Document 8p1rMdyq5VJOd0j8BanvR4dZ

InternatioRneaslearcahndDevelopmenCtorporation SPONSOR: COMPOUND: SUBJECT: 3M Company FluoradO Fluorochemical FC-143 Ninety Day Subacute Rat Toxicity Study. Collaborators: s ....... enthal, Ph.3. V4ce @-a 4@@nc and D4-recl---or Researcl-, D. C. Jessup, Ph.D., Associate Director of Research R. G. Geil, D.V.,\I.V,ice President and Director of Pathology N. D. Jefferson, B.A., Acting Director of Small Animal Toxicology R. J. Arceo, M.D., Staff Pathologist 137-089 Date: November 6. 1978 InternatioRneaslearcahndDevelopmenCtorporation TABLE 0F C0NTEN TS I. II. III. Page Synopsis . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 Compound . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 Clinical Methods . . . . . . . . . . . . . . . . . . . . . . . . . 4 A. Method . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4 1. General Procedure . . . . . . . . . . . . . . . . . . . . . 4 2. Compound Administration . . . . . . . . . . . . . . . . . . 4 3. Observations . . . . . . . . . . . . . . . . . . . . . . . 5 4. Laboratory Tests . . . . . . . . . . . . . . . . . . . . . 5 a. Hematology . . . . . . . . . . . . . . . . . . . . . .. .5 b. Biochemistry . . . . . . . . . . . . . . . . . . . . . 5 c. Urinalysis . . . . . . . . . . . . . . . . . . . . . . 5 d. Serum Samples . . . . . . . . . . . . . . . . . . . . . 5 .5. Statistical Analysis . . . . . . . . . . . . . . . . . . . 6 B. Results . . . . . . . ... . . . . . . . . . . . . . . . . . . . 6 1. General Behavior, Appearance and Survival . . . . . . . . . 6 2. Body Weights . . . . . . . . . . . . . . . . . . . . . . . 6 3. Food and Compound Consumption . . . . . . . . . . . . . . . 7 4. Laboratory Tests . . . . . . . . . . . . . . . . . . . . . 7 a. Hematology . . . . . . . . . . . . . . . . . . . . . . 7 b. Biochemistry . . . . . . . . . . . . . . . . . . . . . 8 c. Urinalysis . . . . . . . . . . . . . . . . . . . . . . 8 IV. Pathological Studies . . . . . . . . . . . . . . . . . . . . . . . 9 A. Methods . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9 1. Gross Pathology . . . . . . . . . . . . . . . . . . . . . . 9 2. ilistopathology . . . . . . . . . . . . . . . . . . . . . . 9 B. Results . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9 1. Gross Pathology and Organ Weights . . . . . . . . . . . . . 9 2. Histopathology . . . . . . . . . . . . . . . . . . . . . . 10 137-089 InternatiRoensaelarcahndDevelopmeCnotrporation TA BLE 0F C0N TENTS (Continue Table No. 1. Group Mean Body Weights; Weight Ranges; and Survival 2. Individual Weekly Body Weights . . . . . . . . . . . . . . . 3. Mean Food Consumption . . . . . . . . . . . . . . . . . . . . 4. St--gry of Means and Significance of Hematological Values . . 5- 7. Individual Rematological Values . . . . . . . . . . . . . . . 8. Slimmaroyf Means and Significance of Biochemical Values . . . 9-11. Individual Biochemical Values . . . . . . . . . . . . . . . . 12-14. 15. Individual Urinalysis Values . . . . . . . . . . . . . . . . Summary of Gross Necropsy Observations . . . . . . . . . . . 16. Absolut,! and Relative Organ Weights . . . . . . . . . . . . . 17. Individual Organ Weights . . . . . . . . . . . . . . . . . . 18. Histomorphologic Observations . . . . . . . . . . . . . . . . Page 12 13-14 15 16-17 18-'3A' 24-25 26-31 32-37 38 39 40-41 42-47 137-089 InternatioRneaslearcahndDevelopmenCtorporation Page 1 SYNOPSIS Fluoradt)Fluorochemical FC-143 was fed in the diet at levels of 10, 30, 100, 300 and 1,000 ppm to Charles River CD rats for 90 days. Five male and five female rats were initiated at each dosage level and in the control group. The rats were observed twice daily for overt signs of toxicity and mortality. Individual body weights and sex-group food consumption were recorded weekly. Hematologic, biochemical and urinalysis studies were conducted during the pretest period and at 1 and 3 months of study. No changes considered to be directly related to the compound were seen in general behavior, appearance or survival. A slight decrease in body weight gain and food consumption was seen for male rats at the 300- and 1,000-ppm dosage levels. Hematologic, biochemical and urinalysis values for the female rats showed no changes considered to be related to the compound. A few values obtained for the males showed a slight deviation from the control values (i.e. slightly lower erythrocyte count, and elevated blood urea nitrogen and alkaline phosphatase values). Compound-related gross observations such as enlargement and varying degrees of discoloration on the surface of the liver were observed among male rats in the 1,000-ppm group. There were no such observations amoung female rats from the 1,000-ppm group or in males or females from lower dietary levels. Statistically significant variations in sex-group mean organ weights, which were considered compound related, occurred in the liver of rats in the 300- and 1,000-ppm dosage groups. All other variations were unaccompanied by any morphologic alterations. 