643450
Terminal Sacrifice Killed on Day : 181
Exposure Group : THREE-MONTH RECOVERY
Animal is signed off from necropsy
Gross Pathology :
643450
No Macroscopic Abnormality Observed : LIVER, KIDNEYS, LUNGS, HEART, SKELETAL MUSCLE, SPLEEN,
AORTA, BRAIN, SPINAL CORD, STOMACH, DUODENUM, JEJUNUM, ILEUM, PANCREAS, CECUM, COLON, RECTUM, MESENTERIC LYMPH
NODE, SALIVARY GLANDS, MANDIBULAR LYMPH NODE, THYMUS, ADRENAL GLANDS, SCIATIC NERVE, PITUITARY GLAND,
Continued on the next page ....
1055
tSompanySanitized, Does not
H-24516: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproduction Evaluations
INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS
Dose Group : VIII - 250 mg/kg/day Sex: Females
Animal Ref
Microscopic & Macroscopic Findings
643450
Continued from previous page
Gross Pathology :
No Macroscopic Abnormality Observed :
THYROID GLAND, PARATHYROID GLANDS, TRACHEA, ESOPHAGUS, PHARYNX/LARYNX, EYE(S) WITH OPTIC NERVE, SKIN, MAMMARY GLAND (FEMALE), OVARIES, UTERUS, URINARY BLADDER,
FEMUR/KNEE JOINT, STERNUM, NOSE
Histopathology :
THYROID GLAND :
ALTERATION, COLLOID, mild.
NO'SE :
INFLAMMATION, SUBACUTE/CHRONIC, minimal.
HYPERPLASIA/SQUAMOUS METAPLASIA, TRANSITIONAL
minimal.
CELL,
643456
Terminal Sacrifice Killed on Day : 125
Exposure Group : ONE-MONTH RECOVERY
Animal is signed off from necropsy
Gross Pathology :
643456
No Macroscopic Abnormality Observed : LIVER, KIDNEYS, LUNGS, HEART, SKELETAL MUSCLE, SPLEEN,
AORTA, BRAIN, SPINAL CORD, STOMACH, DUODENUM, JEJUNUM, ILEUM, PANCREAS, CECUM, COLON, RECTUM, MESENTERIC LYMPH
NODE, SALIVARY GLANDS, MANDIBULAR LYMPH NODE, THYMUS, ADRENAL GLANDS, SCIATIC NERVE, PITUITARY GLAND,
Continued on the next page ....
1056
Company Sanitized. Does not co
^
^
H-24516: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproduction Evaluations
INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS
Dose Group : VIII - 250 mg/kg/day Sex: Females
Animal Ref
Microscopic & Macroscopic Findings
643456
Continued from previous page
Gross Pathology :
No Macroscopic Abnormality Observed :
THYROID GLAND, PARATHYROID GLANDS, TRACHEA, ESOPHAGUS, PHARYNX/LARYNX, EYE(S) WITH OPTIC NERVE, SKIN, MAMMARY GLAND (FEMALE), OVARIES, UTERUS, URINARY BLADDER,
FEMUR/KNEE JOINT, STERNUM, NOSE, MANDIBLE
Histopathology :
LIVER : INFLAMMATION, SUBACUTE/CHRONIC, minimal.
KIJ3NEYS :
NEPHROPATHY, CHRONIC PROGRESSIVE, minimal.
THYROID GLAND :
ALTERATION, COLLOID, minimal.
NOSE :
DEGENERATION, AMELOBLASTS, mild.
INFLAMMATION, SUBACUTE/CHRONIC, NASOLACRIMAL
DUCT,
mild.
No Microscopic Abnormality Observed :
MANDIBLE
1057
Company Sanitized. Doe
H
H-24516: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproduction Evaluations
INDIVIDUAL AMIMAL GROSS AND MICROSCOPIC OBSERVATIONS
Dose Group : VIII - 250 mg/kg/day Sex: Females
Animal Ref
Microscopic & Macroscopic Findings
643466 .
Terminal Sacrifice Killed on Day : 93
Exposure Group : 90-DAY EXPOSURE
Animal is signed off from necropsy
Gross Pathology :
No Macroscopic Abnormality Observed :
LIVER, KIDNEYS, LUNGS, HEART, SKELETAL MUSCLE, SPLEEN, AORTA, BRAIN, SPINAL CORD, STOMACH, DUODENUM, JEJUNUM. ILEUM, PANCREAS, CECUM, COLON, RECTUM, MESENTERIC LYMPH NODE, SALIVARY GLANDS, MANDIBULAR LYMPH NODE, THYMUS, ADRENAL GLANDS, SCIATIC NERVE, PITUITARY GLAND,
THYROID GLAND, PARATHYROID GLANDS, TRACHEA, ESOPHAGUS,
PHARYNX/LARYNX, EYE(S) WITH OPTIC NERVE, SKIN, MAMMARY GLAND (FEMALE), OVARIES, UTERUS, URINARY BLADDER,
FEMUR/KNEE JOINT, STERNUM, NOSE, MANDIBLE
Histopathology :
643466
LIVER :
HYPERTROPHY, HEPATOCYTE, CENTRILOBULAR, minimal. INFLAMMATION, SUBACUTE/CHRONIC, minimal.
KIDNEYS :
NEPHROPATHY, CHRONIC PROGRESSIVE, minimal.
MESENTERIC LYMPH NODE :
NOT PRESENT.
THYROID GLAND :
HYPERTROPHY, FOLLICULAR, minimal. ALTERATION, COLLOID, mild. EYE(S) WITH OPTIC NERVE :
OPTIC NERVE NOT PRESENT.
Continued on the next page ....
1058
Company Sanitized. Does no
'
H-24516: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproduction Evaluations
INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS
Dose Group : VIII - 250 nig/kg/day Sex: Females
Animal Ref
Microscopic & Macroscopic Findings
643466
Continued from previous page
Histopathoiogy :
NOSE : DEGENERATION,
MANDIBLE : DEGENERATION,
AMELOBLASTS, AMELOBLASTS,
mild. minimal.
No Microscopic Abnormality Observed :
LUNGS, HEART, SKELETAL MUSCLE, SPLEEN, AORTA, BRAIN, SPINAL CORD, STOMACH, DUODENUM, JEJUNUM, ILEUM, PANCREAS, CECUM, COLON, RECTUM, SALIVARY GLANDS, MANDIBULAR LYMPH NODE, THYMUS, ADRENAL GLANDS, SCIATIC NERVE, PITUITARY GLAND, -" PARATHYROID GLANDS, TRACHEA, ESOPHAGUS, PHARYNX/LARYNX, EYE(S) WITH OPTIC NERVE, SKIN, MAMMARY GLAND (FEMALE), OVARIES, UTERUS, URINARY BLADDER, FEMUR/KNEE JOINT, STERNUM, BONE MARROW
643474
Terminal Sacrifice Killed on Day : 125
Exposure Group : ONE-MONTH RECOVERY
Animal is signed off from necropsy
Gross Pathology :
643474
No Macroscopic Abnormality Observed : LIVER, KIDNEYS, LUNGS, HEART, SKELETAL MUSCLE, SPLEEN,
AORTA, BRAIN, SPINAL CORD, STOMACH, DUODENUM, JEJUNUM, ILEUM. PANCREAS, CECUM, COLON, RECTUM, MESENTERIC LYMPH
NODE, SALIVARY GLANDS, MANDIBULAR LYMPH NODE, THYMUS, ADRENAL GLANDS, SCIATIC NERVE, PITUITARY GLAND,
Continued on the next page ....
1059
Company SanWzed. Doe
6).
H-24516: Subchronic Toxicity
90-Day Gavage Study in Rats with One-Generation Reproduction Evaluations
INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS
Dose Group : VIII - 250 mg/kg/day Sex: Females
Animal Ref
Microscopic & Macroscopic Findings
643474
Continued from previous page
Gross Pathology :
No Macroscopic Abnormality Observed :
THYROID GLAND, PARATHYROID GLANDS, TRACHEA, ESOPHAGUS, PHARYNX/LARYNX, EYE(S) WITH OPTIC NERVE, SKIN, MAMMARY GLAND (FEMALE), OVARIES, UTERUS, URINARY BLADDER,
FEMUR/KNEE JOINT, STERNUM, NOSE, MANDIBLE
Histopathology :
LIVER : INFLAMMATION, SUBACUTE/CHRONIC,
THYROID GLAND :
ALTERATION, COLLOID, minimal.
minimal.
No Microscopic Abnormality Observed :
KIDNEYS, NOSE, MANDIBLE
643481
Terminal Sacrifice Killed on Day : 125
Exposure Group : ONE-MONTH RECOVERY
Animal is signed, off from necropsy
Gross Pathology :
643481
No Macroscopic Abnormality Observed : LIVER, KIDNEYS, LUNGS, HEART, SKELETAL MUSCLE, SPLEEN,
AORTA, BRAIN, SPINAL CORD, STOMACH, DUODENUM, JEJUNUM, ILEUM, PANCREAS, CECUM, COLON, RECTUM, MESENTERIC LYMPH NODE, SALIVARY GLANDS, MANDIBULAR LYMPH NODE, THYMUS,
ADRENAL GLANDS, SCIATIC NERVE, PITUITARY GLAND,
Continued on the next page ....
1060
Company Sanitized. Does not
0
H-24516: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproduction Evaluations
INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS
Dose Group : VIII - 250 mg/kg/day Sex: Females
Animal Ref
Microscopic & Macroscopic Findings
643481
Continued from previous page
Gross Pathology :
No Macroscopic Abnormality Observed :
THYROID GLAND, PARATHYROID GLANDS, TRACHEA, ESOPHAGUS,
PHARYNX/LARYNX, EYE(S) WITH OPTIC NERVE, SKIN, MAMMARY GLAND (FEMALE), OVARIES, UTERUS, URINARY BLADDER,
FEMUR/KNEE JOINT, STERNUM, NOSE, MANDIBLE
Histopathology :
LIVER :
INFLAMMATION, SUBACUTE/CHRONIC, minimal.
KIDNEYS.:
NEPHROPATHY,
THYROID GLAND :
CHRONIC PROGRESSIVE,
minimal.
ALTERATION, COLLOID, moderate.
NOSE :
DEGENERATION, AMELOBLASTS, mild.
No Microscopic Abnormality Observed :
MANDIBLE
1061
Company Sanitized. Does not cont
e
H-24516: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproduction Evaluations
INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS
Dose Group : VIII - 250 mg/kg/day Sex: Females
Animal Ref
Microscopic & Macroscopic Findings
643487 .
Terminal Sacrifice Killed on Day : 181
Exposure Group : THREE-MONTH RECOVERY
Animal is signed off from necropsy
Gross Pathology :
No Macroscopic Abnormality Observed : LIVER, KIDNEYS, LUNGS, HEART, SKELETAL MUSCLE, SPLEEN,
AORTA, BRAIN, SPINAL CORD, STOMACH, DUODENUM, JEJUNUM, ILEUM, PANCREAS, CECUM, COLON, RECTUM, MESENTERIC LYMPH NODE, SALIVARY GLANDS, MANDIBULAR LYMPH NODE, THYMUS,
ADRENAL GLANDS, SCIATIC NERVE, PITUITARY GLAND, THYROID GLAND, PARATHYROID GLANDS, TRACHEA, ESOPHAGUS,
- " PHARYNX/LARYNX, EYE(S) WITH OPTIC NERVE. SKIN, MAMMARY GLAND (FEMALE), OVARIES, UTERUS, URINARY BLADDER, FEMUR/KNEE JOINT, STERNUM, NOSE
Histopathology :
THYROID GLAND :
ALTERATION, COLLOID, mild.
No Microscopic Abnormality Observed :
NOSE
1062
APPENDIX 0 REPRODUCTIVE TOXICOLOGY INDIVIDUAL BODY WEIGHTS OF PI MALE RATS
1063
Company SanHIzed. Does not contain TSCA CB)
H-24516: Subchronic Toxicity
90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations_____________DuPont-5386 REPRODUCTIVE TOXICOLOGY
INDIVIDUAL BODY WEIGHTS OF Pi MALE RATS EXPLANATORY NOTES
Notes:
Test Days 75-89 = Cohabitation period
d^
1064
Company Sanllzed. Does not contain TSCA CBI
INDIVIDUAL BODY WEIGHTS (grams) OF Pi MALE RATS
GROUP: 1-0
DOSE: 0 MG/KG/DAY
TEST DAYS:
ANIMAL NUMBER
643239 643270 643148 643284 643229 643196 643176 643218 643207 643280 643271 643211 643163 643197 643242 643251 643155 643147 643276 643254
78
85
92
99
106
602 .8 514 .2 515 .9 624 .5 465 .5 441 .0 522 .9 564 .4 507 .3 560 .0 635 .1 525 .9 651 .7 565 .1 587 .4 524 .9 582 .0 562 .8 677 .2 482 .3
614 .2 539 .7 520 .4 644 .1 480 .7 454 .9 533 .6 575 .4 522 .7 578 .7 636 .5 540 .9 675 .1 580 .0 591 .1 539 .2 597 .9 574 .2 696 .9 494 .6
627 .7 552 .6 539 .2 647 .5 484 .6 465 .7 556 .8 595 .5 528 .4 586 .8 649 .3 551 .5 692 .9 596 .4 617 .3 557 .9 601 .1 587 .9 716 .4 512 .6
625 .4 562 .6 556 .3 664 .9 506 .3 482 .6 569 .3 608 .0 538 .7 598 .1 669 .5 570 .5 704 .6 604 .4 627 .2 563 .1 613 .8 600 .1 725 .5 522 .5
648. 8
569. 4
569. 5 681. 1 513. 3
493. 0 575. 8 626. 0
541. 9 614. 9
676. 4
582. 0 716. 0
617. 4 637. 9 577. 1 631. 2 605. 8
738. 2 536. 8
1065
Company Sanflzed. Does not contain TSCA CBI
INDIVIDUAL BODY WEIGHTS (grams) OF P^ MALE RATS
GROUP: III-O
DOSE: 25 MG/KG/DAY
TEST DAYS:
78
85
92
99
106
ANIMAL NUMBER
643287 643188 643230 643170 643144 643277 643214 643261 643166 643153 643177 643198 643291 643184 643167 643223 643233 643183 643219 643263
469 .8 626 .4 495 .5 570 .3 477 .4 606 .8 566 .9 589 .6 549 .5 529 .1 558 .2 623 .5 574 .0 464 .8 554 .3 517 .3 465 .1 584 .7 569 .3 484 .8
473 .5 641 .6 513 .5 568 .3 485 .6 619 .3 567 .9 607 .3 568 .7 542 .3 578 .2 637 .1 581 .1 460 .9 579 .6 525 .8 480 .6 582 .7 590 .0 502 .0
480 .6 660 .3 530 .1 583 .2 496 .3 642 .7 583 .2 624 .1 580 .6 558 .4 585 .8 643 .9 596 .7 472 .6 583 .1 530 .9 493 .3 594 .2 615 .9 520 .0
490 .8 679 .0 538 .7 597 .3 504 .1 662 .5 595 .4 646 .7 597 .8 577 .8 583 .8 653 .0 614 .6 495 .0 597 .7 533 .7 511 .3 605 .3 629 .5 529 .5
495 .4 695 .9 541 .3 610 .4 513 .9 676 .7 612 .9 657 .4 613 .5 588 .6 592 .1 660 .5 623 .5 476 .9 605 .2 544 .7 518 .4 614 .2 636 .2 532 .8
1066
Company San't'zed. Does not contain TSCA CBI
INDIVIDUAL BODY WEIGHTS (grams) OF Pi MALE RATS
'
GROUP: V-0
DOSE: 100 MG/KG/DAY
TEST DAYS:
ANIMAL NUMBER
643313 643182 643146 643312 643199 643267 643216 643244 643245 643301 643200 643255 643157 643238 643227 643164 643154 643156 643208 643190
78
85
92
99
106
511. 6 566. 3 558. 8 512. 4 543. 0 547. 4 592. 5 507. 2 466. 6 545. 1 560. 7
601. 1 552. 8 538. 6
568. 5
592. 7 499. 6 606. 0
526. 7 553. 2
515.1 S90.0
576.7 523.6 556.5 568.7 614.7 516.6 474.0 561.9 576.0 600.0 571.6 546.3 582.1 604.7 505.8 618.5 530.6 551.9
527 .8 604 .1 597 .7 533 .3
551 .1 572 .7 622 .7 529 .3 489 .0 581 .2 592 .4 619 .0 585 .7 538 .2 591 .1 616 .0 520 .2 633 .6 531 .9 552 .4
538 .8 630 .8 611 .8 541 .9 552 .8 584 .7 629 .1 551 .4 496 .6 586 .5 605 .6 637 .4 599 .9 538 .8 601 .2 626 .2 495 .1 645 .2 540 .9 567 .7
536 .6 636 .4 610 .9 550 .9 554 .2 561 .4 581 .4 542 .0 493 .4 600 .9 610 .9 640 .7 605 .3 537 .4 616 .0 640 .0 497 .4 637 .4 465 .9 563 .9
1067
Company Sanitized. Does not contain TSCA CBI
INDIVIDUAL BODY WEIGHTS (grams) OF Pi MALE RATS
GROUP: VII-0
DOSE: 250 MG/KG/DAY
TEST DAYS:
ANIMAL NUMBER
643289 643171 643158 643249 643161 643248 643285 643278 643299 643274 643192 643222 643160 643191 643203 643282 643302 643317 643281
78
85
92
99
106
403 .6 536 .3 577 .3 499 .4 505 .7 429 .6 443 .1 490 .4 477 .9 491 .0 542 .1 513 .5 481 .5 509 .4 513 .3 578 .4 433 .6 447 .6 530 .5
431 .4 572 .0 596 .1 528 .9 542 .4 457 .8 457 .6 501 .4 506 .7 508 .7 563 .5 512 .7 485 .4 519 .2 539 .0 599 .4 473 .5 472 .1 538 .9
440 .0 592 .9 615 .9 554 .9 567 .1 464 .5 473 .0 507 .7 516 .6 511 .0 579 .1 529 .7 489 .5 538 .3 559 .3 626 .8 500 .5 478 .8 544 .8
449 .3 611 .8 624 .7 565 .8 576 .1 419 .4. 480 .5 523 .8 524 .6 515 .1 597 .4 536 .6 498 .4 528 .8 574 .6 654 .0 524 .6 486 .1 548 .6
454 .2 627 .6 632 .1 576 .7 587 .0 397 .7 495 .4 534 .0 538 .4 518 .9 604 .5 538 .3 505 .3 529 .7 584 .5 674 .5 540 .6 496 .8 560 .8
APPENDIX P REPRODUCTIVE TOXICOLOGY INDIVIDUAL BODY WEIGHT GAINS OF Pi MALE RATS
^'Bompany^anllf1e.Deoge,s not contain TSCA CBT
H-24516: Subchronic Toxicity
90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations_____________DuPont-5386
REPRODUCTIVE TOXICOLOGY INDIVIDUAL BODY WEIGHT GAINS OF Pi MALE RATS
EXPLANATORY NOTES
Test Days 75-89 = Cohabitation period
1070
INDIVIDUAL BODY WEIGHT GAINS (grams) OF Pi MALE RATS
GROUP: 1-0
DOSE: 0 MG/KG/DAY
TEST DAYS:
ANIMAL NUMBER
643239 643270 643148 643284 643229 643196 643176 643218 643207 643280 643271 643211 643163 643197 643242 643251 643155 643147 643276 643254
78-85
85-92
92-99
99-106 78-106
11.4 25.5
4.5 19.6
15.2 13.9 10.7 11.0 15.4 18.7
1.4 15.0 23.4 14.9
3.7 14.3 15.9 11.4 19.7 12.3
13.5 12.9 18.8
3.4 3.9 10.8 23.2
20.1 5.7 8.1
12.8 10.6 17.8 16.4
26.2 18.7
3.2 13.7 19.5 18.0
-2.3 10.0 17.1 17.4 21.7 16.9 12.5 12.5 10.3
11.3 20.2 19.0 11.7
8.0 9.9 5.2 12.7 12.2
9.1 9.9
23.4
6.8 13.2 16.2
7.0 10.4
6.5 18.0
3.2 16.8
6.9 11.5 11.4 13.0 10.7
14.0 17.4
5.7 12.7 14.3
46.0 55.2
53.6 56.6 47.8 52.0 52.9 61.6 34.6 54.9 41.3 56.1
64.3 52.3 50.5 52.2 49.2 43.0 61.0 54.5
1071
Company Sanitized. Does not contain TSCA CBI
INDIVIDUAL BODY WEIGHT GAINS (grams) OF Pi MALE RATS
'
GROUP: III-O
DOSE: 25 MG/KG/DAY
TEST DAYS:
ANIMAL NUMBER
643287 643188 643230 643170 643144 643277 643214 643261 643166 643153 643177 643198 643291 643184 643167 643223 643233 643183 643219 643263
78-85
85-92
92-99
99-106 78-106
3 .7 15 .2 18 .0 -2 .0
8 .2 12 .5
1 .0 17 .7 19 .2 13 .2 20 .0 13 .6
7 .1
-3 .9 25 .3
8 .5 15 .5
-2 .0 20 .7 17 .2
7 .1 18 .7 16 .6 14 .9 10 .7 23 .4 15 .3 16 .8 11 .9 16 .1
7 .6 6 .8 15 .6 11 .7 3 .5 5 .1 12 .7 11 .5 25 .9 18 .0
10 .2 18 .7
8 .6 14 .1
7 .8 19 .8 12 .2 22 .6 17 .2 19 .4 -2 .0
9 .1 17 .9 22 .4 14 .6
2 .8 18 .0 11 .1 13 .6
9 .5
4.6 16.9
2.6 13.1
9.8 14.2
17.5
10.7 15.7 10.8
8.3 7.5 8.9 -18.1 7.5 11.0
7.1 8.9 6.7 3.3
25.6 69.5
45.8 40.1 36.5
69.9 46.0 67.8 64.0 59.5 33.9 37.0 49.5 12.1 50.9 27.4 53.3 29.5 66.9 48.0
1072 Company Sanitized. Does not contain TSCACB1
INDIVIDUAL BODY WEIGHT GAINS (grams) OF Pi MALE RATS
GROUP: V-0
DOSE: 100 MG/KG/DAY
TEST DAYS:
ANIMAL NUMBER
643313 643182 . 643146 643312 643199 643267 643216 643244 643245 643301 643200 643255 643157 643238 643227 643164 643154 643156 643208 643190
78 -85
85 -92
92 -99
99 -106 78 -106
3 .5 23 .7 17 .9 11 .2 13 .5 21 .3 22 .2
9 .4 7 .4 16 .8 15 .3
-1 .1 18 .8
7 .7 13 .6 12 .0
6 .2 12 .5
3 .9
-1 .3
12 .7 14 .1 21 .0
9 .7
-5 .4
4 .0 8 .0 12 .7 15 .0 19 .3 16 .4 19 .0 14 .1
-8 .1 9 .0
11 .3 14 .4 15 .1
1 .3 0 .5
11 .0 26 .7 14 .1
8 .6 1 .7 12 .0 6 .4 22 .1 7 .6 5 .3 13 .2 18 .4 14 .2 0 .6 10 .1 10 .2
-25 ,1 11 .6 9 .0
15 .3
-2 .2 5 .6
-0 .9 9 .0 1 .4
-23 .3 -47 .7
-9 .4 -3 .2 14 .4
5 .3 3 .3 5 .4 -1 .4 14 .8 13 .8 2 .3
-7 .8 -75 .0
-3 .8
25 .0 70 .1 52 .1 38 .5 11 .2 14 .0
-11 .1 34 .8 26 .8 55 .8 50 .2 39 .6 52 .5 -1 .2 47 .5
47 .3 -2 .2 31 .4 -60 .8 10 .7
1073
Company Sanitized. Does not contain TSCA CBI
INDIVIDUAL BODY WEIGHT GAINS (grams) OF Pi MALE RATS
GROUP: VI I-0
DOSE: 250 MG/KG/DAY
TEST DAYS:
ANIMAL NUMBER
643289 643171 643158 643249 643161 643248 643285 643278 643299 643274 643192 643222 643160 643191 643203 643282 643302 643317 643281
78-85
85-92
92-99
99-106 78-106
27 .8 35 .7 18 .8 29 .5 36 .7 28 .2 13 .9 11 .0 28 .8 17 .7 21 .4 -0 .8
3 .9 9 .8 25 .7 21 .0 39 .9 24 .5 8 .4
8 .6 20 .9 19 .8 26 .0 24 .7
6 .7 15 .4
6 .3 9 .9 2 .3 15 .6 17 .0
4 .1 19 .1 20 .3 27 .4 27 .0
6 .7 5 .9
9 .3
18 .9 8 .8
10 .9 9 .0
-45 .1 7 .5
16 .1 8 .0 4 .1
18 .3 6 .9 8 .9
-9 .5
15 .3 27 .2 24 .1
7 .3 3 .8
4 .9 15 .8
7 .4 10 .9 10 .9
-21 .7 14 .9 10 .2 13 .8 3 .8 7 .1 1 .7 6 .9 0 .9 9 .9 20 .5 16 .0 10 .7 12 .2
50 .6 91 .3 54 .8 77 .3 81 .3
-31 .9 51 .7 43 .6 60 .5 27 .9 62 .4 24 .8 23 .8
20 .3 71 .2 96 .1 107 .0 49 .2 30 .3
1074
Company Sanitized. Does not contain TSCA CBI
APPENDIX Q REPRODUCTIVE TOXICOLOGY INDIVIDUAL BODY WEIGHTS OF Pi FEMALE RATS DURING GESTATION
1075
Company Sanitized. Does not contain TSCA CBI
H-24516: Subchronic Toxicity
90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations_____________DuPont-5386 REPRODUCTIVE TOXICOLOGY
INDIVIDUAL BODY WEIGHTS OF Pi FEMALE RATS DURING GESTATION
EXPLANATORY NOTES
Footnotes
a No litter delivered; data excluded from statistical analysis.
b No gestation data since no copulation plug was observed; no litter was delivered.
c
Data not collected due to error.
d No litter delivered, however, implants were observed at necropsy. Data was excluded from statistical
analysis.
e No gestation data since no plug was observed, however a Utter was delivered.
/ Dam delivered prior to collection of Day 21 G body weight.
g Accidentally killed Test Day 91 (Day 14G).
1076
Company Sanitized. Does not contain TSCA CBI
INDIVIDUAL BODY WEIGHTS (grams) OF Pi FEMALE RATS DURING GESTATION
GROUP: II-O
DOSE: 0 MG/KG/DAY
GESTATION DAYS:
ANIMAL NUMBER
6433523 643343 643459 6433943 643480 6433192' 643350S 643363 643397 643421 643420s 643419 643414^ 643401 643455 643378 643393^ 643447 643478 643386
14
21
306.1 274.2 318.3 302.2 304.6
306.1 336.7 311.1 269.9 365.6 357.8 343.8 269.6 281.1 359.5
322.0 281.7 287.7
328.9 294.4 355.7 333.8 334.7
311.0 361.8 332.2 301.7 403.0 396.0 381.6 299.9 313.9 383.3
350.3 308.9 308.0
339 .3 322 .4 382 .0 344 .3 363 .5
327 .3 400 .1 369 .3 339 .6 426 .8 428 .2 416 .5 332 .9 340 .2 419 .9
394 .3 340 .8 337 .5
322.7 394.4 478.0 349.9 451.6
318.2 476.5
-C -C 397.9 533.9 370.9 421.3 444.7 471.9
-C 433.1 426.7
1077
Company Sanitized. Does not contain TSCA CBI
INDIVIDUAL BODY WEIGHTS (grams) OF Pi FEMALE RATS DURING GESTATION
GROUP: IV-0
DOSE: 25 MG/KG/DAY
GESTATION DAYS:
ANIMAL NUMBER
643399 643334 643464 643369 643490 643342 643438 6434453 643418 643325 643479 6434033 643376 643422'^ 643452 643475 643372 643400 643395 643457
0
7
14
21
307 .2 292 .4 327 .7 309 .8 301 .0 345 .8 306 .5 391 .8 303 .8 363 .9
-
297 .8 315 .9 349 .0 336 .1 345 .7 315 .4 275 .4 289 .7 307 .2
341 .6 317 .4 348 .1 352 .4 340 .4 375 .2 325 .8 415 .8 335 .6 404 .7
-
323 .0 336 .2 374 .6 375 .7 374 .3 339 .9 287 .3 316 .7 339 .9
366 .8 358 .6 386 .5 386 .7 375 .9 412 .3 345 .9 434 .8 364 .5 388 .7
-
333 .3 368 .6 401 .0 392 .3 383 .9 358 .4 322 .4 339 .3 368 .8
447 .7 C C -
499. .2 437 .9 511 .0 408 .7 422 .7 451 .1 555 .5
-
313 .9 f -
400 .1 445 .3 386 .7 489 .6 371 .4
C C -
1078
Company SanTzed. Does not conta'n TSCA CBI
INDIVIDUAL BODY WEIGHTS (grams) OF PI FEMALE RATS DURING GESTATION
GROUP: VI-0
DOSE: 100 MG/KG/DAY
GESTATION DAYS:
ANIMAL NUMBER
643320 6434883 643428 643439 643353 6433853 643339 6434733 643337 643416 643407 6433573 643331 643427 643470^ 643434 643349 643454 643333 643460
0
7
14
21
312 .5 288 .9 321 .4 294 .8 310 .0 310 .4 304 .7 274 .2 315 .0 271 .5 326 .2 278 .6 313 .6 271 .9
-
297 .8 304 .1 312 .3 266 .4 309 .6
338 .6 311 .2 348 .9 327 .5 346 .8 312 .8 333 .5 288 .1 341 .1 301 .1 358 .4 283 .3 336 .7 299 .6
-
338 .9 345 .1 342 .2 311 .5 331 .7
371 .2
433 .2
326 .3
308 .7
379 .2
455 .2
360 .1
463 .4
381 .7
452 .3
331 .6
301 .9
363 .9
C -
301 .6
296 .6
377 .7 .
