Document 2RxxLkQerxGkem1Bjkam7gV4R
AR226-2824
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International Research and Development Corporation
SPONSOR: E.I. duPont de Nemours and Company MATERIAL: - SUBJECT: Ninety-Day Feeding Study in the Rat.-
Development Corporation
Collaborators: R. H. Buller, Ph.D., Director of Pharmacology R. G. Geil, D.V.M., Director of Pathology
Date : November 30, 1965 SSoinpany Sanitized. Does not contain TSCA CB1
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Page 1
I. SYNOPSIS
In a 90-day feeding study, male and female albino rats were fed diets containing ^ H ^ t levels of 100, 500 or 2500 ppm. After 35 days of continuous'feeding, the 500 and 2500 ppm. dietary levels were increased to 1000 and 5000 ppm., respectively for the remainder of the study. After the prescribed 90-day period of com pound administration, representative animals were placed on a with drawal study.
All rats appeared essentially normal with respect to behavior and appearance throughout the study.
No adverse effect on body weight gain was found at any dietary level employed in this study, both in the active compound administra tion phase and in the withdrawal period.
Average total weekly food consumption measured in grams/rat/week
in those groups fed 100 and 500 - 1000 ppm.
the diet
compared favorably with the control rats throughout the study. At
the 2500 - 5000 ppm. dietary level, food consumption of the male
raps ranged from 1.1 to 8.7 per cent less than control male rats,
and food consumption of the female rats ranged from 5.2 to 16.4 per
cent less than the female control rats. These differences were first
noted in the 8th week for males and in the 4th week for females and
continued throughout the treatment period.
No meaningful differences in food consumption were reflected by the treated groups of rats in comparison to the control group on the basis pf grams of food consumed per day per kilogram of body weight.
No compound-related hematologic or biochemical changes were found
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i
at the 100 and 500 - 1000 ppm. dietary levels of
^ However,
slightly decreased values for erythrocyte counts, hematocrits and
hemoglobin concentrations were found for males and females at the
2500 - 5000 ppm. level, particularly at the terminal (90-day)
clinicopathology examination. Urinalyses were normal at all times.
Compound-related changes observed at the 90-day necropsy examina tion consisted of increased liver and kidney weight at the 1000 and 5000 ppm. dosage levels and pale yellowish livers in some male rats from the 500 - 1000 and 2500 - 5000 ppm. dosage levels. In histologic section, only livers from the 2500 - 5000 ppm. dosage level showed any change and this consisted of a slight hypertrophy of centrolobular hepatocytes. The increase in l^ver and kidney weights and centro lobular hepatocyte hypertrophy persisted with diminished magnitude through 21 days of compound withdrawal. Similar organ weight and histologic changes were observed at the 30 and 60-day interim sacri fices .
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Page 3 II. COMPOUND
The test compound was received from E. I. duPont de Nemours and Company, Wilmington, Delaware, on June 19, 1965. It was a brown amorphous solid in containers bearing the labe]
Haskell No. 4212."
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III. CLINICAL STUDIES: A. METHODS: 1. General Procedure: Eighty male (weighing from 45 to 64 grams) and eighty female (weighing from 47 to 63 grams) albino rats of the Charles River strain were used for this study. The rats were housed individually in cages suspended above the droppings in an air-conditioned room throughout the study and were fed a diet of Purina Laboratory Chow for rats ad libitum. Water also was available at all times. The animals were divided into one control group and three treated groups of 20 male and 20 female rats each. The rats in each sex group were selected so that the average body weight of each group was similar to that of the other groups of the same sex. 2. Compound Administration: incorporated into the standard powdered laboratory
diet of Purina Laboratory Chow and offered to the treated groups of rats ad libitum. The test diet was freshly prepared each week and the compound-in-diet levels mixed so that the rats received^[|^|^^at dietary levels of 100, 500, or 2500 ppm. In the sixth week of com pound administration those groups receiving 500 or 2500 ppm. were increased in concentration to dietary levels of 1000 or 5000 ppm., respectively. Those animals receiving 100 ppm. o f ^ m | ^ i n the diet continued to receive this level throughout the 13-week study period.
The control groups of rats received the powdered diet of Purina Laboratory Chow, but without
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Following 13 weeks of compound administration rats in all groups were sacrificed and subjected to necropsy examination with the exception'of certain selected animals from the control`group and from the treated groups at the 1000 and 5000 ppm. dietary levels which were continued on study in a compound withdrawal phase. The withdrawal phase of this study will: be reported in its entirety in a subsequent and separate report.
3. Observations: The control and test animals were observed daily for mortality,
alteration in general appearance and behavior, and signs of pharmaco dynamic and/or toxic effects.
Body weights, food consumption, and food efficiency values were recorded for each rat weekly throughout the study.
4. Laboratory Tests:
a . Hematology:
Hematologic examination consisted of erythrocyte counts,
1.
2T
total and differential leucocyte counts, hematocrits , and hemoglobin
concentrations. These studies were performed individually on 6 male
and 6 female rats randomly selected in the control and each test group
during the control period and again at 30, 60, and 90 days.
b . Urinalysis: Urine samples were obtained from the same animals at the
same time intervals used to obtain blood for hematology. Urinalysis
Coulter Particle Size Counter, Model A., Coulter Electronics,
2 590 W. 20th Street, Hialeah, Florida.
Miller, S., Microcapillary Method, Textbook of Clinical Pathology,
1960, Williams and Wilkins Company, Philadelphia, Pa., p. 43. 3
Miller, S., Cyanmethemoglobin Method, Textbook of Clinical Pathology,
1960, Williams and Wilkins Company, Philadelphia, Pa., p. 35.
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consisted of qualitative tests for g l u c o s e , b i l i r u b i n ^ , occult
b l o o d , a n d albumin,^'
measurements of volume,
and
specific gravity, and microscopic examination of the urinary sediments.
c. Biochemistry: Biochemical examinations were conducted at the same inter
vais as for hematology. Serum transaminase (SGOT and SGPT) . and' plasma alkaline phosphatase determinations^ were performed on 6 male
4 "Combistix" 5 "Clinistix" 6 "Clinitest"
(Ames Reagent Strips). (Ames Reagent Strips). (Ames Reagent Tablets).
7 "Ictotest"
(Ames Reagent Tablets).
8 "Heraastix"
(Ames Reagent Strips).
9 "Hematest"
(Ames Reagent Tablets).
10 "Occultest"
(Ames Reagent Tablets).
11 "Albustix"
(Ames Reagent Strips).