137-089 InternatioRneaslearcahndDevelopmenCtorporation Page 2 nicroscopically, compound-related lesions were confined to the liver. The lesions consisted of focal to multifocal, very slight to slight, cytoplasmic enlargement of hepatocytes located in centrilobularmidzonal regions of the affected liver lobules, accompanied in some instances by increased amount of yellowish-brown pigment resembling lipofuscin in cytoplasm of hepatocytes and occasionally in sinusoidal lining cells. The incidence and relative severity of the above lesions were predominantly amoung males and more pronounced among rats at 1,000 ppm. The other changes recorded in the liver and other tissues were lesions of naturally occurring diseases and they were present in most instances among the control and test rats. 137-089 InternatioRneaslearcahndDevelopmenCtorporation Page 3 II. COMPOUND The compound was received from 3M Company, Saint Paul, Minnesota on October 24, 1977 as indicated below: Label FluoradO Flurochemical FC-143 3M Stock No. 98-0211-0008-0 Lot 340 Description white powder 137-089 InternatioRneaslearcahndDevelopmenCtorporation Page 4 III. CLINICAL METHODS A. METHOD: 1. General Procedure: Thirty male (222 to 254 grams) and 30 female (151 to 179 grams) Charles River CD rats purchased from The Charles River Breeding Laboratories, Inc., Portage, Michigan were used in this study. The rats were distributed among the groups, based upon a computer-generated table of random numbers. The rats were housed individually in suspended wire-mesh cages and maintained in a temperature-, humidityand light-controlled room. During the pretest period, rats were provided PurinaS Laboratory Chows and water ad libitum. During the test period, the rats were provided the appropriate test diet and water ad libitum. This study was initiated on November 1, 1977 and terminated by sacrifice of all remaining rats on January 30, 1978. 2. COMDound Administration: The test compound was mixed weekly with ground PurinaO Laboratory ChowO (i.e., ground basal diet) to provide dosage levels of 10, 30, 100, 300 and 1,000 ppm. Five male and five female rats were used at each dosage level and in a control -roup. The control rats received the basal diet only, on the same regimen as treated rats. Samples of diet (100 grams each) were taken immediately after preparation and after 7 days standing in weeks 1, 4 and 12. The samples were frozen and subsequently shipped to the sponsor. Diets were prepared in the following manner: to produce a premix, the required amount of Fluorade Fluorochemical FC-143 was mixed with 500 grams of PurinaO Laboratory Chowg using a Hobart blender. To provide the proper dosage level diets, appropriate quantities of the premix were combined with additional ground basal diet in a twin-shell blender. The diets were prepared week'-y. 137-089 InternatiRoensaelarcahndDevelopmeCnotrporation Page 5 3. Observations: The rats were observed twice daily for overt signs of toxi- city and for mortality. Detailed observations were recorded weekly. Individual body weights and food consumption were recorded weekly during the pretest and treatment periods. 4. Laboratory Tests: once during the pretest period and at 1 month and 3 months of the study, blood (orbital sinus puncture technique) and urine samples were obtained for analysis from all surviving rats. Food and water were withheld overnight prior to the sample collection. a. Hematology: Hematological studies included: hemoglobinl, hpmAtocrit2, total erythrocytes3, reticulocytes4, and total3 and differential leucocyte counts. b. Biochemistry: Biochemical studies included: fasting glucose5, blood urea nitrogen (BL-N)5,plasma glutamic pyr-uvictransaminase (PGPT)5 and plasma glutamic oxalacetic transaminase (PGOT)5 activity, plasma alka- line phosphatase5 activity, y-glutamyl peptidase6, creatiaine phosphokinase7 and calcium8. Alkaline phosphatase activity was not determined in the pretest period because of interference by the anti- coagulant. c. Urinalysis: Urinalysis included: description of color and appearance; measurement of volume, pH9, and specific gravity9; qualitative tests for protein9, glucose9, ketone9, bilirubin9, and occult blood; and microscopic examination of the sediment. d. Serum Samples: Serum samples were obtained for all surviving rats at 13 weeks of study. The samples were pooled by sex and group, frozen, and subsequently shipped to the sponsor. 137-089 InternatioRneaslearcahndDevelopmenCtorporation .eage6 S. Statistical_Analysis: All statistical analyses compared the treatment groups with the control group, by sex. Body weights (week 13) food consumption (weeks 1-13), hematological, biochemical and urinalysis parameters and abso- lute and relative organ weights were compared by analysis of variance (one-way classification), Bartlett's test for homogeneity of variances and the appropriate t-test (for equal or unequal variances) as described by Steel and TorrielO using Dunnett'sll multiple comparison tables to judge significance of differences. B. RESULTS: 1. General Behavior, Appearance and Survival: No changes considered to be related to the compound were observed in general behavior or appearance. Incidental findings noted for control and treated rats included ocular discharge and pupil dila- tion. Survival (prior to sacrifice) after 3 months of compound con- sumption was as follows: Dosage Level No. Surviving/No. Initiated Male Female Control 10 ppm 30 ppm 100 ppm 300 ppm 1,000 ppm 5/5 5/5 5/5 5/5 5/5 5/5 5/5 4/5 5/5 4/5 5/5 5/5 Both deaths occurred following collection of blood. death was preceded by any signs of toxicity. Neither 2. Body Weights (Tables 1-2): Comparison of group mean body weights, by sex showed a decrease in body weight gain for male rats at the 300- and 1,000-ppm dosage 137-089 InternatioRneaslearcahndDevelopmenCtorporation Page 7 levels. Changes in body weight were similar for control and treated female rats. At 13 weeks, the group mean body weight for male rats was significantly (p<0.05) lower than the control group mean. The group mean body weights at 13 weeks of study were as follows: Dosage Level Mean Body Weights, g Male Female Control 10 ppm 30 ppm 100 ppm 300 ppm 1,000 ppm 466 259 478 260 500 268 457 278 431 263 362 255 3. Food Consumption (Table 3 Declines in food consumption were noted at the higher dosage levels for male rats (100, 300 and 1,000 ppm). Food consumption values were similar for control and treated female rats. The average food consumption through the 13-week study were as shown below: Dosage Level Average Food Consumption (g/rat/day) Male Female Control 10 ppm 30 ppm 100 ppm 300 ppm 1,000 ppm 27.0 26.7 28.7 25.8 25.7 23.0 19.7 19.2 20.7 21.5 19.6 19.5 4. Laboratory Tests (Tables 5-14 a. Hematology: A comparison of male rats, by dosage group, to the control group, showed a slight decrease in erythrocytes at 3 months of study. However, the individual values were within the normal range for Charles Piver CD rats of this age in this laboratory. A similar comparison of female rats showed no variations that could be attribu- table to compound consumption. 