C
329 .5
385 .2
405 .3
C -
287 .5
282 .7
366 .4
410 .5
333 .8
381 .4
-
-
362 .3 376 .0 . 373 .7 345 .5 363 .1
454 .8 498 .7
C -
373 .0 451 .8
1079 Company Sanitized. Does not contain TSCA CBI
INDIVIDUAL BODY WEIGHTS (grams) OF Pi FEMALE RATS DURING GESTATION
GROUP: VIII-0
DOSE: 250 MG/KG/DAY
GESTATION DAYS:
ANIMAL NUMBER
643467 643443 643417 643413 643338 643335^ 643468 643440 643430^ 643431-b 643326 643365 643375 643328 6433483 643346 643449 643429 6434243
0
7
14
21
276.6 255.0 331.7 284.5 295.4
-
273.8 292.0 272.4
-
312.0 318.5 312.8 302.1 265.7 307.5 328.1 314.1 240.8
319.8 300.5 364.9 307.1 322.1
-
310.0 327.6 280.6
-
325.1 350.8 361.7 346.1 276.0 263 .6 361.6 348.0 267.8
345.2 336.0 399.2 341.1 354.6
-
347.3 363.4 282.2
-
362.0 369.8 401.2 384.5 283.4
-9 386.4 382.6 281.8
436.3 415.1 495.7 433.6 447.5
-
440.3 476.6 267.0
-
443.6 435.4
-C -C 283.7
-g 493.9 371.4 283.8
1080
Company Sand-zed. Does not contain TSCA CBI
APPENDIX R REPRODUCTIVE TOXICOLOGY INDIVIDUAL BODY WEIGHT GAINS OF Pi FEMALE RATS DURING GESTATION
1081
Company Sanitized. Does not contain TSCA CBI
H-24516: Subchronic Toxicity
90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations_____________DuPont-5386 REPRODUCTIVE TOXICOLOGY
INDIVIDUAL BODY WEIGHT GAINS OF Pi FEMALE RATS DURING GESTATION
EXPLANATORY NOTES
Footnotes
a No litter delivered; data excluded from statistical analysis.
b No gestation data since no copulation plug was observed; no litter was delivered.
c
Data not collected due to error.
d No litter delivered, however, implants were observed at necropsy. Data was excluded from statistical analysis.
e No gestation data since no plug was observed, however a litter was delivered.
/ Dam delivered prior to collection of day 21 G body weight.
g Accidentally killed Test Day 91 (Day 14G).
1082
Company Sanitized. Does not contain TSCA CBI
INDIVIDUAL BODY WEIGHT GAINS (grams) OF Pi FEMALE RATS DURING GESTATION
GROUP: II-O
DOSE: 0 MG/KG/DAY
GESTATION DAYS:
ANIMAL NUMBER
6433523 643343 643459 6433943 643480
6433192?
6433503 643363 643397 643421 6434203 643419 643414'3 643401 643455 643378 643393^ 643447 643478 643386
0-7
7-14
14-21
0-21
22 .8 20 .2 37 .4 31 .6 30 .1
4 .9 25 .1 21 .1 31 .8 37 .4 38 .2 37 .8 30 .3 32 .8 23 .8
28 .3 27 .2 20 .3
10 .4 28 .0 26 .3 10 .5 28 .8
16 .3 38 .3 37 .1 37 .9 23 .8 32 .2 34 .9 33 .0 26 .3 36 .6
44 .0 31 .9 29 .5
-16 .6 72 .0 96 .0 5 .6 88 .1
-9 .1 76 .4
C a -
-28 .9 105 .7 -45 .6
88 .4 104 .5
52 .0
-C 92 .3 89 .2
16 .6 120 .2 159 .7
47 .7 147 .0
12 .1 139 .8
-C -C 32 .3 176 .1 27 .1 151 .7 163 .6 112 .4
-C 151 .4 139 .0
1083 Company Sanitized. Does not contain TSCACBI
INDIVIDUAL BODY WEIGHT GAINS (grams) OF Pi FEMALE RATS DURING GESTATION
GROUP: IV-0 .
DOSE: 25 MG/KG/DAY
GESTATION DAYS:
ANIMAL NUMBER
643399 643334 643464 643369 643490 643342 643438 643445s 643418 643325 643479S 6434033 643376 643422^ 643452 643475 643372 643400 643395 643457
0 -7
7-14
14-21
0-21
34 .4 25 .0
20 .4 42 .6 39 .4 29 .4 19 .3 24 .0 31 .8 40 .8
-
25 .2 20 .3 25 .6 39 .6 28 .6 24 .5 11 .9 27 .0 32 .7
25.2 41.2 38.4 34.3 35.5 37.1 20.1 19.0 28.9 -16.0
-
10.3 32.4 26.4 16.6
9.6 18.5 35.1 22.6 28.9
80.9 -C -C
112.5 62.0 98.7 62.8
-12.1 86.6
166.8
-
-19.4 f
-0.9 53.0
2.8 131.2
49.0
-C -C
140.5 -C -C
189.4 136.9 165.2 102.2
30.9 147.3 191.6
-
16.1 f
51.1 109.2
41.0 174.2
96.0
-C -C
1084
S.n^.O---------"^01'1
Company
INDIVIDUAL BODY WEIGHT GAINS (grams) OF Pi FEMALE RATS DURING GESTATION
GROUP: VI-0
DOSE: 100 MG/KG/DAY
GESTATION DAYS:
ANIMAL NUMBER
643320 643488-3 643428 643439 643353 6433853 643339 6434733 643337 643416 643407 643357^ 643331 643427 643470^ 643434 643349 643454 643333 643460
0-7
7- 14
14-21
0-21
26.1 22.3 27.5 32.7 36.8
2.4 28.8 13.9 26.1 29.6 32.2
4.7 23.1 27.7
41.1 41.0 29.9 45.1 22.1
32 .6 15 .1 30 .3 32 .6 34 .9 18 .8 30 .4 13 .5 36 .6 28 .4 46 .9
4 .2 29 .7 34 .2
23 .4 30 .9 31 .5 34 .0 31 .4
62.0 -17.6
76.0 103.3
70.6 -29.7
-C
-5.0
-C 55.7
-C
-4.8 44.1
47.6
92.5 122.7
-C
27.5 88.7
120.7 19.8
133.8 168.6 142.3
-8.5 c
22.4 -C
113.7 -C
4.1 96.9 109.5
157.0 194.6
-C 106.6 142.2
1085 Company Sanitized. Does not contain TSCA CBI
INDIVIDUAL BODY WEIGHT GAINS (grams) OF Pi FEMALE RATS DURING GESTATION
GROUP: VIII-0
DOSE: 250 MG/KG/DAY
GESTATION DAYS:
AMIMAL NUMBER
643467 643443 643417 643413 643338 6433356 643468 643440 6434303 643431^ 643326 643365 643375 643328 6433483 643346 643449 643429 6434243
0-7
7-14
14-21
0- 21
43.2 45.5 33,2 22.6 26.7
-
36.2 35.6
8.2
-
13.1 32.3 48.9 44.0 10.3 -43.9 33.5 33.9 27.0
25.4 35.5 34.3 34.0 32.5
-
' 37.3 35.8 1.6
-
36.9 19.0 39.5 38.4
7.4 -g 24.8 34.6 14.0
91.1 79.1 96.5 92.5 92.9
-
93.0 113.2 -15.2
-
81.6 65.6
-C -C 0.3
-9 107.5 -11.2
2.0
159 .7 160 .1 164 .0 149 .1 152 .1
-
166 .5 184 .6
-5 .4
-
131 .6 116 .9
C -
C -
18 .0
- 9
165 .8 57 .3 43 .0
1086 Company Sanitized. Does not contain TSCACB1
APPENDIX S REPRODUCTIVE TOXICOLOGY INDIVIDUAL BODY WEIGHTS OF Pi FEMALE RATS DURING LACTATION
1087
Company Sanitized. Does not contain TSCA CSS
H-24516: Subchronic Toxicity
90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations_____________DuPont-5386
REPRODUCTIVE TOXICOLOGY INDIVIDUAL BODY WEIGHTS OF Pi FEMALE RATS DURING LACTATION
EXPLANATORY NOTES
Footnotes
a No litter delivered. b No litter delivered, however, implants were observed at necropsy. Data was excluded from
statistical analysis.
c Found Dead Test Day 99 (Day 22G). d Accidentally killed Test Day 91 (Day 14G). e Found dead Test Day 106 (Lactation Day 0).
1088
Company Sanded. Does not contain T8CA C6)
INDIVIDUAL BODY WEIGHTS (grams) OF Pi FEMALE RATS DURING LACTATION
GROUP: II-O
DOSE: 0 MG/KG/DAY
LACTATION
DAYS:
0
ANIMAL NUMBER
7
14
21
643352^ 643343 643459 6433943 643480 6433193 6433503 643363 643397 643421 6434203 643419
643414-13
643401 643455 643378 6433933 643447 643478 643386
297.4 360.5
331.7
367.4 356.1 320.1
412.6
312.9 305.9 389.9
387.7 320.5 329.0
319.1 378.4
353.2
335.8 392.7
361.0
380.0 300.2 320.1
398.0
324.1 327.2 372.2
376.9 321.5 339.2
392.4 358.8 283.8
414.8
338.7 343.3 375.9
-387.2 355.5 347.9
336.3 377.8
330.8
379.1 361.1 286.3
402.9
324.0 331.8 376.7
365.9 339.1 354.3
1089
Company Sanitized. Does not contain TSCA CBI
INDIVIDUAL BODY WEIGHTS (grams) OF Pi FEMALE RATS DURING LACTATION
GROUP: IV-0
DOSE: 25 MG/KG/DAY
LACTATION DAYS:
ANIMAL NUMBER
643399 643334 643464 643369 643490 643342 643438 6434453 643418 643325 643479 643403s 643376 643422^ 643452 643475 643372 643400 643395 643457
14
21
340 .9 328 .5 369 .8 360 .2 325 .7 381 .6 336 .3
-
352 .7 435 .4 341 .2
-
343 .9
-
324 .7 367 .9 363 .1 301 .4 336 .2 368 .5
352 .7 346 .8 306 .1 375 .6 354 .9 377 .3 339 .9
-
353 .4 434 .8 301 .7
-
337 .0
-
334 .1 372 .6 347 .0 322 .5 345 .5 370 .5
387 .6 370 .7 385 .7 398 .1 388 .4 397 .8 368 .7
-
368 .1 431 .8 370 .2
-
371 .9
-
375 .4 394 .0 374 .3 344 .7 364 .6 383 .5
342 .4 355 .0 391 .5 377 .9 353 .7 381 .8 352 .0
-
346 .4 405 .7 358 .6
-
366 .9
-
375 .0 388 .9 346 .7 356 .0 350 .5 371 .1
1090 Company Sanitized. Does not contain TSCA CBI
INDIVIDUAL BODY WEIGHTS (grams) OF Pi FEMALE RATS DURING LACTATION
GROUP: VI-0
DOSE: 100 MG/KG/DAY
LACTATION DAYS:
ANIMAL NUMBER
643320 6434883 643428 643439 643353 6433853 643339 643473s 643337 643416 643407 6433573 643331 643427 6434703 643434 643349 643454 643333 643460
14
21
376.8
-
354.8 353.1 379.7
-
338.5
-
367.8 330.7 318.1
-
294.7 292.9
-
335.9 354.1
-
270.6 353.6
371.7
-
374.9 353.0 374.0
_
346.9
-
373.5 319.5 328.4
-
345.0 334.4
-
355.2 369.3
-
341.2 313.3
370.7
-
390.6 374.6 393.0
-
378.5
-
389.2 350.1 341.4
-
379.3 341.2
-
376.9 390.1
-
371.2 353.0
367.8
-
380.6 363.0 360.9
-
353.0
-
381.7 341.5 356.3
-
378.3 329.2
-
360.8 365.2
-
346.8 360.0
1091
Company Sanitized. Does not contain TSCA CBI
INDIVIDUAL BODY WEIGHTS (grams) OF Pi FEMALE RATS DURING LACTATION
GROUP: VIII-0
DOSE: 250 MG/KG/DAY
LACTATION DAYS:
ANIMAL NUMBER
643467 643443 643417 643413 643338 643335 643468 643440 643430^ 6434313 643326 643365 643375 643328 6433483 643346'3 643449 643429 6434243
14
21
345 .3 316 .1 388 .9 324 .2 328 .8 328 .7 319 .8 345 .3
336 .2 353 .2 365 .3 327 .5
363.0
350 .1 331 .3 408 .9 343 .5 341 .2 359 .9 322 .9 304 .2
348 .6 353 .4 366 .3 340 .3
370.6
362 .8 352 .8 415 .0 348 .9 371 .8 319 .0 348 .4 384 .3
375 .2 371 .2 368 .3 305 .6
391.2
345 .4 259 .3 306 .4 283 .6 357 .6 362 .4 319 .3 390 .6
361 .5 380 .5 378 .7 312 .4
377.1
1092 Company Sanitized. Does not contain TSCA CBf
APPENDIX T REPRODUCTIVE TOXICOLOGY INDIVIDUAL BODY WEIGHT GAINS OF Pi FEMALE RATS DURING LACTATION
1093
Company Sanitized. Does not contain TSCACM
^T
H-24516: Subchronic Toxicity
90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations_____________DuPont-5386 REPRODUCTIVE TOXICOLOGY
INDIVIDUAL BODY WEIGHT GAINS OF Pi FEMALE RATS DURING LACTATION
EXPLANATORY NOTES
Footnotes
a No litter delivered. b No litter delivered, however, implants were observed at necropsy. Data were excluded from
statistical analysis.
c Found Dead Test Day 99 (Day 22G). d Accidentally killed Test Day 91 (Day 14G). e Found Dead Test Day 106 (Lactation Day 0).
1094
Company Sanitized. Does not contain TSCA CBI
INDIVIDUAL BODY WEIGHT GAINS (grams) OF Pi FEMALE RATS DURING LACTATION
GROUP: II-O
DOSE: 0 MG/KG/DAY
LACTATION DAYS:
ANIMAL NUMBER
6433523 643343 643459 . 6433943 643480 6433193 6433503 643363 643397 643421 6434203 643419 643414h 643401 643455 643378 6433933 643447 643478 643386
0-7
7-14
14-21
0-21
-
21.7 17.9
-
21.5
-
-
12.6 -55.9
0.0
_
-14.6
-
11.2 21.3 -17.7
-
-10.8 1.0
10.2
-
16.7 14.3
-
7.8
-
-
12.4 58.6 -36.3
-
16.8
-
14.6 16.1
3.7
-
10.3 34.0
8.7
-
0.5 -14.9
.
-30.2
-
-
-13.3 2.3 2.5
-
-11.9
-
-14.7 -11.5
0.8
-
-21.3 -16.4
6.4
-
38.9 17.3
-
-0.9
-
-
11.7 5.0
-33.8
-
-9.7
-
11.1 25.9 -13.2
-
-21.8 18.6 25.3
1095
Company Sanitized. Does not contain TSCA CBl
INDIVIDUAL BODY WEIGHT GAINS (grams) OF P^ FEMALE RATS DURING LACTATION
GROUP: IV-0
DOSE: 25 MG/KG/DAY
LACTATION DAYS:
ANIMAL NUMBER
643399 643334 643464 643369 643490 643342 643438 643445^ 643418 643325 643479 643403^ 643376 643422^ 643452 643475 643372 643400 643395 643457
0-7
7-14
14-21
0-21
11.8 18.3 63.7 15.4 29.2 -4.3 3.6
0.7 -0.6 39.5
-6.9
9.4 4.7 16.1 21.1 9.3 2.0
34 .9 23 .9 79 .6 22 .5 33 .5 20 .5 28 .8
14 .7 -3 .0 68.5
34 .9
41 .3 21 .4 27 .3 22 .2 19 .1 13 .0
-45.2 -15.7
5.8 -20.2 -34.7 -16.0 -16.7
-21.7 -26.1 -11.6
-5.0
-0.4 -5.1 -27.6
11.3
-14.1 -12.4
1.5 26.5 21.7 17.7 28.0
0.2 15.7
-6.3 -29.7 17.4
23.0
50.3 21.0 -16.4 54.6
-14.3
2.6
1096
Company Sanitized. Does not contain TSCA CBI
INDIVIDUAL BODY WEIGHT GAINS (grams) OF Pi FEMALE RATS DURING LACTATION
GROUP: VI-0
DOSE: 100 MG/KG/DAY
LACTATION DAYS:
ANIMAL NUMBER
643320 6434883 643428 643439 643353 6433853 643339 6434733 643337 643416 643407 6433573 643331 643427 6434703 643434 643349 643454 643333 643460
0 -7
-5 .1
-
20 .1 -0 .1 -5 .7
-
8 .4
-
5 .7 -11 .2
10 .3
-
50 .3 41 .5
-
19 .3 15 .2
-
70 .6 -40 .3
7-14
14- 21
0-21
-1.0
-
15.7 21.6 19.0
-
31.6
-
15.7 30.6 13.0
-
34.3 6.8
-
21.7 20.8
-
30.0 39.7
-2 .9
-
-10 .0 -11 .6 -32 .1
-
-25 .5
-
-7 .5 -8 .6 14 .9
-
-1 .0 -12 .0
-
-16 .1 -24 .9
-
-24 .4 7 .0
-9.0
-
25.8 9.9
-18.8
-
14.5
-
13.9 10.8 38.2
-
83.6 36.3
-
24.9 11.1
-
76.2 6.4
1097
CgoommnpwanvySSa"ann*ii(gMeJ-d.l9Dooaesno ^i c-on<tainwT<SC^A^OgB( 7
INDIVIDUAL BODY WEIGHT GAINS (grams) OF Pi FEMALE RATS DURING LACTATION
GROUP: VIII-0
DOSE: 250 MG/KG/DAY
LACTATION DAYS:
ANIMAL NUMBER
643467 643443 643417 643413 643338 643335 643468 643440 6434303 6434313 643326 643365 643375 643328 6433483 643346^ 643449 643429 6434243
0-7
7-14
14-21
0-21
4 .8 15 .2 20 .0 19 .3 12 .4 31 .2
3 .1 -41 .1
-
-
12 .4 0 .2 1 .0
12 .8
-
-
7 .6
-
-
12 .7 21 .5
6 .1 5 .4 30 .6 -40 .9 25 .5 80 .1
-
-
26 .6 17 .8
2 .0
-34 .7
-
-
20 .6
-
-
-17. 4 -93. 5 -108. 6 -65. 3 -14. 2 43. 4 -29. 1
6. 3
-
-
-13. 7 9. 3
10. 4 6. 8
-
-
-14. 1
-
-
0. 1
-56. 8 -82. 5 -40. 6 28. 8 33. 7 -0. 5 45. 3
-
-
25. 3 27. 3 13. 4
-15. 1
-
-
14. 1
-
-
1098
Company Sanitized. Does not contain TSCA CB1
APPENDIX U REPRODUCTIVE TOXICOLOGY INDIVIDUAL DAILY FOOD CONSUMPTION BY Pi FEMALE RATS
DURING GESTATION
1099
Company Sanitized. Does not contain TSCA CBI
H-24516: Subchronic Toxicity
90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations_____________DuPont-5386
REPRODUCTIVE TOXICOLOGY INDIVIDUAL DAILY FOOD CONSUMPTION BY Pi FEMALE RATS
DURING GESTATION EXPLANATORY NOTES
Footnotes
a No litter delivered; data excluded from statistical analysis. b No gestation data since no plug was observed; no litter was delivered. c No litter delivered, however, implants were observed at necropsy. Data were excluded from
statistical analysis.
d No gestation data since no plug was observed, however a litter was delivered. e Accidentally killed Test Day 91 (Day 14G).
1100
Company Sanitized. Does not contain TSCA CBI
INDIVIDUAL DAILY FOOD CONSUMPTION (grams) BY Pi FEMALE RATS DURING GESTATION
GROUP: II-O
DOSE: 0 MG/KG/DAY
GESTATION DAYS:
ANIMAL NUMBEF|
6433523 643343 643459 6433943 643480 643319^ 6433503 643363 643397 643421 6434203 643419 643414^ 643401 643455 643378 643393^ 643447 643478 643386
0 -7
24 .5 20 .9 26 .3 27 .7 15 .4 21 .6 29 .6 25 .9 23 .3 34 .6 30 .0 30 .8 25 .5 23 .2 . 27 .5 27 .2 25 .3 21 .8
7- 14
14-2 1
25 .8 25 .1 27 .7 25 .9 30 .3
26 .3 32 .5 28 .1 27 .9 35 .1 32 .3 29 .4 29 .0 37 .1 32 .6
31 .4 27 .2 22 .7
19. 8 25. 0 25. 2 25. 4
9. 0
21. 8 30. 1 28. 4 26. 2 22. 1 31. 2 23. 6 29. 4 24. 6 28. 8
30. 9 26. 3 23. 8
0- 21
23 .4 23 .7 26 .4 26 .4 18 .2 23 .2 30 .7 27 .5 25 .8 30 .6 31 .2 27 .9 28 .0 28 .3 29 .6 29 .8 26 .3 22 .8
1101
Company Sanitized. Does not contain TSCA CBt
INDIVIDUAL DAILY POOD CONSUMPTION (grams) BY Pi FEMALE RATS DURING GESTATION
GROUP: IV-0
DOSE: 25 MG/KG/DAY
GESTATION DAYS:
ANIMAL NUMBER
643399 643334 643464 643369 643490 643342 643438 643445s 643418 643325
643479..d
643403^ 643376 643422C 643452 643475 643372 643400 643395 643457
0 -7
23 .8 24 .1 ..23 .4 27 .6 27 .8 28 .5 20 .4 26 .1 25 .2 32 .1
-
22 .9 22 .6 24 .1 27 .1 26 .7 21 .5 23 .7 24 .0 25 .5
7-1.4
14- 21
28. 3 26. 0 26. 1 27. 4 28. 8 28. 9 22. 4
28. 4 26. 5 35. 4
-
22. 9 24. 6 31. 2 27. 4 26. 2 22. 3 24. 1 23. 5 28. 5
27 .8 27 .3 27 .1 24 .6 27 .0 29 .1 26 .4
6 .5 24 .8 37 .1
-
19 .5 26 .4 29 .3 26 .6 24 .4 32 .5 25 .0 22 .9 26 .4
0- 21
26 .6 25 .8 25 .5 26 .5 27 .9 28 .8 23 .1 20 .3 25 .5 34 .9
-
21 .7 24 .6 28 .2 27 .0 25 .8 25 .4 24 .3 23 .5 26 .8
1102
Company Sanitized. Does not contain TSCA C31
INDIVIDUAL DAILY FOOD CONSUMPTION (grams) BY Pi FEMALE RATS DURING GESTATION
GROUP: VI-0
DOSE: 100 MG/KG/DAY
GESTATION DAYS:
ANIMAL NUMBER
643320 6434883 643428 643439 643353 6433853 643339 6434733 643337 643416 643407 643357S 643331 643427 64347023 643434 643349 643454 643333 643460
0- 7
7-1.4
14-2 1
0- 21
26. 8 22. 5 25. 6 25. 2 28. 3 21. 0 26. 8 22. 3 23. 3 24. 9 27. 9 17. 7 22. 9 22. 8
-
30. 0 25. 6 26. 7 26. 9 23. 8
32. 4 24. 2 27. 7 28. 8 30. 1 22. 4 27. 6 22. 8 29. 8 27. 5 30. 7 21. 2 27. 2 25. 0
-
28. 0 26. 7 28. 1 29. 8 . 26. 9
29. 5 16. 8 26. 7 28. 1 30. 5 18. 3 28. 7 19. 0 33. 4 27. 0 26. 8 18. 2 22. 3 23. 4
-
26. 3 21. 5 26. 6 26. 6 28. 1
29 .6 21 .2 26 .7 27 .4 29 .6 20 .6 27 .7 21 .3 28 .8 26 .4 28 .5 19 .1 24 .1 23 .7
-
28 .1 24 .6 27 .1 27 .8 26 .3
1103
Company Sanitized. Does not contain TSCA CSf
INDIVIDUAL DAILY FOOD CONSUMPTION (grams) BY Pi FEMALE RATS DURING GESTATION
GROUP: VIII-0
DOSE: 250 MG/KG/DAY
GESTATION DAYS:
ANIMAL NUMBER
643467 643443 643417 643413 643338 643333d 643468 643440 643430^ 643431^ 643326 643365 643375 643328 6433483 643346 643449 643429 6434243
0 -7
7- 14
14-2 1
0-21
32 .1 25 .5 27 .0 29 .1 25 .3
26 .7 28 .9 25 .4
25 .1 29 .6 27 .7 30 .5 24 .0 14 .3 31 .0 22 .5 19 .4
30 .2 . 26 .3
26 .4 28 .6 29 .4
27 .7 29 .5 22 .1
27 .7 30 .5 31 .7 32 .2 24 .2 36 .8 26 .1 25 .3 22 .7
31. 7 23. 8 24. 3 18. 7 32. 4
28. 9 26. 3 17. 3
28. 7 27. 0 30. 0 27. 0 23. 9
-e 28. 8
. 17. 3 21. 0
31.3 25.2 25.9 25.5 29.0
27.8 28.2 21.6
27.2 29.0 29.8 29.9 24.0
-e 28.7 21.7 21.0
1104
Company Sanitized. Does not contain TSCA CBI
APPENDIX V REPRODUCTIVE TOXICOLOGY INDIVIDUAL CLINICAL OBSERVATIONS IN Pi MALE RATS
1105
Company Sanitized. Does not contain TSCA CBl
INDIVIDUAL CLINICAL OBSERVATIONS IN Pi MALE RATS
GROUP: 1-0
DOSE: 0 MG/KG/DAY
ANIMAL NUMBER
OBSERVATION
FIRST DAY
OBSERVED
LAST DAY OBSERVED
643239 643270 643148 643284 643229 643196 643176 643218 643207
643280 643271 . 643211 643163 643197
NO ABNORMALITIES DETECTED SACRIFICED BY DESIGN TEST DAY 107
NO ABNORMALITIES DETECTED SACRIFICED BY DESIGN TEST DAY 107
NO ABNORMALITIES DETECTED SACRIFICED BY DESIGN TEST DAY 107
NO ABNORMALITIES DETECTED SACRIFICED BY DESIGN TEST DAY 107
NO ABNORMALITIES DETECTED SACRIFICED BY DESIGN TEST DAY 107
NO ABNORMALITIES DETECTED SACRIFICED BY DESIGN TEST DAY 108
NO ABNORMALITIES DETECTED SACRIFICED BY DESIGN TEST DAY 108
NO ABNORMALITIES DETECTED SACRIFICED BY DESIGN TEST DAY 108
ALOPECIA RIGHT FRONT PAW(S) ALOPECIA BOTH FRONT PAW(S) SACRIFICED BY DESIGN TEST DAY 108
NO ABNORMALITIES DETECTED SACRIFICED BY DESIGN TEST DAY 108
NO ABNORMALITIES DETECTED SACRIFICED BY DESIGN TEST DAY 109
NO ABNORMALITIES DETECTED SACRIFICED BY DESIGN TEST DAY 109
NO ABNORMALITIES DETECTED SACRIFICED BY DESIGN TEST DAY 109
NO ABNORMALITIES DETECTED SACRIFICED BY DESIGN TEST DAY 109
85
85
92
108
1106
Company Sanitized. Does not contain TSCA CO)
INDIVIDUAL CLINICAL OBSERVATIONS IN PI MALE RATS
GROUP: 1-0
DOSE: 0 MG/KG/DAY
AMIMAL NUMBER
OBSERVATION
FIRST DAY
OBSERVED
LAST DAY OBSERVED
643242 643251 643155 643147 643276 643254
NO ABNORMALITIES DETECTED SACRIFICED BY DESIGN TEST DAY 109
NO ABNORMALITIES DETECTED SACRIFICED BY DESIGN TEST DAY 109
NO ABNORMALITIES DETECTED SACRIFICED BY DESIGN TEST DAY 109
NO ABNORMALITIES DETECTED SACRIFICED BY DESIGN TEST DAY 109
NO ABNORMALITIES DETECTED SACRIFICED BY DESIGN TEST DAY 109
NO ABNORMALITIES DETECTED SACRIFICED BY DESIGN TEST DAY 109
1107
Company Sanitized. Does not contain TSCACBI
INDIVIDUAL CLINICAL OBSERVATIONS IN Pi MALE RATS
GROUP: III-O
DOSE: 25 MG/KG/DAY
ANIMAL NUMBER
OBSERVATION
FIRST DAY
OBSERVED
LAST DAY OBSERVED
643287 643188 643230 643170 643144 643277 643214 643261 643166 643153 643177 643198 643291 643184
NO ABNORMALITIES DETECTED SACRIFICED BY DESIGN TEST DAY 107
.NO ABNORMALITIES DETECTED SACRIFICED BY DESIGN TEST DAY 107
NO ABNORMALITIES DETECTED SACRIFICED BY DESIGN TEST DAY 107
NO ABNORMALITIES DETECTED SACRIFICED BY DESIGN TEST DAY 107
NO ABNORMALITIES DETECTED SACRIFICED BY DESIGN TEST DAY 107
NO ABNORMALITIES DETECTED SACRIFICED BY DESIGN TEST DAY 108
NO ABNORMALITIES DETECTED SACRIFICED BY DESIGN TEST DAY 108
NO ABNORMALITIES DETECTED SACRIFICED BY DESIGN TEST DAY 108
NO ABNORMALITIES DETECTED SACRIFICED BY DESIGN TEST DAY 108
NO ABNORMALITIES DETECTED SACRIFICED BY DESIGN TEST DAY 108
NO ABNORMALITIES DETECTED SACRIFICED BY DESIGN TEST DAY 109
NO ABNORMALITIES DETECTED SACRIFICED BY DESIGN TEST DAY 109
NO ABNORMALITIES DETECTED SACRIFICED BY DESIGN TEST DAY 109
NO ABNORMALITIES DETECTED SACRIFICED BY DESIGN TEST DAY 109
1108 Company Sanitized. Does not contain TSCA CBI
INDIVIDUAL CLINICAL OBSERVATIONS IN Pi MALE RATS
GROUP: III-O
DOSE: 25 MG/KG/DAY
ANIMAL NUMBER
OBSERVATION
FIRST DAY
OBSERVED
LAST DAY OBSERVED
643167 643223 643233 643183 643219 643263
NO ABNORMALITIES DETECTED SACRIFICED BY DESIGN TEST DAY 109
NO ABNORMALITIES DETECTED SACRIFICED BY DESIGN TEST DAY 109
NO ABNORMALITIES DETECTED SACRIFICED BY DESIGN TEST DAY 109
NO ABNORMALITIES DETECTED SACRIFICED BY DESIGN TEST DAY 109
NO ABNORMALITIES DETECTED SACRIFICED BY DESIGN TEST DAY 109
NO ABNORMALITIES DETECTED SACRIFICED BY DESIGN TEST DAY 109
1109
Company Sanitized. Does not contain TSCA CBI
INDIVIDUAL CLINICAL OBSERVATIONS IN Pi MALE RATS
GROUP: V-0
DOSE: 100 MG/KG/DAY
ANIMAL NUMBER
OBSERVATION
FIRST DAY OBSERVED
LAST DAY OBSERVED
643313 643182 643146 643312 643199 643267 643216 643244 643245 643301
643200 643255 643157 643238
NO ABNORMALITIES DETECTED SACRIFICED BY DESIGN TEST DAY 107
NO ABNORMALITIES DETECTED SACRIFICED BY DESIGN TEST DAY 107
ALOPECIA BOTH FRONT PAW(S) SACRIFICED BY DESIGN TEST DAY 107
NO ABNORMALITIES DETECTED SACRIFICED BY DESIGN TEST DAY 107
NO ABNORMALITIES DETECTED SACRIFICED BY DESIGN TEST DAY 107
NO ABNORMALITIES DETECTED SACRIFICED BY DESIGN TEST DAY 108
NO ABNORMALITIES DETECTED SACRIFICED BY DESIGN TEST DAY 108
NO ABNORMALITIES DETECTED SACRIFICED BY DESIGN TEST DAY 108
NO ABNORMALITIES DETECTED SACRIFICED BY DESIGN TEST DAY 108
ALOPECIA LEFT FRONT PAW(S) ALOPECIA LEFT FRONT LEG(S) SACRIFICED BY DESIGN TEST DAY 108
NO ABNORMALITIES DETECTED SACRIFICED BY DESIGN TEST DAY 109
NO ABNORMALITIES DETECTED SACRIFICED BY DESIGN TEST DAY 109
NO ABNORMALITIES DETECTED SACRIFICED BY DESIGN TEST DAY 109
NO ABNORMALITIES DETECTED, SACRIFICED BY DESIGN TEST DAY 109
85
107
85
108
85
108
1110 Company SanilAeti. uues ut contain TSCACBI
INDIVIDUAL CLINICAL OBSERVATIONS IN Pi MALE RATS
GROUP: V-0
DOSE: 100 MG/KG/DAY
ANIMAL NUMBER
OBSERVATION
FIRST DAY OBSERVED
LAST DAY OBSERVED
643227 643164 643154 643156 643208 643190
NO ABNORMALITIES DETECTED SACRIFICED BY DESIGN TEST DAY 109
NO ABNORMALITIES DETECTED SACRIFICED BY DESIGN TEST DAY 109
NO ABNORMALITIES DETECTED SACRIFICED BY DESIGN TEST DAY 109
NO ABNORMALITIES DETECTED SACRIFICED BY DESIGN TEST DAY 109
NO ABNORMALITIES DETECTED SACRIFICED BY DESIGN TEST DAY 109
NO ABNORMALITIES DETECTED SACRIFICED BY DESIGN TEST DAY 109
1111
Company Sanitized. Does not contain TSCA CB(
INDIVIDUAL CLINICAL OBSERVATIONS IN Pi MALE RATS
GROUP: VI I-0
DOSE: 250 MG/KG/DAY
ANIMAL NUMBER
OBSERVATION
FIRST DAY
OBSERVED
LAST DAY OBSERVED
643289 643171
643158 643249 643161 643248
643285 643278 643299 643274 643192 643222
NO ABNORMALITIES DETECTED SACRIFICED BY DESIGN TEST DAY 107
COLORED DISCHARGE RIGHT EYE(S) RED TEETH CLIPPED ALOPECIA BOTH FRONT LEG(S) ALOPECIA BOTH FRONT PAW(S) SACRIFICED BY DESIGN TEST DAY 107
NO ABNORMALITIES DETECTED SACRIFICED BY DESIGN TEST DAY 107
NO ABNORMALITIES DETECTED SACRIFICED BY DESIGN TEST DAY 107
TEETH CLIPPED SACRIFICED BY DESIGN TEST DAY 107
TEETH CLIPPED COLORED DISCHARGE NOSE BLACK COLORED DISCHARGE BOTH EYE(S) TEETH CROOKED COLORED DISCHARGE RIGHT EYE(S) SACRIFICED BY DESIGN TEST DAY
RED
RED 108
NO ABNORMALITIES DETECTED SACRIFICED BY DESIGN TEST DAY 108
NO ABNORMALITIES DETECTED SACRIFICED BY DESIGN TEST DAY 108
NO ABNORMALITIES DETECTED SACRIFICED BY DESIGN TEST DAY 108
TEETH CLIPPED SACRIFICED BY DESIGN TEST DAY 108
NO ABNORMALITIES DETECTED SACRIFICED BY DESIGN TEST DAY 109
NO ABNORMALITIES DETECTED SACRIFICED BY DESIGN TEST DAY 109
85
92
85
85
99
107
99
107
85
85
85
92
99
106
99
106
99
108
108
108
85
85
1112
Company Sanitized. Does noi contain TSCA CBI
INDIVIDUAL CLINICAL OBSERVATIONS IN Pi MALE RATS
GROUP: VI I-0
DOSE: 250 MG/KG/DAY
ANIMAL NUMBER
OBSERVATION
FIRST DAY
OBSERVED
LAST DAY OBSERVED
643160 643191 643203 643282 643302 643317 643281
NO ABNORMALITIES DETECTED SACRIFICED BY DESIGN TEST DAY 109
NO ABNORMALITIES DETECTED SACRIFICED BY DESIGN TEST DAY 109
NO ABNORMALITIES DETECTED SACRIFICED BY DESIGN TEST DAY 109
NO ABNORMALITIES DETECTED SACRIFICED BY DESIGN TEST DAY 109
TEETH CLIPPED SACRIFICED BY DESIGN TEST DAY 109
NO ABNORMALITIES DETECTED SACRIFICED BY DESIGN TEST DAY 109
NO ABNORMALITIES DETECTED SACRIFICED BY DESIGN TEST DAY 109
85
92
113
Company S^,t..eQ. uoes noi contain TSCACBI
H-24516: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations
DuPont-5386
APPENDIX W
REPRODUCTIVE TOXICOLOGY
INDIVIDUAL CLINICAL OBSERVATIONS IN Pi FEMALE RATS DURING GESTATION
1114 Company Sanitized. Does not contain TSCACBl
H-24516: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations
REPRODUCTIVE TOXICOLOGY
DuPont-5386
INDIVIDUAL CLINICAL OBSERVATIONS DM Pi FEMALE RATS DURING GESTATION
Footnotes
EXPLANATORY NOTES
a Copulation plug observed but no litter delivered. b Data not collected on day 21 due to error. c No litter delivered, however, implantation sites observed at necropsy.