12 "Bumintest"
(Ames Reagent Tablets).
13 Heller's Ring Test, Practical Physiologic Chemistry, Hawk, Oser and
Summerson, 13th Ed., p. 830. 14 Beckman Expanded Scale pH Meter, Model No. 76.
15 Reitman, S., and Frankel, S., Colorimetric Method for the Determina tion of Serum Transaminase Activity, Am. J. of Clin. Path., 8: 56,
1957.
^ Marsh, W., Modified King-Armstrong Method, Clin. Chem. 5: 119, 1959.
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and 6 female rats randomly selected from the control and treated groups. The animals chosen for hematology values were not used for these bio chemical determinations.
B. RESULTS: 1. General Behavior and Appearance: No adverse changes in behavior or appearance were encountered
that could be related to the administration Animals in the control and all treated groups appeared essen
tially normal each day with the exception of an occasional rat in each group that exhibited slight nasal and/or ocular porphyrin discharge.
Other incidental findings, unrelated to compound administration, included one treated female animal (Rat #14374) at the 5000 ppm. dietary level which exhibited a swollen nose in the 13th week of study, one treated male (Rat #14298) at this dietary level which exhibited a mass on the flank from the 16th week (withdrawal period) until terminal necropsy examination, and one treated male (Rat #14324) at this same dietary level which exhibited destruction of the right eye, from the 15th week to the terminal (in the withdrawal period) necropsy examina tion.
2. Body Weights (Tables 1-8 and Figures 1 and 2): a. Control: The control animals maintained body weight curves which
were consistent with those curves exhibited by control animals of the same age and strain maintained in these laboratories from time-to-time.
b. 100 and 500 ppm.*: Male and female rats at these dietary levels maintained
body weights which paralleled closely those of their respective control groups. * 500 ppm. dietary level increased to 1000 ppm. in the 6th week of study.
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i Page 8
I j
c . 2500 ppm.** :
No marked body weight changes occurred among male and female
rats at this dietary level during the course of compound administration.
Male animals in the 9th week exhibited a body weight gain 8.8 per"cent
less than control males. This difference in body weight gain persisted
for the duration of the study period. During the withdrawal phase of
this study the greatest decrease in body weight gain occurred. Even
then, however, this difference was only about.10 per cent less than that of
the male control animals.
Female treated animals in this group in the 7th week of study exhibited a weight gain which was 11.5 per cent less than that of the control female animals. This difference in body weight gain per sisted for the duration of the treatment period. The greatest differ ence in body weight gain of the female group was noted in the 12th week of study at which time a difference of only 11.7 per cent occurred.
3. Food Consumption (Tables 10 and 11): a. Grams/Rat/Week: Average total weekly food consumption for male and female
rats in those groups receiving 100 ppm. and 500 ppm.* compared favorably with similar measurements obtained from the control group.
Treated rats receiving 2500 ppm.** showed food consumption values less than those of control animals beginning in the 4th week for treated females and in the 8th week for treated males. This decrease in food consumption continued throughout the study period and ranged from 1.1 to 8.7 per cent for the males and 5.2 to 16.4 per cent for the females in this group. The decreased food consumption in this
* 500 ppm. dietary level increased to 1000 ppm. in the 6th week of study. ** 2500 ppm. dietary level increased to 5000 ppm. in the 6th week of study.
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Page 9
group continued in both sexes for the duration of the treatment period.
b. Grams/Kg,/Day:
-
No biologically meaningful differences were observed on
food consumption in the treated groups of rats when compared with the
control group on a basis of grams/kg./day food consumed.
4. Survival (Table 9):
Other than for those animals subjected to interim necropsy
examination at 30 and 60 days, all control and treated animals survived
the course of study with two exceptions. One control female (Rat
S) #14160) succumbed in the terminal (13th) week of study and one treated
male (Rat #14212) at the 100 ppm. level of
succumbed in the
11th week of study.
5. Laboratory Tests:
a. Hematology:
No compound-related hematologic changes were found at the
100 and 500 ppm. dietary levels
At the 2500 ppm. level,
group values for both sexes, with respect to erythrocyte count, hema
tocrit and hemoglobin concentration, generally were slightly lower
than those for the control animals and rats at the 100 and 500 ppm.
dietary levels of
though some changes in these parameters
were seen at the 60-day interval of examination, they were overall more
pronounced after 90 days of compound administration. It is of interest
that inspection of these values for individual rats in the high dietary
level groups failed to reveal marked changes for any given animal, that
is, whereby that animal's value would tend to markedly lower the group
average, but rather that lower values, with a relatively small spread
from individual to individual, were found for most of these rats.
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Group average values are summarized for male rats in Table
12 and for female rats in Table 13. Individual values for all male and
female rats appear in Tables 14 through 17.
.
b. Plasma Biochemistry: No compound-related changes were found at any period of
examination with respect to serum alkaline phosphatase activity or serum glutamic pyruvic transaminase (SGPT) or serum glutamic oxalacetic transaminase (SGOT) activities.
Values obtained in these studies appear in Tables 18 through 21.
c. Urinalysis : Urinalysis examinations failed to reveal changes which were
considered to be related to treatment with the test compound. Results of these measurements appear in Tables 22 through 25.
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IV. PATHOLOGICAL STUDIES A. METHODS: 1. Gross Examination: After 30 and 60 days of compound administration, 3 male and 3 female rats from the control and each treated group were sacri ficed by exsanguination and subjected to necropsy examination. After 90 days of compound administration, 10 male and 10 female rats from the control, 1000, and 5000 ppm. dietary level groups and all surviving rats from the 100 ppm. group were sacrificed by exsanguina tion and subjected to necropsy examination. Three male and 3 female rats from the control, 1000 and 5000 ppm. groups were sacrificed and subjected to necropsy examination after a 21-day compound withdrawal
. period. (Other rats that remained on withdrawal beyond 21 days will be reported on in a separate report.) At necropsy major organs were weighed and representative tissues from each rat were collected into 10 per cent neutral buffered formalin for subsequent histologic processing. At the 90-day sacrifice, specimens of brain, liver, kidneys, muscle, fat, spleen, testes and blood were pooled by sex and diet^jry group, frozen and forwarded to the sponsor. Specimens of liver from the interim and withdrawal sacrifice were also pooled by sex and dietary group, frozen and shipped to the sponsor. Rats which died on study were also subjected to necropsy examination unless this was precluded by advanced autolysis. 2 \ Microscopic Examination: The following tissues from each of 3 male and 3 female rats from the control and high dosage groups from the 30 and 60-day interim and 21-day withdrawal sacrifices and from each of 10 male and 10
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Page 12
female control and high dietary group rats from the 90-day terminal sacrifice were paraffin-embedded, sectioned, stained with hematoxylin and' eosin and examined microscopically:
brain spinal cord peripheral nerve
eye pituitary thyroid parathyroid adrenal lung
heart spleen lymph node thymus bone marrow salivary gland stomach small intestine large intestine
pancreas liver kidneys urinary bladder testes or ovaries prostate or uterus skeletal muscle skin bone
Sections of liver from 10 male and 10 female rats from the 1000 ppm. level - 90-day sacrifice rats were also processed as above and examined.