137-089 InternatioRneaslearcahndDevelopmenCtorporation Page 8 b. Biochemistry: A comparison of male rats, at the higher dosage levels, to the control male rats, showed a slight increase in the BUN and alkaline phosphatase values. A similar comparison of female rats showed no variations that could be attributable to compound consumption. c. Urinalysis: The presence of occult blood was of a higher frequency in females than males at all dosage levels. No changes considered to be related to compound consumption were observed in urinalysis values. 137-089 InternatioRneaslearcahndDevelopmenCtorporation Page 9 IV. PATHOLOGICAL STUDIES: A. METHODS: 1. Gross Pathology: After 90 days of compound administration, five rats/se@x/groupwere sacrificed with carbon dioxide and were necropsied. At necropsy, or- gans and tissues were examined for gross abnormalities and collected in 10mlneutral buffered formalin (eyes in Russell's fixative). Liver samples, obtained from all of the rats at terminal sacrifice, were frozen and subsequently shipped to the sponsor. Two female rats which died prior to termination were also nec- ropsied and tissues collected as above. 2. Histopathology: ,Microscopic examination of formalin-fixed, hematoxylin and eosin stained, paraffin sections was performed for all rats in control, 100-, 300-, and 1,000-ppm groups. The following tissues were examined histo- logically. brain with cervical cord lumbar spinal cord peripheral nerve eyes pituitary thyroid with para- thyroid adrenals lung heart with coronary vessels aorta spleen mesenteric lymph node thymus bone with marrow (sternum) salivary gland small intestines (duodenum, jejunum, ileum) colon pancreas liver kidneys urinary bladder testes ovaries prostate uterus skin (mammary gland) any tissue(s) with gross lesions In addition, the livers from rats from the 10- and 30-ppm dosage level were also microscopically e--.amined. B. RESULTS: 1. Gross Pathology (Table -15 ) and Orvan 1;eizhts--(Tab'Les1-6-17) Gross necropsy observations in liver, such as enlargement, and varying degrees of discoloration on the surface were present among male rats at the 1,000-ppm level and were considered compound related. No such observation was present among the females at 1,000 ppm or in males or females from lower dietary-level grot@ps. 137-089 InternatioRneaslearcahndDevelopmenCtorporation Page 10 Statistically significant variations in sex-group moan weights of several organs occurred between the control and experimental groups. These variations were of unkno%m biological significance with the ex- ception of the increase in liver weight noted in males at the 300- and 1,000-ppm dosage levels. This variation in liver weights was accompanied by morphologic alterations. One female rat at 1,000-ppm, also had morphologic alterations noted in the liver. Or*,an Liver Group 30 ppm 300 ppm 1,000 ppm Sex Weight - m absolute, relative m absolute, relative m absolute, relative F absolute, relative Kidney 10 ppm F relative 30 ppm M absolute 100 ppm m relative 300 ppm m relative 1,000 ppm m relative Brain 1,000 ppm m relative 2. Histooathologv (Table 18): -Change increase increase increase increase increase increase increase increase increase increase P< 0.01, 0.01, 0.01, 0.05, 0.05 0.01 0.01 0.05 0.05 0.05 0.05 0.05 0.01 0.01 Compound-related liver lesions occurred in almcst all male test rats at 100, 300 and 1,000 ppm and one female at 1,000 ppm. The lesions consisted of focal to multifocal, very slight to slight cytoplasmic en- largement (hypertrophy) of hepatocytes in centrilobular to midzonal reaion.,; of the affected liver lobules. These were accompanied in some instances by increased amount of yellowish-brown pigment resembling lipoj'uscin in cytoplasm of hepatocytes and occasionally in sinusoidal lining cells. The incidence and relative severity of the above lesions were more pronounced among male rats at the 1,000-ppm dietary level. 137-089 InternatioRneaslearcahndDevelopmenCtorporation Page 11 References 1. Coulter Remoglobinometer, Coulter Electronics, 590 W. 20th Street, Hialeah, Florida. 2. Microhematocrit, John B. !4iale,3rd Ed., 1967, The C. V. Mosby Company, p. 1154. 3. Coulter Particle Size Counter, Model ZB, Coulter Electronics, 590 W. 20th Street, Hialeah, Florida. 4. Gradwhol's Clinical Laboratory Methods and Diagnosis, Frankel and Reitman, Editors 6th Ed., 1963, The C. V. Mosby Company, p. 1132. S. Technicon Auto Analyzer 6/60 Micro Methodology. 6. Glutamyl Peptidase - Sigma GGTP Procedure Bulletin #545, Sigma Chemical Co., St. Louis, MO. 7. Micro Auto Analyzer 11, 6/60 Micro Methodology. 8. Photovolt PV4, Photovolt Corporation. 9. Multistix (Ames Reagent Strips). 10. Steel, R. G. D. and Torrie, J. H. (1960), Principles and Procedures of Statistics, McGraw-Hill, New York, N. 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Page 14 @Ut S 10 733z5 7 .;9. @00 n:,--: 715,)2 ,-3393 733@4 m 73595 -%1 73397 73-.93 73 73@.00 73:Doi ',JCO 736,;2 7--6C3 7 .60.@ 71-:Z9 z 263 23 3 -'So -'30 29-1 .-9 7@- --;3 -.71-2 -69 is.