Notes
This appendix includes only signs from rats with copulation plug observed.
1115
Company Sanitized. Does not contain TSCA CB1
H-24516: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations
DuPont-5386
INDIVIDUAL CLINICAL OBSERVATIONS IN Pi FEMALE RATS DURING GESTATION
GROUP: II-O
DOSE: 0 MG/KG/DAY
ANIMAL NUMBER
OBSERVATION
FIRST DAY
OBSERVED
LAST DAY OBSERVED
6433523 643343 643459 643394s 643480 6433503 643363 643397^ 64342123 6434203
NO NO
NO NO NO
NO NO NO
NO ABNORMALITIES DETECTED
NO ABNORMALITIES DETECTED
NO ABNORMALITIES DETECTED
NO ABNORMALITIES DETECTED
NO ABNORMALITIES DETECTED
NO ABNORMALITIES DETECTED
NO ABNORMALITIES DETECTED
NO ABNORMALITIES DETECTED
NO ABNORMALITIES DETECTED
ALOPECIA RIGHT FRONT LEG
ALOPECIA RIGHT FRONT PAW
643419 ALOPECIA RIGHT SHOULDER SORE RIGHT SHOULDER
ABNORMALITIES DETECTED
664433440114C ABNORMALITIES DETECTED ABNORMALITIES DETECTED 643455 ABNORMALITIES DETECTED 643378
ABNORMALITIES DETECTED
664433447487^ ABNORMALITIES DETECTED ABNORMALITIES DETECTED 643386
ABNORMALITIES DETECTED 21
21
21
21
21
21
21
21
11
Company Sanitized. Does not contain TSCACBI
H-24516: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations
DuPont-5386
INDIVIDUAL CLINICAL OBSERVATIONS IN Pi FEMALE RATS DURING GESTATION
GROUP: IV-0
DOSE: 25 MG/KG/DAY
ANIMAL NUMBER
OBSERVATION
FIRST DAY
OBSERVED
LAST DAY OBSERVED
643399 643334b 643464^ 643369 643490 643342
643438 6434453 643418 643325 6434033 643376 643422C 643452 643475 643372 643400 643395^ 643457^
NO ABNORMALITIES DETECTED NO ABNORMALITIES DETECTED NO ABNORMALITIES DETECTED NO ABNORMALITIES DETECTED NO ABNORMALITIES DETECTED ALOPECIA RIGHT FRONT LEG(S) ALOPECIA BOTH FRONT LEG(S) NO ABNORMALITIES DETECTED
NO ABNORMALITIES DETECTED NO ABNORMALITIES DETECTED NO ABNORMALITIES DETECTED NO ABNORMALITIES DETECTED NO ABNORMALITIES DETECTED NO ABNORMALITIES DETECTED NO ABNORMALITIES DETECTED NO ABNORMALITIES DETECTED NO ABNORMALITIES DETECTED NO ABNORMALITIES DETECTED NO ABNORMALITIES DETECTED NO ABNORMALITIES DETECTED
14
21
1117
Company Sanitized. Does not contain TSCA CBI
H-24516: Subchionic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations
DuPont-5386
INDIVIDUAL CLINICAL OBSERVATIONS IN PI FEMALE RATS DURING GESTATION
GROUP: VI-0
DOSE: 100 MG/KG/DAY
AMIMAL NUMBER
OBSERVATION
FIRST DAY OBSERVED
LAST DAY OBSERVED
643320 6434883 643428 643439 643353 6433853 64333923 643473s 643337^ 643416 643407^ 6433573 643331 643427 643434 643349 643454!) 643333 643460
NO ABNORMALITIES DETECTED NO ABNORMALITIES DETECTED NO ABNORMALITIES DETECTED NO ABNORMALITIES DETECTED NO ABNORMALITIES DETECTED NO ABNORMALITIES DETECTED NO ABNORMALITIES DETECTED NO ABNORMALITIES DETECTED STAINED ABDOMEN YELLOW NO ABNORMALITIES DETECTED ALOPECIA LEFT FRONT LEG(S) STAINED PERINEUM YELLOW NO ABNORMALITIES DETECTED NO ABNORMALITIES DETECTED NO ABNORMALITIES DETECTED NO ABNORMALITIES DETECTED
FOUND DEAD 03/20/01 (Test Day 99)
NO ABNORMALITIES DETECTED ALOPECIA LEFT FRONT LEG(S) ALOPECIA BOTH FRONT LEG(S)
14
22
22
14
21
1118
Company Sanitized. Does not contain TSCA CBI
H-24516: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations
DuPont-5386
INDIVIDUAL CLINICAL OBSERVATIONS IN P^ FEMALE RATS DURING GESTATION
GROUP: VIII-0
DOSE: 250 MG/KG/DAY
ANIMAL NUMBER
OBSERVATION
FIRST DAY OBSERVED
LAST DAY OBSERVED
643467
ALOPECIA LEFT HIND QUARTERS
21
ALOPECIA RIGHT SIDE(S)
21
643443
NO ABNORMALITIES DETECTED
643417
NO ABNORMALITIES DETECTED
643413
NO ABNORMALITIES DETECTED
643338
NO ABNORMALITIES DETECTED
643468
NO ABNORMALITIES DETECTED
643440
NO ABNORMALITIES DETECTED
6434303
STAINED PERINEUM YELLOW WET PERINEUM
643326
NO ABNORMALITIES DETECTED
643365
NO ABNORMALITIES DETECTED
643375
NO ABNORMALITIES DETECTED
643328
NO ABNORMALITIES DETECTED
6433483
NO ABNORMALITIES DETECTED
643346
ACCIDENTALLY KILLED 03/12/01 (Test Day 91)
14
14
643449
NO ABNORMALITIES DETECTED
643429
ALOPECIA BOTH REAR LEG(S) ALOPECIA RIGHT FRONT LEG(S) TEETH CLIPPED ALOPECIA RIGHT FRONT PAW(S) DIARRHEA WET UNDERBODY
STAINED PACE BROWN WEAK
0
21
0
14
0
0
21
21
21
21
21
21
21
21
21
21
6434243
NO ABNORMALITIES DETECTED
1119
Company Sanitized. Does not contain TSCA CBI
APPENDIX X REPRODUCTIVE TOXICOLOGY INDIVIDUAL CLINICAL OBSERVATIONS IN Pi FEMALE RATS
DURING LACTATION
1120 Company Sanitized. Does not contain TSCACBI
^^
H-24516: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations
__________DuPont-5386
REPRODUCTIVE TOXICOLOGY
INDIVIDUAL CLINICAL OBSERVATIONS IN Pi FEMALE RATS DURING LACTATION EXPLANATORY NOTES
Footnotes
a No copulation plug was observed, however, a litter was delivered. b Found dead prior to collection of Day 0 lactation clinical signs.
Note
This appendix includes clinical observations from lactating rats only.
%
1121
Company Sanitized. Does not contain TSCA CBl
INDIVIDUAL CLINICAL OBSERVATIONS IN Pi FEMALE RATS DURING LACTATION
GROUP: I.I-O
DOSE: 0 MG/KG/DAY
ANIMAL NUMBER
OBSERVATION
FIRST DAY
OBSERVED
LAST DAY OBSERVED
643343 643459 643480 643363 643397 643421 643419 643401 643455 643378 643447 643478 643386
NO ABNORMALITIES DETECTED SACRIFICED BY DESIGN TEST DAY 122
MO ABNORMALITIES DETECTED SACRIFICED BY DESIGN TEST DAY 120
NO ABNORMALITIES DETECTED SACRIFICED BY DESIGN TEST DAY 122
NO ABNORMALITIES DETECTED SACRIFICED BY DESIGN TEST DAY 122
NO ABNORMALITIES DETECTED SACRIFICED BY DESIGN TEST DAY 120
NO ABNORMALITIES DETECTED SACRIFICED BY DESIGN TEST DAY 120
NO ABNORMALITIES DETECTED SACRIFICED BY DESIGN TEST DAY 122
NO ABNORMALITIES DETECTED SACRIFICED BY DESIGN TEST DAY 121
NO ABNORMALITIES DETECTED SACRIFICED BY DESIGN TEST DAY 122
NO ABNORMALITIES DETECTED SACRIFICED BY DESIGN TEST DAY 125
NO ABNORMALITIES DETECTED SACRIFICED BY DESIGN TEST DAY 120
NO ABNORMALITIES DETECTED SACRIFICED BY DESIGN TEST DAY 122
ALOPECIA LEFT FRONT PAW(S) SACRIFICED BY DESIGN TEST DAY 126
21
21
1122
Company Sanitized. Does not contain TSCACBl
INDIVIDUAL CLINICAL OBSERVATIONS IN Pi FEMALE RATS DURING LACTATION
GROUP: IV-0
DOSE: 25 MG/KG/DAY
ANIMAL NUMBER
OBSERVATION
FIRST DAY OBSERVED
LAST DAY OBSERVED
643399
NO ABNORMALITIES DETECTED SACRIFICED BY DESIGN TEST DAY 132
643334
NO ABNORMALITIES DETECTED SACRIFICED BY DESIGN TEST DAY 120
643464
DISCHARGE VAGINAL OPENING RED SACRIFICED BY DESIGN TEST DAY 121
643369
ALOPECIA BOTH FRONT PAW(S)
21
SACRIFICED BY DESIGN TEST DAY 119
643490
NO ABNORMALITIES DETECTED SACRIFICED BY DESIGN TEST DAY 119
643342
ALOPECIA BOTH FRONT LEG(S)
21
SACRIFICED BY DESIGN TEST DAY 123
643438
NO ABNORMALITIES DETECTED SACRIFICED BY DESIGN TEST DAY 121
643418
NO ABNORMALITIES DETECTED SACRIFICED BY DESIGN TEST DAY 125
643325
NO ABNORMALITIES DETECTED SACRIFICED BY DESIGN TEST DAY 123
6434793
NO ABNORMALITIES DETECTED SACRIFICED BY DESIGN TEST DAY 120
643376
NO ABNORMALITIES DETECTED SACRIFICED BY DESIGN TEST DAY 120
643452
NO ABNORMALITIES DETECTED SACRIFICED BY DESIGN TEST DAY 120
643475
NO ABNORMALITIES DETECTED SACRIFICED BY DESIGN TEST DAY 120
643372
ALOPECIA BOTH FRONT PAW(S)
21
SACRIFICED BY DESIGN TEST. DAY 122
1123
.Company Sanitized. Does not contain TSCACBI
INDIVIDUAL CLINICAL OBSERVATIONS IN Pi FEMALE RATS DURING LACTATION
GROUP: IV-0
DOSE: 25 MG/KG/DAY
ANIMAL NUMBER
OBSERVATION
FIRST DAY
OBSERVED
LAST DAY OBSERVED
643400 643395 643457
NO ABNORMALITIES DETECTED SACRIFICED BY DESIGN TEST DAY 121
NO ABNORMALITIES DETECTED SACRIFICED BY DESIGN TEST DAY 120
NO ABNORMALITIES DETECTED SACRIFICED BY DESIGN TEST DAY 120
1124
Company Sanitized. Does not contain TSCA CBI
INDIVIDUAL CLINICAL OBSERVATIONS IN Pi FEMALE RATS DURING LACTATION
GROUP: VI-0
DOSE: 100 MG/KG/DAY
ANIMAL NUMBER
OBSERVATION
FIRST DAY
OBSERVED
LAST DAY OBSERVED
643320 643428 643439 643353 643339 643337 643416 643407 643331
643427 643434 643349 643333 643460
NO ABNORMALITIES DETECTED SACRIFICED BY DESIGN TEST DAY 122
NO ABNORMALITIES DETECTED SACRIFICED BY DESIGN TEST DAY 122
NO ABNORMALITIES DETECTED SACRIFICED BY DESIGN TEST DAY 122
NO ABNORMALITIES DETECTED SACRIFICED BY DESIGN TEST DAY 120
NO ABNORMALITIES DETECTED SACRIFICED BY DESIGN TEST DAY 120
NO ABNORMALITIES DETECTED SACRIFICED BY DESIGN TEST DAY 120
NO ABNORMALITIES DETECTED SACRIFICED BY DESIGN TEST DAY 122
ALOPECIA BOTH FRONT LEG(S) SACRIFICED BY DESIGN TEST DAY 120
COLORED DISCHARGE NOSE BROWN ABNORMAL GAIT OR MOBILITY HUNCHED OVER DISCHARGE VAGINAL OPENING RED SACRIFICED BY DESIGN TEST DAY 120
NO ABNORMALITIES DETECTED SACRIFICED BY DESIGN TEST DAY 122
NO ABNORMALITIES DETECTED SACRIFICED BY DESIGN TEST DAY 122
ALOPECIA BOTH FRONT PAW(S) SACRIFICED BY DESIGN TEST DAY 121
ALOPECIA RIGHT FRONT PAW(S) SACRIFICED BY DESIGN TEST DAY 120
ALOPECIA BOTH FRONT LEG(S) SACRIFICED BY DESIGN TEST DAY 120
21
14
21
21
21
21
1125
Company Sanitized. Does not contain TSCA CBI
INDIVIDUAL CLINICAL OBSERVATIONS IN Pi FEMALE RATS DURING LACTATION
GROUP: VII I-0
DOSE: 250 MG/KG/DAY
ANIMAL NUMBER
OBSERVATION
FIRST DAY OBSERVED
LAST DAY OBSERVED
643467 643443 643417
643413 643338 6433353 643468 643440 643326 643365 643375 643328 643449 64342927
NO ABNORMALITIES DETECTED SACRIFICED BY DESIGN TEST DAY 125
NO ABNORMALITIES DETECTED SACRIFICED BY DESIGN TEST DAY 119
TEETH CLIPPED ALOPECIA RIGHT FRONT LEG(S) ALOPECIA LEFT FRONT PAW(S) SACRIFICED BY DESIGN TEST DAY 119
NO ABNORMALITIES DETECTED SACRIFICED BY DESIGN TEST DAY 122
NO ABNORMALITIES DETECTED SACRIFICED BY DESIGN TEST DAY 122
NO ABNORMALITIES DETECTED SACRIFICED BY DESIGN TEST DAY 121
NO ABNORMALITIES DETECTED SACRIFICED BY DESIGN TEST DAY 125
NO ABNORMALITIES DETECTED SACRIFICED BY DESIGN TEST DAY 122
NO ABNORMALITIES DETECTED SACRIFICED BY DESIGN TEST DAY 122
NO ABNORMALITIES DETECTED SACRIFICED BY DESIGN TEST DAY 122
NO ABNORMALITIES DETECTED SACRIFICED BY DESIGN TEST DAY 121
NO ABNORMALITIES DETECTED SACRIFICED BY DESIGN TEST DAY 121
NO ABNORMALITIES DETECTED SACRIFICED BY DESIGN TEST. DAY 125
FOUND DEAD TEST DAY 106
7
7
14
21
21
21
1126 Company Sanitized. Does not contain TSCA CBI
APPENDIX Y INDIVIDUAL ANIMAL ESTROUS CYCLE PARAMETERS DURING PREMATING AND
COHABITATION IN Pi FEMALE RATS
1127 Company Sanitized. Does not contain TSCA CBI
H-24516: Subchronic Toxicity
90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations_____________DuPont-5386
INDIVIDUAL ANIMAL ESTROUS CYCLE PARAMETERS DURING PREMATING AND COHABITATION IN PI FEMALE RATS
EXPLANATORY NOTES
Footnotes:
a Mean cycle length was not calculable due to insufficient data. b No evidence of copulation was found; animal was not pregnant. c No precoital interval could be calculated since no evidence of copulation was found. d No evidence of copulation was found, but animal was pregnant. Data were excluded from
statistical analysis since the animal was pregnant during part of the estrous cycle evaluation.
Abbreviations:
--
= No Data
1128 Company Sao.tAed. uos nu contain TSCA CBI
ANIMAL
NUMBER
643421 643397 643363 643350 643319^ 643480 643394 643459 643343 643352 643386 643478 643477
64339323
643378 643455 643401 643414 643419 643420
INDIVIDUAL ANIMAL ESTROUS CYCLE PARAMETERS DURING PREMATING AND COHABITATION
GROUP II-O: 0 MG/KG/DAY
NUMBER OF DAYS OF DATA
( SELECTION
PERCENT OF
DAYS IN
ESTRUS
PERCENT OF
DAYS IN
DIESTRUS
PERCENT OF
DAYS IN
PROESTRU!3
W AN
CYICLE LEKIGTH (da>ys)
PRECOITAL INTERVAL
(days)
23
22
65
22
23
50
25
24
64
27
89
7
35
71
23
24
21
75
25
20
68
21
19
71
24
21
75
22
27
73
29 :
24
59
25
24
68
23
17
78
35
26
54
27
22
67
24
25
58
23
26
65
22
32
50
25
24
56
30
23
63
13
3. 80
2
27
4. 00
2
12
4. 00
4
4
-- -a
6
6
10 .50
---C
4
4. 00
3
12
4. 50
5
10
5. 33
1
4
4. 50
3
0
4. 00
1
17
4. 60
8
8
4. 00
4
4
4. 00
2
20
4. 00
---C
11
4.25
6
17
5. 00
4
9
5. 00
3
18
4. 00
1
20
4. 00
4
13
6. 50
10
1129
C.mp,S^ed.D.esnot^"TSC*CB.
INDIVIDUAL ANIMAL ESTROUS CYCLE PARAMETERS DURING PREMATING AND COHABITATION
GROUP IV-0: 25 MG/KG/DAY
ANIMAL NUMBER
NUMBER OP DAYS OF DATA
CX)LLECTION
PERCENT OF
DAYS IN
ESTRUS
PERCENT OP
DAYS IN
DIESTRUS
PERCENT OF
DAYS IN
PROESTRUi3
M EAN C^FCLE LENGTH
(days)
PRECOITAL INTERVAL
(days)
643325
26
643418
27
643445
24
643438
24
643342
26
643490
22
643369
22
643464
23
643334
23
643399
34
643457
23
643395
23
643400
24
643372
25
643475
21
643452
22
643422
24
643376
23
643403
22
64347913
35
31
58
26
70
17
71
8
79
31
54
23
73
36
59
13
78
22
70
18
68
22
74
13
70
25
67
24
48
19
67
27
55
29
54
22
57
5
73
17
74
12
5 .00
5
4
4 .20
7
13
4 .00
3
13
7 .33
3
15
4 .00
5
5
4 .00
1
5
5 .00
1
9
4 .00
2
9
4 .00
2
15
4 .83
13
4
4 .00
2
17
5 .00
2
8
4 .00
3
28
4 .00
4
14
4 .67
1
18
4 .67
1
17
3 .80
3
22
4 .00
3
23
4 .50
1
9
4 .75
---C
1130
Sanitized. Does not contain TSCACB1 Company
ANIMAL
NUMBER
643416 643337 643473 643339 643385 643353 643439 643428 643488 643320 643460 643333 643454 643349 643434 643470C 643427 643331 643357 643407
INDIVIDUAL ANIMAL ESTROUS CYCLE PARAMETERS DURING CREMATING AND COHABITATION
GROUP VI-0: 100 MG/KG/DAY
NUMBER OF DAYS OP DATA
CX3LLECTION
PERCENT OF
DAYS IN
ESTRUS
PERCENT OF
DAYS IN DIESTRUS
PERCENT OF
DAYS IN
PROESTRUS
MEAN CYI=LE
LEN[GTH (da.ys)
PRECOITAL INTERVAL
(days)
25
20
76
4
5. 00
4
23
22
65
13
5. 00
2
25
24
68
8
4. 75
4
23
22
70
9
4. 25
2
21
24
67
10
5. 00
1
22
27
55
18
4. 67
1
25
20
60
20
4. 00
4
25
8
80
12
6. 67
4
25
28
60
12
4. 50
4
25
24
64
12
4. 75
4
21
10
62
29
3. 75
1
22
27
55
18
4. 33
1
23
26
61
13
4. 50
2
24
25
63
13
4. 00
3
25
20
76
4
4. 00
4
35
91
9
0
a
--
---C
24
8
71
21
6. 00
3
22
9
77
14
4. 00
1
22
32
55
14
4. 00
1
23
30
65
4
5. 00
2
1131
C<npy S,n,.^. "" COTtaI" TSCACBI
ANIMAL
NUMBER
643431-1'
643430 643440 643468 643335'3 643338 643413 643417 643443 643467 643424 643429 643449 643346 643348 643328 643375 643365 643326
INDIVIDUAL ANIMAL ESTROUS CYCLE PARAMETERS DURING PREMATING AND COHABITATION
GROUP VIII-0: 250 MG/KG/DAY
NUMBER OP DAYS OF DATA
COLLECTION
IPERCENT OF
I3AYS IN
ESTRUS
PERCENT OF
DAYS IN
DIESTRUS
PERCENT OF
DAYS IN
PROESTRUE!
M EAN CTFCLE LENGTH
(days)
PRECOITAL INTERVAL
(days)
35
23
69
9
5 .33
--c
22
18
68
14
4 .33
1
24
13
79
8
9 .50
4
--c 27
7
78
15
6 .00
6
33
12
88
0
6 .00
24
21
67
13
4 .25
4
25
24
72
4
4 .00
4
22
23
59
18
4 .00
1
22
32
55
14
3 .75
1
27
7
70
22
4 .00
6
22
32
68
0
4 .33
1
29
10
69
21
4 .40
8
27
26
67
7
3 .67
7
22
14
82
5
4 .00
2
24
25
71
4
4 .00
4
23
17
70
13
5 .33
2
23
13
74
13
5 .00
2
24
25
58
17
5 .00
4
25
24
64
12
4 .00
4
1132
Company Sanitized. Does not contain TSCACBl
APPENDIX Z
INDIVIDUAL ANIMAL ESTROUS CYCLE STAGES DURING PREMATING AND COHABITATION IN Pi FEMALE RATS
1133
company Sanitized. Does not contain TSCA CBl
INDIVIDUAL ANIMAL ESTROUS CYCLE STAGES DURING PREMATING AND COHABITATION IN Pi FEMALE RATS
EXPLANATORY NOTES
Notes:
Test Days 54-75 Test Days 75-88
Prematmg Cohabitation period
Abbreviations:
D = Diestrus
E
= Estrus
P
= Pi-oestrus
X = No sample or stage could not be defined from sample.
Footnotes:
a No evidence of copulation was found; animal was not pregnant. b No evidence of copulation was found; animal was pregnant.