B. RESULTS:
`
1. Gross Pathology (Table 26) and Organ Weights (Tables 2.7 and 28):
Compound related gross changes observed at necropsy were
limited to male rats from the 1000 and 5000 ppm. dietary level groups
and consisted of pale, yellowish livers in some but not all male
rats from the 5000 ppm. dietary level group and in a few rats from
the 1000 ppm. dietary level group.
None of the rats dying on study died of compound related causes. Rat #14160 (Control) died of pneumonia. Autolysis precluded diagnostic necropsy of Rat #14212 (100 ppm.).
Compound related variations in organ weights were limited to the livers and kidneys of treated rats. At the 90-day sacrifice there was a moderate increase in actual and relative liver weights of the 1000 and 5000 ppm. dietary level rats. This increase was also seen in the 5000 ppm. dietary level rats at the 60-day interim
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sacrifice and in the 2500 ppm. dietary level rats at the 30-day interim sacrifice. After 21 days of compound withdrawal, a slrght increase in*liver weight persisted at the 5000 ppm. dietary level. -
Mean actual and relative kidney weights were slightly^m the 1000 and 5000 ppm. dietary level rats at the 90-day sacrifice. Kidney weights were also slightly increased in the 1000 and 5000 ppm. level rats at the 60-day interim sacrifice and 21-day withdrawal sacrifice and in the 500 and 2500 ppm. level at the 30-day interim sacrifice. Although the values from the interim and withdrawal sacrifices represent only 3 rats per sex group, these variations in kidney weights always had a dietary-level relationship.
2. Histopathology (Tables 29 and 30): Compound related histopathologic changes were found only in
the livers of rats from the highest (2500-5000 ppm.) dietary level and consisted of slight hypertrophy of centrolobular hepatocytes. Affected liver cells had cytoplasm which was less coarsely granular and more homogeneous than the unaffected cells at the periphery of the liver lobules and in the livers of rats in the control and lower dietary levels. This change, to a slight degree was seen after 30 days at the 2500 ppm. level. After this group was raised to 5000 ppm., the change was more marked at the 60 and 90-day sacrifices. A very slight change persisted in the 5000 ppm. level male rats sacrificed after a 21-day compound withdrawal period. This liver change was always more marked in male rats and was seen only at the highest (2500-5000 ppm.) dietary level.
No lesions in other organs were considered to have been of compound related origin. No histologic basis was found for the slight increase in kidney weights in treated rats.
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Ninety-Day Feeding Study in the Rat.
t~ / 0 - r 9 a - 'T"
14142 14143 14144 14145 14146 14147 14148 14149 14150 14151 14152 14153 14154 14155 14156 14157 14158 14159 14160 14161
Me an
55 93 54 68 56 99 56 83 56 94 55 91 57 88 60 101: 55 72 58 83 56 67 50 52 57 63 57 71 51 67 58 64 57 73 58 54 50 76 54 48
55 75
129 95
134 107 136 123 124 135 103 116 114
93 82 116 115 105 106 99 124 91
149 175 123 136 163 187 130 142 161 184 141 160 149 170 162 177 126 149 137 158 133 154
122 138
117 141 142 160 139 161
121 134
132 153 146 156
147 162 128 148
185 144 207 159 196 179 178 199 164 181 171 143 156 170 161 154 149 181 157 144
195 155 249 166. 217 184 197 215 191 189 189 166 172 192 196 153 172 199 189 178
Sacrificed
169 191
260 285
Sacrificed
Sacrificed 191 231 214 249 230 261 213 243 202 237 203 235 183 231 195 237 203 239 210 243 166 165 190 232 219 240 206 221 192 231
198 296
218 241 265 243 224 226 207 225 223 241 174 244 232 215 214
Sacrificed 306 314
221 236 252 268 Sacrificed 252 271 224 234 Sacrificed 216 248 233 246 244 258 250 261 178 185 215 236 250 264 239 256 226 236
112 138 157 169 188 203 234 229 236 251
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O0Q>
TABLE 1.
Rat Number
Ninety*Day Feeding Study in the Rat. Continued. Individual Weekly Body Weights, Grams.
1i
--------- -- -- _ ..........Compound Administration Weeks LjL 1J 14* 15 16 17 18
Control - Female :
14144
14147 14148 14150 14151 14153 14154 14155 14156 14157 14158 14159 14160 14161 14313
320 326 332
244 252 332
271 285 267
285 288 233
241 251 242
260 248 244
256 263 241
265 271 238
275 283 259
200 200 191
245 277 265
253 281 271
231 282 Died
250 289
264 299
266 310
Sacrificed Sacrificed
241 251 257 261 268 276 Sacrificed 242 249 251 256 255
Mean
260 266 258 261 270 276 256 255
Initiation of withdrawal period (14th week),
19
254 254
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Ninety-Day Feeding Study in the Rat
TABLE 2.
Individual Weekly Body Weight s, Grams.
Rat Number
Control Period
12
12
Control - Male:
14162 14163 14164 14165 14166 14167 14168 14169 14170 14171 14172 14173 14174 14175 14176 14177 14178 14179 14180 14181
64 62 60 59 55 50 61 45 58 51 60 52 51 54 57 54 62 52 53 55
99 97 100 94 92 67 98 74 95 83 83 55 64 76 76 71 64 66 67 67
143 185 151 207
89 169 157 214 133 175 103 145 147 189 113 143 136 185 119 158 152 205 105 153 113 155 137 185 136 180 123 167 117 153
130 181
120 172
128 177
Mean
55 79
128 175
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* '
Compound Administration Weeks 3 4 5 6 7 8 9 10
230 244 263 Sacrificed
256 229 251
294 288 309
309 324 346
338 354 366 388
Sacrificed
388 446
402 461
412 480
211 248 274 300 321 344 360 37 0 187 231 260. 290 311 308 Sacrificed 243 276 308 Sacrificed
224 231 191
274 265 260
307 285 257
337 317 287
365 348 310
39.5 413
433
380 Sacr ificed
349 364 390
263 307 300 336 371 417 441 467
199 242 263 291 306 334 346 370
204 238 273 318 341 373 382 412
234 222
251 264
293 294
317 328
370 354
422 390
449 393
469 420
209 241 271 300 318 336 341 358
200 '234 250 283 311 340 Sacrificed
231 238 261 322 347 380 395 420
224 272 300 334 360 388 398 423
234 241 300 344 373 401 409 441
224 261 287 318 344 376 397 420
O0Q3 fO ON
Ninety-Day Feeding Study in the Rat.