@ -72 161 1.73 21-6 330 374 2.30 1. 38 @:3 @-65 -60 303 319 ;j-@ 354 31: :1 3@l3 351 384 338 420 320 3 @l6 370 360 339 @.@ 3 @..3 373 isl@ 1-0 333 363 3so 386 .12 -73 ;133 4 1:.5 '-55 Z-,0 275 290 -S.@ 301 30,@ 220 ;-oa -'60 2" 267 :9-1 :48 JC3 3:0 2-10 :56 253 -135 -'6 70 -98 '-9,z D:L--d zi5 i-20 -1 !50 :51 7 0 :36 27i 177 '-,3 @937 3T0-0- 3;. -?7 31-7 3-1 -C' ?'6 ;g 288 237 300 -.10 -02 '6 @77 -790 _,.;;z -19@o 21-2 :.1 260 239 2,56 :3-L@ 2 285 17C 13i @72 1.,-9 -66 ii0 -7- 1-33 !-%3 130 Z70 275 300 312 308 348 345 38C 382 272 276 290 306 322 330 336 373 380 23.@ 232 290 310 319 360 352 385 394 310 325 354 36.@ 130 @04 @i: 4@,@6 @ 30 200 322 34.3 364 330 ;,as "3 3-9 436 208 226 -'30 234 :-9 238 753 258 270 206 2:0 234 -'3.1 232 1.0 :5- 256 209 1-07 22.@ 221 2410 21.1 -,:.a 230 230 -11-0 2 Died 232 -38 -i '- ZSO 26.@ -'57 252 ZL3 397 -19 @O @oo @.12 @1-8 .05 3 4,30 73 492 @93 473 -56 7 _4.5 :43 .@5 @73 242 210 ;-76 60 sl@ :,a 273 -'77 3 :@3 2-'- Z@7 - ;o :3: :70 14:z 'sa ZZ3 '73 ii3 @-73 --33 31C 2-13 2 3-,a- 3@.@ 373 @oo - :30 :76 320 38', - L.@ 3:0 309 3CO -Cs 2:3 :_-o '343 zzc Zia 294 330 34S 323 25- 3%2 .62 386 210 1.@z 27@, 253 177 -136 303 1 @l i-10 1,1t i-53 '73 300 3:.6 3 370 25i- 29 3 !90 2'-0 21-0 -'3.@ :36 -:4, 2:11- i9s :a,- ::o ::a :11-4 :.i- 224 I-" 7 -i ZZ: 237 @-6 2 @-6- -732 26.@ :91) ::c -101- i0 :_Io -'-i 23C Z-Z.@ i5- Z;z3 '@7 li 2 IZ 26- -!a 3c7 I- I-;i.lFitior4ii-itt!imlFcln:i14 1; Wo-f-k off Stfitly (,tii-irt4ii B/ rill UR/ Iily fifty 1 2 i 4 5 6 1 6 9 10 11 12 11 FFtIAI.F,S: 1 1 .1 4 5 9 10 11 12 1) 26.') 24.2 2te.1 21.'l 11.0 29.11 Z(ol(i 11.9 2".,) 25.5 21.5 241.4 75.1 all.(, 11).? 69.6 ll.b 68.9 66.5 60.h lot)./ b2.1 51.4 51.4 58.6 55.1 19.6 11.1 18.6 21.9 19.2 21.1 iti.9 241.3 19.6 19.5 19.6 21.'l 19.0 94.7 10.7 19.6 93.7 ?6.2 16.5 1/.() 11.11 I'J." 11.1 it.2 11.4 71.5 R/ Vitt/ tiny R/ kR/ tiny NIOIO!IY1).IyStilliti-oRlillel l'i.xivityStilely. If,-ilFoliool.(1:IlllmitioIlmillt. -I'.)p-li@t R/ R/ lilt kx/ (lily tiny Ifin-PP@!-- r;bt il;ly it/ UR/ tiny 24.9 24.4 24.1 21.6 21.9 28.1 25.8 26.8 18.0 16.2 26.8 29.1 21.3 19.3 18.1 19.3 20.6 20.1 19.6 17.7 18.5 19.8 10.3 19.6 19.6 19.6 ?7.9 10.1 6/1 . 1 11.4 61.9 64.5 59.0 57.6 64).0 54.9 54.3 SR.S 57.1 94.4 83.5 Ri.6 80.8 19.9 16.0 71.1 70.4 73.1 61.7 10.4 1().) 7r,.4 21.4 25.2 25.10 26.2 2B.6 31).S 21.7 29.1 10.9 10.6 30.0 1(1.4 11).2 84.3 11.6 65.9 73.4 68.3 68.0 61.1 61.5 61.6 57.0 58.6 58.6 60.5 20.3 ln.9 20.6 22.1 21.) 12.1) 18.6 20.2 21.4 19.9 21.4 20.1 21.4 95.6 85.6 67.4 94.2 81.0 B2.7 10.6 13.6 15.8 68.2 IJ.7 69.4 $0.1) 25." 23.9 24.1 27.1 21.2 27.9 25.1 26.2 24.8 25.5 26.8 26.1 26.8 20.1 20.0 20.4 24.8 19.0 24.R 20.4 21.6 22.7 21.5 21.9 20.9 20.6 80.1 69.4 65.5 73.1 59.9 67.0 61.3 59.3 5).S 57.1 57.0 sa.s 5".l 91.4 91.5 01.6 98.9 11.8 88.2 15.1 75.8 11.5 69.6 II.R 68.3 71.8 3!10_iope! -R7 it/ rat/ kit/ flay 4lay ......... 19.9 zi.t 22.1 27.7 24.2 26.7 25.3 26.9 71.9 27.1 27.2 28.1 21.9 69.4 71.3 11.8 R'l.9 7(l.) 76.9 67.2 66.2 68.3 61.5 61.2 fiz.8 64.8 20.6 16.5 19.0 20.2 19.0 22.2 10.0 20.1 20.4 18.6 19.4 20.1 20.8 98.6 IS.8 81.8 05.8 it.1 116.4 12.0 16.9 17.1 69.4 10.4 12.1 19.1 Page 16 7luoradS rluorochez:lca: FC-143: ginety Day Subacute L&z TcxicitY Studr. TABLE 4. MA'-7S: Su=ma-n, of M"ns and Signific=ctscf Roma--ological Values. Hematology Study %ouch Central 10 ppm 30 ppa 100 ppe 300 pps @-rt rocy-ces. 109/c= samatocrit. liamaglabin. S/100 a-' Llueoc3rtes, 031== .Noucrophils, Lymphocytes, @-asinaph4-ls, .4onacytes, BaSOPh:Ll3, r%e:iculoc7tes, Protest 1 3 "rates-- 3 protest 1 3 Pretest 1 3 Pretest 1 3 Pre--es-1 3 Pretest I 3 ?I-a:ast 1 3 ?rates: 1 3 Pretest 1 3 6.01 6.39 7.95 47 49 15.9 16.4 16.2 12.57 12.67 10.64 9 9 11 90 as as I I 1 0 z 0 0 0 0 7.7 3.1 2.4 6.53 7.36 7.46 49 50 47 16.6 17.0 14.r 10.58 12.57 8.98 13 10 11 86 as 88 1 1 0 1 0 0 0 0 6.3 2.8 2.9 16.00 6.89 7.05* 47 46* 13.6 16.2 15.0 10.39 11.27 9.33 12 9 16 87 90 82 2 0 0* 0 0 0 0 7.5 3.0 3.2 5.93 6.62 7.16* 1.6 47 46 L5.0 15.7 13.4 9.94 13.54 9.35 11 10 11 as 88 86 2 2 0 0* 1. 0 0 0 5.5 2.8 2.8 5.91 6.34 6.72** 46 /-6 45* 13.2 15.1 14.9 6.30 10.71 7.63* 12 1.1 16 67 87 8-@ 1 2 i c 0 0 c 6.9 -..s @.8 ..Ooo a a 6. 3 6.93 6.94** 50 47 47 16.2 15.9 13.1 13.01 14.13 8.06 9 8 17 90 89 a, 1 1 0 2 0 0 0 6.9 Z.6 2.8 i37-oe9 d:L!!e--e--@-4.r= Control ;roup mean. p-cO.C5. **Si;ni!icaztlv dl-!!aran-.!ro= Control groud mean, icG.01-. a Sta-is-.icAi inalysis no-. conduc--ad on pretest @riauas Page 17 TiucradI Fluorocktar-4cal FC-143: TABLE -6. Canr-. ha=tolcgv S tu& 14= Zh E:7-1-roc,wtas. Hematocrit, Hamo$lobin, &1100 CLI Precast 1 3 Pretest 1 3 Pretest 1 LauSocyces. 10 %autrophils, Lymphocytes, T-osi-naphils, honocytos, Basoph4-,-s, Raziculocvtas. Pretest 1 3 Prezesz 1 3 ?races: I 3 Pretest 3 Pretast 1 3 Pretest 1 3 ?-.etas-. i 3 Ninacy Dar Subacute R.Lc TomicirT StudY. Su=&-.-,o:f !taansane s--S-.1.1icAnce%s!matologicia values. Control 6.1-9 6.99 7.15 45 50 46 15.6 16.3 15.6 7.33 7.35 6.60 ii 17 i3 88 so St. I 2 1 0 1 0 0 0 0 4.7 2.7 3.0 *&0 ppc 6.35 6.96 7.07 47 49 46 16.4 16.4 15.4 8.61 9.56 5.77 9 11 17 90 a& 8: 2 1 0 1 c 0 0 0 7.3 1.8 2.4 30 ppe 6.41 7.113 6.91. 46 52 47 16.2 17.1 L5.1 7.22 9.35 6.74 14 20 91 8/1 79 1 1 1 0 c 0 0 0 3.8 2.0 @1.2 100 ppm 6.12 6.9/. 6.90 46 50 47 15.2 16.5 15.3 7.87 9.63 5.74 16 8 19 84 91 so 0 1 0 0 0 0 0 0 5.2 2.6 3.3 300 ppm 6.18 6.71. 6.&6 46 49 4," 15.1 16.6 16.1 7.28 9.70 5.00 11 148 19 se so 79 2 0 0 0 0 0 0 3.5 2.7 1,000 ?PC 6.49 6.85 -,.31 49 48 47 16.2 le.-; 15.8 10.72 1C.89 6.04 6 LS 1.6 93 !3 3: 0 0 0 0 0 0 3.2 Z.i a 137-089 =a2!rs:Ls no: conducted an pre-.as-.va:.uts F Ito,or,lot V Iistir.)i-lIirti,tIm Fi'.1-4 1 "lilriy));IV listTi,xii7itSyLOO41y. 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'v it.17 7 0 q2 I 1%. 7 I'l.54 lit to an 2 16.1 11.0 15.8 17.2 16.5 It.79 12 0.97 6 12.1)2 %. 