1134 Company Sanitized. Does not contain TSCA CBl
H-24516: SubchronicToxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations
INDIVIDUAL ANIMAL ESTROUS CYCLE STAGES DURING PREMATING AND COHABITAT
GROUP II-O: 0 MG/KG/DAY
1135
Wi^I^teeAWi.^^
H-24516: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations
INDIVIDUAL ANIMAL ESTROUS CYCLE STAGES DURING PREMATING AND COHABITATI
GROUP IV-0: 25 MG/KG/DAY
1136
.CompanySanitized, Does not cont
I /H-24516: Subchronic Toxicity
90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations
INDIVIDUAL ANIMAL ESTROUS CYCLE STAGES DURING PREMATING AND COHABITAT
GROUP VI-0: 100 MG/KG/DAY
ANIMAL
TEST DAYS
NUMBER 541551561571581591606|116216316416516616716|f8i9|7017117217317417517617717817890|18118218
643416 miBalBlljBi|IH|^^ gtera^iffl
lipl liliBaMliBlliMBaii'] IS1iil
643337MaifI|| lligii:iiii iiilllEiii|llB8^aiAlii:E>j!l;m:!lJ
643473 11!i|3a||ii|a|liJB31pl|Bl|8|
643339 ^|i|^Jia|iHH i|jMi|graEiH^
ririBiaiA _ _
643385 llgfallill
g|lil|IH]i|xra^aJ|!^ijffiJJidl5iii.B^^
643353 Ml^^igiSQll^jllHHiBj'l^
__ ____ 643439 'D i3J D |D |b2lD I D ID 13 D ID ID 13 D ID
D|D'
UJ 643428 8iil|lijB|E
643488|!aal||!'Ii|
643320|a||l|ai
|ijp
_^______plilgll^tBglialiitEtM
j_iI3_ll_l^_J!_!^_|J_Ji_PEllgllilD^^,ii^
64346o|iJJN| |D|D|D|DBaD|DBaD|xE|D|Di3aaD|PBa
643333pJigJ
' i^'i^iiEi^
'"^T'yl
643454 PpB
643349|^Jg|ffi3
llBllpl^p^^iBlft*
|g^
643434||El,pSlM|Ji llN3Nlaabi|ia!^
664433442770|Bi!jr;aDte|lB!iiaali|iIaP|lBii|B^ i_____
Sill
64333lp|5Bili|!i|lHBiJM^
643357 fcaip!paa||ai^^|^ b434U7B|'!i)||biiia
1137
H-24516: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations
INDIVIDUAL ANIMAL ESTROUS CYCLE STAGES DURING PREMATING AND COHABITAT
GROUP VIII-0: 250 MG/KG/DAY
1138
Company Sanitized. Does not con
APPENDIX AA REPRODUCTIVE TOXICOLOGY INDIVIDUAL ANIMAL SPERM MOTILITY DATA IN Pi MALE RATS
1139
Company Sanitized. Does not contain TSCA CBI
INDIVIDUAL ANIMAL SPERM MOTILITY DATA IN Pi MALE RATS
GROUP 1-0
0 MG/KG/DAY
Animal Number
643239 643270 643148 643284 643229 643196 643176 643218 643207 643280
Percent
Motile
93 90 95 99 96 91 86 94 95 94
GROUP III-0
25 MG/KG/DAY
Animal Number
643287 643188 643230 643170 643144 643277 643214 643261 643166 643153
Percent Motile
89 92 78 98 95 92 91 93 96 98
GROUP V-0 100 MG/KG/DAY
Animal Number
643313 643182 643146 643312 643199
643267 643216 643244 643245 643301
Percent Motile
96 91 96 84 93
95 96 92 98 92
GROUP VII-0
250 MG/KG/DAY
Animal Number
Percent Motile
643289
80
643171
89
643158
97
643249
95
643161
95
643248
92
643285
81
643278
89
643299
97
643274
88
1140
Company Sanitized. Does not contain TSCA CBI
APPENDIX BB INDIVIDUAL ANIMAL SPERM MORPHOLOGY DATA IN Pi MALE RATS
1141
Company Sanitized. Does not contain TSCACBI
INDIVIDUAL ANIMAL SPERM MORPHOLOGY DATA IN Pi MALE RATS
GROUP 1-0: 0 MG/KG/DAY
Animal Number
643239 643270 643148 643284 643229 643196 643176 643218 643207 643280
Total
Normal
199 200 195 197 199 198 197 197 196 198
Tail
Abnormal
1 0 0 0 1 0 1 0 2 0
Head Abnormal
0 0 5 3 0 2 2 3 2 2
Tail & Head
Abnormal
0 0 0 0 0 0 0 0 0 0
Percent Normal
99.5 100.0 97.5 98.5 99.5 99.0 98.5 98.5 98.0 99.0
0: 25 MG/KG/DAY
Animal Number
643287
6431P,8
643230 643170 643144 643277 643214 643261 643166 643153
Total
Normal
199 . 199 198 198 199 199 192 200 198 197
Tail
Abnormal
0 0 0 0 0 1 2 0 0 1
Head Abnormal
1 1 2 2 1 0 6 0 2 2
Tail & Head
Abnormal
0 0 0 0 0 0 0 0 0 0
Percent Normal
99.5 99.5 99.0 99.0 99.5 99.5 96.0 100.0 99.0 98.5
1142 Company Sanitized. Does not contain TSCA CBI
INDIVIDUAL ANIMAL SPERM MORPHOLOGY DATA IN Pi MALE RATS
GROUP V-0: 100 MG/KG/DAY
Animal Number
643313 643182 643146 643312 643199 643267 643216 643244 643245 643301
Total
Normal
195 198 198 200 199 199 199 198 198 199
Tail
Abnormal
0 1 1 0 0 0 0 1 1 0
Head Abnormal
5 1 1 0 1 1 1 1 1 1
Tail & Head
Abnormal
0 0 0 0 0 0 0 0 0 0
Percent Normal
97.5 99.0 99.0 100.0 99.5 99.5 99.5 99.0 99.0 99.5
GROUP VII- 0: 250 MG/KG/DAY
Animal Number
Total
Normal
643289
196
643171
193
643158
199
643249
200
643161
197
643248
200
643285
197
643278
198
643299
200
643274
197
Tail
Abnormal
2 6 1 0 0 0 0 0 0 0
Head Abnormal
2 1 0 0 3 0 3 2 0 3
Tail & Head
Abnormal
0 0 0 0 0 0 0 0 0 0
Percent Normal
98.0 96.5 99.5 100.0 98.5 100.0 98.5 99.0 100.0 98.5
1143 Company Sanitized. Does not contain TSCA CBl
APPENDIX CC INDIVIDUAL ANIMAL SPERM AND SPERMATID COUNTS IN Pi MALE RATS
1144
Company Sanitized. Does not contain TSCACBl
INDIVIDUAL ANIMAL SPERM AND SPERMATID COUNTS (Millions) IN Pi MALE RATS
GROUP 1-0: 0 MG/KG/DAY
Animal Number
Epididymal Sperm Per cauda Per g cauda
643239 643270 643148 643284 643229 643196 643176 643218 643207 643280
311.0 299.3 256.0 254.9 311.0 341.4 332.0 332.0 282.9 266.6
1067.8 1249.0
758.6 858.1 1002.4 1154.4 1195.5 1216.1 869.1 938.2
GROUP III-O-0: 25 MG/KG/DAY
Animal Number
Epididymal Sperm Per cauda Per g cauda
643287 643188 643230 643170
643144 643277 643214 643261 643166 643153
274.2 229.1
272.4 346.0 280.6 225.6 280.6 254.9 337.9 296.9
1191.1 850.8 906.7 1045.1 1131.3
836.3 934.9 899.9 1238.4 948.4
Testicular Spermatids
Per testis
Per g
testis
109.9 128.0 147.9 131.0 144.4 151.4
146.7 103.5
118.7 119.3
69.0 81.3 90.0 84.2 86.4 103.0 100.5 65.4
75.1 89.8
Testicular Spermatids
Per testis
Per g
testis
114.0 112.2 118.7 136.8 107.0 152.6 122.8 124.5
114.6 114.6
94.8 66.5 74.0 79.8
88.4 110.5
79.6 86.2 81.4 83.3
1145
Company Sanitized. Does not contain TSCA CB1
INDIVIDUAL ANIMAL SPERM AND SPERMATID COUNTS (Millions) IN Pi MALE RATS
GROUP V-0: 100 MG/KG/DAY
Animal Number
Epididymal Sperm Per cauda Per g cauda
643313 643182 643146 643312 643199
643267 643216 643244 643245 643301
339.0 285.3 301.6
240.8 261.9
321.5 187.1 249.0 281.7 312.1
1239.5 945.8
970.4 723.6 879.6 1054.7 690.2 884.2 910.9 1198.6
GROUP VI I--00: 250 MG/KG/DAY
Animal Number
Epididymal Sperm Per cauda Per 9 cauda
643289 643171 643158 643249 643161 643248 643285 643278 643299 643274
368.3 282.9 327.3 328.5 426.7 244.3 231.5 318.0 245.5 218.6
1280.8 894.7 884.9 977.7 1116.7
906.9 742.6 897.5 859.3 895.6
Testicular Spennatids
Per testis
Per g
testis
154.3 158.4 166.0 135.0 168.4 154.9 163.7 162.5 166.6 169.5
106.3 101.0 103.1 81.1 98.0
91.4 108.3 102.6 106.1 112.8
Testicular Spennatids
Per testis
Per 9
testis
144.4 119.8 133.9 122.2 161.3
154.3 166.0 169.5 151.4 142.6
96.1 94.0 79.1 81.5 101.8
99.4 110.8 87.3 91.3 90.7
1146
Company Sanitized. Does not contain TSCA CBI
APPENDIX DD REPRODUCTIVE TOXICOLOGY INDIVIDUAL MATING DATA AND GESTATION LENGTH: Pi GENERATION
1147 Company Sanitized. Does not contain TSCA CBI
H-24516: Subchronic Toxicity
90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations_____________DuPont-5386
REPRODUCTIVE TOXICOLOGY INDIVIDUAL MATING DATA AND GESTATION LENGTH: Pi GENERATION
EXPLANATORY NOTES
Notes:
Column labeled "Plug Observed"
+
indicates that a copulatory plug was observed
indicates that no copulatory plug was observed
Column labeled "Litter Produced"
+
indicates that a litter was produced
indicates that no litter was produced
Footnotes:
a No litter delivered, however, implantation sites were observed at necropsy. b No copulation plug was observed, however, a litter was delivered. Gestation length
unknown. c Found dead on Day 22G (Test Day 99). d Accidentally killed on Day 14G (Test Day 91). e Found dead on Lactation Day 0 (Test Day 106).
1148
Company Sanitized. Does not contain TSCA CErf
FEMALE
ANIMALtt
643352 643343 643459 643394 643480 643319 643350 643363 643397 643421 643420 643419 6434143 643401 643455 643378 643393 643447 643478 643386
INDIVIDUAL MATING DATA AND GESTATION LENGTH: Pi GENERATION
GROUPS: 11-0,1-0
DOSE: 0 MG/KG/DAY
MALE #1 ANIMAL#
643239 643270 643148 643284 643229 643196 643176 643218 643207 643280 643271 643211 643163 643197 643242 643251 643155 643147 643276 643254
PLUG OBSERVED
+ + + + +
-
+ + + + + + + + + + .' + + +
MALE #2 ANIMAL*
PLUG OBSERVED
LITTER
PRODUCED
-
+ +
-
+
-
+ + +
-
+
-
+ + +
-
+ + +
GESTATION LENGTH(days)
--
23 23
--
23
---
22 22 22
--
22
--
22 22 23
--
22 22 22
1149
Company Sanitized. Does not contain TSCA C6l
FEMALE
ANIMAL#
643399 643334 643464 643369 643490 643342 643438 643445 643418 643325 643479b 643403 643376 6434223 643452 643475 643372 643400 643395 643457
INDIVIDUAL MATING DATA AND GESTATION LENGTH: Pi GENERATION
GROUPS: IV-0,111-0
DOSE: 25 MG/KG/DAY
MALE ftl ANIMAL*
643287 643188 643230 643170 643144 643277 643214 643261 643166 643153 643177 643198 643291 643184 643167 643223 643233 643183 643219 643263
PLUG OBSERVED
+ + + + + + + + + +
-
+ + + + + + + + +
MALE #2 ANIMALft
PLUG OBSERVED
LITTER
PRODUCED
+ + + + + + +
-
+ + +
-
+
-
+ + + + + +
GESTATION LENGTH(days)
23 22 23 22 22 22 22
--
22 22
---
21
--
23 23 22 22 22 22
t
1150
Company Sanitized. Does not contain TSCACSf
FEMALE ANIMALft
643320 643488 643428 643439 643353 643385 643339 643473 643337 643416 643407 643357 643331 643427 643470 643434 643349 6434540 643333 643460
INDIVIDUAL MATING DATA AND GESTATION LENGTH: Pi GENERATION
GROUPS: VI-0,V-0
DOSE: 100 MG/KG/DAY
MALE ttl
ANIMALft
643313 643182 643146 643312 643199 643267 643216 643244 643245 643301 643200 643255 643157 643238 643227 643164 643154 643156 643208 643190
PLUG OBSERVED
+ + + + + + + + + + + + + +
-
+ + + + +
MALE #2 ANIMALtt
PLUG OBSERVED
LITTER
PRODUCED
+
-
+ + +
-
+
-
+ + +
-
+ +
-
+ +
-
+ +
GESTATION LENGTH(days)
22
--
22 22 23
--
22
2--2
22 22
2-3-
23
2-2-
22
2-3-
23
1151
Company Sanitized. Does not contain TSCA CBI
FEMALE ANIMAL#
643467 643443 643417 643413 643338 6433356 643468 643440 643430 643431 643326 643365 643375 643328 643348 643346'^ 643449 6434296 643424
INDIVIDUAL MATING DATA AND GESTATION LENGTH: Pi GENERATION
GROUPS: VIII-0,VII-0
DOSE: 250 MG/KG/DAY
MALE #1 ANIMAL#
643289 643171 643158 643249 643161 643274 643248 643285 643278 643299 643192 643222 643160 643191 643203 643282 643302 643317 643281
PLUG OBSERVED
+ + + + +
-
+ + +
-
+ + + + + + + + +
MALE #2 ANIMAL#
PLUG OBSERVED
LITTER
PRODUCED
+ + + + + + + +
-
-
+ + + +
-
-
+ +
-
GESTATION LENGTH(days)
23 22 22 22 22
--
23 22
---
22 22 23 23
---
22 23
--
1152 Company Sanitized. Does not contain TSCA CBI
APPENDIX EE REPRODUCTIVE TOXICOLOGY INDIVIDUAL IMPLANTATION SITE DATA AND IMPLANTATION EFFICIENCY
1153 Company Sanitized. Does not contain TSCACBl
H-24516: Subchronic Toxicity
90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations_____________DuPont-5386 REPRODUCTIVE TOXICOLOGY
INDIVIDUAL IMPLANTATION SITE DATA AND IMPLANTATION EFFICIENCY
EXPLANATORY NOTES
Footnotes:
a No implantation efficiency can be calculated. b No litter produced; no implantation efficiency calculated. c Found dead Day 22G (Test Day 99); the uterus contained 17 fetuses. d Accidentally killed Day 14G (Test Day 91); the uterus contained 12 fetuses. e Found dead Lactation Day 0 (Test Day 106).
Abbreviations:
--
= No data
1154
Company San-rtized. Does not contain TSCA Cffl
INDIVIDUAL IMPLANTATION SITE DATA AND IMPLANTATION EFFICIENCY
GROUPS: II-O
DOSE: 0 MG/KG/DAY
Animal Number
Pups
Bom
Number of
Implantation Sites
Implantation Efficiency
643343
12
10
643459
15
16
643480
15
15
643363
17
18
643397
16
17
643421
12
13
643419
16
15
643414^
0
2
643401
15
16
643455
16
16
643378
8
8
643447
19
19
643478
15
15
643386
15
16
---a
93.8 100.0 94.4 94.1 92.3
---a
93.8 100.0 100.0 100.0 100.0 93.8
1155
Company Sanitized. Does not contain TSCA CBI
INDIVIDUAL IMPLANTATION SITE DATA AND IMPLANTATION EFFICIENCY
GROUPS: IV-0
DOSE: 25 MG/KG/DAY
Animal Number
Pups Born
Number of
Implantation Sites
Implantation Efficiency
643399
14
17
643334
15
16
643464
14
14
643369
18
14
643490 .
14
14
643342
16
16
643438
14
17
643418
15
15
643325
15
16
643479
7
9
643376
15
16
64342223
0
2
643452
12
15
643475
2
4
643372
17
18
643400
15
15
643395
8
8
643457
16
16
82.4 93.8 100.0
---a
100.0 100.0 82.4 100.0 93.8 77.8 93.8
---
80.0 50.0 94.4 100.0 100.0 100.0
1156
Company Sanitized. Does not contain TSCA CBI
INDIVIDUAL IMPLANTATION SITE DATA AND IMPLANTATION EFFICIENCY
GROUPS: VI-0
DOSE: 100 MG/KG/DAY
Animal Number
Pups
Bom
Number of
Implantation Sites
Implantation Efficiency
643320
6
643428
14
643439
14
643353
9
643339
15
643337
15
643416
6
643407
16
643331
9
643427
14
643434
16
643349
18
643454C
---
643333
7
643460
14
15 16 16 11 16 . 17
8
14 12 15 14 18 17
9
14
40.0 87.5 87.5 81.8 93.8 . 88.2 75.0
---a
75.0 93.3
---a
100.0
---
77.8 100.0
1157
Company Sanitized. Does not contain TSCA CB(
INDIVIDUAL IMPLANTATION SITE DATA AND IMPLANTATION EFFICIENCY
GROUPS: VIII-0
DOSE: 250 MG/KG/DAY
Animal Number
Pups Bom
Number of
Implantation Sites
Implantation Efficiency
643467
13
12
643443
12
11
643417
10
13
643413
12
12
643338
14
16
643335
14
16
643468
14
18
643440
18
18
643326
14
16
643365
9
8
643375
5
14
643328
11
12
643346^
---
12
643449
17
17
6434296
16
15
---a ---a
76.9 100.0
87.5 87.5 77.8 100.0 87.5
---a
35.7 91.7
---
100.0
---a
1158
Company Sanitized. Does not contain TSCA CB(
APPENDIX FF REPRODUCTIVE TOXICOLOGY INDIVIDUAL PUP SURVIVAL: Fi GENERATION
1159 Company Sanitized. Does not contain TSCA CBl
H-24516: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations
REPRODUCTIVE TOXICOLOGY INDIVIDUAL PUP SURVIVAL: Fi GENERATION
EXPLANATORY NOTES
DuPont-5386
Footnotes:
a No litter delivered. b Found dead test day 99 (Day 22G). c Accidentally killed test day 91 (Day 14G); no litter was delivered. d Found dead test day 106 (Lactation Day 0); data excluded from statistical analysis. e Number bom includes 13 unsexable fetuses.
1160 Company Sanitized. Does not contain TSCA CBt
ANIMAL NUMBER
6433523 643343 643459 6433943 643480 643319s 6433503 643363 643397 643421 6434203 643419 6434143 643401 643455 643378 6433933 643447 643478 643386
BORN
12 15
-
.15
-
-
17 16 12
-
16
-
15 16
8
-
19 15 15
INDIVIDUAL PUP SURVIVAL: Fi GENERATION
GROUP: II-O
DOSE: 0 MG/KG/DAY
NUMBE19. OF PUPS
BORN P RECULLING POSTCULLI1W
ALIVE
DAY 4
DAY 4
DAY 7
DAY 14
DAY 21
.
12
12
8
8
8
8
15
15
8
8
8
8
-
-
-
-
-
-
15
15
8
8
8
8
-
-
-
-
-
-
-
-
-
-
-
-
17
17
8
8
8
8
16
16
8
8
8
8
12
12
8
8
8
8
-
-
-
-
-
-
16
16
8
8
8
8
-
-
-
-
-
-
15
15
8
8
8
8
15
15
8
8
8
8
8
8
8
8
8
8
-
-
-
-
-
-
19
19
8
8
8
8
15
15
8
8
8
8
15
15
8
8
8
8
1161
Company Sanitized. Does not contain TSCA CBI
ANIMAL NUMBER
643352s 643343 643459 643394s 643480 643319s 643350s 643363 643397 643421 643420s 643419 643414s 643401 643455 643378 643393s 643447 643478 643386
BORM
6
12
-
6
-
-
7 8 6
-
11
-
12 10
5
-
12
8
10
INDIVIDUAL PUP SURVIVAL: Fi GENERATION
GROUP: II-O
DOSE: 0 MG/KG/DAY
NUMBEI1 OF MALE 1?UPS
BORN P RECULLING POSTCULLI1re
ALIVE
DAY 4
DAY 4
DAY 7
DAY 14
DAY 21
6
6
4
4
4
4
12
12
5
5
5
5
-
-
-
-
-
-
6
6
4
4
4
4
-
-
-
-
-
-
-
-
-
-
-
-
7
7
4
4
4
4
8
8
4
4
4
4
6
6
4
4
4
4
-
-
-
-
-
-
11
11
4
4
4
4
-
-
-
-
-
-
12
12
5
5
5
5
9
9
4
4
4
4
5
5
5
5
5
5
-
-
-
-
-
-
12
12
4
4
4
4
8
8
4
4
4
4
10
10
4
4
4
4
1162 Company Sanitized. Does not contain TSCA CBl
ANIMAL NUMBER
6433523 643343 643459 6433943 643480 643319s 6433503 643363 643397 643421 6434203 643419 643414s 643401 643455 643378 6433933 643447 643478 643386
BORN
6 3
-
9
-
10
8 6
-
5
-
3 6 3
-
7 7 5
INDIVIDUAL PUP SURVIVAL: Fi GENERATION
GROUP: II-O
DOSE: 0 MG/KG/DAY
NUMBER OF FEMAL1E PUPS
BORN PIIECULLING POSTCULLI1TO
ALIVE
DAY 4
DAY 4
DAY 7
DAY 14
DAY 21
.
6
6
4
4
4
4
3
3
3
3
3
3
.- -
-
9
9
4
-
-
-
-
-
-
4
4
4
-
-
-
-
-
-
-
-
10
10
4
4
4
4
8
8
4
4
4
4
6
6
4
4
4
4
-
-
-
-
-
-
5
5
4
4
4
4
-
-
-
-
-
3
3
3
3
3
3
S
6
4
4
4
4
3
3
3
3
3
3
-
-
-
-
-
-
7
7
4
4
4
4
7
7
4
4
4
4
5
5
4
4
4
4
1163
Company Sanitized. Does not contain TSCA CBl
ANIMAL NUMBER
6433523 643343 643459 6433943 643480 6433193 6433503 643363 643397 643421 6434203 643419 6434143 643401 643455 643378 6433933 643447 643478 643386
INDIVIDUAL PUP SURVIVAL: Fi GENERATION
GROUP: II-O
DOSE: 0 MG/KG/DAY
NUMBER OF PUPS
SEX RATIO (MALES) % BORN ALIVE 0-4 DAY VIABILITY
0.50 0.80
0.40
0.41 0.50 0.50
0.69
0.80 0.63 0.63
0.63 0.53 0.67
100.0 100.0
100.0
100.0 100.0 100.0
100.0
100.0 93.8
100.0
100.0 100.0 100.0
100.0 100.0
100.0
100.0 100.0 100.0
100.0
100.0 100.0 100.0
100.0 100.0 100.0
LACTATION INDEX
100.0 100.0
100.0
100.0 100.0 100.0
100.0
100.0 100.0 100.0
100.0 100.0 100.0
1164
Company Sanitized. Does not contain TSCA CBI
ANIMAL NUMBER
6433523 643343 643459 6433943 643480 643319s 643350a 643363 643397 643421 6434203 643419 6434143 643401 643455 643378 6433933 643447 643478 643386
INDIVIDUAL PUP SURVIVAL: Fi GENERATION
GROUP: II-O
DOSE: 0 MG/KG/DAY
% BORN ALIVE
NUMBER OP MALE PUPS
0-4 DAY VIABILITY
LACTATION INDEX
100.0 100.0
100.0
100.0 100.0 100.0
100.0
100.0 90.0
100.0
100.0 100.0 100.0
100.0 100.0
100.0
100.0 100.0 100.0
100.0
100.0 100.0 100.0
100.0 100.0 100.0
100.0 100.0
100.0
100.0 100.0 100.0
100.0
100.0 100.0 100.0
100.0 100.0 100.0
1165
Company Sanitized. Does not contain TSCA CSK
ANIMAL NUMBER
6433523 643343 643459 643394S 643480 6433193 6433503 643363 643397 643421 6434203 643419 6434143 643401 643455 643378 6433933 643447 643478 643386
INDIVIDUAL PUP SURVIVAL: Pi GENERATION
GROUP: II-O
DOSE: 0 MG/KG/DAY
BORN ALIVE
NUMBER OF FEMALE PUPS
0-4 DAY VIABILITY
LACTATION INDEX
100.0 100.0
100.0
100.0 100.0 100.0
100.0
100.0 100.0 100.0
100.0 100.0 100.0
100.0 100.0
100.0
100.0 100.0 100.0
100.0
100.0 100.0 100.0
100.0 100.0 100.0
100.0 100.0
100.0
100.0 100.0 100.0
100.0
100.0 100.0 100.0
100.0 100.0 100.0
1166
Company Sanitized. Does not contain TSCA Cfif
ANIMAL NUMBER
643399 643334 643464 643369 643490 643342 643438 6434453 643418 643325 643479 6434033 643376 6434223 643452 643475 643372 643400 643395 643457
BORN
14 15 14 18 14 16 14
-
15 15
7
-
15
-
12
2
17 15
8
16
INDIVIDUAL PUP SURVIVAL: Fi GENERATION
GROUP: IV-0
DOSE: 25 MG/KG/DAY
NUMBEI? OF PUPS
BORN P RECULLING POSTCULLIIre
ALIVE
DAY 4
DAY 4
DAY 7
DAY 14
14
14
8
8
8
15
15
8
8
8
14
14
8
8
8
18
18
8
8
8
14
14
8
8
8
16
16
8
8
8
14
13
8
8
8
-
-
-
-
-
15
13
8
8
B
15
15
8
8
B
7
7
7
7
7
-
-
-
-
-
14
14
8
8
8
-
-
-
-
-
12
12
8
8
8
2
2
2
2
2
17
17
8
8
8
14
12
8
8
8
8
8
8
8
8
16
15
8
8
8
DAY 21
8 8 8 8 8 8 8
-
8 8 7
-
8
-
8 2 8 8 8 8
1167
Company Sanitized. Does not contain TSCA CBI
ANIMAL NUMBER
643399 643334 643464 643369 643490 643342 643438 643445s 643418 643325 643479 6434033 643376 6434223 643452 643475 643372 643400 643395 643457
BORN
6
10
5 7
10
8 6
-
8
11
1
-
11
-
7 0
10
9 4
10
INDIVIDUAL PUP SURVIVAL: Fi GENERATION
GROUP: IV-0
DOSE: 25 MG/KG/DAY
NUMBEI1 OF MALE 1PUPS
BORN P RECULLING POSTCULLI11G