TABLE 2.
Rat Number
Continued. Individual Weekly Body Weights, Grams.
Compound Administration Weeks 11 12 13 14* 15 16 17 18
Control - Male :
14163 14164 14166 14169 14171 14172 14173 14174 14175 14176
14177 14179 14180 14181 14314 14315
406 391 375 505 505 495 398 409 383 446 453 431 412 423 385 488 483 478
389 405 376 427 440 401 498 496 506 442 452 425
365 374 357 396 402 414 Sacrificed 435 455 461 479 489 500 Sacrificed 415 463 461 489 472 514 Sacrificed 451 463 472 476 466 497 506 515
538 518 556 574 571 512 503 523 539 544
Mean
434 444 429 482 475 501 540 543
* Initiation of withdrawal period (I4th week).
19
522 585 559 555
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TSCA cp
Page 17
Ninety-Day Feeding Study in the Rat.
TABLE 3.
Individual Weekly Body Weight, Grams.
Rat Number
Control Period 12
12
Compound Administration Week? 3 4 5 6 7 8 9 10
100 ppm. - Female:
14182 14183 14184 14185 14186 14187 14188 14189 14190 14191 14192 14193 14194 14195 14196 14197 14198 14199 14200 14201
56 86 51 77 59 82 55 87 57 101
55 76 55 80 55 63 55 88 53 84 54 60 53 67 61 73 59 69 57 65 50 58 62 76 51 60 53 70 59 65.
112 131 151 167 175
Sacrificed
123 113 110
153 171 126 145 135 154
203 165 174
210 182 186
231 250 194 211
Sacrificed
262 218
273 285 Sacrificed
144 109 111
176 210 134 155 124 139
252 175 149
251 194, 162
275 290 206 230
Sacrificed
303 245
307 252
331 269
91 116 122 106 113 .90 107 105 .98 123 102 123 115
119 150 137 154 153 177 127 141 141 158 124 148 133 157 147 159 121 146
141 167 125 141 147 165 152 179
168 176 187 172 181 160 175 179 157 195 144 184 183
177 180 208 174 199 179 190 183 179 202 180 197 208
198 200 223 185 210 203 211 199 197 220 197 212 235
216 211 241 193 222 221 231 213 207 237 215 224 245
230 225 258 207 238 234 245 227 227 253 236 244 263
245 257 225 242 269 286 215 234 Sacrificed Sacrificed 243 ' 265 236 267 238 258 259 270 241 256 246 264 271 275
Mean
56 74
112 137 158 177 191 212 227 242 251 269
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TJ o ce
Ninety-Day Feeding Study in the Rat.
14183 14186 14187 14189 14190 14191 14192 14195 14196 14197 14198 14199 14200 14201
Mean
290 306 283 3'45 353 333 271 285 258 272 274 252 248 255 227 287 303 283 236 248 221 280 286 261 277 276 247 251 262 244 283 296 278261 269 273 273 278 285 298 301 308
277 285 268
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Ninety-Day Feeding Study in the Rat
TABLE 4.
Individual Weekly Body Weight, Grams
Rat Number
Control Period 12
100 ppm. - Male:
14202 14203 14204 14205 14206 14207 14208 14209 14210 14211 14212 14213 14214 14215 14216 14217 14218 14219 14220 14221
58 51 62 55 63 54 55 55 60 54 50 53 61 63 53 49 58 55 61 60
Mean
57
79 76 87 86 103 85 81 88 86 87 60 81 83 83 70 58 64 73 68 74
79
1
119 168 116 157 149 203 139 189 160 215 124 165 120 159 128 166 142 197 134 173 108 122 116 161 149 205 136 171 126 164
97 135 100 142 121 155 110 136 135 176
127 168
________ Compound Administration Weeks 3 4- 5 6 7
214
246
:270'
Sacrificed
201 224 261 296 328
256
310
343..'
371
407
242 275 286 Sacrificed
255 298 320 346 373
209
248
282,
306
338
199 211 228 Sacrificed
209 244 254 269 301
252 303 330 354 388
217 251 284 312 339
130 168 211 250 256
195 238 243 271 290
267 284 326 352 377
210 250 259 267 289
217 271 308 247 377
168 186 219 260 286
199 247 286 330 369
207 216 275 310 333
196 213 264 287 307
227 255 281 308 331
214 252 277 308 335
8
356 448
403 363
327 398 369 296 305 399 320 407 316 398 358 329 357
362
9 10
376 400 467 495
405 434 378 402
347 372 417 454 385 410 317 300 308 335 407 441 349 375 420 457 Sacri ficed 321 454 364 393 Sacrificed Sacrificed
376 409
igRifed: Bees net contain TSC CBf
Ninety-Day Feeding Study in the Rat.
TABLE 4. Continued.
Rat 11
100 ppm. - Male:
14203 14204 14206 14207 14209 14210 14211 14212 14213 14214 14215 14216 14218 14219
411 521 450 423 385 462 432
Died 353 446 385 482 473 406
Individual Weekly Body Weight, Grams.
Compoiand Administration Weeks 12 13 14 15 16 17
440 427 527 515 468 432 436 410 398 363 477 481 456 432
368 348 456 448 405 383 501 500 496 507 421 430
Mean
433 450
437
18 19
*
Wffeetf Dna Does
tsca CBl
Page 21
Ninety-Day Feeding Study in the Rat
TABLE 5.
Individual Weekly Body Weight, Grams.