1.03 11 6.6% 5 an 0 92 1 44 1 A6 1 43 2 16.5 9.61 a 0 91 1 11.9 11).()1 11 1) 04 2 16.0 9. sit is 0 $I 11.9 lip.91) 1 If 93 ifi.1 8.15 13 0 R5 Ili.16 9 (1 91 141.71 11 0 87 15.6 11.70 17 1 82 0 1 (W.7 7.5(1 24 (1 . 74 1 1). 1 11.15 11 of 8% 2 16.8 9.39 to 0 78 4 16.6 6.76 16 Ri 1 16.6 9. 7(1 18 an 2 15.6 11. 16.2 l(I.92 to 0 11.0 1(1.12 9 0 17.4 sq. It, 5 (1 Its.(, 11).St) I if 1%.9 R to 17.9 7 1) 16.') 21 0 15.1 is 0 1 r,.4 I.Hi a 1/.() to.SH 16.5 10.119 1 9n H% 041 92 1)11 89 92 19 0 64 1 I)f) 2 91) 4 at 2 Cyl i-S 0 11 0 0 I 0 1 0 1 0 0 0 0 2 6 1 2 0 2 0 (1 0 0 1 1) F Iit.toi.l 7. Hill Nitaiii-i Seg y 1551 lii%'l to 7islill it 1 ON51i m .11, 1 111 it tk-@ill 71551 F /lilin v 71'159 r 7)Shfl F 13561 F tit-iiii 1-0 @l@PM!, , 1'15(WZ to @.1561 to 1)564 pi 73565 to 1'1%(.6 Mt-ilik 7*1561 r 715611 F 11%64) v 11511) v iii?l F 11j7l 73,011 II 114 ?1 It F F 731)),) F iiiiiii F 7'lif1l p Ied4 10 '/I-ow 1. 9h 8.21 8. 11 1. 11 1.41 1.1)li 6. gR 7. 11 7. It2 1.49 6. lis 7.15 7.(1% 7.61 7.59 7.95 7.0/ l.l16 6.65 1. 32 6.')Z 7.1th 6.90 7.07 7. 1)'t 7.10 1.44 (i.r,4 1.14 7.(1% 6.1110 6. '14 I,.fin 1.5'1 6.91) 6.94 crit z 48 S7 Sfl 48 49 49 45 46 45 48 44 4h 41 47 50 45 Ili 41 lo6 147 III 49 45 46 46 IOR 45 44 41 146 46 /16 46 11 41 1 I'll-Olill Nisti-tyllioy K1.11,lot it/)IImIi, 15.2 16.6 16. 7 16. 1 16.2 16.2 15.2 16.1 14.8 16.6 15.2 15.6 15.2 11.9 16.2 14.2 13.9 14. 7 16.3 15.5 Iif.0 16.4 15.0 15.4 14. 7 15.5 14. 1 14. (1 15.1 15.41 111.9 14.2 Ill.1 16.1 15.5 15.1 4:it 4!ti am Neut Seg. z i-Ia Ni)ii-SPK. 8. 1/$ 4 (1 lt.til In 0 1 1./I 9 0 10.115 6 (1 1).12 16 0 IO.fill II (I 7.04 23 0 5.97 12 0 5.58 .9 0 0.41 26 0 5.99 5 (1 6.60 Is 0 1.17 10 0 0.90 11 10.00 6 141.19 19 0.01 1() 0.88 11 7.It 8 0 S.40 7 0 1).[(1 10 n 5.41 31 0 5.81 26 s.17 17 0 8.18 16 0 8.111 11 H. rib 25 0 9. 27 12 0 17.11 16 q.,Il 16 't.'12 III 0 5.112 % 8. Ri 2(1 0 1.24 2R 1) 6. 24) 2q f) (1.14 20 0 r.Yten 96 79 09 94 84 On 13 B7 90 13 95 Rio B9 ps 94 no 88 OR q2 9(1 on 66 11 B2 nI 86 72 RI R'l R2 @I its 76 70 70 7'1 FAtUitUt- I'lilIa I (1 1 2 0 Millo- cyten 0 a 4 0 1 0 1 0 1 0 0 0 1 0 1 0 I 0 0 I (I 2 0 1 0 0 0 z 1 2 0 0 1 1 0 1 0 1 11 .1 (1 1 0 2 0 a 0 (I (I If 0 2 (1 1 0 1 (1 V111.10.11 Viiiiar4i(,IiemiFcin:l-141: 'I'Ahl-F. 8(.x yi'yIttriplexteNA 11 /t-mw 1.0.41 7'15112 ?1 7 lin 1 11 1151(4 #I 115"5 ti 11511(1 m K@1611 11,1"7 v I'lsnm F 115041 v 11590 v P1591 F Ik-nit ,I.tmllilts: I'lIJ91. H 73%9'1 11 71,10/0 ti lji,)$ to 7151)6 ti Ik-itis 7Is)I F I 159R p illaill F 7'16(Xl F 71601 v 1.56 1.42 1.19 6.14 (1.91 7.ifi I,.17 7.(Il 6. RO I)IC41 6.90 6.41(1 6.96 6.1)2 6. *19 6.20 ?.()1 6.12 6.68 6.95 I.IZ 6.(iff ItIpsi 6.R(i lociusItu crit 46 41 47 4S 146 46 44 49 45 48 41 47 111 41 44 45 45 /o4 48 41 68 67 11(k(oz it 1'16(il ti 73604 pi 1161)1 it 11606 ti K-all 716(it r 73608 r )1(61)9 r lifill) v 7*1611 v 6. R 1 44 6.11 41 6.66 41 B. 11 51 6.19 48 fi.414 41 7.51 4R 1.711 /,I 1.1111 46 @.'i 1 47 1.'Ilp 40 7. 11 to/ No.1-mill Mlisety I)ay StobacieteRiii '1'.)xicltSytio.1y. ties")- gluto(st it/1(1o0l lleiu;ltott)RliV.n.lOllii-s 3 Ho,fillin. ic tea 01/caim --- Met selt. 2 N,Vtl-leg. I.ymllll(o4*.yten Pon IOld)pillto Mostocytes 1 1.80 R 0 15.4 9. lfi 20 0 16.1 12. 14 11 a lslo 9.69 1 41 14.9 7. 16 11 15.4 9. 15 11 0 14,6 16.2 14. 5 5.6% 21 0 4.24 1 ri 0 7.11 lot I 15,9 5. 72 le I 15.1 5.74 1fl 1 ls.s 7.55 16 1) 15.1 6.11 to 0 13.8 7. 4? 11 f) 14.9 1.29 17 0 15. 1 7. Ili 16 (1 14.9 7.63 16 0 14.8 6.51 21 0 11.6 *).ti1 19 0 1%.g S.29 17 16.0 4. 16 19 0 16.1 5.1)0 19 1) 14.4 7.21, 16 it 14.6 7.62 14 0 1).a S. 1" 20 0 16.7 11.18 13 0 16.0 ti.09 21 0 15.1 B. 06 17 16.2 7.61 24 0 15.1 4.112 16 0 11. 5 4.011 13 11 li.7 S.11, 12 0 16.1 1.1)1 11 (1 15.0 6.(P/. 16 0 91 1 0 74 1 3 R% 2 0 92 0 1 oq I (I 86 2 1 IR 1 1) Ri 2 0 R1 2 0 ro 1 0 8(1 1 11 8() 4 III 1 0 al 2 0 82 1 0 82 2 0 82 2 0 in 1 9) 7q 2 0 Ki 0 11 7 4 0 19 2 1) lt4 0 (1 "4 2 0 79 1 0 ol (1 0 III 0 112 75 1 (1 RI (I al 0 86 0 06 1 (1 82 2 F]IloI-dit I-'Iitoro(:IieiiFi(t,c'a-l143: Nlnety 1);iySul),ictitReat 'I'oxiell:Sytsitly. 'rAill.1Bi. HAT.ES: Stittut%ioAfrytteitisanti Sigilificitilcel)Bolfocliemteal.Valuen. B io c IteniItiL I-y (;IIII-.ooe itig/100 111]. Mi)iiLli llreteat 1 iiig1/00 Bit Y-C IiicniiiIy Pe,-)Li(laae Signin iiiitls/nit C. 1'.K. 11, SIRI4.1tillitR/ffl.t 0 .,1*. iiiilLa/l. Ca Ic Iiiin, Alk. Plios. Ilit'l Pretefit 1 3 Pretest 1 3 ]'retest 1 3 Pretest I 3 Pretest 1 3 11re t:etot 1 3 Pretest c 1 3 Coitt ro 1 91 112 121 24.7 15.4 lfi.2 19 3 1 7 17 11 94 t55 111 78 89 9.6 12.7 9.8 194 104 10 I)PI[I 92 112 120 11.3 t4. 0 18.8 1 2 1 13 17 8 89 143 105 90 78 39 10.4 11.6* 9.3 30 1)1)111 81) 1 ll* 136** 9.6 17.9 18.0 1 2 1 15 It, to 89 128 94 81 71 41 10.() 11.3* 9.2** 100 PI)III 94 127 t 34 10.9 17.0 20.4* 1 2 t 16 19 13 114 121** 128 67 76 63 9.7 12.0* 9.5 300 1)1)m 106 127 14 3* 11. 19.6** 23.9* 1 2 I 10 15 14 106 log* 108 61 75 54 9.5 11.8* 9.3 225 220 137 120 216 147* 2/o9 20/1* 137--Oflt) *S IgilIf I(';ILIIIy (IIf fereiit froiii(t)itiro 1. gr4)iilnpicali,p<O. 01 Stitri,st@icalallkl5,..lllfilol@ c Not citti.eriiijii(!ii ,iiii oii iirt-L(*.9Vt-111vfl. FltiorocitoiiiienIi-C-143: Niiiety Day Siol),ictiILteat'I'oxicityStti(ly. I'Alil.i-B,. Coiit. Itioclienif.gliry FrtIA1.1@S: giiiiiiiita)if-Myeatigiiii(Sii.giiifl(-tiii(l-teilo)colfielnicaVlalueti. Study Mositla Cooitrol 10 I)PI)I 30 lil)tn 100 ppm 300 ppin Pretest 91 100 99 108 107 ilig1/00 nil I 111 117 120 124 lofi 3 119 12fi 131 127 122 D. [I.N.. 100 int 1'el)ltdni4e Sip,iiiiifilifi@0/1111 llretetit I 3 Protest 1 i lt.7 ifl.] 21.4 I 2 I 11.9 18.3 t7.5' 1 2 t B.0 17.0 16.7 0 2 1 10.6 16.1 1.9.4 0 2 2 9.9 15.4 17.fi 2 2 C.1l.K.A*, Pretest 9 13 13 14 17 Sil,,Inatillit.H/lill 1 14 17 12 25 17 3 14 9 7 ta 12 P .C. 0. -1-. llrecest 75 86 74 96 111 litt'lilillts/.I. 1 156 1119 158 135 133 3 Ito 131 96 109 113 l.iiL'tIi.tilts/i ellIc I%$in, iiih-/100loll Atkit. -ifit'uliilts/i llrel@est 1 3 I'vel-eat 1 3 I) llretetil 1 3 80 71 25 10.4 11.8 9.7 115 69 118 78 5() 10.3 tt.6 9.4 133 69 75 80 26 ).7 It.4 9.4 121 57 64 82 32 9.8 12.2* 9.8 106 52 67 71 39*@ 9.5 12.2* 9.0 106 53 137-1)119 ,itIF,l(-;111y1: (IIffe reiit froitiCoettro I group inean, p-0.05 **Crelit@lile 1) SLnit9tl(,iiiiiiiilytillsiot Lett t)npretelivtaltiefi Fluorad9 Fluorochanical "C-143: TA3LE 9. Group, .U z G;.Ucose Nl=b*r Sax asi'loo al -Cingc'rDav Subacur-a Rat Toxir-i,.7S.tvudy Individual liachazical Valuas - precost. B.C.N. a&/100 al Y-Clutami Paptid"'e sig=a =its/22 C.P.K.