ALIVE
DAY 4
DAY 4
DAY 7
DAY 14
6
6
4
4
4
10
10
4
4
4
5
5
4
4
4
7
7
4
4
4
10
10
4
4
4
8
8
4
4
4
6
6
4
4
4
-
-
-
-
-
8
7
4
4
4
11
11
4
4
4
1
1
1
1
1
-
-
-
-
-
10
10
4
4
4
-
-
-
-
-
7
7
4
4
4
0
0
0
0
0
10
10
4
4
4
8
8
4
4
4
4
4
4
4
4
10
10
4
4
4
DAY 21
4 4 4 4 4 4 4
-
4 4 1
-
4
-
4 0 4 4 4 4
1168 Company Sanitized. Does not contain TSCA CBI
ANIMAL NUMBER
643399 643334 643464 643369 643490 643342 643438 6434453 643418 643325 643479 643403s 643376 643422^ 643452 643475 643372 643400 643395 643457
BORN
8 5 9
11
4 8 8
-
7 4 6
-
4
-
5 2 7 6 4 6
INDIVIDUAL PUP SURVIVAL: Fi GENERATION
GROUP: IV-0
DOSE: 25 MG/KG/DAY
NUMBE1? OF FEMAI^E PUPS
BORN P RECULLING POSTCULL][NG
ALIVE
DAY 4
DAY 4
DAY 7
DAY 14
8
8
4
4
4
5
5
4
4
4
9
9
4
4
4
11
11
4
4
4
4
4
4
4
4
8
8
4
4
4
8
7
4
4
4
-
-
-
-
-
7
6
4
4
4
4
4
4
4
4
6
6
6
6
6
-
-
-
-
-
4
4
4
4
4
-
-
-
-
-
5
5
4
4
4
2
2
2
2
2
7
7
4
4
4
6
4
4
4
4
4
4
4
4
4
6
5
4
4
4
DAY 21
4 4 4 4 4 4 4
-
4 4 6
-
4
-
4 2 4 4 4 4
1169
Company Sanitized. Does noi contain TSCA CBI
ANIMAL NUMBER
643399 643334 643464 643369. 643490 643342 643438 6434453 643418 643325 643479 643403s 643376 6434223 643452 643475 643372 643400 643395 643457
INDIVIDUAL PUP SURVIVAL: Pi GENERATION
GROUP: IV-0
DOSE: 25 MG/KG/DAY
NUMBER OF PUPS
SEX RATIO (MALES) % BORN ALIVE 0-4 DAY VIABILITY
0.43 0.67 0.36 0.39 0.71 0.50 0.43
0.53 0.73 0.14
0.73
0.58 0.00 0.59 0.60 0.50 0.63
100.0 100.0 100.0 100.0 100.0 100.0 100.0
100.0 100.0 100.0
93.3
100.0 100.0 100.0
93.3 100.0 100.0
100.0 100.0 100.0 100.0 100.0 100.0
92.9
86.7 100.0 100.0
100.0
100.0 100.0 100.0
85.7 100.0
93.8
LACTATION INDEX
100.0 100.0 100.0 100.0 100.0 100.0 100.0
100.0 100.0 100.0
100.0
100.0 100.0 100.0 100.0 100.0 100.0
1170 Company Sanitized. Does not contain TSCA CBI
ANIMAL NUMBER
643399 643334 643464 643369 643490 643342 643438 6434453 643418 643325 643479 643403^ 643376 6434223 643452 643475 643372 643400 643395 643457
INDIVIDUAL PUP SURVIVAL: E\ GENERATION
GROUP: IV-0
DOSE: 25 MG/KG/DAY
BORN ALIVE
NUMBER OP MALE PUPS
0-4 DAY VIABILITY
LACTATION INDEX
100.0 100.0 100.0 100.0 100.0 100.0 100.0
100.0 100.0 100.0
90.9
100.0
100.0 88.9
100.0 100.0
100.0 100.0 100.0 100.0 100.0 100.0 100.0
87.5 100.0 100.0
100.0
100.0
100.0 100.0 100.0 100.0
100.0 100.0 100.0 100.0 100.0 100.0 100.0
100.0 100.0 100.0
100.0
100.0
100.0 100.0 100.0 100.0
1171
Company Sanitized. Does not contain TSCA CBI
ANIMAL NUMBER
643399 643334 643464 643369 643490 643342 643438 6434453 643418 643325 643479 6434033 643376 6434223 643452 643475 643372 643400 643395 643457
INDIVIDUAL PUP SURVIVAL: Fi GENERATION
GROUP: IV-0
DOSE: 25 MG/KG/DAY
% BORN ALIVE
NUMBER OF FEMALE PUPS
0-4 DAY VIABILITY
LACTATION INDEX
100.0 100.0 100.0 100.0 100.0 100.0 100.0
100.0 100.0 100.0
100.0
100.0 100.0 100.0 100.0 100.0 100.0
100.0 100.0 100.0 100.0 100.0 100.0
87.5
85.7 100.0 100.0
100.0
100.0 100.0 100.0
66.7 100.0
83.3
100.0 100.0 100.0 100.0 100.0 100.0 100.0
100.0 100.0 100.0
100.0
100.0 100.0 100.0 100.0 100.0 100.0
1172
Company Sanitized. Does not contain TSCA CBt
ANIMAL NUMBER
643320 643488'' 643428 643439 643353 6433853 643339 6434733 643337 643416 643407 643357s 643331 643427 6434703 643434 643349 643454^ 643333 643460
BORN
6
-
14 14
9
-
15
-
15
6
16
-
9
14
-
16 18
-
7
14
INDIVIDUAL PUP SURVIVAL: Fi GENERATION
GROUP: VI-0
DOSE: 100 MG/KG/DAY
NUMBEI^ OF PUPS
BORN P RECULLING POSTCULLII1G
ALIVE
DAY 4
DAY 4
DAY 7
DAY 14
4
4
4
4
4
-
-
-
-
-
14
14
8
8
8
10
10
8
8
8
9
9
8
8
8
-
-
-
-
-
15
15
8
8
8
-
-
-
-
-
15
15
8
8
8
6
5
5
5
5
16
0
0
0
0
-
-
-
- -
0
0
0
0
0
14
14
8
8
8
-
-
-
-
-
16
16
8
8
8
18
17
8
8
8
-
-
-
-
-
7
7
7
7
7
14
14
8
8
8
DAY 21
4
-
8 8 8
-
8
-
8 5 0
-
0 8
-
8 8
-
7 8
1173
Company Sanitized. Does not contain TSCA CBI
ANIMAL NUMBER
643320 6434883 643428 643439 643353 6433853 643339 643473s 643337 643416 643407 6433573 643331 643427 643470s 643434 643349
643454-1' 643333 643460
BORN
3
-
7 9 5
-
6
-
8 5 7
-
4 5
-
6 7
3e
7
INDIVIDUAL PUP SURVIVAL: Pi GENERATION
GROUP: VI-0
DOSE: 100 MG/KG/DAY
NOMBE1a OF MALE 1PUPS
BORN E'RECULLING POSTCULLIIrc
ALIVE
DAY 4
DAY 4
DAY 7
DAY 14
DAY 21
2
2
2
2
2
2
-
-
-
-
-
-
7
7
4
4
4
4
7
7
5
5
5
5
5
5
4
4
4
4
-
-
-
-
-
-
6
6
4
4
4
4
-
-
-
-
-
-
8
8
4
4
4
4
5
4
4
4
4
4
7
0
0
0
0
0
-
-
-
-
-
-
0
0
0
0
0
0
5
5
4
4
4
4
-
-
-
-
-
-
6
6
4
4
4
4
7
6
4
4
4
4
3
3
3
3
3
3
7
7
4
4
4
4
1174
Company Sanitized. Does not contain TSCA CBI
ANIMAL NUMBER
643320 643488s 643428 643439 643353 643385s 643339 643473s 643337 643416 643407 643357s 643331 643427 6434703 643434 643349 643454^ 6433336 643460
BORN
3
-
7 5 4
-
9
-
7 1 9
-
5 9
-
10 11
46
7
INDIVIDUAL PUP SURVIVAL: Pi GENERATION
GROUP: VI-0
DOSE: 100 MG/KG/DAY
NOMBE]1 OF FEMAL1S PUPS
BORN P RECULLING POSTCULLI1TO
ALIVE
DAY 4
DAY 4
DAY 7
DAY 14
2
2
2
2
2
-
-
-
-
-
7
7
4
4
4
3
3
3
3
3
4
4
4
4
4
-
-
-
-
-
9
9
4
4
4
-
-
-
-
-
7
7
4
4
4
1
1
1
1
1
9
0
0
0
0
-
-
-
-
-
0
0
0
0
0
9
9
4
4
4
-
-
-
-
-
10
10
4
4
4
11
11
4
4
4
-
-
-
-
-
4
4
4
4
4
7
7
4
4
4
DAY 21
2
-
4 3 4
-
4
-
4 1 0
-
0 4
-
4 4
-
4 4
1175
Company Sanitized. Does not contain TSCA CBI
ANIMAL NUMBER
643320 6434883 643428 643439 643353 6433853 643339 6434733 643337 643416 643407 6433573 643331 643427 64347Q3 643434 643349 643454b 643333 643460
INDIVIDUAL PUP SURVIVAL: Fi GENERATION
GROUP; VI-0
DOSE: 100 MG/KG/DAY
NUMBER OF PUPS
SEX RATIO (MALES) % BORN ALIVE 0-4 DAY VIABILITY
0.50
0.50 0.64 0.56
0.40
0.53 0.83 0.44
0.44 0.36
0.38 0.39
0.43 0.50
66.7
100.0 71.4
100.0
100.0
100.0 100.0 100.0
0.0 100.0
100.0 100.0
100.0 100.0
100.0
100.0 100.0 100.0
100.0
100.0 83.3 0.0
100.0
100.0 94.4
100.0 100.0
LACTATION INDEX
100.0
100.0 100.0. 100.0
100.0 100.0 100.0
100.0 100.0 100.0 100.0 100.0
1176
Company Sanitized. Does not contain TSCA CBl
ANIMAL NUMBER
643320 6434883 643428 643439 643353 6433853 643339 6434733 643337 643416 643407 643357s 643331 643427 6434703 643434 643349 643454^' 643333 643460
INDIVIDUAL PUP SURVIVAL: Pi GENERATION
GROUP: VI-0
DOSB: 100 MG/KG/DAY
% BORN ALIVE
NUMBER OF MALE PUPS
0-4 DAY VIABILITY
LACTATION INDEX
66.7
100.0 77.8
100.0
100.0
100.0 100.0 100.0
0.0 100.0
100.0 100.0
100.0 100.0
100.0
100.0 100.0 100.0
100.0
100.0 80.0 0.0
100.0
100.0 85.7
100.0 100.0
100.0
100.0 100.0 100.0
100.0
100.0 100.0
100.0
100.0 100.0
100.0 100.0
1177
Company Sanitized. Does not contain TSCA CBl
ANIMAL NUMBER
643320 6434883 643428 643439 643353 6433853 643339 643473s 643337 643416 643407 6433573 643331 643427 6434703 643434 643349 64345423 643333 643460
INDIVIDUAL PUP SURVIVAL: Pi GENERATION
GROUP: VI-0
DOSE: 100 MG/KG/DAY
BORN ALIVE
NUMBER OF FEMALE PUPS
0-4 DAY VIABILITY
LACTATION INDEX
66.7
100.0 60.0
100.0
100.0
100.0 100.0 100.0
0.0 100.0
100.0 100.0
100.0 100.0
100.0
100.0 100.0 100.0
100.0
100.0 100.0
0.0
100.0
100.0 100.0
100.0 100.0
100.0
100.0 100.0 100.0
100.0
100.0 100.0
100.0
100.0 100.0
100.0 100.0
1178
Company Sanitized. Does not contain TSCA CBl
ANIMAL NUMBER
BORN
643467
. 13
643443
12
643417
10
643413
12
643338
14
643335
14
643468
14
643440
18
6434303
-
6434313
-
643326
14
643365
9
643375
5
643328
11
6433483
-
643346C
-
643449
17
643429d'e
16
6434243
-
INDIVIDUAL PUP SURVIVAL: Pi GENERATION
GROUP: VII I-0
DOSE: 250 MG/KG/DAY
NUMBEI1 OF PUPS
BORN P'RECULLING POSTCULLIIrc
ALIVE
DAY 4
DAY 4
DAY 7
DAY 14
13
13
8
8
8
12
12
8
8
8
10
10
8
8
8
12
12
8
8
8
14
14
8
8
8
14
14
8
8
8
14
14
8
8
8
18
18
8
8
8
-
-
-
-
-
-
-
-
-
-
13
12
8
8
8
8
8
8
8
8
1
1
1
0
0
11
8
8
8
8
-
-
-
-
-
-
-
-
-
-
17
17
8
8
8
0
-
-
-
-
-
-
-
-
-
DAY 21
8 8 8 8 8 8 8 8
-
-
8 8 0 8
-
-
8
-
-
1179
Company Sanitized. Does not contain TSCA CBI
ANIMAL NUMBER
643467 643443 643417 643413 643338 643335 643468 643440 6434303 6434313 643326 643365 643375 643328 643348s 643346'' 643449 643429d 6434243
BORN
8 7 6 7 8 7 9 9
-
-
8 4 3 6
-
-
10
0
-
INDIVIDUAL PUP SURVIVAL: Fi GENERATION
GROUP: VIII-0
DOSE: 250 MG/KG/DAY
NUMBEIt OF MALE PCrps
BORN PRECULLING POSTCULLING1
ALIVE
DAY 4
DAY 4
DAY 7
DAY 14
DAY 21
8
8
4
4
4
4
7
7
4
4
4
4
6
6
4
4
4
4
7
7
4
4
4
4
8
8
4
4
4
4
7
7
4
4
4
4
9
9
4
4
4
4
9
9
4
4
4
4
-
-
-
-
-
-
-
-
-
-
-
-
7
6
4
4
4
4
3
3
3
3
3
3
.0
0
0
0
0
0
6
4
4
4
4
4
-
-
-
-
-
-
-
-
-
-
-
-
10
10
4
4
4
4
0
-
-
-
-
-
-
-
-
-
-
-
1180
Company Sanitized. Does not contain TSCA CBl
ANIMAL NUMBER
643467 643443 643417 643413 643338 643335 643468 643440 6434303 6434313 643326 643365 643375 643328 6433483 643346 643449 643423d 643424s
BORN
5 5 4 5 6 7 5 9
-
-
6 5 2 5
-
-
7 3
-
INDIVIDUAL PUP SURVIVAL: F^ GENERATION
GROUP: VIII-0
DOSE: 250 MG/KG/DAY
NUMBEI? OF FEMAL1S PUPS
BORN P RECULLING POSTCULLI11G
ALIVE
DAY 4
DAY 4
DAY 7
DAY 14
5
5
4
4
4
5
5
4
4
4
4
4
4
4
4
5
5
4
4
4
6
6
4
4
4
7
7
4
4
4
5
5
4
4
4
9
9
4
4
4
-
-
-
-
-
-
-
-
-
-
6
6
4
4
4
5.
5
5
5
5
1
1
1
0
0
5
4
4
4
4
-
-
-
-
-
-
-
-
-
-
7
7
4
4
4
0
-
-
-
-
-
DAY 21
4 4 4 4 4 4 4 4
-
-
4 5 0 4
-
-
4
-
1181
Company Sanitized. Does not contain TSCA Cffl
ANIMAL
NUMBER
643467 643443 643417 643413 643338 643335 643468 643440 6434303 6434313 643326 643365 643375 643328 6433483 643346 643449 643429'^ 6434243
INDIVIDUAL PUP SURVIVAL: Fi GENERATION
GROUP: VIII-0
DOSE: 250 MG/KG/DAY
NUMBER C>P PUPS
E3EX RATIO1 (MALES)
% BORN AiLIVE (3-4 DAY VIAABILITY
0. 62 0. 58 0. 60 0. 58 0. 57 0. 50 0. 64 0. 50
-
-
0. 57 0. 44 0. 60 0. 55
-
-
0. 59 0. 00
-
100. 0 100. 0 100. 0 100. 0 100. 0 100. 0 100. 0 100. 0
-
-
92. 9 88. 9 20. 0 100. 0
-
-
100. 0 0. 0
-
100. 0 100. 0 100. 0 100. 0 100. 0 100. 0 100. 0 100. 0
-
-
92. 3 100. 0 100. 0
72. 7
-
-
100. 0
-
-
LACTATION INDEX
100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0
-
-
100.0 100.0
0.0 100.0
-
-
100.0
-
-
1182 Company Sanitized. Does not contain TSCA CBI
ANIMAL NUMBER
643467 643443 643417 643413 643338 643335 643468 643440 6434303 6434313 643326 643365 643375 643328 643348s 643346 643449 643429'3 6434243
INDIVIDUAL PUP SURVIVAL: Fi GENERATION
GROUP: VIII-0
DOSE: 250 MG/KG/DAY
% BORN ALIVE
NUMBER OF MALE PUPS
0-4 DAY VIABILITY
LACTATION INDEX
100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0
100.0 100.0
100.0 100.0 100.0 100.0 100.0 100.0
100.0 100.0
100.0 100.0 100.0 100.0 100.0 100.0
87.5
75.0 0.0
100.0
85.7 100.0
66.7
100.0 100.0
100.0
100.0
100.0
100.0
1183
Company Sanitized. Does not contain TSCA CBI
ANIMAL NUMBER
643467 643443 643417 643413 643338 643335 643468 643440 6434303 6434313 643326 643365 643375 643328 643348s 643346C 643449 643423d 6434243
INDIVIDUAL PUP SURVIVAL: Fi GENERATION
GROUP: VIII-0
DOSE: 250 MG/KG/DAY
% BORN ALIVE
NUMBER OP FEMALE PUPS
0-4 DAY VIABILITY
LACTATION INDEX
100.0 100.0 100.0 100.0
100.0 100.0 100.0 100.0
100.0 100.0 100.0
100.0. 100.0 100.0 100.0 100.0
100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0
100.0 100.0
50.0 100.0
100.0 100.0 100.0 80.0
100.0 100.0
0.0 100.0
100.0 0.0
100.0
100.0
1184
Company Sanitized. Does not contain TSCA CBl
APPENDIX GG REPRODUCTIVE TOXICOLOGY INDIVIDUAL PUP WEIGHTS: Fi GENERATION
1185
Company Sanitized. Does not contain TSCA CBI
H-24516: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations
REPRODUCTIVE TOXICOLOGY INDIVIDUAL PUP WEIGHTS: Fi GENERATION
EXPLANATORY NOTES
DuPont-5386
Footnotes:
a No litter delivered. b Two pups were missexed; data excluded from male and female mean pup weights. c One pup was missexed; data excluded from male and female mean pup weights. d No male pups bom. e No live pups at birth. / Found dead Day 22G (Test Day 99). g Recording error, data excluded. h No male pups bom alive. i Accidentally killed Day 14G (Test Day 91). j Found dead Lactation Day 0 (Test Day 106). k No live pups on Lactation Day 4. 7 No live pups on Lactation Day 7.
1186
Company Sanitized. Does not contai,"TSCACB<
H-24516: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations
DuPont-5386
Animal Number 6433523
643343
643459
6433943
Individual Pup Weights (grams): Lactation Day 0
FI Generation
Group: 11 - 0
Dose: 0 mg/kg/day
Pup Sex
7 .90 7 .40 8 .20 7 .10
7 .50 6 .90 8 .30 8 .40
7 .60 7 .00 7 .20 7 .50
7 .40 7 .00 8 .00
7 .30 7 .40 8 .40
Pup Number
6789
7 .70 7 .40 7 .70 8.10 8.20 8.30
10
8.70
11
8.10
12
8.10
643480 6433193
6 .50 7 .20
8 .50 8 .40
8 .00 7 .40
7 .40 8 .10
8 .00 7 .30
7 .90 7 .90
7.80
7.90
7.70
643350a
643363 643397 643421
6 .70 6 .60 7 .10 6 .50
7 .00 6 .70
7 .10 6 .20
7 .20 6 .70 6 .70 6 .50
6 .20 6 .20 7 .30 7 .20 5 .90 6 .30
6 .80 6 .40 7 .50 6 .90 6 .30 6 .10
6 .40 6 .30 6 .30 6 .10 6 .60 6 .20
6 .40 6 .00 7 .00 6 .30 6 .70 6 .60
6.60 6.20 7.00 5.60
6.40
7.10 6.50
6.00
6.20
1187
Company Sanitized. Does not contah. TCCA CB
H-24516: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations
DuPont-5386
In.dividiial Puip Wei<?hlts (grams]1:
Lac ta,tioi1 Day 0
FI Geneiration
Animal
Number
Eiup
S ex
1
643420a
Groui?: II -0
2
3
4
Dose;: 0 m g/kgAlay
Pup Mumber
5
6
7
8
9
10
11
12
643419 6434143
7.50 5.60
7.20 6.50
7.30 6.50
6.90 6.00
7 .00 6 .00
7.10
6.60
6.00
5.60
6.90
6.40
643401 643455 643378 6433933
6.10 5.30 7.00 6.40 8.70 8.10
6.20 5.80 6.50 5.90 9.20 6.60
6.20 5.60 6.60 6.30 7.90 7.90
6.30
6.90 6.50 7.90
6 .10
6 .60 6 .70 8 .40
6.90
7.10 5.90
6.00 7.00
6.20 7.20
6.40 6.90
5.40
6.10
5.90
643447 643478 643386
6.60 6.20 6.00 5.70 6.40 5.90
6.30.
6.60 7.20 6.00 6.30 6.20
6.20 6.20 6.50 6.40 6.30 5.70
6.50 6.40 6.60 6.50 6.30 6.30
6 .70 6 .40 6 .50 5 .40 6 .40 6 .00
7.00 6.60 6.20 6.40 6.70
7.20 6.50 6.80 5.80 6.10
6.50 5.60 7.00
6.60 6.40
5.50 6.30
7.10
6.50
1188
Company Sanitized. Does not contain TSCA CBI
H-24516: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations
DuPont-5386
Animal Number 643399^ 643334 643464 643369 643490 643342 643438 6434453
In div'idlual PiUp KFei.ght 8 (graims) : La.ctat:icin D.ay O
F 1 G<ine'rat ion
Gr(3U]3: 1\r-Q
Do,se: ; !5 mg/ kg /dasr
E Tip
S ex
: L
7. 30 7. 50
6. 30 6. 30 8. 10 6. 90 6. 50 6. 00 7. 00 6. 60 7. 60 6. 20 6. 20
6. 00
2
8 .10 7 .40 7 .10 6 .40 7 .50 7 .40 6 .90 5 .70 6 .90 6 .40 7 .20 6 .90 6 .30 6 .30
3
8 .00 7 .50 6 .20 6 .20 7 .40 6 .90 6 .80 6 .00 6 .60 5 .70 7 .40 7 .30 5 .80 5 .90
4
7 .60 8 .10 7 .30 6 .40 8 .20 7 .20 6 .10 6 .50 6 .40 6 .40 6 .00 6 .30 5 .80 6 .10
Pup Numb er
5
6
7
7 .50 6 .60 6 .20 8 .20 7 .60 6 .50
6.20 6 .90 6 .20 6 .50 5 .90 6 .00 5 .40
7.60 6.60
6.90 7.00 5.80 6.80
6.90 6.70 6.00 5.60
7 .80 7 .00
7 .20 6 .80 6 .10 6 .60
6 .90 6 .60
6 .10
8
7 .50 6 .40
7 .50 6 .20 6 .70 6 .90 7 .10 6 .40
9
7 .00 7 .00
6 .80 5 .10 6 .00
10 7 .00 6 .00
6 .00
11
5.60
643418 643325
6. 80 7. 00
7. 20 6. 80
6 .80 6 .10 6 .60 6 .80
6 .30 6 .60 7 .50 5 .80
4 .30 6 .60 7 .10 7 .20
6 .90 6 .30 7 .10
6.70 6.00 6.90
6 .80 6 .40 7 .00
6 .90 7 .50
6 .90
6 .70
7.30
1189
company saniti2ed- Does not contain TSCA CBl
H-24516: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations
DuPont-5386
Animal Number 643479
6434033
Individual PiUp Vrei<3ht s (grcims) :
Lactat:ion D ay O
FI G(in<;rat ion
Grcsup: IVr-0
Do se: ;25 mg/ kg /dair
P up
Puip Numbier
S ex
l
2
3
J l
5
6
7
8
9
8.30 7.00
7.50
7 .70
7. 60
7.20
7.20
10 11
643376 643422s
6.90 6.00
6.70 6.50
7 .40 6 .70
6. 50 6. 90
7.40
6.60
7.40
6 .80
6.90
7 .10
643452 643473d 643372 643400 643395C 643457
7.50 6.70
7.30 7.50
7 .00 6 .50
7. 30 7. 10
7.90 6.50
7.80
6.60
7.40 7.60 6.60 5.60 5.90 7.50 6.40 6.30 6.40
7.00 6.90 7.00 6.00 5.40 6.30 6.50 6.00 6.00
6 .50 5 .80 6 .00 5 .40 6 .10 6 .60 6 .40 6 .20
7. 00 6. 20 5. 50 5. 60
6. 90 6. 00 5. 80
7.30 6.60 5.90 4.10
6.20 6.10 6.00
7.10 7.10 5.90 5.10
5.90 5.50
7.50 6.90 5.50
5.80
6 .00 5 .70
5 .90
6.70 6.50
7 .20 6 .90
1190
capawswllwl^'M^rscAcal
H-24516: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations
Individual Pup Weights (grams): Lactation Day 0
PI Generation
Group: VI - 0
Dose: 100 mg/kg/day
DuPont-5386
Animal Number 643320 643488s 643428 643439 643353 6433853 643339 6434733 643337 643416
Pup Sex
7.20 8.00 7.00 7.30
Pup Number
567
10
11
6.40 6.00 6.80 6.70 9.10 7.50
6.70 6.00 7.00 5.50 7.50 8.40
6.70 6.70 6.10 5.30 8.90 7.40
7.00 6.40 5.70
8.30 7,10
6.00 7.20 6.40
8.30
6.50 6.80 6.90
6.40 6.80 6.80
7.40 6.80 6.50 6.30 6.20 6.70 6.90 6.50 6.30 6.70 6.40 6.20 6.20 6.50 5.80
6.40 6.50 7.00 6.00
6.20 5.50 6.20
6.60 6.40 7.10
6.80 6.50 7.60
6.40 6.50 7.00
7.20 6.10
6.60 5.20
7.20
1191 Company Sanitized. Does not contain TSCA CBI
H-24516: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations
Animal Number 643407
643357''
Individual Pup Weights (grams): Lactation Day 0
FI Generation
Group: VI - 0
Dose: 100 mg/kg/day
Pup Number Pup
5 6 7 8 Sex 5.70 5.00
5.30 4.50
6.50 5.40
5.70 4.90
6.30 5.20
5.70 5.20
5.70 6.00
6.10
5.40
6433310
643427 6434703
7.70 6.80
7.10 6.70
7.10 6.70
6.70 7.80
7.30 7.00
7.00
7.10
7.10
7.10
643434 643349 643454^'
6.70 5.50 6.50 6.20
5.70 6.00 5.90 6.10
6.50 5.50 6.20 6.10
6.50 6.20 6.30 6.00
5.60 5.70 6.40 5.60
6.50 6.20 6.30 6.70
6.70 6.30 6.00
6.50 5.60
5.80 6.20
6433339
643460
8.20 7.60
8.20 7.50
7.60 7.20
8.70 7.70
8.20 7.30
8.20 7.70
7.30 7.10
DuPont-5386
10
11
5.90 6.40
6.00
1192 Company Sanitized. Does not contain TSCA CBI
H-24516: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations
Animal Number 643467 643443 643417 643413 643338 643335 643468 643440 6434303
Ind;Lvidual Pup W(iights (grams).: L actaticm Day 0
FI General;ion
Grc3Up: V III-O
Dose;; 250 mg/kg/clay
Pup N umber Pup
Sex
l
2
3
4
5
6
7
8
7.20 6.90 7.00 6.80 6.30 7.50 6.80 5.30 6.80 6.60 6.90 6.00 7.80 7.50 6.30 6.00
6.60 6.90 6.20 6.60 6.10 5.40 7.00 6.40 6.30 5.50 6.80 6.10 7.50 6.80 6.60 6.10
7.00 6.80 7.20 6.70 8.00 5.70 6.10 6.70 6.90 6.20 6.30 6.50 7.80 7.60 6.40 6.10
7.30 6.30 7.20 6.00 8.10 7.40 7.20 6.80 6.90 6.80 7.30 6.40 7.80 6.50 6.30 5.80
7.40 7.00 6.40 6.70 5.90
7..30 5.90 6.60 5.70 6.60 5.90 6.30
7.50 6.30 5.80
7.10
7.10
6.00
6.70
7.40 6.80 6.50 5.40 7.60
6.80 5.60
7.10 7.10
5.30 6.60 6.80 5.90 6.80 6.10 6.50
7.50
6.80 7.10 7.00 6.60
6434313
DuPont-5386
9
10
7.60
6.10 5.60
1193
Company Sanitized. Does not contain TSCA CBI
H-24516: Subchronic Toxicity
90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations_____________DuPont-5386
Individual Pup Weights (grams): Lactation Day 0
FI Generation
Group: VIII-p
Dose: 250 mg/kg/day
Animal Number 643326
643365
12345678 Pup
Sex
5.70 6.30 6.90
6.60 6.50 7.60
6.20 6.10 7.90
6.90 5.50
Pup Number --^----------
6.50 6.30
6.50 6.00
6.20
643375A
7.00 6.50 7.00 7.20 7.50
643328 6433483
5.30 5.80 5.30
5.30 5.60
6.00 5.50
4.90 5.20
5.20 5.00
5.50
9
10
6433461
643449 643429J
6.40 5.70
6.80 5.70
6.20 6.20
6.70 5.90
6.80 6.10
6.10 5.60
5.70 6.20
6.50
5.80
6.10
6434243
1194