Rat Number
Control Period 12
123
500 ppm. - Female:*
1.4222 14223 14224 14225 14226 14227 14228 14229 14230 14231 14232 14233 14234 14235 14236 14237 14238 14239 14240 14241
55 60 58 48 57 57 55 55 55 52 50 52 59 58 56 52 50 57 55 55
88 83 92 59 73 92 86 78 90 76
57 64 73 68 76 52 77 74 75 72
126 153 116 134 111 127 '91 115 115 140 130 157 130 154 113 140 119 134 114 153 100 134 105 125 110 129 119 148 117 150
86 123 119 150 129 146
117 138 100 128
177 154 141 136 161 178 166 160 147 184 147 130 140 175 171 145 171 163 154 144
Mean
55 75
113 139
157
Compound Administration Weeks 4 567
8
190 204
Sacrificed
172 181 195 202 213
163 185 200 212 238
141 154
Sacrificed
182 188 204 215 223
201 210 .. 230
244 256
178 197
Sacrificed
174 184 202 215 237
158 175 190 202 215
195 219 237 254 272
174 186 204 216 234
148 160 170 181 191
140 164 176 187 195
201 214 255 249 266
193 213 216 236 242
146 168 188 200 212
195 199 211 222 227
183 198 206 221 234
157 188 197 214 224
143 180 188 200 206
172 188 204 216 229
9 10
Sacrificed 273 260
235 247 264 276
254 261 Sacrificed 287 303 241 253 201 204 Sacrificed 279 297 248 263 221 223 236 243 242 253 230 245 216 236
243 255
Dosage level increased in the 5th week of study to 1000 ppm. Company Sanitized. Does not contain TSCA CBS
nPid
TABLE 5.
Ninety-Day Feeding Study in the Rat.
_500 ppm, - Femaie
14224 14226 14227 14229 14231 14232 14233 14235 14236 14237 14238 14239 14240 14241 14306 14308 14320
Mean
267 279 263
246 257 239
244 282 269
265 277 270
310 314 268
255 269 251
212 216 207
304 312 299
262 272 254
232 244 234
253 259 256 235
256 266 263 245
242 261 259 246
263 262 274 254
276 272 278 269
278 279 280 267
Sacrificed Sacrificed
Sacrificed 269 282
276
254 266 270 272 284 284
249 258 266 265 273 283
234 236 241 246 250 253
257 268 254 256 265 269 263 272 274
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Ninety-Day Feeding Study in the Rat.
TABLE. 6.
Individual Weekly Body Weight, Grams.
Rat Number
Control Period 12
500 ppm.
-
* Male:
'
14242
1424.3 14244 14245 L4246 14247 14248 14249 14250 14251 14252 14253 14254 14255 14256 14257 14258 14259 142 60 14261
58 85 57 92 56 78 63 96 56 63 58 72 55 83 62 90 58 85 52 75 63 89 62 78
55 75 57 70 55 67 53 81 56 98 52 63 58 69 59 79
124 155 185 136 178 226 134 196 249 136 172 213
91 133 172 120 162 209 114 149 183 134 176 224 130 192 236 124 165 207 147 195 249 144 189 230
134 187 235 123 162 188 102 140 182 117 154 192
151 189 235 105 145 191
124 169 220
151 203 271
Mean
57 79
127 170 215
Compound Administration Weeks 67
201 228 269 297 295 314 251 265 210 234 266 305 208 234 270 291 276 300 239 272 293 321 238 299 258 297 221 250 221 258 219 268 285 328 225 249 229 289 285 324
248 281
Sacrificed 325 351 371 412 Sacrificed 268 292 342 365 Sacrificed 325 356 321 334 297 328 355 326 327 355 317 348 281 306 280 300 306 339 359 385 274 303 324 352 377 408
321 345
* Dosage level increased in the 5th week of study to 1000 ppm.
8
374 443
320 386
381 359 357 391 379 381 329 328 369 412 330 372 436
373
9 10
387 410 465 485
Sacrificed 407 430
378 415 379 397 Sacrificed 399 445 Sacrificed 396 423 345 368 334 351 365 390 425 453 346 372 385 398 446 467
390 415
Sanitized. Does not contain t s c a c b i
Company
h3 0(0I
TABLE 6.
Rat Number
Ninety-Bay Feeding Study in the Rat. Continued. Individual Weekly Body Weights, Grams.
500 ppm. ~ Male:
14243 14244 14247 14249 14250 14252 14254 14255 14256 14257 14258 14259 14260 14261 14321 14322 14325
445 435 422
509 525 499
449 471 447
434 451 441
412 431 411
453 463 434
452 437 428
382 396 380
369 377 348
408 415 390
478 384 400 500
499 404 417 520
477 419 434 548
517 435 452 568
496 446 458 542
545 465 476 563
507 487 532
516 497 531
549 525 562
Mean
434 446 434 506 493 525
Initiation of withdrawal period (14th week).
S a c r ific e d S a c r ific e d S a c r ific e d 582 612 538 559 545 550 569 586
559 577
632 544 549 577
576
Company Sanitized. Does not contain TSCACBI
Ninety-Day Feeding Study in the Rat.
TABLE 7.
Individual Weekly Body Weights, Grams.
kat Number
Control Period 12
___________________
12
3
* 2500 ppm . - Female
14262 14263 14264 14265 14266 14267 14268 14269 14270 14271 14272 14273 14274 14275 14276 14277 14278 14279 14280 14281
52 53 53 55 50 55 63 56 56 60 58 51 47 57 52 52 47 61 56 53
87 79 71 72 63 76 85 86 85 95 74 66 61 75 63 66 55 76 75 66
120 119 107 104
78 113 114 115 116 134 117 116
99
122 107 106
85 123 126 108
138 145 124 127 109 134 132 130 136 161 134 140 133 144 135 134 115 144 154 132
164 166 140 143 133, 147 137 148 151 180 148 161 151 168 148 152 141 160 178 146
Mean
55 75
113 136
154
Compound Administration. Weeks 4567
174 182 149 154 153 163 135 163 161 187 158 169 171 174 162 151 149 155 173 142
161
181* 200 160 165 171 175 158 173 171 212 173 185 182 198 179 168 174 185 204 171
179
Sacrificed 230 246 169 180 Sacrificed 181 195 188 202 Sacrificed 182 192 174 184 225 240 186 193 197 202 195 206 207 222 191 209 188 196 189 198 206 211 221 233 180 189
196 207
* Dosage level increased in the 5th week of study to 5000 ppm.