* SI-sma UZI-tsimz P.G.O.T. inc"- unlcs/l Control: 73352 .4 81, 12.3 0 73553 m 93 15.0 1 7355;. m 90 66.0 86 13555 90 14.7 2 i'3.956 93 15.3 2 Maan 91 24.7 19 73557 T 90 10.2 1 73551! F 87 8.7 1 73559 r 96 9.3 1 73560 F 90 15.0 1 735bl F 90 15.3 1 Maar. 91 11.7 1 10 D=: 73562 m 99 14.7 1 73563 m 102 15.0 0 73564 x 99 9.3 1 73565 m 78 9.0 1 73566 %1 81 8.7 2 .iaan 92 11.3 1 73567 F 90 9.3 1 7356e F 109 10.8 0 7'@1569 r 87 11.4 1 73570 F ill 14.4 1 ,35,-l F 102 L3.5 2 Maan 100 11.9 1 30 vam: 84 9.9 0 13573 %1 78 8.7 2 73574 78 '.0.2 2 13@C75 m 102 7.5 73576 .11 102 11.7 Mean 89 9.6 73577 F L20 6.9 0 73578 F 93 6.6 0 73579 F 99 7.2 0 73580 F 93 9.3 0 73591 F 90 10.2 0 99 8.0 0 9 90 7 114 5 87 9 96 7 ei 7 9/. 10 69 7 78 14 78 5 78 7 71@ 9 75 13 99 14 93 is 84 12 87 13 89 17 87- 8 75 19 90 12 90 10 90 13 86 16 14 i@10 22 90 13 66 11 8i. 15 as 13 Si. 18 34 16 69 10 72 10 63 13 7/. Page 26 int'i units'll Calcium 69 96 60 67 112 78 78 7@^ 87 78 84 so 64 il-7 93 87 69 90 90 84 99 67 ai se 69 90 96 7Z 8-1 83 87 66 66 84 7: 75 9.6 8.8 9.2 10.3 9.9 9.6 10.0 9.3 9.5 12.8 10.2 io./A 9.9 10.4 10.2 10.5 10.4 10.8 10.2 1C.9 9.6 9.9 10.3 10.0 10.2 9.7 9.5 10.4 10.0 9.i 10.2 g.i, 10.2 9.7 137-099 phoschokl-=ase 71u,)rad ?Iuoroza4m:Lca2. .43LZ 9. Cant. C-1-3 Gr-,up. Glucose Ms. 100 -LI !-DO 731-82 733,i.l 73!83 -33.36 .-Eean 7334i,- '735a8 F --39 r 73590 F 73591 r .4*an 300 nom: J3592 73393 73594 73395 7339f3 @l 7339- 73-@3 T 73600 7 73601 .)5 90 1: 99 108 102 117 108 90 117 103 Ili Il:a 1-06 99 -I @ 2. 102 1-07 7;50@ 7260-5 1-3:! 90 73 :;Lnacy Day Sub-Lcure :tar :ndivldual 31,.)cli*m,"al ,alues ? ma" LOG -al Pepcidase Sir-a -4ni--.i 7@l 9.3 0 3.3 0 i:. 9.0 0 9.3 0 9.3 0 11.4 0 io.6 0 10.2 0 12.0 1 9.6 12.0 il-..4 0 I 11.0 9.0 0 9.0 0 9.0 0 0 1 9.9' 0 0 -0.3 i3 9 13 13 12 1 4L 9 io @3 1.@ -9 :7 i6 13 ? 7@-iC7 7 3-; 1-@@ 736 *' -0 90 .7 753 33 0 90 13 93 102 99 913 99 1*-i L20 1--* -@-7 106 i' @i 99 Page 27 37 9.3 .39 6- 13 69 3160 6c 6.7- -D 7@ -7i6 67 oz 9.6 10.1 9.3 5.6 9.7 10.0 9.7 9.19.z 9.3 g.- 9.5 9.9 @.3 7 F;.ucrad -Fluaroche=:LZ&l FC-143: VizOtY Dav Subacu:e Rat Toxicity Study. UBLE 10. Individual Biac-amical values 1 Mcnch. Gro%:p. RAL: .iur.ber Sax Glucose as,-'loo =I B. L:.-V. zg,'IOO al Y-Glutsorl Popcidas@ sism =Its!ml C.P.E.* sigma ur@its/mi P.G.O.7. izr.II Un4--.S!A. con:rol: 7333-' x 1.08 15.6 5 "13553 m 120 16.8 4 73554 108 14.7 3 ;13535 x 117 14.7 2 73356 108 15.0 2 mean 1., 15 . IA 3 -,3337 T ill 11.0 1 73558 F 1;5 ;.6 1 73539 r 117 10.9 2 73560 7 108 19.5 1 73561 7 114 38.7 1 .Uan ill 18.1 2 10 guz: 73562 iz.0 1 73563 bi 105 I/A.7 1 73564 m III 15.0 2 73565 %1 108 17.7 3 73566 M 117 14.4 3 Mean 112 14.8 2 7356" F 117 14.7 1 73568 r 120 1-.7 .1 73569 F li@, 2@.7 3 73570 r 1'4, 17.4 3 73371 F 1!7 18.0 Mean 117 18.3 2 11 i2g 13 ISO 20 iao 19 132 20 136 17 133 9 129 14 11.1 16 ISO 11 16Z 20 168 14 156 20 A23 22 153 15 138 I,, 138 16 165 17 143 9 ISO is 153 is 144 28 130 1.3 147 1-7 lk9 30 735-12 -M 1.7 20.7 3 73373 m 129 16.8 2 7357L m 1.23 15.3 3 73575 m 1 115.3 1 73376 m 153 .6 1 .4a&z 133 I"@.9 2 73577 1,3: zl@.3 3 73378 F -123 15.0 3 73579 F 123 19.3 2 73380 F 1.14 15.3 0 73581 F 108 15.3 3 120 il-.c 15 1.23 16 138 8 IlL. 15 IZ3 13 14.1 14 .128 16 129 9 147 13 165 12 195 12 .36 !2 ills P.G.P.T. lz:'l umi:s,ll caici= mtq! liter 6-@ 13.0 93 Z.F- 93 ii.6 90 -1.6 8.4 @.6 89 1:.7 66 1-1.6 7: 1-1.8 78 ii-8 63 i2.2 75 ii-4 71 i.-.S 72 ii.8 87 :.1.4 66 il.S I's ii-4 90 11.1- !s '1.6 96 @'..6 78 1..6 5i. 93 69 i..@6 Is ii-f 60 Zi -4 84, il-.l 48 ii.: 69 91 9- ii-6 60 2 1-12 il-.: 96 6 78 @z..4 Page 28 Alk. ?has. !.a:'I' ur-i:sl'- z@" 6 !56 Z:2 192 19-1 i,4 io: 165 87 105 Ii5 168 201, 318 21C, 1.28 :z i-Z lot 12; 11-7 138 26-1 2-10 1.98 1,77 214::!o 95 ii7 1.71 108 102 QNS - Quan=icr no: su!!iciezz PhosphoiL'-nase Fluor&4i@Fluaracbemical FC-143-. =KBLE lo. Cour.. lizatt Da? Subacute Rat TaxicitY Studv. individual DiathemiciLlValues I Mouth. C;roup, Ra,. .Number Sam Glucos* Ms..,Ioo =1 mg/100 XZ Peptldas* SI-1--a u nIt r-I Sig=& uni-zs:'=L F.C.C.T. int'l umits/'- 100 on : 73592 m 105 15.0 2 73583 m 135 17.7 2 73584 x 138 15.3 2 73585 m 132 18.3 3 73586 m 123 18.6 1 Mann iz-, 17.0 2 73567 F 114 1/..7 3 ,'3388 r 105 14.7 1 1"3589 7 138 18.3 3 73590 F 11.1. 17.7 2 73391 F 120 15.0 QNS 'VA&Z 124, 16.1 2 30C uu=: 7.1149.1 m 123 20.7 a 73593 m 132 17.7 1 7 '@ 1594- x 123 18.0 1 73395 m 132 20.,- 3 11 3596 m 123 21.0 3 Mean 127 19.6 2 72591 F 102 19.5 3 72598 F 105 13.0 1 73399 105 15.3 3 73600 F 1117 1Z.3 1 73601 F 102 15.0 1 ,vaan 106 15.1. 2 1.000 oz 73602 m 126 24.0 1 73603 .14 il4 20.4 1 13604 m 120 23.. 2 73605 120 .7.4 1 73606 m 126 19.2 1 Ilaan 121 20.9 1 73bO,- r 105 18.9 0 7360a r 120 15.3 1 73609 T 129 IB.D 1 73610 F 114 2-1.9 2 73611 F 114, 21.3 1 Meat 116 19.3 1 is 135 is 135 17 96 2i. lz6 16 114. 19 121 1., 132 53 132 17 120 31 174 11 il7 Z" 135 1,, 108 15 lL7 11 84 10 117 28 114 15 108 21 11.3 10 1!5 12 108 1. 1.4 28 136 17 133 9 99 11, 120 IL s 126 13 105 21 1 IL 13 113 16 163 10 114 io 122 17 120 zo 126 15 135 Page 29 U;izs@-2'. Calct= I A-k. Phos. intli urti -@5 78 90 63 61 66 76 81 "2 37 108 60 82 78 81 48 78 90 75 63 ,-,I 37 9f) 66 )-1 93 96 '3 96 78 97 11 d, 66 00 87 87 89 iz.4 iz.2 ii-it 1-1.6 17. 