Company Sanitized. Does not contain TSCA CB(
H-24516: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations
Individual Pup Weights (grams): FI Generation Lactation Day 4 Preculling
Group: II-O
Dose: 0 mg/kg/day
DuPont-5386
Animal Number 643352s 643343 643459 643394s 643480 643319s 6433503 643363 643397 643421
I?up Piip Number
!ex
1
2
3
4
1 5
6
7
8
9
10
11
12
12 .10 12 .10 11 .10 12 .30
13 .00 11 .90 12 .30 10 .10
12 .70 12 .00 10 .90 13 .20
12 .30 12 .10 13 .80
12 .20 11 .10 13 .50
12 .60 12 .10 14 .20
12.10
13.00
12.70
13.80
13.60
13.30
14 .60 14 .20 13 .30 11 .70 13 .90 12 .90 13 .40 14 .30 12 .70 12 .50 13 .20 12 .30 12.20 12.40 12.40
10 .20 10 .90 10 .60
9. 20 11 .20
9. 10
10 .90 10 .40 12 .00
10 .90 9. 20
9. 90
10 .20 10 .30 11 .60
11 .50 11 .20
10 .90
11 .10 9. 50 12 .80
11 .30 8. 60
10 .20
11 .40 10 .40 11 .90
11 .40 9. 80
10 .20
12 .70 10 .40 11 .70
10 .50 11 .60
10 .10
10.70 11.00 10.40
9.70
9.90 11.90
10.80
9.20
10.90
1195
Company Sanitized. Does not contain TSCA CB(
H-24516: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations
DuPont-5386
Individual Pup Weights (grams): FI Generation Lactation Day 4 Preculling
Group: 11 - 0
Dose: 0 mg/kg/day
Animal
Pup
Number
Sex
6434203
Pup Number
6
7
8
9
10
11
12
643419 6434143
12.70 12.50 11.60 9.70 10.60 12.80 10.60 9.80 12.10 10.80 9.90 11.50 11.40 11.10 11.20 9.80
643401 643455 643378 643393s
10.10 9.00 10.10 9.30 14.10 15.50
10.30 9.10 9.80 10.30 15.50 12.80
10.00 8.40 10.50 9.70 13.40 15.70
11.00
10.90 9.70 16.60
10.10
11.50 10.60 14.70
9.70
11.30 10.30
9.80 11.60
10.00 10.60
9.60 10.30
10.20
10.70
9.70
643447 643478 643386
10.70 9.50 11.70 10.80 11.20 9.50
10...80
10.80 11.20 10.10 10.40 10.00
9.90 9.80 11.40 10.00 10.40 9.60
9.60 9.40 10.40 10.50 11.60 10.50
9.50 9.90 11.90 10.50 10.50 9.60
9.70 10.00 10.90 10.30 10.90
6.30 9.80 11.90 11.60 11.10
11.00 11.30 9.80
9.90 10.20
11.00 9.40
10.90
9.90
1196 Company Sanitized. Does not contain TSCA CBl
H-24516: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations
lir In dividijal PULp Ktei<ght,S (;graims ) : F] Ge'iteration
]Lactatioia. D.ay 4 Ereicul ig
GR(3OT IV -0
DO;SE: !5 ]MG/ KG/DAY
DuPont-5386
Animal Number 643399 643334 643464 643369 643490 643342 643438 6434453 643418 643325
Pup
PuP ^rumber
Siex
1
2
3
4
5
6
7
8
9
10
11
13 .50 11 .20 10 .70 10 .00 13 .20 13 .00 10 .20 9. 50 9. 90
9. 00 13 .00 12 .10 10 .00 9. 90
13 .80 12 .40 10 .00 10 .80 13 .90 11 .70 10 .70 8. 50 10 .10
8. 00 11 .20 11 .40 10 .20 10 .10
12 .40 12 .30 10 .00 10 .20 12 .20 11 .80 9. 40 9. 40 9. 90
8. 30 10 .80 12 .00
11 .00 10 .80
12 .40 12 .60 10 .70 9. 70 13.20 11 .80 9. 70 9. 10 8. 70
8. 30 10.20 10 .40 10 .90 9. 90
12 .60 11 .80 10 .80 10 .00 12 .50 12 .60 9. 90 6. 90 10 .50
10 .00 11 .80 9. 60 10 .50
12 .10 12 .90 11 .30
11 .80 11 .50 11 .20 9. 40
12 .60 10 .50 10 .50 9. 80
11 .60 11 .00
12 .00 9. 80 10 .20 10 .10
12 .50 11 .70
10 .30
11.50 10.90
11.90
10.20 9.70
12.10 11.20
10.30
11.50 9.40 9.80
10.80
10.20 10.20
10.50
11 .70
11 .10 11 .40 12 .90
11 .30
11 .00 13 .50 11 .40
11 .00
10 .10 12 .30 12 .30
10 .80
11 .20 13 .00 11 .90
11 .20
11 .70 12 .80
11 .60
10 .60 13 .60
6. 10 12 .60
13.20
12.80
12.90
12.80
1197 Company Sanitized. Does not contain TSCA Cflt
H-24516: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations
DuPont-5386
Animal Number 643479
643403s
Individual Pup Weights (grams): FI Generation Lactation Day 4 Preculling
Group: IV-0
Dose: 25 mg/kg/day
EUp
PU;p hlumber
S!ex
1
2
3
4
5
6
7
8
9
15 .40 12 .70 14 .50 13 .70 13 .70 14 .40 14 .20
10
11
643376 643422^
10 .40 11 .40 11 .10 10 .50 10 .50 10 .80 11.10 9. 50 10 .50 10 .00 10 .10
9.80
9.70 11.70
643452 643473d 643372 643400 643395 643457
12 .40 12 .40 11 .80 11 .50 12 .70 12 .30 11.10 11 .60 12 .70 11 .00 11 .70 11 .70
15 .10 10 .10 10 .30 7. 70 8. 60 12 .60 13 .20 11 .70 11 .00
13 .50 10 .20
10 .90 8. 70 8. 00 13 .80 13 .20 12 .00 10 .30
11 .10
10 .10 7. 10 8. 10 13 .40 14 .40
11 .10 10 .50
11 .10 10 .90
9. 70 7. 80 13 .00
12 .90 12 .60 11 .20
10 .40 9. 20 9. 00
11 .30 11 .70
10 .00 9. 50 9. 30
11 .20
12.20 8.60 8.60
11.60
11.00 7.90
10.80
11.00 10.50
9.60 11.50
1198
Company Sanitized. Does not contain TSCA CBl
H-24516: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations
DuPont-5386
Animal Number 643320
6434883
Individual Pup Weights (grams): FI Generation Lactation Day 4 Preculling
Group: VI - 0
Dose: 100 mg/kg/day
Pup Number Pup
1 2 3 4 Sex 13.50 15.10 14.10 14.00
5
6
7
8
9
10
11
643428 643439 643353 643385a 643339 643473s 643337 643416
11.20
9.10 10.20
12.00 14.40 10.80
11.00
10.50 13.60
13.30 16.70 13.70
10.90
10.60 12.40
10.40 14.70 15.40
9.90 11.10 13.30
16.50 14.60
10.40 9.10 10.20
15.80
10.70 11.00 13.60
10.20 10.20 12.30
10.50 10.60 11.70 11.20 11.30 10.40 11.00 11.10 9.60 10.30 8.40 9.90 11.20 10.60 10.90
11.00
10.60 13.30 10.70
11.40
11.40 13.40
12.70
12.00 13.90
11.90
10.70 13.80
12.00 11.70
11.50 8.90
12.50 11.50
11.10
1199
Company Sanitized. Does not contain TSCA ftal
H-24516: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations
DuPont-5386
Animal
Pup
Number
Sex
643407^
6433573
Individual Pup Weights (grams): FI Generation Lactation Day 4 Preculling
Group: VI-0
Dose: 100 mg/kg/day
Pup Number
5678
10
n
643331S 643427 643470a 643434 643349 643454f 643333 643460
12.50 11.70 11.00 12.10 11.50 11.90 11.30 11.60 11.90 13.10 11.70 11.70 11.40 12.00
9.90 8.50 10.90
9.00
8.90 9.50 10.10
10.60
10.00 6.90 10.20
8.30
10.30 10.80 10.40
10.00
9.40 9.10 9.80
8.40
8.80 7.10 8.60
10.50
8.80 8.90
8.70 9.00
9.80 9.80
9.00 8.90
8.10
15.60 14.80 12.90 12.10
14.60 13.40 12.40 12.20
13.80 14.00 12.20 11.30
13.50 11.80 12.40
12.90 12.00
12.80 12.20
12.60 11.90
1200 Company Sanitized. Does not contain TSCACB1
H-24516: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations
DuPont-5386
Ind ividual PUp w<iiglits (grams] : FI Gen.era1:ioi3 Lac tat3Lon Day 4 Pre<=Ul]Ling
Gnoup: V III -0
Animal
PU]P
Number
Se:C
1
2
3
4
Dose ! 41250 mg/ kg/(lay
Pup N umbisr
5
6
7
8
9
10
643467 643443 643417 643413 643338 643335 643468 643440 6434303
10.00 8.50 11.20 12.30 9.50 9.50 10.80 9.40 11.40 11.10 10.40 10.40 11.80 9.00 11.60 9.00
10.70 8.30 12.10 11.00 13.80 6.80 12.70 11.30 12.00 11.60 10.20 8.80 12.20 9.60
9,. 90
9.90
9. 90 10 .30 11 .90
12 .30
9. 30 8. 30 11 .90
10 .70 11 .30 11 .20 9. 20 8. 40 10 .20
11 .40 10 .30 10 .60
9. 10 8. 80 11 .90 12 .00 7. 20 11 .80 12 .70 11 .40 11 .30 11 .50
11 .70 10 .50 10 .40 11 .20 11 -20 10 .50
8.60 10.00 12.80 11.60 9.40
9.20 11.60 11.70 9.80 11.40 9.60 12.50 11.00 10.00 9.70
7. 90
12 .40
10 .70
12 .30
10 .40 9. 30 11 .00 10 .50 11 .70
10 .90 9. 00
9. 70 13 .30
10 .90 11 .00 12 .10 10 .10 9. 60 10 .30 10 .30
8. 60
10 .70 8. 20 10 .80 11 .00
10.80
11.10 10.20
6434313
1201
Company Sanitized. Does not contain TSCA CBl
H-24516: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations
Animal Number 643326 643365
643375h 643328
6433483
Individual Pup Weights (grams): FI Generation Lactation Day 4 Preculling
Group: VIII-0
Dose: 250 mg/kg/day
Pup Sex
Pup Number
5
6
11.40 11.70 10.80
9.90
11.00 10.10 11.10
9.70
10.90 11.10 11.30
11.30
11.40 11.30
10.80
9.80 10.50
10.20
10.90 10.30
4.80 10.10
9.80
11.30 11.70
11.40 9.20
7.90 11.40
6433461 643449 643429 J 6434243
11.10 9.50
12.20 10.80
10.30 10.40
11.30 10.10
9.90 8.00
9.70 8.60
8.40 8.60
10.10
DuPont-5386 10
9.70 8.60
1202 Company Sanitized. Does not contain TSCA CM
H-24516: Subchronic Toxicity
90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations_____________DuPont-5386
Individual Pup Weights (grams): PI Generation Lactation Day 4 Postculling
Group: II-0
Dose: 0 mg/kg/day
Animal Number 6433523
643343
643459
6433943
1 2 3 4 5 Pup Number
Pup
------------
Sex
13.00 12.30 12.20 12.60
12.10 11.90 12.10 12.10
12.30 13.80 13.50 14.20 12.70
12.30 10.10 13.20
643480 6433193
14.60 13.40
13.30 14.30
13.90 13.20
12.90 12.20
6433503
643363 643397 643421
10.20 10.40 10.60
10.90 11.20
10.90
10.90 9.50 12.00
11.30 9.20
10.20
11.10 11.00 12.80
9.70 11.20
10.20
12.70 9.20 10.40
10.80 9.80
10.10
1203 Company Sanitized. Does not contain TSCA CBf
H-24516: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations
Individual Pup Weights (grams): FI Generation Lactation Day 4 Postculling
Group: II-O
Dose: 0 mg/kg/day
Animal Number 6434203 643419 6434143 643401 643455 643378 6433933 643447 643478
643386
Pup Sex
11.60 11.40
Pup Number
2 3 4 10.60 10.60 12.10
11.10 11.20 9.80
11.00 9.00 10.90 10.30 14.10 15.50
10.10 9.10 11.50 9.70 15.50 12.80
9.80 8.40 11.30 9.70 13.40 15.70
10.00
11.60 10.60 16.60
10.20 14.70
10.80 9.50 11.20
10.10 11.20
9.50
6.30 10.80 10.40
10.50 10.50
10.00
9.90 9.80 10.90
10.30 10.90
10.50
10.90 9.90 11.90
11.60 11.10
9.60
DuPont-5386
1204
TSCACBl
Company Sanitized. Does not contain
H-24516: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations
Individual Pup Weights (grams): PI Generation Lactation Day 4 Postculling
Group: IV-0
Dose: 25 mg/kg/day
Animal
Number 643399 643334 643464 643369 643490
643342 643438 6434453
ETip
Pilp N[un>er
4 5 6 ;ex
1
2
3
13 .80 12 .40 12 .60 12 .10 12 .40 12 .30 12 .60 11 .80
10 .70 10 .80 11 .00 10 .30
10 .80 10 .20 9. 70 10 .00 13 .90 12 .20 13 .20 12 .50
11 .80 12 .60 12 .00 11 .90
10 .20 10 .70 9. 40 11 .50 8. 50 10 .20 10 .20 9. 40
9. 90 8. 70 10 .50 10 .20
9. 00 8. 00 8. 30 8. 30
10 .80 10 .00 12 .50 12 .10
11 .40 12 .00 10 .50 11 .70
10 .20 11 .00 9. 60 10 .50 10 .80 9. 90 10 .50 9. 80
643418 643325
11 .30
11 .00 11 .40 12 .90
10 .80
10 .10 12 .80 11 .40
11 .60
11 .20 13 .60 12 .30
6. 10
11 .70 13 .20 11 .90
DuPont-5386
1205
^^s^.--------^^081
H-24516: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations
Individual Pup Weights (grams): FI Generation Lactation Day 4 Postculling
Group: IV-0
Dose: 50 nig/kg/day
Animal Number 643479
643403a
2 3 4 5 6 Pup
Sex
1
Pup Number
15.40 12.70 14.50 13.70 13.70 14.40 14.20
643376 6434223
10.40 11.10 10.50 11.70 9.50 10.50 10.00 10.10
643452 643475d 643372 643400 643395 643457
12.40 12.40 11.50 12.70 11.60 12.70 11.70 11.70
15.10 11.10 10.30 8.70 8.60 12.60 13.20 11.70 11.00
13.50 10.40 10.90 7.10 8.00 13.80 13.20 12.00 10.30
12.20 10.10 9.00 8.10 13.40 14.40 11.10 10.50
11.00 9.20 7.90 7.80 13.00 12.90 11.20 11.20
DuPont-5386
1206 Company Sanitized. Does not contain TSCA CBl
H-24516: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations
Individual Pup Weights (grams): FI Generation Lactation Day 4 Postculling
Group: VI - 0
Dose: 100 mg/kg/day
Animal Number 643320
643488a
Pup
PVip t lumb er
Sex
1
2
3
4
5
13 .50 14 .10
15 .10 14 .00
643428 643439 643353 6433853 643339 6434733 643337 643416
11 .00
10 .50 10 .20
12 .00 14 .40 10 .80
9. 90
10 .60 13 .60
13 .30 16 .70 13 .70
10 .40
11 .10 13 .30
10 .40 16 .50 15 .40
10 .20 11 .00 10 .20
15 .80 14 .60
13.60
10 .50 11 .00
10 .60 9. 60
11 .20 9. 90
10 .40 11 .20
12 .70
12 .00 13 .30 10 .70
11 .90
11 .70 13 .40
11 .50
8. 90 13 .90
12 .50
11 .50 13 .80
DuPont-5386
1207 Company Sanitized. Does not contain TSCACBl
H-24516: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations
Individual Pup Weights (grams): FI Generation Lactation Day 4 Postculling
Group: VI-0
Dose: 100 mg/kg/day
Animal Number 643407^
6433573
1 2 3 4 5 Pup Number
Pup
------------
Sex
643331
643427 6434703 643434 643349 643454-^ 643333 643460
12.50 11.70 11.00 12.10 11.60 11.90 11.70 11.40
9.90 6.90 10.10 9.00
10.00 7.10 10.40 8.30
10.30 8.70 9.80 8.90
9.40 9.80 8.60 8.90
15.60
14.80 12.40 12.10
14.60
13.40 12.20 11.30
13.80
14.00 12.90 12.20
13.50 12.80 11.90
DuPont-5386
1208
Company Sanitized. Does not contain TSCA CBI
H-24516: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations
Individual Pup Weights (grams): FI Generation Lactation Day 4 Postculling
Group:
Animal Number 643467 643443 643417 643413 643338 643335 643468 643440 6434303
VIII-0
Pup Sex
1
10 .70 8. 30 11 .20
12 .30 9. 50
9. 50 11 .90
11 .30 12 .00 11 .60 10 .40 10 .40 12 .20 9. 60 9. 90 10 .60
Dose: 250 mg/kg/day
Pilp t lumber
2
3
4
5
9. 90 10 .30 12 .10
11 .00 13 .80
6. 80 9. 20
10 .70 11 .30 11 .20 11 .70 8. 80 11 .70 11 .40 10 .30 10 .50
7. 90 8. 80 12 .80
12 .30 9. 30
8. 30 12 .30
11 .40 11 .30 11 .50 11 .40 8. 40 9. 60 11 .20 10 .00 9. 70
9. 70 10 .00 12 .40
12 .00
7.20
11 .80 10 .90
11 .60 11 .70 9. 30 11 .00 10 .50 8. 20 11 .00 10 .80 11 .00
6434313
DuPont-5386
1209
Company Sanitized. Does not contain TSCA CBI
H-24516: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations
Individual Pup Weights (grams): FI Generation Lactation Day 4 Postculling
Group: VIII-0
Dose: 1000 mg/kg/day
Animal Number 643326 643365
643375A
643328
6433483
2 3 4 5 Pup Number
Pup Sex
11.00 10.90 11.40 10.90 11.70 11.30 10.50 10.30 10.80 11.10 11.30 9.90 9.70 11.30 10.80 10.20
4.80 10.10
9.80
11.30 11.70
11.40 9.20
7.90 11.40
6433462
643449 643429J
12.20 11.30 9.90 10.10 10.40 10.10 8.00 8.60
6434243
DuPont-5386
1210
Company Sanitized. Does not contain TSCA CBt
H-24516: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations
Individual Pup Weights (grams): Lactation Day 7
PI Generation
Group: II-0
Animal
Pup
Number
Sex
643352s
643343 643459 6433943
19.40 18.40 22.70 17.10
Dose: 0 mg/kg/day
Pup Number
2 3 4 5 18.70 19.60 19.70
19.00 18.70 18.80 21.50 22.70 22.40 20.30 20.70 19.00
643480 643319s
21.20 19.60
23.10 21.40
20.20 22.20
22.90 20.10
6433503
643363 643397 643421
19 .40 17 .10 17 .60
16 .90 16 .00
14 .50
16 .90 16 .30 20 .00
19 .40 13 .70
15 .00
20 .70 18 .20 22 .10
18 .80 14 .40
15 .10
18 .90 18 .50 18 .30
18 .10 16 .90
15 .80
DuPont-5386
1211
Company Sanitized. Does not contain TSCA CBl
H-24516: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations
Individual Pup Weights (grams): Lactation Day 7
FI Generation
Group: II-0
Animal
Pup
Number
Sex
643420s
643419 643414s
19 .50 16 .20
Dose: 0 mg/kg/day
Pup Number
2 3 4 5 17 .90 20 .00 18 .20
19 .00 18 .40 18 .70
643401 643455 643378 643393s
17 .00 14 .80 16 .90 14 .70 19 .40 18 .40
17 .50 15 .50 17 .40 15 .70 20 .50 22 .00
17 .00 15 .90 17 .20 17 .30 19 .60 22 .00
17 .40
16 .50 15 .10 23 .00
16.60 19.70
643447.. 643478 643386
18 .50 17 .20 16 .70 15 .80 18 .80 16 .80
18 .70 18 .70 17 .10 16 .40 19 .00 17 .40
18 .30 15 .80 17 .50 15 .70 19 .60 15 .40
15 .70 17 .20 15 .60 15 .20 18 .80 17 .90
DuPont-5386
1212
Company Sanitized. Does not contain TSCA CBf
H-24516: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations
Individual Pup Weights (grams): Lactation Day 7
FI Generation
Group: IV-Q
Dose: 25 mg/kg/day
Animal
Number 643399 643334 643464 643369 643490
643342 643438 6434453
I ?up
PiJlp li[unit:>er
4 5 6 i3ex
1
2
3
19 .70 21 .30 19 .50 19 .00 19 .30 19 .70 19 .20 18 .80
17 .60 18 .00 19 .30 19 .40
16 .70 14 .40 18 .90 15 .80 16 .90 17 .30 19 .10 18 .00
16 .50 16 .50 16 .30 17 .10
15 .90 17 .70 16 .30 17 .50 15 .00 14 .60 16 .40 16 .40
15 .20 17 .00 17 .20 16 .90
14 .90 15 .60 16 .00 15 .70
16 .80 18 .20 16 .40 17 .10
18 .00 19 .40 17 .50 15 .80
17 .90 18 .80 16 .40 16 .70
19 .30 18 .30 18 .40 17 .40
643418 643325
9. 20
17 .20 19 .00 21 .70
19 .30
17 .70 22 .30 19 .60
17 .80
18 .80 20 .70 21 .90
18 .80
18 .20 22 .80 19 .70
DuPont-5386
1213 Company Sanitized. Does not contain TSCA CBl
H-24516: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations
Individual Pup Weights (grams): Lactation Day 7
PI Generation
Group: IV-0
Dose: 25 mg/kg/day
Animal
Number 643479
6434033
2 3 4 5 6 Pup
Sex
1
Pup Number
22 .50 21 .00 21 .40 19 .10 18 .10 19 .60 20 .50
643376 643422s
17 .70 19 .20 15 .60 16 .80 15 .00 16 .60 15 .10 17 .20
643452 643475'3 643372 643400 ; 643395 643457
19 .40 20 .10 19 .60 18 .00 18 .30 19 .30 18 .40 18 .20
22 .50 17 .90 17 .10 12 .50 13 .40 19 .40
19 .90 19 .90 18 .20
20 .60 17 .00 17 .00 14 .40 11 .90 20 .90
19 .00 20 .80 18 .10
18 .80 15 .50 13 .00 12 .80 20 .40
18 .70 19 .00 17 .80
17 .90 15 .80 10 .60 12 .20 21 .20
20 .40 17 .90 17 .30
DuPont-5386
t
1214
Company Sanitized. Does not contain TSCA CBl
H-24516: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations
Individual Pup Weights (grams): Lactation Day 7
PI Generation
Group: VI - 0
Dose: 100 mg/kg/day
Animal Number 643320
643488a
Pup Number Pup
2 3 4 5 Sex 22.50 21.20
21.30 22.60
643428 643439 643353 6433853 643339 6434733 643337 643416
17 .10
17 .70 20 .50
17 .10 23 .50 20 .80
17 .40
17 .80 16 .90
18 .00 23 .30 22 .40
18 .10
18 .50 20 .80
20 .00 21 .30 20 .50
17 .80 16 .90 16 .90
23 .50 16 .20
20.00
17.70 18.10 17.10 17.00 17.50 16.00 17.50 16.30
20.30
18.50 17.70 15.00
19.40
19.50 18.10
21.70
19.40 19.20
20.10
15.70 19.00
DuPont-5386
1215
Company Sanitized. Does not contain TSCA CSl
H-24516: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations
Individual Pup Weights (grams): Lactation Day 7
F^ Generation
Group: VI - 0
Dose: 100 mg/kg/day
Animal
P UP
Pilp t lumbisr
Number
S ex
1
2
3
4
5
643407^
6433573
6433316 643427 643470s 643434 643349 643454^^
19 .80 19 .10
17 .80 19 .00
19 .50 19 .30
19.20 19.30
17 .10 14 .10 16 .60
15 .40
14 .90 15 .80 17 .60
13 .70
15 .90 11 .40 17 .60
14 .80
16.90 10.70 15.40
14.00
643333 643460
20 .90 20 .60 16 .20 14 .30
22 .70 19 .70 16 .00 15 .00
20 .20
21 .30 15 .90 15 .10
19.50 15.50 13.90
DuPont-5386
1216
Company Sanitized. Does not contain TSCA CBt
H-24516: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations
Individual Pup Weights (grams): Lactation Day 7
PI Generation
Group: VIII-0
Animal Number 643467 643443 643417 643413 643338 643335 643468 643440 6434303
Pup
Sex
1
12 .40 11 .50 18 .80 18 .10 20 .00 15 .00 13 .10 16 .80 16 .50 16 .70 19 .50 17 .20 13 .80 16 .40 12 .20 12 .70
Dose: 250 mg/kg/day
I >up t lumbe r
2
3
4
5
10 .20 13 .60
20 .10 19 .00 12 .90 17 .20 18 .10 16 .50 15 .90 16 .00
19 .60 15 .40 11 .80 16 .10 11 .80 12 .30
13 .50 15 .60 19 .60 19 .50 9. 60 11 .80 16 .20 16 .90
15 .80 14 .00 18 .30 17 .60 17 .10 12 .00 12 .80 10 .80
13 .80 11 .30 20 .20 19 .50 14 .90
9..80 18 .40 15 .20 16 .30 16 .50 17 .80 15 .20 17 .90 17 .20 11 .70 11 .90
643431s
DuPont-5386
1217 Company Sanitized. Does not contain TSCA CBl
H-24516: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations
Individual Pup Weights (grams): Lactation Day 7
FI Generation
Group: VIII-0
Animal
Number 643326
643365
643375h'l
Pup Sex
14.80 17.70 14.90 12.60
Dose: 250 mg/kg/day
Pup Number
3
4
17.10 16.70 14.10 13.90
18.40 17.80 14.80 12.90
16.90 15.80
13.60
14.60
643328. 643348s
12.20 17.60
15.00 16.00
16.20 17.30
17.30 14.60
643346-1
643449 643429-?