8
264 195
208 216
200 193 246 200 210 219 233 226 208 216 222 244 193
218
9 10
Sacrificed 194 207
222 228 . 223 232
202 216 Sacrificed 256 260 207 213 220 226 215 225 Sacrificed 231 243 205 223 221 230 230 236 256 265 207 207
221 229
Company Sanitized. Does not c o p ^ n T S C A C J I
N5 G>
14264 14266 14267 14269 14271 14272 14273 14274 14276 14277 14278 14279 14280 14281 14311 14326 14329
Mean*
205 216 201
226 228 213
234 244 213
214 217 208
261 264 244
207 210 204
226 233 223
226 218 212
262 260 263
228 232 212
229 236 274 214
241 239 276 216
231 237 276 218
249 257 278 222
259 254 284 239
270 269 285 245
Sacrificed Sacrificed Sacrificed 252 258
257
233 246 253 260 278 278
233 236 239 246 258 261
198 202 209 207 220 218
232 235 225 239 246 253 241 254 254
* Initiation of withdrawal period. (14th week)
Page 27
Company Sanitized. Does not contain TSCA CBI
Ninety-Day Feeding Study in the Rat.
TABLE 8.
Individual Weekly Body Weights, Grams.
Rat Number
Control Period 12
1
2
3
4
tia ulull WfcifciK.0 567
8
9
10
* 2500 ppm. - lale
14282 14283
14284 14285 14286 14287 14288 14289 14290 14291 14292 14293 14294 14295 14296 14297 14298 14299 14300 14301
60 80
53 84
55 76 55 84
52 65 55 84
46 71 60 98 56 84 57 60 52 69 57 82 58 82 64 92 61 84
58 75 52 82 63 89 55 78
52 76
117 141 184 225 246 Sacrificed 124 151 193 237 268 299 321 343 354 374 129 182 219 277 310 351 382 416 440 454 133 178 226 260 283 Sacrificed
92 125 147 173 203 222 245 270 291 302 133 181 227 262 289 308 332 357 371 388 193 171 227 265 274 Sacrificed
151 194 249 298 322 373 404 437 Sacrificed 125 154 193 234 275 314 335 366 387 399 107 163 206 228 271 306 332 354 370 381
72 104 138 181 203 239 273 297 315 334 143 184 228 261 285 312 339 364 Sacrificed 133 165 207 231 266 291 315 337 339 355 149 189 228 265 294 341 378 416 Sacrificed 144 189 .231. . 272 295 321 345 363 365 385 133 196 247 281 323 363 396 385 422 446 107 140 178 214 236 258 284 306 312 331 143 190 241 290 325 351 378 406 411 435 114 135 197 215 272 303 325 342 345 370 132 169 205 240 271 292 312 332 345 370
Mean
56 80
129 165 209 245 276 308 335 358 362 380
increased in the 5th week of study to 5000 ppm.
Company Sanitized. Does not contain TSCA CBt
Ninety-Day Feeding Study in the Rat.
TABLE 8. Continued. Individual Weekly Body Weights, Grams.
Rat Number
11
12
13
Compound Administration Weeks 14* 15 16 17 18
25U DDTTl. - Male :
14283 14284 14286 14287 14290 14291 14292 14294 14296 14297 14298 14299 14300 14301 14327 14328 14324
Mean
394 410 393
478 507 497
318 328 316
400 414 401
415 425 413
401 410 385
344 373 357
367 388 364
405 418 412
468 480 456
349 465 327 341 339 342 Sacrificed
453 381 382
463 395 398
476 407 414
472 416 431
473 429 447
512 442 448
Sacrificed Sacrificed 466 486
362 377 390 497 427
492 500 517 537 550
461 478 489 500 516
397 420 401 425 435 449 500 495
* Initiation of withdrawal period. (14th week)
19
508 433 556 531 507
Page 29
Company Sanitized. Does not contain TSCACB3
FIGURE 1. Group Mean Body Weights. Female Rats 500 S3 Control
450 O 100 ppm.
400 350 --
A 500 ppm. - 1000 ppm.
o 2500 ppm. - 5000 ppm.
300
250
200 -
150 -
100 _ 50
(
<
o oA A fi A
o'
c
0 1 ___ 1
00
1
1 ___ 1_ 23
1 4
J------- J --------- 1--------- 1______ I______ 1 I I I I I______ L J 7 8 9 10 11 12 13 14 15 16 17 18 u
COMPOUND ADMINISTRATION WEEKS Company Sanitized. Does not contain TSCA CBi
^I OQ
> fl)
FIGURE 2. Group Mean Body Weights. Male Rats Company Sanitized. Does not contain TSCA CBI
A C
__ I 19
Ninety-Day Feeding Study in the Rat.
LE 9.
Mean Body Weights, Grams; Weight Ranges, Grams; and Survival:
impound Sminisation feeks
Mean Body Wt.
Control
Weight Ranges
Survival
Mean Body Wt.
100 ppm.
Weight Ranges
Survival
Mean Body Wt.
FEMALE RATS
500 ppm.*
Weight Ranges
Survival
Mean Body Wt.
**
Weight Ranges
Survival
0 55 50-60 20/20 56 51-62 20/20 55 48-60 20/20 55 47-63 20/20
0
75
48-101
20/20
74
58-101
20/20
75
52-92
20/20
75
55-95
20/20
1 112
82-136 20/20 112 .91-144 20/20 113
86-130
20/20
113
78-134
20/20
2 138 117-163 20/20 137 119-176 20/20 139 115-157 20/20 136 109-161 20/20
3 157 134-187 20/20 158 139-210 20/20 157 130-184 20/20 154 133-180 20/20
4 169 143-207 20/20 177 144-252 20/20 172 140-201 20/20 161 135-187 20/20
5 188 153-249 17/20 191 174-251 17/20 188 154-219 17/20 179 160-212 17/20
6 203 166-260 17/20 212 185-275 17/20 204 170-237 17/20 196 169-230 17/20
7 234 165-285 17/20 227 193-290 17/20 216 181-254 17/20 207 180-246 17/20
8 229 174-296 17/20 242 207-303 17/20 229 191-272 17/20 218 193-264 17/20
9 236 178-306 14/20 251 215-307 14/20 243 201-287 14/20 221 194-256 14/20
10 251 135-314 14/20 269 234-331 14/20 255 204-303 14/20 229 207-265 14/20
11 260 230-320 14/20 277 236-345 14/20 257 212-310 14/20 232 207-274 14/20
12 266 230-326 14/20 285 248-353 14/20 268 216-314 14/20 235 210-276 14/20
13 258 191-332 13/20 268 221-333 14/20 254 207-299 14/20 225 201-276 14/20
14 267 250-289 3/20
0/20 259 249-274
6/22 248 222-278
5/22
15 277 254-299 3/20
270 258-278
6/22 256 239-284
5/22
16 284 256-310 3/20
273 266-280
6/22 264 253-285
5/22
17 0/20
269 265-272
3/22 256 252-260
2/22
18
280 273-284
3/22 268 258-278
2/22
19
281 276-284
3/22 243 228-257
2/22
awai period was initiated following 13-weeks of compound administration. Selected animals were continued into
the Perid o_ withdrawal which continues at the writing of this report.
f'Dosage level in this group increased to 1000 ppm. in the 5th week of studgompany Sanitized. Does not contain TSCA CB1
aiot)
Jj^osage level in this group increased to 5000 ppm, ih the 5th week of study,
LO
N
iinety-Day Feeding Study in the Rat.
lBLE
impound Iminisation ieeks
Mean Body Wt.