8 :2.2 12.2 1-1-41 7,. 1-1.8 --'.2 1-i.6 1.2.6 2 1:.-; IZ-0 1Z.-, 1-i-S ::.c Ii.2 il.0 @- c @:.z 23i 2416 189 219 195 1:3 73 I'll 123 99 lD6 213 238 186 2-'S 360 249 132 7S !)C 125 106 1 f5a 26' 2!"299 1.1 lee 75 132 103 112 C%'S Ouacz'--,r not sufficient *C.-ea-.1alme p.Los,.ihakinase Fluorse r-ucrochazlcxlFC-1-3: SinacyDAY SubacuteRat Tox:LcieS?tudv. WLE I.:. individualglachemic4iValues - 3 .4ac-.ho. Grouz. Ra-. \u=ber Sax .!Ucose arb.110C CLI 1. mglloo al v Gluta=vl P:Ptigias's Sig= =itsiiml C.P.9.* Sigza unitsiml P.G.O.T. in:'! uul-.s/l Czmtrol: i-3551. x 1 ii. 13.9 1 72333 m 125 17.4 1 7--354 m 1!9 @7.0 1 ,;-,35 L'@6 15.0 0 1:3 15.9 0 izi 16.2 1 73557 1-12 18.8 0 i3358 r 11. 16.1 1 73!59 F '@25 16.1 1 73560 F 117 19.9 1 73561 F 116 36.1 1 .Sean i.i9 21.4 1 10 zac: 73;62 m 123 16.6 c 73363 4 loi 22.0 1 7336; m ill 17.0 1 '.4 i26 20.4 1 73.566 m 13. 18.2 0 Mae= 120 18.8 1 73567 r 117 16.9 2 ,3568 F 1:5 19.0 1 73=69 F 135 16.8 0 73;70 T 119 16.1 1.32 18.% .Me= 126 1-$.S 30 Do=: 73572 13@; 17.0 73!1-3 m i29 16.0 1 73374. m 3-' 17.1 1 ,3573 x 1-5' 16.9 2 7-13,'e m 143 23.0 1 Mea.i 136 18.0 1 7337-, r 129 16.0 1 73,c78 izs 15.9 1 ;-3579 r 124. 15.1 2 73580 r 141 16.6 2 7358. F :32 20.0 .iean 131 16.7 1 9 95 14 138 10 1.06 12 111 9 115 11 113 7 95 28 29 13 107 10 lis 10 130 14 110 5 sa 9 126 12 ill 115 $1. 8 105 6 1.06 10 96 7 92 16 21.9 8 ill 9 131 6 90 7 so 5 91 10 102 22 105 1.0 94 6 71 4 so 10 100 9 105 6 "1 7 96 @.G.P.7. Calci= int'! maq.- '.,.ter 33 9.8 31 10.1 43 9.7 30 10.3 55 9. 38 9.8 30 io.1- 28 9.4 '@7 9.5 29 9.8 zi 9.9 25 9.7 33 9.: 36 9.4 52 9.8 42 9.3 30 9.0 39 9.3 .0 9.5 i.0 8.6 37 9.5 103 9.9 30 9.1 50 g./ 9.0 .;2 9.4 4i 54, 8. 411. 9.6 41 9.2 21 9.2 zi 9.i 13 9.2 21 ic.: li3 9.2 26 9.4 Page 30 klk. Phos. lzt'l =its."! 95 11-4 86 97 54 42 101 f.; 104 69 96 !:7 .96 130 li.L3;' 86 65 97 6? 1.2i -.24 85 i39 12C 4'56 7: tt 66 57 '37-089 not su!!Iciimc *Cr*atl-tine phosphokinase I Fl.,icrsd Fluoroch=lcsl FC-143: %inety Day Subacuce Rat TaxicitY Study- ZABL-T 11. Cout. individual 3ioche=cal values - 3 4o=tbs. Grou-,, Ra: %uzber Sax Glucose mg!IOO =1 I -U.'%. mg/100 =I @-Clutazvl Paptidas Six=& unit:/=a C.P.;:.* Sigma un,-Zsl=' ?.G.O.T. intli ur-its/1 Page 31 ?.G.P.T. 1=.l units/! Ca@c'.= =eq '.Itar Alk. phos. Lnz'l unitsil 43582 m ':%3:Debro'Ke In centrifuge no sampl* 73583 x 121 20.1 2 119 192 73564 134 20.7 i 11. 83 7.1365 130 20.0 1 7 106 73586 m 130 20.7 1 12 130 .%iesn 134 20.4 1 13 128 73557 F 126 16.4 1 73588 F 140 15.9 z 73589 F 125 24.2 2 73590 r Died 73591 T 116 21.0 2 .Meaz 1."7 19.1. 2 20 105 16 110 13 120 24 101 18 109 300 zz=: 73592 m 1;,4 29.0 1 73593 145 2Z.1 1 7,3594 14,1 20.1 1 '359,9 7@1396 139 23.0 1 144 23.5 1 !Jaan 1.3 23.9 1 22 95 13 143 11 9i 13 120 Ll 91 14 108 73597 F 12i 17.1 2 -;3398 p 116 17.0 2 73599 F I---- 19.1 ',2 73600 r ---27 73601 F :)ied 14 98 1.1 127 to 1!7 12 iii Mean lz2 17.6 z 12 113 1.,OOC 73602 130 27.0 2 736c3 136 Z3.3 2 @-3604 140 79.1 7 73603 m .2@. 2..l 2 73606 m 14@, 2-.8 1 1.3 90 12 83 16 139 it. z: 11-1 Mean 133 35.1 3 is 119 736C7 139 21.0 1 73606 r IZ2 17.0 2 73609 F 1'-71 18.8 2 73610 r 11.7 22.1 1 73611 7 l@16 24.0 2 16 150 24 11: 11 IZ6 1; 97 7 99 Maar. 12.c 20.6 2 15 117 101 i2 145 62 63 30 24-. 42 30 32 42 86 57 so 37 54k 29 i Ll 4.1- 39 48 26 76 37 at 54 49 30 4@@ 23 3: 38 9.5 9.7 9.Z 9. @. 9.3 9.8 10.3 9.3 9.6 9.8 9.z s.i 5.8 9.9.6 9.3 6.9 S.s.: 9.6 9.0 -^..0 9.,g.;, 9.9 8.8 9.5 9.0 @0.0 9.! E.8 1.5c isi l@., 1.@4 I,.,31 56 @4 -'5 sz 249 210 148 is-L 225 201. 59 146 5c 34 53 1 6.@ 350 118: 1.-1 ?3 70 34 6.@ 36 61. i3l--0!9 Phosphokinase Nl@"!ly"'By'%"IlattliRtAet I"Ixli'lLSytisily. lls"ltinlymiYaolin-H NeoWser spx (@iiit r4)1 1'1552 ti I lsil N 1'1534 ti /1111 11 7 lili6 ti 11557 v Ili DR p 11,159 F I lr)(10 F I'tri6i F Via Itoml. alid mI Alijoemr, 1,11 2.fl '1.0 1.5 1. 1 2. 1 2.5 3.0 2.0 2.11 1.5 S-(.1 1..-% (: I.S-(, 1).-,r.1 I.S.1: I)S-(@1 lq -4.1 I)S-CI I.S-C 7. 1 1.0 7. 1 1.0 1. 1 6.0 7.2 R.0 6.4 1.0 Slier. r itv. 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R4 1'b.04 11.64 fi.lo 7.8o 6..96 6.85 7.57 16. 37 10.61 tS. 87 21. 56 1.25 7.(11 7.82 10.12 7. 78 7.44 19.91 ]?.no 18.51 16.70 22.')2 1.91 8.58 1.14 7.51 7.47 16.12 14.,)7 29.S2 16. 1() 16.10 8.24 8.61 7.185 7.17 3. n 1 2.99 3.94 3.73 1.22 2.00 2.25 2.40 2.01 L. 9 7 3.88 3.82 1.85 4.14 4.66 2.27 2.15 2.72 2.26 2.72 4.12 4.21 4.74 4.22 4.11 2.32 2.46 2.17 2.30 2.62 le.12 4.01 5.21 3.79 3.19 2.75 2.67 2.13 2.34 2.18 2.41 2.31) 2. 1(1 2.21 2.03 2.00 1.97 2.22 2.06 2.16 2.36 2.25 2.31 2.23 1.90 1.91 1.96 1.95 2.04) 2.33 2.35 2.14 2.27 2. t? 2.o6 2.06 I.Bi 2.00 2.09 2.19 2.1)1) 2.27 2.25 2.4'1 2.16 2.05 1 .4141 2.18 91 70 go R? is 101 110 91 92 A[ 56 68 64 99 72 76 87 130 99 oil 62 60 93 80 6B 69 91 so 86 82 5) 69 a] 64 in2 86 110 86 p Tleyro IJ/ 47 4 ro 36 44 20 32 16 25 34 28 28 40 is 31 30 25 25 23 24 31 47 39 34 in 12 27 22 28 26 21 19 17 29 11 12 11.0 2 Is 'I'Alil.1F7. (:rglilil Hiii Nie. Sex 3T 71591 71593 11 rqi, iii9s 71596 71,91 p 13%911 p 1)599 v 164 10 v 7J602 11 736(11 m 716(14 ? 3ft(is 71606 m 7361)7 F 13608 r 7:1609 F 71610 p lifill p fill,ly Wt. into IN'l )94 4 lb9 4 Iq 247 2 li2 219 255 381 31)4 '14 1 2811 'In# 221 223 267 2:16 252 Sptecii 9 0.78 0.50 0.47 0.73 0.73 0.46 0.41 0.41 11.45 0.61 0.38 0.54 0.42 0.42 0.49 0.39 0.52 0.43 0.48 N IoteIv I)aYS,,IinIie,,iiiiit irIIy 81lijy. liltilVJdtiniOFRitit WellllitH I'l-EMIOS.1S1n4:rfflre. I.Iver K 141rIL-y R Itralit Adreointo 09 20.01, 11.5) 17.91 21 R5 23.31 7.20 7.93 7.26 7.17 19.98 19.42 18.29 11.97 20.25 7.90 8.2(1 9.83 8.59 9.27 4.23 3.63 3. an 3.82 3. 