15,20 15.80
20.30 17.10
17.60 15.30
15.80 13.50
643424s
DuPont-5386
1218
Company Sanitized. Does not contain TSCA CBI
H-24516: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations
Individual Pup Weights (grams): F^ Generation Lactation Day 14
Group: II-O
Dose: 0 mg/kg/day
Animal Number 6433523
643343
643459
643394s
2 3 4 5 Pup
Sex
Pup Number
37.90 40.90 39.20 38.70
36.00 38.10 37.20 37.30
43.70 43.10 44.50 40.60 46.10
36.00 40.60 40.50
643480 6433193
43.30 44.50
45.00 41.90
43.70 43.30
46.30 43.90
6433503
643363643397 643421
38 .20 39 .60 41 .00
34 .80 30 .60
31 .60
42 .30 38 .80 33 .30
35 .80 33 .30
30 .60
43 .10 36 .80 34 .60
33 .10 30 .30
32 .10
41 .00 40 .10 37 .20
35 .20 34 .80
32 .10
DuPont-5386
1219
Company Sanitized. Does not contain TSCA CB(
H-24516: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations
Individual Pup Wteiglits (gr ams ):
L.actciti(3n D ay 14
FI Generation
Group: II-O
D ose : 01 me(/kg/day
Animal
P Up
Piup 1iuiribe'r
Number
S ex
l
2
3
4
5
6434203
643419 643414s
43 .30 38 .50
42 .10 41 .10
42 .90 40 .70
41 .60 41 .30
643401 643455 643378 643393s
35 .70 35 .00 36 .20 32 .30 36 .70 40 .10
35 .70 31 .30 35 .30 30 .60 38 .90 39 .60
36 .30 33 .80
35 .30 34 .50 38 .10 33 .60
37 .40
30 .50 35 .20 37 .30
35.30 40.60
643447 643478 643386
39 .50 34 .00 36 .90 37 .20 39 .80 37 .10
37 .50 36 .40 37 .60
36 .50 39 .20 39 .60
37 .30 35 .50 38 .80 38 .80 40 .20 37 .50
34 .30 38 .00 38 .70 37 .40 40 .90 37 .40
DuPont-5386
1220
Company Sanitized. Does not contain TSCA CBI
H-24516: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations
Individual Pup 1Wei(3ht.3 (gr,a.ms,) : ]Lad;at.ioni D,ay :L4
FI Generation
Group: IV-0
DO!se: K )0 mg/kg/day
Animal Number
I ?up
Siex
l
Pilp K[umbfsr
2
3
4
5
6
643399 643334 643464 643369 643490 643342 643438 6434453
39 .90 37 .40 38 .30
37 .10 38 .30 37 .50 36 .00 35 .30 35 .10
33 .80 39 .30 39 .80 34 .90 37 .10
39 .00 37 .30 38 .50 34 .60 40 .10 38 .20 37 .90 37 .20 37 .70
34 .80 41 .70 38 .90 33 .80 34 .40
39 .10 38 .70 37 .60 38 .00 38 .20 37 .90 35 .70 34 .40 34 .30
33 .70 38 .20 40 .30 37 .70 36 .50
37. 20 36. 90 38. 20 35. 30 41. 10 37. 40 38. 30 36. 20 36. 50
36. 30 42. 70 39. 10 36. 90 32. 90
643418 643325
39 .00
37 .60 47 .10 43 .20
37 .80
36 .10 42 .80 45 .20
38 .30
37 .90 46 .90 46 .40
25. 10
38. 10 44. 90 40. 60
DuPont-5386
1221
Company Sanitized. Does not contain TSCA CBl
H-24516: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations
Individual Pup Weights (grams): F]_ Generation Lactation Day 14
Group: IV-0
Dose: 100 mg/kg/day
Animal Number 643479
6434033
Pup Sex
Pup Number
3
4
39.90 35.10 35.90 40.20 36.70 31.30 34.40
643376 6434223
34.70 34.40 33.70 39.90 31.20 31.00 35.80 32.20
643452 643475d 643372 643400 . 643395 643457
36.30 38.00 36.70 36.90 36.40 37.00 35.80 34.60
39.80 38.40 35.40 32.20 32.20 37.50 37.30 40.10 38.30
38, 50 39, 60 35, 80 29 90 30 00
36 80 35 30
40 80 38 60
37.00 33.90 27.30 28.90 36.50 37.00 39.30 38.70
37.00 32.60 30.70 29.50 38.20 36.10 36.30 37.80
DuPont-5386
1222
Company Sanitized. Does not contain TSCA Cfil
H-24516: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations
Individual Pup Weights (grams): FI Generation Lactation Day 14
Group: VI - 0
Dose: 100 mg/kg/day
Animal Number 643320
6434883
Pup Number Pup
2 3 4 5 Sex 44.60 43.00
43.90 41.20
643428 643439 643353 6433853 643339 6434733 643337 643416
36 .10
36 .20 36 .40
38 .80 40 .20 35 .40
36 .40
34 .40 37 .80
35 .00 38 .40 36 .20
33 .60
32 .70 38.70
34 .80 39 .60 31.40
34 .50 33 .60 32 .50
39 .80 38 .30
38.80
36.10 38.00 38.90 37.10 39.50 34.20 35.50 35.80
38.40
38.50 36.20 32.40
41.30
37.70 36.10
38.80
39.60 35.30
40.70
33.20 38.10
DuPont-5386
1223 Company Sanitized. Does not contain TSCA CBI
H-24516: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations
Individual Pup Weights (grams): FI Generation Lactation Day 14
Group: VI - 0
Dose: 100 nig/kg/day
Animal
Ptip
PVlp I tunib er
Number
S!ex
1
2
3
4
5
643407^
6433573
6433318 643427 6434703 643434 643349 643454f 643333 643460
35. 70 39 .90 36 .20 36.80 36. 50 37 .40 38 .20 36.70
31. 60 23. 50 28. 30
30. 10
34 .40 27 .90 34 .30
32 .20
37 .10 30 .30 34 .40
31 .10
34.30 32.60 32.00
29.90
36. 30 38. 80 33. 40 32. 10
38 .00 35 .80 34 .90 32 .20
40 .30 35 .70 33 .20 32 .50
35.60 34.90 33.40
DuPont-5386
1224
H-24516: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations
Individual Pup Weights (grams): FI Generation Lactation Day 14
Group: VIII-0
Animal
Number 643467 643443 643417 643413 643338 643335 643468 643440
643430s
Pup
Sex
1
30 .40 25 .50 35 .10 32 .20 34 .40
31 .50 28 .90 25 .80 30 .70 31 .60 29 .60 29 .60 32 .80 36 .90 28 .10 28 .50
Dose: 1000 mg/kg/day
t >up ^luinbe:r
2
3
4
5
25 .60 34 .10 34 .00 34 .90 26 .90 19 .60 25 .90 26 .90 33 .00 29 .80 31 .30 27 .10 37 .70 35 .20 26 .90 25 .50
16 .70 30 .50 35 .30 32 .50 20 .50 27 .90 28 .00 26 .60 31 .00 32 .20 31 .20 29 .00 28 .10 33 .60 26 .00 29 .00
24 .30 23 .60 34 .80 33 .80 28 .20 ;
24 .90 22 .30 26 .30 33 .10 31 .50 29 .90 26 .80 35 .70 31 .10 30 .10 29 .70
643431s
DuPont-5386
1225
Company Sanltbed. Does not contain TSCA<
H-24516: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations
Individual Pup Weights (grams): FI Generation Lactation Day 14
Group: VIII-0
Dose: 1000 mg/kg/day
Animal Number 643326
643365
643375^ 1
Pup Sex
33.40 30.70 30.00 28.00
Pup Number
2
3
4
32.50 31.70 29.30 29.00
32.50 33.10 23.30 28.20
30.20 31.80
26.90
c
26.90
643328 643348s
20.80 21.90
27.40 23.60
24.10 26.40
25.20 25.60
6433461
643449 643429J
35.50 35.20
36.60 33.00
31.80 28.80
33.30 31.60
6434243
DuPont-5386
1226
H-24516: Subchronic Toxicity . 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations
Individual Pup Weights (grams): FI Generation Lactation Day 21
Group: II-O
Dose: 0 mg/kg/day
Animal Number 643352s
643343
643459
643394s
2 3 4 5 Pup Number
Pup Sex
66 .50 64 .30 65 .60 62. 70 58 .70 61 .00 64 .00 59. 30 72 .00 67 .80 69 .90 71. 70 74.60 67 .40 65 .60 59 .10
643480 643319s
70.90 72.50
79.00 72.80
77.40 71.50
73.20 67.40
6433503
643363 643397 643421
67. 60 65. 30 62. 20
55. 60 45. 70
45. 30
68 .30 61 .80 60 .10
57 .60 47 .60
47 .70
66 .30 65 .20 58 .10
57 .40 44 .20
44 .10
73 .60 62 .00 64 .60
55 .10 49 .50
45 .90
DuPont-5386
1227
CompanySanitized. Does not contain TSCA CB,
H-24516: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations
Individual Pup Weights (grams): FI Generation Lactation Day 21
Group: II-O
Dose: 0 mg/kg/day
Animal Number 6434203
643419
6434143
2 3 4 5 Pup Number
Pup Sex
62.50 62.30 66.30 63.70 66.80 58.60 63.70 60.50
643401 643455 643378 6433933
57 .70 56 .20
56 .90 54 .20 66 .70 65 .50
61 .00 56 .00 55 .20 49 .50 61 .60 54 .30
56 .20 50 .30 48 .40 57 .50 60 .40 63 .10
57 .40 58.10
54 .00 46 .50 59 .60
67.20
643447643478 643386
58 .80 58 .60 63 .80 58 .60 66 .90 64 .40
62 .60 50 .70 59 .00 61 .30 67 .90 59 .70
56 .20 57 .50 61 .30 63 .50 66 .30 60 .60
59 .50 58 .40 59 .70 58 .50 63 .00 58 .30
DuPont-5386
1228
Company Sanitized. Does not contain TSCA CB
H-24516: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations
Individual Pup Weights (grams): PI Generation Lactation bay 21
GROUP: IV-0
DOSE: 25 MG/KG/DAY
Animal Number 643399 643334 643464 643369 643490 643342 643438 643445' 643418
643325
Pup Sex
Pup Number
3
4
59.80 59.40 60.30 61.00 70.50 65.20 63.30 56.80 55.20
56.40 67.50 61.70 54.30 62.00
65 50 62 60 61 90 61 80 66 90 61 80 59 50 54 60 65 40
57 20 61 10 61 80 63, 00 53, 90
65.20 64.90 61.30 56.60 67.80 63.70 57.20 55.70 53.80
52.70 67.80 61.90 56.80 58.50
67.50 61.40 63.20 58.50 68.10 63.90 56.40 56.30 58.10
54.50 64.50 65.10 62.00 59.10
61.60
57.00 68.70 66.40
39.30
56.20 77.90 66.60
59.40
56.10 70.10 72.30
60.20
59.90 72.90 69.00
DuPont-5386
1229 Company Sanitized. Does not contain TSCA CB1
H-24516: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations
Individual Pup Weights (grams): FI Generation Lactation Day 21
Group: IV-Q
Dose: 25 mg/kg/day
Animal Number 643479
643403s
3 4 5 6 Pup Number
Pup Sex
70.90 60.40 69.60 60.20 66.10 61.20 60.50
643376 6434223
54.00 56.60 58.00 64.30 49.50 55.70 50.10 44.80
643452 643475d 643372 643400 643395 643457
62.50 66.60 60.90 61.70 60.40 60.30 61.00 58.40
66.50 62.00 55.60 47.00 45.60 61.00 60.50 57.00 56.90
67.00 66.20 58.00 47.30 43.90 60.60 56.80 61.40 55.60
62.80 61.10 51.90 48.20 58.30 58.80 58.40 58.80
64.80 56.50 42.10 46.70 59.50 56.00 63.50 59.00
DuPont-5386
1230
Company Sanitized. Does not contain TSCA CBf
H-24516: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations
Individual Pup Weights (grams): FI Generation Lactation Day 21
Group: VI - 0
Dose: 100 mg/kg/day
Animal Number 643320
643488a
Pup
Sex
1
Pup Number
2
3
4
5
68 .50 60 .50 60 .60 65 .70
643428 643439 643353 643385a 643339 6434733 643337 643416
58 .40
54 .00 59 .00
60 .40 65 .80 64 .30
57 .10
56 .70 61 .40
56 .50 60 .30 50 .20
58 .70
54 .20 55 .10
53 .10 66 .10 59 .70
52 .10 52 .10 60 .40
66 .30 59 .00
48.20
59 .40 60 .30 56 .60 56 .60 53 .10 58 .80 57 .70 55 .80
62 .60
55 .90 61 .30 54 .30
64 .20
61 .40 64 .50
64 .40
52 .80 63 .30
60 .70
62 .50 59 .90
DuPont-5386
1231
Company Sanitized. Does not contain TSCA CB(
H-24516: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations
Individual Pup Weights (grams): FI Generation Lactation Day 21
Group: VI - 0
Dose: 100 mg/kg/day
Animal
Elip
Pilp Ilurnber
Number
S;ex
1
2
3
4
5
643407^
6433573
643331 643427 643470s 643434 643349 643454^ 643333 643460
63 .10 60.80
61 .70 57 .30
62 .40 57 .80
66 .00 60 .40
59 .20 38 .90 43 .90
46 .30
50 .30 45 .30 56 .30
48 .90
56 .10 48 .00 51 .60
51 .60
53 .40 51 .50 55 .80
49 .30
58 .80 59 .60 63 .20 55 .70
66 .70 61 .60 64 .90 57 .00
63 .70 60 .10 64 .50 56 .00
56 .10 59 .60 60 .10
DuPont-5386
1232 Company Sanitized. Does not contain TSCA CBI
H-24516: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations
Individi13.1 Pui3 Wei.ghtis (gi-ams ):
Lac;tat:ion r)ay 21
1?'! Generation
Group: VIII--0
Animal
PiIP
Number
S(iX
; 1
643467 643443 643417 643413 643338 643335 643468 643440 6434303
43 .70 45 .10 38 .10 35 .60 32 .00 33 .60 31 .20 36 .10 49 .60 50 .30 54 .60 49 .00
43 .40 60 .30. 45 .00
44 .60
643431s
I tose : 2"50 mgr/kg/day
I 'up Kfumbe]r
2
3
4
5
54 .00 43 .00 39 .20 35 .10 23 .00 22 .10 39 .50 34 .20 50 .30 46 .10 50 .80 45 .50 59 .10 52 .80 46 .60
48 .90
29 .80 54 .60 35 .70 35 .70 29 .00 30 .30 37 .00
34 .60 52 .80 51 .70 56 .90 49 .00 57 .80 55 .70 53 .60 50 .70
42. 60 58. 40 41. 30 39. 70 40. 00 27. 90 40. 80 35. 80 50. 70 47. 60 50. 70 45. 20 52. 40 45. 60 48. 50 49. 00
DuPont-5386
1233
osipany SanHIzed. Does not contain TSCA CBI
H-24516: Subchronic Toxicity
90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations_____________DuPont-5386
Individual Pup Weights (grams): FI Generation Lactation Day 21
Group: VIII-0
Dose: 250 mg/kg/day
Animal Number 643326
643365
643375^ 1
1 2 3 4 5 Pup Number
Pup
------------
Sex
53.70 53.50 49.40 51.20 55.40 50.60 53.50 52.20
39.90 47.10 46.50
44.70 41.80 42.90 44.00 43.60
643328 6433483
34.60 47.50 41.00 43.40 45.50 39.70 45.60 40.40
6433462 643449 643429J
52.40 53.10 60.40 55.70 47.40 58.40 54.30 51.50
6434243
1234
Company Sanitized. Does not contain TSCA CBI
APPENDIX HH REPRODUCTIVE TOXICOLOGY INDIVIDUAL LITTER CLINICAL OBSERVATIONS: Fi GENERATION
1235
H-24516: Subchronic Toxicity
90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations_____________DuPont-5386 REPRODUCTIVE TOXICOLOGY
INDIVIDUAL LITTER CLINICAL OBSERVATIONS: Fi GENERATION
EXPLANATORY NOTES
Footnotes
a No live pups bom
1236
'"contain TSCACBt
ANIMAL NUMBER
INDIVIDUAL LITTER CLINICAL OBSERVATIONS: Fi GENERATION
GROUP: II-O
DOSE: 0 MG/KG/DAY
LACTATION DAY
SIGN INCIDENCE
OBSERVATIONS
643343 643459 643480 643363 643397 643421 643419 643401 643455 643378 643447 643478 643386
NO ABNORMALITIES DETECTED NO ABNORMALITIES DETECTED NO ABNORMALITIES DETECTED NO ABNORMALITIES DETECTED NO ABNORMALITIES DETECTED NO ABNORMALITIES DETECTED NO ABNORMALITIES DETECTED NO ABNORMALITIES DETECTED NO ABNORMALITIES DETECTED NO ABNORMALITIES DETECTED NO ABNORMALITIES DETECTED NO ABNORMALITIES DETECTED NO ABNORMALITIES DETECTED
1237
-^^^Sf SanKteeA ^ ^ ^^,
INDIVIDUAL UTTER CLINICAL OBSERVATIONS: F^ GENERATION
GROUP: IV-0
DOSE: 25 MG/KG/DAY
ANIMAL NUMBER
LACTATION DAY
SIGN INCIDENCE
OBSERVATIONS
643399 643334 643464 643369 643490 643342 643438 643418 643325 643479 643376 643452 643475 643372 643400 643395 643457
NO ABNORMALITIES DETECTED NO ABNORMALITIES DETECTED NO ABNORMALITIES DETECTED NO ABNORMALITIES DETECTED NO ABNORMALITIES DETECTED NO ABNORMALITIES DETECTED . NO ABNORMALITIES DETECTED NO ABNORMALITIES DETECTED NO ABNORMALITIES DETECTED NO ABNORMALITIES DETECTED NO ABNORMALITIES DETECTED NO ABNORMALITIES DETECTED NO ABNORMALITIES DETECTED NO ABNORMALITIES DETECTED NO ABNORMALITIES DETECTED NO ABNORMALITIES DETECTED NO ABNORMALITIES DETECTED
1238
comPanySanHfced. "ow not contain TSC/
ANIMAL NUMBER
INDIVIDUAL LITTER CLINICAL OBSERVATIONS: Fi GENERATION
GROUP: VI-0
DOSE: 100 MG/KG/DAY
LACTATION DAY
SIGN INCIDENCE OBSERVATIONS
643320 643428 643439 643353 643339 643337 643416 643407 6433313 643427 643434 643349 643333 643460
NO ABNORMALITIES DETECTED NO ABNORMALITIES DETECTED NO ABNORMALITIES DETECTED NO ABNORMALITIES DETECTED NO ABNORMALITIES DETECTED NO ABNORMALITIES DETECTED NO ABNORMALITIES DETECTED NO ABNORMALITIES DETECTED
NO ABNORMALITIES DETECTED NO ABNORMALITIES DETECTED NO ABNORMALITIES DETECTED NO ABNORMALITIES DETECTED NO ABNORMALITIES DETECTED
1239
Company Sanitized. Does not contain TSCA CBI
ANIMAL NUMBER
INDIVIDUAL LITTER CLINICAL OBSERVATIONS: Fi GENERATION
LACTATION DAY
GROUP: VIII-0
DOSE: 250 MG/KG/DAY
SIGN INCIDENCE
OBSERVATIONS
643467
NO ABNORMALITIES DETECTED
643443
NO ABNORMALITIES DETECTED
643417 DAY 21
3 OF 8 2 OF 8
DISCHARGE NOSE BLACK WEAK
LITTER SUMMARY:
3
2
DISCHARGE NOSE WEAK
DAY 21 PUP DATA:
PUP:
a
b
C
DISCHARGE WEAK DISCHARGE WEAK DISCHARGE
NOSE NOSE NOSE
BLACK BLACK BLACK
643413
NO ABNORMALITIES DETECTED
643338
NO ABNORMALITIES DETECTED
643335
NO ABNORMALITIES DETECTED
643468
NO ABNORMALITIES DETECTED
643440
NO ABNORMALITIES DETECTED
643326
NO ABNORMALITIES DETECTED
643365
NO ABNORMALITIES DETECTED
643375
NO ABNORMALITIES DETECTED
643328
NO ABNORMALITIES DETECTED
643449
NO ABNORMALITIES DETECTED
6434293
1240 Company Sanitized. Does not contain TSCA CBl
APPENDIX n REPRODUCTIVE TOXICOLOGY INDIVIDUAL BODY WEIGHTS: Fi GENERATION
1241
Company Sanitized. Does not contain TSCA CBI
H-24516: Subchronic Toxicity
90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations____________DuPont-5386 REPRODUCTIVE TOXICOLOGY
INDIVIDUAL BODY WEIGHTS: Fi GENERATION EXPLANATORY NOTES
Notes
Day of weaning = Test Day 1. a No data due to weighing error.
1242
Company Sanitized. Does not contain TSCA CBl
INDIVIDUAL BODY WEIGHTS (grams) OF Fi MALE RATS
GROUP: 1-1
DOSE: 0 MG/KG/DAY
DAYS ON TEST:
ANIMAL NUMBER
647068 647069 647070 647071 647072 647073 647074 647075 647076 647077 647078 647079 647080
1
8
15
22
29
36
62 .7 74 .6 73 .2 73 S
64 .6 49 .5 63 .7 58 .1 54 .0 67 .2 59 .5 59 .7 63 .0
103 .2 132 .2 118 .0 130 .1 115 .0
94 .7 107 .2
98 .9 93 .7 114 .4 101 .1 95 .2 109 .0
156 .5 207 .8 182 .8 201 .1 181 .8 156 .0 176 .4 154 .7 153 .0 179 .9 167 .6 158 .8 162 .3
204 .0 279 .5 248 .8 264 .2 243 .5 213 .7 250 .0 215 .9 218 .3 250 .6 227 .3 228 .7 227 .5
251. 7
352. 7 310. 2 336. 7
307. 8 265. 6 325. 4 257. 3 279. 2 282. 6 273. 9 302. 6 285. 8
303 .9 411 .7 326 .6 333 .8 367 .0 325 .4 314 .3 323 .3 284 .7 366 .5 349 .4 325 .9 302 .2
1243
Company Sanitized. Does not contain TSCA CBI
DAYS ON TEST:
ANIMAL NUMBER
647123 647124 647125 647126 647127 647128 647129 647130 647131 647132 647133 647134 647135 647136 647137 647138
INDIVIDUAL BODY WEIGHTS (grams) OF Fi MALE RATS
GROUP: III-l
DOSE: 25 MG/KG/DAY
1
8
15
22
29
36
67 .5 63 .2 68 .1 56 .4 58 .1 64 .5 62 .0 60 .2 72 .9 70 .9 64 .3 61 .7 64 .8 42 .1 59 .5 63 .5
106 .2 108 .5 103 .3
97 .6 103 .5 105 .7 102 .2 107 .1 122 .8 113 .1 104 .3 108 .7 103 .4
73 .3 95 .2 108 .2
176 .4 172 .2 158 .8 156 .8 166 .5 163 .7 167 .0 168 .5 187 .5 176 .0 165 .5 170 .8 164 .4 118 .6 145 .1 165 .0
230 .8 236 .4 213 .2 215 .0 225 .8 232 .3 234 .8 237 .5 242 .4 231 .0 224 .4 231 .7 229 .1 171 .6 207 .3 220 .4
301 .6 282 .6
278 .2 276 .4 290 .2 247 .0 260 .1 293 .3 319 .2 285 .7 280 .5 308 .6 279 .2 222 .2 261 .9 272 .8
a
343.9 304.5 336.7 348.4 341.2 283.5 363.8 383.2 341.5 302.5 376.1 311.9 276.8 324.0 339.1
1244
Company Sanitized. Does not contain TSCA CBI
INDIVIDUAL BODY WEIGHTS (grams) OF Fi MALE RATS
GROUP: V-l
DOSE: 100 MG/KG/DAY
DAYS ON TEST:
ANIMAL NUMBER
647184 647185 647186 647187 647188 647189 647190 647191 647192 647193 647194 647195
1
8
15
22
29
36
60.5
52.1
48.2 66.3
56.6 60.7 59.9 66.0 53.4 55.8 63.7 59.6
99.6 92.8 81.8 114.4
98.8 106.5
98.0 109.8
96.1 94.4 104.7 108.8
151.8 150.0 135.3 181.3
167.6 168.7 158.9 175.1 157.7 150.7 165.0 173.0
217.6 212.6
203.5 244.6 221.1 231.2 223.3
237.6 225.3 210.1 223.4 225.2
264.4 279.5 232.7 315.5 302.2 267.4 280.7 275.2 286.7 274.0
288.7 283.9
276.6 298.2
259.1 382.7 375.5 299.1 300.9
305.1 300.2 300.1
313.4 314.5
1245
Company Sanitized. Does not contain TSCA CBI
INDIVIDUAL BODY WEIGHTS (grams) OF Fi MALE RATS
GROUP: VII-1
DOSE: 250 MG/KG/DAY
DAYS ON TEST:
ANIMAL NUMBER
647230 647231 647232 647233 647234 647235 647236 647237 647238 647239 647240 647241
1
8
15
22
29
36
42.6 41.3 40.0 40.8 50.7 50.7
52.4 48.5 51.2 46.5 43.4 55.7
86.3
91.5 96.7 82.1 96.4 85.3
87.4 83.9 84.8
80.3 80.5 100.9
137.5 144.5 170.4 139.6 158.8 143.5 143.3
139.6 131.4 135.8
133.4 155.8
203.2 211.9 224.0 197.3 221.1 200.7 209.1 210.9 190.5 202.0 187.0 214.3
258.8 272.7 344.6 252.2 281.3 255.5 259.0 242.8 239.8 270.4 245.1 246.2
318.3
331.9
417.0 280.9 296.9
275.0 318.9 265.3 299.5 277.7 313.3 327.4
1246
Company Sanitized. Does not contain TSCA CBl
INDIVIDUAL BODY WEIGHTS (grams) OF Fi FEMALE RATS
GROUP: II-1
DOSE: 0 MG/KG/DAY
DAYS ON TEST:
ANIMAL NUMBER
647277 647278 647279 647280 647281 647282 647283 647284 647285 647286 647287 647288 647289
1
8
15
22
29
36
59.3 59.1 67.4 62.0
55.1 45.9 60.5
50.3 46.5 63.1 58.4 58.5 58.3
96.0 103.1 103.8
99.6 96.4 84.1 93.2 85.0 78.1
95.5 102.2
94.0 91.4
130.3 139.6 136.8
143.7 144.1
132.3 139.9 122.5 121.7 137.1 156.4 135.0
126.3
156.9 160.9 152.2 180.4 185.9 163.3 179.6 158.2 155.0 181.8 185.8 167.0 150.2
177.1 182.7
170.8 199.8
204.7 192.7 207.7 173.2 176.8 210.2 217.7 194.6 161.6
203.4 201.4
179.7 221.4 219.6
212.8 219.6 200.7 191.0 211.6 231.0 213.7
176.7
1247
Company Sanitized. Does not contain TSCA CBI
INDIVIDUAL BODY WEIGHTS (grams) OP Fi FEMALE RATS
GROUP: IV-1
DOSE: 25 MG/KG/DAY
DAYS
ON TEST:
ANIMAL NUMBER
647326 647327 647328 647329 647330 647331 647332 647333 647334 647335 647336 647337 647338 647339 647340 647341 647342
1
8
15
22
29
36
61 .4 58 .5 63 .9 56 .3 54 .5 65 .1 59 .1 59 .9 69 .0 60 .5 44 .8
58 .4
67 .0 56 .5 46 .7 56 .0 59 .0
91 .7 97 .0 98 .2 96 .0 92 .1 106 .5 98 .1 99 .4 108 .8 100 .3 77 .6 95 .5 99 .0 87 .9 79 .5 86 .7 97 .5
138 .6 143 .9 137 .7 146 .2 141 .0 158 .4 150 .9 145 .1 171 .7 140 .9 114 .8 137 .8 137 .1 124 .0 120 .6 123 .3 140 .4
161 .4 186 .5 168 .8 181 .1 176 .9 212 .3 196 ,4 180 .0 220 .4 162 .9 137 .3 171 .9 171 .9 155 .7 150 .5 151 .1 168 .3
186 .1 204 .9 192 .1 209 .8 201 .1 246 .4 223 .6 191 .4 232 .3 171 .7 146 .5 195 .8 200 .7 174 .7 172 .1 180 .4 196 .1
-a 223.5
206.5 228.5 223.2
283.9 242.1
203.7 280.7 197.7 164.9 222.7 218.1 196.8 192.7 196.2 219.3
1248
Company Sanitized. Does not contain TSCA CBI
INDIVIDUAL BODY WEIGHTS (grams) OF Pi FEMALE RATS
GROUP: VI-1 .
DOSE: 100 MG/KG/DAY
DAYS
OH TEST:
ANIMAL NUMBER
647394 647395 647396 647397 647398 647399 647400 647401 647402 647403 647404 647405
1
8
15
22
29
36
65 .7 52 .1 53 .1 59 .0
55 .8 62 .5 54 .3
60 .4 51 .5 49 .3 56 .1 60 .1
101 .8 88 .9 90 .3 91 .5 96 .1 84 .0 86 .5 97 .6 87 .6 77 .8 84 .3 98 .2
143 .2 135 .5 131 .5 125 .9
138 .5 142 .2 132 .0 141 .8 130 .8 117 .1 123 .9 141 .0
167 .7 166 .5 164 .1 161 .1 177 .8 184 .3 166 .2 177 .2 170 .3 142 .0 160 .1 173 .0
193 .1 194 .3
185 .0 167 .7 211 .5 209 .8 190 .3 204 .7 200 .8 159 .8 181 .8 198 .3
213.2 215.3 206.8
194.1
235.8 235.6 215.2
222.1 219.3 173.7
196.9 222.9
1249
Company Sanitized. Does not contain TSCA CBI
INDIVIDUAL BODY WEIGHTS (grams) OP Pi FEMALE RATS
GROUP: VIII-1
DOSE: 250 MG/KG/DAY
DAYS
ON TEST:
1
ANIMAL NUMBER
8
15
22
29
36
647436 647437 647438 647439 647440 647441 647442 647443 647444 647445 647446 647447
58.4 39.7 27.9
35.8 47.6 45.2 45.6 49.0 52.2 43.6 40.4 51.5
97.2 88.5 68.1 70.4 78.5 76.6 77.8 80.2
84.9 69.1 73.8 94.5
142.1
124.3 117.6 113.2 125.8 123.3
118.3 . 124.3 127.3
115.4 124.6 141.4
176.2
157.1 166.1 143.3 167.8 162.1
153.4 157.1 157.0 158.3 163.2 178.9
203.5 190.5 210.4 170.6 190.7 189.6 164.3 183.4 173.4
186.7 190.3 199.1
197.3
194.5 238.3 193.8
219.7 209.0 187.7 210.1 206.9
217.1 202.0 198.8
1250
Company Sanitized. Does not contain TSCA CBl
APPENDIX JJ REPRODUCTIVE TOXICOLOGY INDIVIDUAL BODY WEIGHT GAINS: Fi GENERATION
1251 Company Sanitized. Does not contain TSCA CBI
H-24516: Subchronic Toxicity
90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations_____________DuPont-5386 REPRODUCTIVE TOXICOLOGY
INDIVIDUAL BODY WEIGHT GAINS: Fi GENERATION EXPLANATORY NOTES
Notes
Day of weaning = Test Day 1. a No data due to weighing error.
1252
Company Sanitized. Does not contain TSCA CBl
INDIVIDUAL BODY WEIGHT GAINS (grams) OP F^ MALE RATS
GROUP: 1-1
DOSE: 0 MG/KG/DAY
DAYS ON TEST:
ANIMAL NUMBER
647068 647069 647070 647071 647072 647073 647074 647075 647076 647077 647078 647079 647080
1- 8
8-1 5
15-2:2
22-2 9
29-3 6
1-36
40 .5 57 .6 44 .8 56 .5 50 .4 45 .2 43 .5 40 .8 39 .7 47 .2 41 .6 35 .5 46 .0
53 .3 75 .6 64 .8 71 .0 66 .8 61 .3 69 .2 55 .8 59 .3 65 .5 66 .5 63 .6
53 .3
47 .5 71 .7 66 .0 63 .1 61 .7 57 .7 73 .6 61 .2 65 .3 70 .7 59 .7 69 .9 65 .2
47 .7 73 .2 61 .4 72 .5 64 .3 51 .9 75 .4 41 .4 60 .9 32 .0 46 .6 73 .9 58 .3
52 .2 59 .0 16 .4
-2 .9 59 .2 59 .8 -11 .1 66 .0
5 .5 83 .9 75 .5
23 .3 16 .4
241.2 337.1 253.4 260.2 302.4 275.9 250.6 265.2 230.7 299.3 289.9 266.2 239.2
1253
Company Sanitized. Does not contain TSCA COl
INDIVIDUAL BODY WEIGHT GAINS (grams) OF Pi MALE RATS
GROUP: III-l
DOSE: 25 MG/KG/DAY
DAYS ON TEST:
ANIMAL NUMBER
647123 647124 647125 647126 647127 647128 647129 647130 647131 647132 647133 647134 647135 647136 647137 647138
1- 8
8-15
15-22
22-29
29-36
1-36
38 .7
45 .3
35 .2 41 .2 45 .4 41 .2 40 .2 46 .9 49 .9 42 .2 40 .0 47 .0 38 .6 31 .2
35 .7 44 .7
70.2 63.7 55.5 59.2 63.0 58.0 64.8 61.4 64.7 62.9 61.2 62.1 61.0 45.3 49.9 56.8
54.4 64.2 54.4 58.2
59.3 68.6 67.8 69.0 54.9 55.0 58.9 60.9
64.7 53.0 62.2 55.4
70.8 46.2 65.0 61.4 64.4 14.7 25.3 55.8 76.8 54.7 56.1 76.9 50.1 50.6
.54.6 52.4
-a 61.3
26.3 60.3
58.2 94.2 23.4 70.5 64.0 55.8 22.0 67.5 32.7 54.6 62.1 66.3
-a 280.7 236.4 280.3 290.3 276.7 221.5 303.6 310.3 270.6 238.2 314.4
247.1 234.7
264.5 275.6
1254
not contain TSCACBl
Company Sanitized. Does
INDIVIDUAL BODY WEIGHT GAINS (grams) OF Fi MALE RATS
GROUP: V-l
DOSE: 100 MG/KG/DAY
DAYS ON TEST:
ANIMAL NUMBER
1-8
8-15 15-22 22-29 29-36
1-36
647184 647185 647186 647187 647188 647189 647190 647191 647192 647193 647194 647195
39.1 40.7 33.6 48.1 42.2 45.8 38.1 43.8 42.7
38'.6
41.0 49.2
52.2 57.2 53.5 66.9 68.8 62.2 60.9 65.3 61.6 56.3 60.3 64.2
65.8 62.6
68.2 63.3 53.5 62.5 64.4 62.5 67.6 59.4 58.4 52.2
46.8 66.9 29.2 70.9 81.1 36.2 57.4 37.6 61.4 63.9 65.3 58.7
12.2 18.7 26.4 67.2 73.3 31.7 20.2 29.9 13.5 26.1 24.7 30.6
216.1 246.1
210.9 316.4 318.9 238.4 241.0 239.1 246.8 244.3
249.7 254.9
1255 Company Sanitized. Does not contain TSCA CBl
INDIVIDUAL BODY WEIGHT GAINS (grams) OF Fi MALE RATS
GROUP: VI I-1
DOSE: 250 MG/KG/DAY
DAYS ON TEST:
ANIMAL NUMBER
1-8
8-15
15-22
22-29
29-36
1-36
647230 647231 647232 647233 647234 647235 647236 647237 647238 647239 647240 647241
43.7 50.2 56.7
41.3 45.7 34.6 35.0 35.4 33.6 33.8 37,1 45.2
51.2 53.0 73.7 57.5 62.4 58.2 55.9 55.7
46.6 55.5 52.9 54.9
65.7 67.4 53.6 57.7 62.3 57.2 65.8 71.3
59.1 66.2 53.6 58.5
55.6 60.8 120.6
54.9 60.2 54.8 49.9 31.9
49.3 68.4 58.1 31.9
59.5 59.2 72.4 28.7 15.6 19.5 59.9 22.5 59.7
7.3 68.2 81.2
275.7
290.6 377.0 240.1 246.2 224.3 266.5 216.8 248.3 231.2 269.9 271.7
1256
Company Sanitized. Does not contain TSCA CBl
INDIVIDUAL BODY WEIGHT GAINS (grams) OF Fi FEMALE RATS
GROUP: II-l
DOSE: 0 MG/KG/DAY
DAYS ON TEST:
ANIMAL NUMBER
1-8
8-15
15-22
22-29
29-36
1-36
647277 647278 647279 647280 647281 647282 647283 647284 647285 647286 647287 647288 647289
36.7 44.0 36.4
37.6 41.3 38.2 32.7 34.7 31.6 32.4 43.8 35.5 33.1
34 .3
36 .5 33 .0 44 .1 47 .7 48 .2 46 .7 37 .5 43 .6 41 .6 54 .2 41 .0 34 .9
26 .6 21 .3 15 .4 36 .7 41 .8 31 .0 39 .7 35 .7 33 .3 44 .7 29 .4 32 .0 23 .9
20 .2 21 .8 18 .6 19 .4 18 .8 29 .4 28 .1 15 .0 21 .8 28 .4 31 .9 27 .6 11 .4
26 .3 18 .7
8 .9 21 .6 14 .9 20 .1 11 .9 27 .5 14 .2
1 .4 13 .3 19 .1 15 .1
144.1 142.3 112.3
159.4 164.5 166.9 159.1 150.4 144.5 148.5 172.6 155.2 118.4
1257
Company Sanitized. Does not contain TSCA CBl
INDIVIDUAL BODY WEIGHT GAINS (grams) OF FI FEMALE RATS
GROUP: IV-1
DOSE: 25 MG/KG/DAY
DAYS ON TEST:
ANIMAL NUMBER
1-8
8-15
15-22
22-29
29-36
1-36
647326 647327 647328 647329 647330 647331 647332 647333 647334 647335 647336 647337 647338 647339 647340 647341 647342
30 .3 38 .5 34 .3 39 .7 37 .6 41 .4 39 .0 39 .5 39 .8 39 .8 32 .8 37 .1 32 .0 31 .4 32 .8 30 .7 38 .5
46 .9 46 .9 39 .5 50 .2 48 .9 51 .9
52 .8 45 .7 62 .9 40 .6 37 .2
42 .3 38 .1 36 .1 41 .1 36 .6 42 .9
22 .8 42 .6 31 .1 34 .9 35 .9 53 .9 45 .5 34 .9 48 .7 22 .0 22 .5 34 .1 34 .8 31 .7 29 .9 27 .8 27 .9
24 .7 18 .4 23 .3 28 .7 24 .2 34 .1 27 .2 11 .4 11 .9
8 .8 9 .2 23 .9 28 .8 19 .0 21 .6 29 .3 27 .8
-a 18.6 14.4
18.7 22.1 37.5 18.5 12.3
48.4 26.0 18.4 26.9 17.4 22.1 20.6 15.8 23.2
-a 165.0 142.6 172.2 168.7 218.8 183.0 143.8 211.7 137.2 120.1 164.3 151.1 140.3
146.0 140.2 160.3
1258
CompanySanitized. Does not contain TSCA CBI
INDIVIDUAL BODY WEIGHT GAINS (grams) OF Fi FEMALE RATS
GROUP: VI-1-
DOSE: 100 MG/KG/DAY
DAYS
ON TEST:
ANIMAL NUMBER
1-8
8-15
15-22
22-29
29-36
1-36
647394 647395 647396 647397 647398 647399 647400 647401 647402 647403 647404 647405
36.1 36.8 37.2
32.5 40.3 21.5 32.2 37.2 36.1 28.5 28.2 38.1
41.4 46.6 41.2 34.4 42.4 58.2
45.5 44.2
43.2 39.3 39.6 42.8
24.5 31.0 32.6 35.2 39.3
42.1 34.2 35.4
39.5 24.9 36.2 32.0
25.4 27.8 20.9
6.6 33.7 25.5 24.1 27.5 30.5 17.8 21.7 25.3
20.1 21.0 21.8 26.4 24.3
25.8 24.9 17.4 18.5 13.9 15.1 24.6
147.5 163.2 153.7 135.1 180.0 173.1 160.9 161.7 167.8
124.4 140.8 162.8
1259
Company Sanitized. Does not contain TSCA CBI
INDIVIDUAL BODY WEIGHT GAINS (grams) OF Fi FEMALE RATS
GROUP: VIII-1
DOSE: 250 MG/KG/DAY
DAYS ON TEST:
AMIMAL NUMBER
1-8
8-15
15-22
22-29
29-36
1-36
647436 647437 647438 647439 647440 647441 647442
647443 647444 647445
647446 647447
38.8 48.8
40.2 34.6 30.9 31.4 32.2 31.2 32.7 25.5 33.4 43.0
44.9 35.8
49.5 42.8
47.3 46.7 40.5 44.1 42.4 46.3 50.8 46.9
34.1 32.8
48.5 30.1
42.0 38.8 35.1 32.8 29.7 42.9 38.6 37.5
27.3 33.4
44.3 27.3 22.9 27.5 10.9 26.3 16.4 28.4 27.1 20.2
-6.2 4.0 27.9 23.2 29.0 19.4 23.4 26.7 33.5 30.4 11.7
-0.3
138.9 154.8
210.4 158.0 172.1 163.8 142.1 161.1 154.7 173.5 161.6 147.3
1260
Company Sanitized. Does not contain TSCA CBI
APPENDIX KK REPRODUCTIVE TOXICOLOGY INDIVIDUAL FOOD CONSUMPTION: Fi GENERATION
1261
Company Sanitized. Does not contain TSCA CBf
H-24516: Subchronic Toxicity
90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations_____________DuPont-5386 REPRODUCTIVE TOXICOLOGY
INDIVIDUAL FOOD CONSUMPTION: Fi GENERATION
EXPLANATORY NOTES
Notes
Day of weaning =
Test Day 1.