Control
Weight Ranges
Survival
s, Grams ; Weight Ranges, Grams ; and Survival: MALE RATS.
Mean Body Wt.
100 DDI.
Weight Ranges
Survival
Mean Body Wt.
500 DDm *
Weight Ranges
Survival
0 55 45-64 20/20 57 49-63 20/20 58 52-63
0
79
55-100
20/20
79
58-103
20/20
80
63-98
1
128
89-157
20/20
127
97-160
20/20
127
91-151
2 175 143-214 20/20 168 122-215 20/20 169 125-203
3 224 187-263 20/20 214 130-267 20/20 215 172-271
4 261 231-309 20/20 252 168-310 20/20 248 201-293
5
287
250-346
17/20
277
211-343
17/20
281
234-324
6 318 283-366 17/20 308 250-371 17/20 321 268-377
7
344
306-388
17/20
335
256-407
17/20
345
292-412
8
376
308-446
17/20
362
296-448
17/20
373
320-443
9 397 341-461 14/20 376 317-467 14/20 390 334-465
10 420 358-480 14/20 409 300-495 14/20 415 351-485
11
434
365-505
14/20
429
353-521
13/20
434
369-509
12
444
374-505
14/20
446
368-527
13/20
446
377-525
13
429
357-506
14/20
437
363-515
13/20
434
348-548
14 447 242-538
7/23
0/20
472-
234-568
15 443 249-518
7/23
461 236-542
16 465 251-556
7/23
489 241-563
17 469 256-574 4/23
496 246-582
18 471 255-571 4/23
511 250-612
19 480 254-585 4/23
511 253-632
TE - W,,ith.drjawa-l `period wa,,s -in-i-t"iatwwev* i.uii.uwiuS j.j-wt;eK.5s ox compound administrati
period of withdrawal which continues at the writing of this report.
** nno!gS i`eVei ^ -3 s*oup lncreased to 1000 ppm. in the 5th week of study. '^ 86 level ln thls SrouP increased to 5000 ppm. in the 5th week of study.
20/20 20/20 20/20 20/20 20/20 20/20 17/20 17/20 17/20 17/20 14/20 14/20 14/20 14/20 14/20
8/24 8/24 8/24 5/24 5/24 5/24
Mean Body Wt.
56 80 129 165 209 245 276 308 335 358 362 380 397 420 401 378 387 399 394 410 418
.... 1
Weight Ranges
Survival
45-64 60-98 72-193 104-196 138-249 173-298 203-325 222-373 245-404 270-437 291-440 302-454 318-478 328-507 316-497 198-492 202-500 209-517 207-537 220-550 218-556
20/20 20/20 20/20 20/20 20/20 20/20 17/20 17/20 17/20 17/20 14/20 14/20 14/20 14/20 14/20
9/25 9/25 9/25 6/25 6/25 6/25 into th
0> o(oD
Sam1i2ea- D* - contain T S C A C B ,
TABLE 10.
Ninety-Day Feeding Study in the Rat.
FEMALE RATS:
Mean Food Consumption, Grams/Rat/Week and Grams/Kilogram/Day; Miligrams/Kiloerams/Dav and Fnnd
Compound Consumption as H uunsumpcion as
Compound
CONTROL
tration
FOOD
week g/r/wk g/kg/d
0
1 96.1 122.3 2 110.5 114.5 3 110.8 100.6 4 104.4 88.1 5 113.8 86.7 6 105.7 74.4 7 111.5 67.9 8 113.2 70.7 9 108.1 65.3 10 102.4 58.2 11 112.6 61.6 12 116.2 62.4 13 123.9 68.6 14 ***5 8 .0 54.3 15 110.7 57.0 16 114.0 57.4 17
18
19
Eff.
0-24 0.17 0.11 0.17 0.14 0.28 -.04 0.07 0.15 0.09 0.05 -.05 + .09 + .09 + .06
100 ppm. FOOD
g/r/wk g/kg/d
99..6 110..7 116..6 113,.7 113,.1 110,.8 115..4 117,.7 112,.8 121,.4 129..4 124..0 128..1
126.8 115.3 105.7
91.5 84.8 74.5 72.7 69.4 64.1 64.3 66.8 62.1 68.3
Eff.
0. 23 0. 18 0. 17 0. 12 0. 13 0. 13 0. 13 0. 08 0. 15 0.06 0. 06
13
CPD,
500 ppm. * FOOD
mg/kg/d g/r/wk g/kg/d Eff.
12..7 11,.5 10..6
9..2 8..5 7..5 7..3 6..9 6..4 6..4 6..7 6..2 6,.8
.98.9 111.9 117.9 108.1 110.2 105.5 110.5 111.7 112.2 123.9 116.7 116.8 128.8 ***59.7
113.7 111.0 109.3 111.0 110.7
124.8 115.1 107.0 89.5 83.5
74.0 73.1 69.9 65.8 69.4 65.0 62.3 72.4 57.5 60.0 58.2 58.0 56.8 56.2
0.23 0.15 0.14 0.15 0.15 0.11 0.12 0.12 0.10 0.02 0.09 -.11 +.05 + .10 + .03 -.04 + .01 +.01
CPD,
2500 ppm. ** FOOD
mg/kg/d g/r/wk g/kg/d Eff.
62.4 57.6 53.5 44.8 41.8 74.0 73.1 69.9 65.8 55.9 65.0 62.3 72.4
91.4 107.0 108.9
95.4 107.6 100.2 102.7 103.5
93.6 107.8
98.0 97.2
112.0
***66.8 118.0 115.2 121.0 119.5 111.5
115.9 112.5 101.3
84.5 86.0 73.0 71.0 67.9 60.6 67.2 60.3 59.1 71.1 63.7 66.0 61.4 67.6 63.8 65.4
0.21 0.17 0.07 0.17 0.17 0.11 0.10 0.03 0.07 0.03 0.03 -.09 + .20 + .07 + .07 -.07 + .10 -.22
CPD.
mg/kg/d
289.8 304.0 253.3 211.3 215.0 365.0 355.0 339.5 303.0 336.0 301.5 295.5 355.5
, - Withdrawal period was initiated following-13-weeks of compound administration, Selected animals were continued into the period of withdrawal which continues at the writing'of this report.