9R 2.42 2.51 2.27 2.IoO 3.89 3.47 3.14 3.20 3.66 2.11 2.10 2.17 2.11 2.26 2.11 1.98 2.10 2.11 2.15 1.82 2.01 2.00 2.12 2.19 2.05 2.'15 2.08 2.19 2.2R 1.80 1.96 2.20 2.06 54 69 59 74 7R 78 101 91 at 19 61 75 60 63 lit 93 85 99 71 I'loryiI,d/ I'aratityro OR 23 30 36 44 4y 27 2a 22 23 44 28 36 34 38 32 it 23 24 30 rr C, 0 W Pi < m @n Z, xm 0 r, -1 Cpi X, m M Mm f,P r- PI Li ti Group, Rat No. Sex 73562 m 73563 m 73564 m 73565 m 73566 m 73567 r 73568 F 73569 F 73570 F 73571 F a* rp MM m0 < 00 M rr oz 0M0 "am pi M. rt m CD M m z mM 0 co G.-oup Rat No. Sex 5 73572 73573 73574 < 73575 m LQ 73576 m Li 0 73577 F x c"o f-T 73578 73579 73580 F 73581 F Plitorad Fitiorochemical FC-143: I'ABI,E 10. Cuitt. 1.00 1oil Brain (With Cervical ('ord) focal perivancular lymplioldlitfiltraten Spinal Cord (i.ijmlinr) 1'eriplieralNerve focal perivascislar lymplioldlisfiltriii-P Eyes acute focal myonitte lnviviviti#l,txtragit@ular mtjncleo focal retinal degeneration Pfttlitary focal cytoplasmic vacuointion of rownsiot of craniopliaryngral cyst I)asoipliilFi Thyroid remnant of ultimobranclifal rest focal Interstitial lymploold Infiltrates Paratiiyrold Ailrennl focal cytgiplasmic vacuntatioii tif (-ortjcnl I-ell@ ltemtoeyst coiigention focal periloroncialal lymphold loyperplapin focal perivescular lympli4ticlioifiltraten focal mineralization of litsioutiorayrtery focal Interstitial Inflammatory (-ell ltifiltrittes congestion (ago"&[) focal milgregntre of tlvenlar mncrq)loliarem lleart focal Interstitial lymploold liefiltrioter myot-ardium focal iiet!runis of moikotiticlpnr cell litfiltratpm, myop.,.,oIrtelm Acirts Ninety Day soil.ai,*iRlaitf,'romicity Stoidy. tiotompriiitolugiOcbtiervatlc)eovi. tu 0 (:%)IrItIif cn -n n -n n no o sn an " in in n wt tn tn in ei on m gn m m ri rt ri [)JIM x: r. Y* ir t. I. g. s@ s@ 300 ppm x )r r. )r )r p.. w s@ C4 ri .4 @ %a @ co a, 0 r4 co -0 go CO a co co GO a@ o@ tn in in in in v% on tn in b-i es rI r, m dn en en en #n fn C4 fn @& wi @D - cc a@ 0 f a@ a@ ol a, ol 0% a. o@ 0 0 wt we in in on tn inwe w %o in on en in on in In fn 2 2 22 22 x x xx x 2 - ---- --- I I 22 3 2 x x x xx 2 2 2 2 2 32 x x nx 32 2 2 2 2 1 '1 2 2 2 2 2 22 3 434 2 2 2 3 2 2 12 1 2 2 2 2 2 22 3 3 2 2 23 2 22 2 42 22 2 22 32 2 2 2 2 3 2 2 2 222 2 2 22 3 2 2 2 1 22 22 2 2 2 232 22 2 2 2 2 II IIIII 2 rot avilllijille I - No-t remarkalite 2 - Very militlit 'I- 811RIel 6 Mcitiprnte morkell 1:,xto,,tsi- Floutfie,lF limpe-epi-lipIicma I F(:-I Is1. I'Aill-K 18. (:tjoit 'I'latilbot ve r foi-alperiportat and sinsisoldal lympleold lliflli,rllteu fiscalpart&[ and iiintimoldatextramedool- loorylie*mitili4ilemin focal cyloillefgmic I lisid) vai:iiolntfitoi (lort@l)mlily fot:alralinisililrlilrooln focal alietiouldittiillutdiluti (at-a[liulsatocc-lltolldorypertropity wooltifot:al lii-ilatace I Isitar hypertropliy lii!patiic.eitiolarnecrosis lii4-rensed yellowlelt-lit-ar.4itplamesit Is% I-yiiiitiioflIm)( lot-lositiol-yieHsold 401@ensitist- silly III littiolsCelle allousoiclial cuismentioii. diffaine K I ifiley fiscal Interstitial lty.fitilipplitoolm tyalilautifitifillratep itilitiliairielilittiols yelliiwipaii-I)rowiipigopett III CYt4ll)lagM Of iii.sx1mil 4-.1livillistif!otlll.lile.9 liroli-iiiai!#tiviiitoilitilarcant@ oloid!riillzpiimler(sciviscretioies lot tioloislen lit-iiiaryhindolitr sidtottellool G@llems joliog In lssocii fiscal atilimiaro)oiiliyr4ilKilallst(lieratitm 1'eal PH Iiii,al tpntlciolnr dierpoirratlilit 4)vnry loot-iiilitte!rgtlliil lyoolili4silttiiffilritirs lsysilito-@l1-;i HilFif-lit I Nitioty [)MY Stilkill-liMtiest Toixtrity Stoicly. litattlook)rlllioloOpllpe"ervitsli@ion. . ......I.(.H) 30 o@m 7: 1' )E; )V.1-. 14 $-. 1. 1., :I:@l:r. I. 1. 1. 1. W V. )r r. Y. r. I. 0. I. $-.g@ )r @l In .4 n @o t. 00 m 0 -4 ri n n n in -n -,I-o -o In n In-n -n on n n " in -4 on @o r- OD a, 0 @f 00 co co to go go co w 0 94 In In @l on t-I n m in on -n -n -n vt n in -n n n wt in in n n in m qq m eq in m n a,. n wi vi *.1. wt vi 0. Vi wi 10 a a 0 a In en r.%ri n ri in ri en 322 122 2 1 2 22 22 2 2 2 2 2 2 22 2 22 2 2 2 22 2 1 22 22 2 2 2 2323 3 2 222 2 2 22 I 2 22 2 2 2 2 2 2 I III IIII I 2 2 12 2 3 22 2 2 II I t I 2 22 22 22 2 22 13 2 2 22 22 2 3 2 2 3 2 II IIII ItI I II I 2 x x II III IIII I I IIt I IIII I IIII 22 2 III It x i:t.li.ilfliiii Ivitilill,li- I II II II I 2 II IIIII II 2 I Ntit rewnrNAlife. 4 fiti4leriet 2 Very fillkilt 5 Hzlrkp.l Slikill 6 VIONI$.$IFIIoIpt i)f-lIiceawI -'I'A I.r IN . -- ----- 1.4!n1itit liewimitlclriikiligmelit lei red 1111111 H4!R4*11foric I.YolillNlide f(p(!Malggr$!Rilteonf sillioIl'll(Il$mascro- ilitaxele ftii!nlufiiiimaidiii dtintalfoioe TiIV allin Mirri)w (slerililm) S;eifvnry Clanil .9tooncle stilinisconni u4icon lot itintidislar portioes blevoinal lyujilinid Infiltrates In Itlandislor III foreotovmi#-Ii (isoli- Smnll I.nrgo tntestiove (Colost) tiewatiocie I)artonite too lsiorit ----------- fili,allieterat11 fol lyol)liiilillit(Ittrates lqot-niryitipindmic voi:okplatltvipOil eiritior it )),IySill.ill:litHeilt 1*4)xlf,ftyStio.ly. r(i1 100 1:)r r. -3 n a $, CO 0 sd ini--nn-,ri-.n,,rotn-wn,-wn, -tnn-onno II I I M M M fn e4 m 't -n ID t- 4.00010 1 rm4 omn 04,-Cn.%ma 1m, 00. a, 4 #nI w#nt -eln In Ienn Len'tn 4enn Ifnn &n Wi bl n on wIen -n n -n 0a en em, m 1 11 11 1 2 2 322 32 22 32 3 2 22 tI t 2 2 2 31 31 I t I I I I I I I I I I II t t II t I 2 2 2 I I I I I II I I I 2 22 I IIII III IIt IIII III 2 2 2 I @ll 4)R4) 114it ilvioll Noti rt?onrkielile 2 Very offil,,Ifl 3 %1 4 5 6 F.xi rt,mm- 7r It Croup, Rat No. Sax 2 553 m 73555 M 73556 m 73557 F 73558 731559 73560 r -356'@ 73582 -4 173583 .4 73584 '4 73585 73586 %1 73587 73588 73589 F 73590 r 173591 r 73592 m 73593 m 73594 1 173595 4 6 73596 173597 r 73598 r 73599 1 73600 F r 173601 F 73602 X 73603 M 736C)k .11 73605 "3606 -'1 ;cl 73607 F L- 173608 F 72' -3609 F 73610 T 73610 F