1262
Company Sanitized. Does not contain TSCA CBI
INDIVIDUAL FOOD CONSUMPTION (grams/day) BY Fi MALE RATS
GROUP: 1-1
DOSE: 0 MG/KG/DAY
DAYS
ON TEST:
ANIMAL NUMBER
647068 647069 647070 647071 647072 647073 647074 647075 647076 647077 647078 647079 647080
1-8
8- 15
15-22
22-29
29-36
1- 36
12.3 15.2 12.7 15.3 12.6 14.4 12.0 12.7 11.0 13.5 12.0 11.1 12.0
20 .5 22 .8 20 .1 23 .6 20 .0 18 .8 20 .6 18 .7 18 .2 19 .6 20 .3 18 .6 18 .0
20.4 27.3 25.1 27.1
23.6 23.3 25.1 22.7 22.9 25.5 23.7 24.1 23.8
22.9 30.3 26.7 31.1 26.1 24.8 30.3 23.9 27.8
25.0 25.6 29.5
27.0
25.6 9.2
26.1 24.4 10.2
9.5 21.8 12.8 23.3 30.9 31.0 26.2
25.8
20 .3 21 .0 22 .2 24 .3 18 .5 18 .2 22 .0 18 .2 20 .6 22 .9 22 .5 21 .9 21 .4
1263
Company Sanitized. Does not contain TSCA CBI
INDIVIDUAL FOOD CONSUMPTION (grams/day) BY Fi MALE RATS
GROUP: III-l
DOSE: 25 MG/KG/DAY
DAYS
ON TEST:
ANIMAL NUMBER
647123 647124 647125 647126 647127 647128 647129 647130 647131 647132 647133 647134 647135 647136 647137 647138
1 -8
8- 15
15- 22
22- 29
29- 36
1-,36
11 .5 11 .9 11 .7 11 .0 11 .5 13 .2 12 .2 13 .3
14 .1 12 .2 11 .8 14 .1 11 .9
9 .8
10 .9 14 .0
19 .4 19 .6 18 .0 17 .2 18 .1 19 .2 19 .3 20 .1 20 .4 18 .9 18 .8 21 .2 19 .6 15 .1 15 .3 19 .0
23 .5 23 .1 21 .8 21 .4 22 .7 24 .6 24 .9 24 .5 25 .0 22 .0 21 .9 24 .6 25 .0 19 .8 20 .6 22 .2
26 .7 24 .3 25 .0 25 .7 25 .6 21 .6 24 .1 28 .1 28 .8 22 .7 23 .8 31 .2 25 .4 22 .5 22 .8 24 .7
46 .6 26 .5 24 .0
2 .3 7 .8 28 .6 22 .8 31 .1 28 .5 25 .9 22 .9 14 .4 25 .2 25 .2 25 .4 15 .5
25 .5 21 .1 20 .1 15 .5 17 .1 21 .4 20 .7 23 .4 23 .4 20 .3 19 .8 21 .1 21 .4 18 .5
19 .0. 19 .1
1264
Company Sanitized. Does not contain TSCA CBI
INDIVIDUAL FOOD CONSUMPTION (grams/day) BY Fi MALE RATS
GROUP: V-l
DOSE: 100 MG/KG/DAY
DAYS ON TEST:
ANIMAL NUMBER
647184 647185 647186 647187 647188 647189 647190 647191 647192 647193 647194 647195
1-8
8-15 15-22 22-29 29-36
1-36
10.7 11.6
9.6 13.7 12.0
12.4 11.5 12.9 11.1 11.3 11.6 15.6
16.9 18.6 17.4
20.9 20.6 20.9 19.1 20.6
18.4 17.1 18.7
21.2
21.7 24.4 24.9 26.0 24.2 25.9 25.2 24.7 24.4 21.8 23.3 22.8
25.0
29.4 26.0
29.3 30.2 26.1 28.2 26.2 29.5 26.3 27.2
24.5
21.1 25.7 23.5 17.7 15.4 27.2 25.2 25.4 24.6 24.9 26.2 25.5
19.1 21.9 20.3
21.5 20.5 22.5 21.8 22.0 21.6 20.3 21.4 21.9
1265 Company Sanitized. Does not contain TSCA CBI
INDIVIDUAL POOD CONSUMPTION (grams/day) BY Fi MALE RATS
GROUP: VI I-1
DOSE: 250 MG/KG/DAY
DAYS ON TEST:
ANIMAL NUMBER
647230 647231 647232 647233 647234 647235 647236 647237 647238 647239 647240 647241
1-8
8-15
15-22
22-29
29-36
1-36
12.0 12.8 12.5 10.9 12.9 10.3 11.0 10.3 11.2
11.2 10.1 12.8
18.0 15.0 19.4 16.9
19.5 16.8 17.9 17.3 17.2 15.7 16.2 18.5
23.4
22.4 24.7 20.8 25.3 21.6 23.3 24.5 21.4 23.2 20.1 22.4
26.0 28.1
34.5 24.1 28.7
24.3 26.0 24.7 24.8 27.4 23.6 22.7
28.0
4.2 8.1 23.0 24.2 23.9 28.3 23.5 25.7
24.7 26.5 28.0
21.5 16.5 19.8 19.1 22.2 19.4 21.3 20.1 20.1
20.4 19.3 20.9
1266
Company Sanitized. Does not contain TSCA CBI
INDIVIDUAL POOD CONSUMPTION (grams/day) BY Fi FEMALE RATS
GROUP: II-l
DOSE: 0 MG/KG/DAY
DAYS ON TEST:
ANIMAL NUMBER
1-8
8-15
15-22
22-29
29-36
1-36
647277 647278 647279 647280 647281 647282 647283 647284 647285 647286 647287 647288 647289
12.1 12.5 11.2 11.0 11.9 11.4 10.8 12.4
9.6
11.'0
13.2 11.4 11.0
16.1 17.1 15.8 15.6 16.9 16.3 16.6
15.3 15.4 15.5 20.9 17.0 15.2
18.6 16.6 15.4 17.5 18.6 17.7 20.1 17.9 17.7 18.3 18.9 17.7 16.3
18.5 17.1 14.9 17.9 18.7
18.8 20.1 16.7 17.2 20.6 20.9 18.3 16.0
19.5 17.7
15.4 17.8 18.5 18.5 18.5
17.4 17.3 17.8 20.4 18.3 15.5
17.0 16.2
14.6 16.0 16.9
16.5 17.2 15.9 15.5 16.6
18.9 16.6 14.8
1267 Company Sanitized. Does not contain TSCA CBI
INDIVIDUAL FOOD CONSUMPTION (grams/day) BY Fi FEMALE RATS
GROUP: IV-1
DOSE: 25 MG/KG/DAY
DAYS
ON TEST:
ANIMAL NUMBER
1-8
8-15 15-22 22-29 29-36
1-36
647326 647327 647328
647329 647330 647331
647332 647333 647334 647335 647336 647337 647338 647339 647340 647341 647342
9.9 12.8 12.2
11.6 10.9 13.3 11.6 12.3
12.3 13.1
9.0 11.8 10.5 10.7 10.2 10.8 11.9
16 .8 16 .9 16 .4 16 .2 15 .4 19 .3 18 .4 16 .1 20 .2 18 .2 13 .7 17 .1 16 .3 14 .9 15 .4 15 .1 16 .7
17 .3 19 .9 17 .4 18 .4 18 .3 23 .4 22 .4 17 .4 23 .3 17 .2 14 .9 19 .9 17 .3 16 .6 16 .3 15 .8 17 .0
17 .3
18 .1 17 .4 19 .7 18 .2 23 .0 21 .5 16 .9 22 .3 16 .2
14 .4 20 .2 18 .1 15 .8 16 .8 16 .8
17 .6
46.8 19.4 17.2
20.4 18.8 25.9 23.7 14.7 27.0 18.0 15.5 22.5 17.3 15.4 17.2 16.6 18.1
21.6
17.4 16.1
17.3 16.3 21.0 19.5 15.5 21.0 16.5 13.5 18.3 15.9 14.7 15.2 15.0 16.2
1268
Company Sanitized. Does not contain TSCA CBf
INDIVIDUAL FOOD CONSUMPTION (grams/day) BY Fi FEMALE RATS
GROUP: VI-1,
DOSE: 100 MG/KG/DAY
DAYS ON TEST:
ANIMAL NUMBER
1-8
8-15
15-22
22-29
29-36
1-36
647394 647395 647396 647397 647398 647399 647400 647401 647402 647403 647404 647405
11.4
11.7 11.1 10.7 12.8
7.9 10.5 13.5 13.1
9.4 9.4 11.7
15.7 16.3
1.6.6 14.3
16.0 18.3
16.4 17.7 16.2 15.6 15.1 18.4
16.5
17.7 19.8 17.0 18.5 19.9 19.5 19.7 19.6 15.5 16.9 20.9
16.8 19.0 19.5 16.1 20.1 21.3 20.3 19.6 19.7
15.8 17.5 21.5
17.7 19.4 19.9 16.0 19.8 21.5 19.7 20.2 19.9 15.6 17.1 20.9
15.6
16.8 17.4
14.8 17.5 17.8 17.3 18.1 17.7 14.4 15.2 18.7
1269
Company Sanitized. Does not contain TSCA CBI
INDIVIDUAL FOOD CONSUMPTION (grams/day) BY Pi FEMALE RATS
GROUP: VIII-1
DOSE: 250 MG/KG/DAY
DAYS
ON TEST:
ANIMAL NUMBER
1-8
8-15 15-22 22-29 29-36
1-36
647436 647437 647438 647439 647440 647441 647442 647443 647444 647445 647446 647447
12.0 12.8 10.2
9.7 10.2
9.6 10.6
9.6 11.3
8.5 9.0 12.2
17.7 15.7 14.8
14.6 15.1 14.5 14.9 16.0 16.8 14.5 16.5 18.5
18.5 17.6 18.6 16.6 18.6 17.5 17.2 17.2 16.4 12.0 19.6 19.6
19.8 19.8 19.5
17.5 19.4 17.6 17.1 18.0
16.7 18.9 19.0 20.5
16.5 14.2 19.4 18.4 19.8 17.9 17.0 18.9 18.3
19.6 20.2 17.5
16.9 16.0 16.5
15.4 16.6 15.4 15.4 15.9 15.9 14.7 16.9 17.7
1270
Company Sanitized. Does not contain TSCA CBl
APPENDIX LL REPRODUCTIVE TOXICOLOGY INDIVIDUAL CLINICAL OBSERVATIONS: Fi GENERATION
1271
Company Sanitized. Does not contain TSCA CBI
H-24516: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations_____________DuPont-5386
REPRODUCTIVE TOXICOLOGY INDIVIDUAL CLINICAL OBSERVATIONS: Fi GENERATION
EXPLANATORY NOTES
Notes
Day of weaning = Test Day 1.
t
1272
Company Sanitized. Does not contain TSCA CBI
ANIMAL NUMBER
INDIVIDUAL CLINICAL OBSERVATIONS IM Fi MALE RATS
GROUP: 1-1
DOSE: 0 MG/KG/DAY
OBSERVATION
FIRST DA1f
OBSERVED
LAST DAY OBSERVED
647068 647069 647070 647071 647072 647073 647074 647075 647076 647077 647078 647079 647080
PREPUTIAL SEPARATION COMPLETE SACRIFICED BY DESIGN TEST DAY 40
PREPUTIAL SEPARATION COMPLETE SACRIFICED BY DESIGN TEST DAY 40
PREPUTIAL SEPARATION COMPLETE SACRIFICED BY DESIGN TEST DAY 40
PREPUTIAL SEPARATION COMPLETE SACRIFICED BY DESIGN TEST DAY 40
PREPUTIAL SEPARATION COMPLETE SACRIFICED BY DESIGN TEST DAY 40
PREPUTIAL SEPARATION COMPLETE SACRIFICED BY DESIGN TEST DAY 40
PREPUTIAL SEPARATION COMPLETE SACRIFICED BY DESIGN TEST DAY 40
PREPUTIAL SEPARATION COMPLETE SACRIFICED BY DESIGN TEST DAY 40
PREPUTIAL SEPARATION COMPLETE SACRIFICED BY DESIGN TEST DAY 40
PREPUTIAL SEPARATION COMPLETE SACRIFICED BY DESIGN TEST DAY 40
PREPUTIAL SEPARATION COMPLETE SACRIFICED BY DESIGN TEST DAY 40
PREPUTIAL SEPARATION COMPLETE SACRIFICED BY DESIGN TEST DAY 40
PREPUTIAL SEPARATION COMPLETE SACRIFICED BY DESIGN TEST DAY 40
19
19
19
19
18
18
20
20
19
19
19
19
19
19
19
19
20
20
20
20
20
20
27
27
20
20
1273
Company Sanitized. Does not contain TSCA CBl
ANIMAL NUMBER
INDIVIDUAL CLINICAL OBSERVATIONS IN Fi MALE RATS
GROUP: ni-1
DOSE: 25 MG/KG/DAY
OBSERVATION
FIRST DA^ir
OBSERVED
LAST DAY OBSERVED
647123 647124 647125 647126 647127 647128 647129 647130 647131 647132 647133 647134 647135 647136 647137 647138
PREPUTIAL SEPARATION COMPLETE SACRIFICED BY DESIGN TEST DAY 40
PREPUTIAL SEPARATION COMPLETE SACRIFICED BY DESIGN TEST DAY 40
PREPUTIAL SEPARATION COMPLETE SACRIFICED BY DESIGN TEST DAY 40
PREPUTIAL SEPARATION COMPLETE SACRIFICED BY DESIGN TEST DAY 40
PREPUTIAL SEPARATION COMPLETE SACRIFICED BY DESIGN TEST DAY 40
PREPUTIAL SEPARATION COMPLETE SACRIFICED BY DESIGN TEST DAY 40
PREPUTIAL SEPARATION COMPLETE SACRIFICED BY DESIGN TEST DAY 40
PREPUTIAL SEPARATION COMPLETE SACRIFICED BY DESIGN TEST DAY 40
PREPUTIAL SEPARATION COMPLETE SACRIFICED BY DESIGN TEST DAY 40
PREPUTIAL SEPARATION COMPLETE SACRIFICED BY DESIGN TEST DAY 40
PREPUTIAL SEPARATION COMPLETE SACRIFICED BY DESIGN TEST DAY 40
PREPUTIAL SEPARATION COMPLETE SACRIFICED BY DESIGN TEST DAY 40
PREPUTIAL SEPARATION COMPLETE SACRIFICED BY DESIGN TEST DAY 40
PREPUTIAL SEPARATION COMPLETE SACRIFICED BY DESIGN TEST DAY 40
PREPUTIAL SEPARATION COMPLETE SACRIFICED BY DESIGN TEST DAY 40
PREPUTIAL SEPARATION COMPLETE SACRIFICED BY DESIGN TEST DAY 40
14
14
20
20
21
21
21
21
21
21
22
22
20
20
23
23
24
24
21
21
22
22
20
20
20
20
27
27
26
26
22
22
1274 Company Sanitized. Does not contain TSCA CBI
ANIMAL NUMBER
INDIVIDUAL CLINICAL OBSERVATIONS IN Fi MALE RATS
GROUP: V-l
DOSE: 100 MG/KG/DAY
OBSERVATION
FIRST DAY
OBSERVED
LAST DAY OBSERVED
647184 647185 647186 647187 647188 647189 647190 647191 647192 647193 647194 647195
PREPUTIAL SEPARATION COMPLETE SACRIFICED BY DESIGN TEST DAY 40
PREPUTIAL SEPARATION COMPLETE SACRIFICED BY DESIGN TEST DAY 40
PREPUTIAL SEPARATION COMPLETE SACRIFICED BY DESIGN TEST DAY 40
PREPUTIAL SEPARATION COMPLETE SACRIFICED BY DESIGN TEST DAY 40
PREPUTIAL SEPARATION COMPLETE SACRIFICED BY DESIGN TEST DAY 40
PREPUTIAL SEPARATION COMPLETE SACRIFICED BY DESIGN TEST DAY 40
PREPUTIAL SEPARATION COMPLETE SACRIFICED BY DESIGN TEST DAY 40
PREPUTIAL SEPARATION COMPLETE SACRIFICED BY DESIGN TEST DAY 40
PREPUTIAL SEPARATION COMPLETE SACRIFICED BY DESIGN TEST DAY 40
PREPUTIAL SEPARATION COMPLETE SACRIFICED BY DESIGN TEST DAY 40
PREPUTIAL SEPARATION COMPLETE SACRIFICED BY DESIGN TEST DAY 40
PREPUTIAL SEPARATION COMPLETE SACRIFICED BY DESIGN TEST DAY 40
20
20
25
25
2?
29
20
20
23
23
22
22
27
27
20
20
23
23
27
27
20
20
22
22
1275
Company Sanitized. Does not contain TSCA CBI
ANIMAL NUMBER
INDIVIDUAL CLINICAL OBSERVATIONS IN Fi MALE RATS
GROUP: VII-1
DOSE: 250 MG/KG/DAY
OBSERVATION
FIRST DAY OBSERVED
LAST DAY OBSERVED
647230 647231 647232 647233 647234 647235 647236 647237 647238 647239 647240 647241
PREPUTIAL SEPARATION COMPLETE SACRIFICED BY DESIGN TEST DAY 40
PREPUTIAL SEPARATION COMPLETE SACRIFICED BY DESIGN TEST DAY 40
PREPUTIAL SEPARATION COMPLETE SACRIFICED BY DESIGN TEST DAY 40
PREPUTIAL SEPARATION COMPLETE SACRIFICED BY DESIGN TEST DAY 40
PREPUTIAL SEPARATION COMPLETE SACRIFICED BY DESIGN TEST DAY 40
PREPUTIAL SEPARATION COMPLETE SACRIFICED BY DESIGN TEST DAY 40
PREPUTIAL SEPARATION COMPLETE SACRIFICED BY DESIGN TEST DAY 40
PREPUTIAL SEPARATION COMPLETE SACRIFICED BY DESIGN TEST DAY 40
PREPUTIAL SEPARATION COMPLETE SACRIFICED BY DESIGN TEST DAY 40
PREPUTIAL SEPARATION COMPLETE SACRIFICED BY DESIGN TEST DAY 40
PREPUTIAL SEPARATION COMPLETE SACRIFICED BY DESIGN TEST DAY 40
PREPUTIAL SEPARATION COMPLETE SACRIFICED BY DESIGN TEST DAY 40
24
24
21
21
20
20
24
24
23
23
20
20
21
21
23
23
24
24
24
24
27
27
21
21
1276
Company Sanitized. Does not contain TSCA CBI
ANIMAL NUMBER
INDIVIDUAL CLINICAL OBSERVATIONS IN Fi FEMALE RATS
GROUP: II-l
DOSE: 0 MG/KG/DAY
OBSERVATION
FIRST DAY
OBSERVED
LAST DAY OBSERVED
647277 647278 647279 647280 647281 647282 647283 647284 647285 647286 647287 647288 647289
VAGINAL PATENCY COMPLETE SACRIFICED BY DESIGN TEST DAY 40
VAGINAL PATENCY COMPLETE SACRIFICED BY DESIGN TEST DAY 40
VAGINAL PATENCY COMPLETE SACRIFICED BY DESIGN TEST DAY 40
VAGINAL PATENCY COMPLETE SACRIFICED BY DESIGN TEST DAY 40
VAGINAL PATENCY COMPLETE SACRIFICED BY DESIGN TEST DAY 40
VAGINAL PATENCY COMPLETE SACRIFICED BY DESIGN TEST DAY 40
VAGINAL PATENCY COMPLETE SACRIFICED BY DESIGN TEST DAY 40
VAGINAL PATENCY COMPLETE SACRIFICED BY DESIGN TEST DAY 40
VAGINAL PATENCY COMPLETE SACRIFICED BY DESIGN TEST DAY 40
VAGINAL PATENCY COMPLETE SACRIFICED BY DESIGN TEST DAY 40
VAGINAL PATENCY COMPLETE SACRIFICED BY DESIGN TEST DAY 40
VAGINAL PATENCY COMPLETE SACRIFICED BY DESIGN TEST DAY 40
VAGINAL PATENCY COMPLETE SACRIFICED BY DESIGN TEST DAY 40
10
10
14
14
12
12
12
12
13
13
13
13
12
12
18
18
12
12
12
12
12
12
1277
Company Sanitized. Does not contain TSCA CBf
ANIMAL NUMBER
INDIVIDUAL CLINICAL OBSERVATIONS IN Fi FEMALE RATS
GROUP: IV-1
DOSE: 25 MG/KG/DAY
OBSERVATION
FIRST DAY OBSERVED
LAST DAY OBSERVED
647326 647327 647328 647329 647330 647331 647332 647333 647334
647335 647336 647337 647338 647339 647340 647341 647342
VAGINAL PATENCY COMPLETE SACRIFICED BY DESIGN TEST DAY 40
VAGINAL PATENCY COMPLETE SACRIFICED BY DESIGN TEST DAY 40
VAGINAL PATENCY COMPLETE SACRIFICED BY DESIGN TEST DAY 40
VAGINAL PATENCY COMPLETE SACRIFICED BY DESIGN TEST DAY 40
VAGINAL PATENCY COMPLETE SACRIFICED BY DESIGN TEST DAY 40
VAGINAL PATENCY COMPLETE SACRIFICED BY DESIGN TEST DAY 40
VAGINAL PATENCY COMPLETE SACRIFICED BY DESIGN TEST DAY 40
VAGINAL PATENCY COMPLETE SACRIFICED BY DESIGN TEST DAY 40
VAGINAL PATENCY COMPLETE ALOPECIA BOTH FRONT PAW(S) SACRIFICED BY DESIGN TEST DAY 40
VAGINAL PATENCY COMPLETE SACRIFICED BY DESIGN TEST DAY 40
VAGINAL PATENCY COMPLETE SACRIFICED BY DESIGN TEST DAY 40
VAGINAL PATENCY COMPLETE SACRIFICED BY DESIGN TEST DAY 40
VAGINAL PATENCY COMPLETE SACRIFICED BY DESIGN TEST DAY 40
VAGINAL PATENCY COMPLETE SACRIFICED BY DESIGN TEST DAY 40
VAGINAL PATENCY COMPLETE SACRIFICED BY DESIGN TEST DAY 40
VAGINAL PATENCY COMPLETE SACRIFICED BY DESIGN TEST DAY '40
VAGINAL PATENCY COMPLETE SACRIFICED BY DESIGN TEST DAY 40
12
12
11
11
19
19
12
12
15
15
13
13
11
11
12
12
13
13
40
40
11
11
11
11
13
13
12
12
11
11
11
11
13
13
1278
Company Sanitized. Does not contain TSCA CBI
H-24516: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations
INDIVIDUAL CLINICAL OBSERVATIONS IN Fi FEMALE RATS
GROUP: VI-1
DOSE: 100 MG/KG/DAY
DuPont-5386
ANIMAL NUMBER
OBSERVATION
FIRST DAY OBSERVED
LAST DAY OBSERVED
647394 647395 647396 647397 647398 647399 647400 647401 647402 647403 647404 647405
VAGINAL PATENCY COMPLETE SACRIFICED BY DESIGN TEST DAY 40
VAGINAL PATENCY COMPLETE SACRIFICED BY DESIGN TEST DAY 40
VAGINAL PATENCY COMPLETE SACRIFICED BY DESIGN TEST DAY 40
VAGINAL PATENCY COMPLETE SACRIFICED BY DESIGN TEST DAY 40
VAGINAL PATENCY COMPLETE SACRIFICED BY DESIGN TEST DAY 40
VAGINAL PATENCY COMPLETE SACRIFICED BY DESIGN TEST DAY 40
VAGINAL PATENCY COMPLETE SACRIFICED BY DESIGN TEST DAY 40
VAGINAL PATENCY COMPLETE SACRIFICED BY DESIGN TEST DAY 40
VAGINAL PATENCY COMPLETE SACRIFICED BY DESIGN TEST DAY 40
VAGINAL PATENCY COMPLETE SACRIFICED BY DESIGN TEST DAY 40
VAGINAL PATENCY COMPLETE SACRIFICED BY DESIGN TEST DAY 40
VAGINAL PATENCY COMPLETE SACRIFICED BY DESIGN TEST DAY 40
12
12
17
17
11
11
10
10
12
12
14
14
12
12
13
13
11
11
12
12
11
11
10
10
1279
Company Sanitized. Does not contain TSCA CBI
ANIMAL NUMBER
INDIVIDUAL CLINICAL OBSERVATIONS IN Fi FEMALE RATS
GROUP: VIII-1
DOSE: 250 MG/KG/DAY
OBSERVATION
FIRST DAY
OBSERVED
LAST DAY OBSERVED
647436 647437 647438 647439 647440 647441 647442 647443 647444 647445 647446 647447
VAGINAL PATENCY COMPLETE SACRIFICED BY DESIGN TEST DAY 40
VAGINAL PATENCY COMPLETE SACRIFICED BY DESIGN TEST DAY 40
VAGINAL PATENCY COMPLETE SACRIFICED BY DESIGN TEST DAY 40
VAGINAL PATENCY COMPLETE SACRIFICED BY DESIGN TEST DAY 40
VAGINAL .PATENCY COMPLETE SACRIFICED BY DESIGN TEST DAY 40
VAGINAL PATENCY COMPLETE SACRIFICED BY DESIGN TEST DAY 40
VAGINAL PATENCY COMPLETE SACRIFICED BY DESIGN TEST DAY 40
VAGINAL PATENCY COMPLETE SACRIFICED BY DESIGN TEST DAY 40
VAGINAL PATENCY COMPLETE SACRIFICED BY DESIGN TEST DAY 40
VAGINAL PATENCY COMPLETE SACRIFICED BY DESIGN TEST DAY 40
VAGINAL PATENCY COMPLETE SACRIFICED BY DESIGN TEST DAY 40
VAGINAL PATENCY COMPLETE SACRIFICED BY DESIGN TEST DAY 40
10
10
11
11
20
20
11
11
13
13
12
12
12
12
12
12
12
12
14
14
12
12
11
11
1280
Company Sanitized. Does not contain TSCA CBI