* Dosage level increased to 1000 ppm. in the 5th week of study.
** Dosage level increased to 5000 ppm. in the 5th week of study.
***' Grams/rat/4 days.
hd ( 0(QD
Does no! contain TSCA CBf
N5
Compound Adminis tration
CONTROL . ______ FOOD________
week g/r/wk g/kg/d Eff.
0
1 108.8 121,.1
2 135.5 110,.9 3 150.3 96,,0
4 151.7 83..1
5 6
151.0 146.6
75,,3 0. 11 65,,7 0. 21
7 . 155.1 64,.5 0. 17
8 165.2 62,.8 0. 19
9 154.1 55,,4 0. 14
10 159.9 54.,3 0. 14
11 158.1 52,,1 0.09
12 162.8 52,.5 o. 06
13
184.8 61,.5
08
14 ***80 -.4 45.,0 +. 13
15
145.1 46,,7
03
16 159.0 48,.8 + .14
17 162.0 49,.3 + .02
18 149.3 45,.2 + .01
19 149.5 44,,6 +. 06
------IQOi-PPtn. ________ _
______500 ppm.*
______ FOOD_______
CPD. _____ FOOD _____
g/r/wk g/kg/d Eff. mg/kg/d g/r/wk g/kg/d Eff.
99.6 126.3 141.9 151.1 152.8 148.0 157.1 158.2 154.1 166.6 175.2 170.9 186.2
118.3 107.1
94.9 85.7 78.7 68.5 66.9 62.4 58.5 58.2 58.3 54.7 60.9
0.33 0.32 0.25 0.20 0.21 0.18 0.17 0.09 0.20 0.11 0.10 -.07
11.8 10.7
9.5 8.6 7.9 6.9 6.7 6.2 5.9 5.8 5.8 5.5 6.1
'
100.4 128.8
144.9 145.3 154.9 150.0 151.6 161.8 148.6 162.5 164.4 159.6 181.3 ***89.3 150.3 169.0 167.4 145.0 161.8
112.6 108.9
96.3 83.9 78.6 66.7 62.9 61.9 54.4 55.9 54.1 51.1 59.7 47.2 46.6 49.3 48.2 40.5 45.2
0.33 0.31 0.23 0.21 0.26 0.16 0.17 0.11 0.15 0.12 0.08 -.07 + .24 -.07 + .17 + .04 +.10
0
_______ _ _____ 2500 ppm. ** CPD. ______ FOOD______ _
mg/kg/d g/r/wk g/kg/d Eff.
56.3 54.5 48.2 42.0 39.3 66.7 62.9 61.9 54.4 55.9 54.1 51.1 59.7
112.2 121.6 140.5 145.0 151.9 149.9 152.3 154.1 140.7 146.8 156.4 150.6 178.5 ***79.6 138.8 138.4 138.3 143.5 145.5
124.0 10-5.5
95.7 84.5 78.6 69. 65.1 61.5 55.5 38.7 56.2 51.2 63.6 52.6 51.2 49.6 50.3 50.0 49.8
0.30 0.31 0.25 0.20 0.21 0.18 0.15 0.03 0.12 0.03 0.03 -.11 -.17 -.06 + .09 -.04 + .11 + .05
CPD.
mg/kg/d
310.0 263.8 239.3 211.3 196.5 347.5 325.5 307.5 277.5 293.5 281.0 256.0 318.0
NOTE - Withdrawal period was initiated following 13-Weeks of compound administration into the period of withdrawal which continues at the writing of this report.
* Dosage level increased to 1000 ppm. in the 5th week of study. ** Dosage' level increased to 5000 ppm. in the 5th week of study. *** Grams/rat/4 days.
Company Sanitized. Does not contain TSCA CBi|
Selected animals were continued
*oT>} 0f9l> WU>
>
Ninety-Day Feeding Study in the Rat.
TABLE 12. Summary of Hematologic Values for Male Rats.
Hematology
Compound Adminis tration Month
Control
100 ppm.
Page 34 500 ppm. * 2500 ppm. * *
Hematocrit, %
Hemoglobin gms./100 ml.
Erythrocytes, xlO /cmm.
Leucocytes, xlO3/CT1T1.
0
47 45
45
44
1
48 46
47
43
2
48 45
45
38
3
48 47
45
38
0
12.7
12.7
12.3
12.4
1
14.6
14.1
14.5
13.3
2
15.9
15.2
15.3
13.2
3
15.7
15.0
14.7
12.0
0
6.38
6.04
6.21
6.04
1
6.60
6.74
6.43
6.31
2
'7.21
7.55
7.35
6.29
3
7.16
7.05
7.06
5.90
0
10 75
9.90
12.48
11.30
1
11.79
11.21
8.83
8.62
2
11.22
9.40
11.24
11.93
3
15.25
10.28
11.15
11.55
Comnany Sanitized. Does not contain T S C A CB!
fa Neutrophils, 7 Seg., T, Non-Seg., 7
Lymphocytes, %
Monocytes, % Eosinophils, 7 Basophils, T.
0
15 .
15
15
12
1
7 17
14
11
2
14 -
13
14
11
3
17 20
16
8
0
11
0
1
1
00
0
0
2
00
0
0
3
00
0
0
0
83 82
83
85
1
90 82
85
87
2
83 84
84
87
3
80 78
82
89
0
11
1
1
1
20
1
1
2
32
1
1
3
20
1
1
0
01
1
1
1
11
0
1
2
01
1
1
3
12
1
2
0
00
0
0
1
00
0
0
2
00
0
0
3
00
0
0
)up increased to 1000 ppm. in the 5th week of study. )up increased to 5000 ppm. in the 5th week of Study.
Ninety-Day Feeding Study in the Rat.
TABLE 13. Summary of Hematologic Values for Female Rats.
Hematology
Compound Adminis tration Month
Control 100 ppm.
Page 35 500 ppm.* 2500 ppm,
Hematocrit, %
0
, 49
45
46
46
1
49 46
45
43
2
46 44
41
33
3
45 47
40
33
Hemoglobin gms./lOO ml.
0
13.3
12.3
12.4
12.9
1
15.1
14.4
14.4
13.5
2
-15.8
14.8
14.3
11.7
3
15.6
14.9
13.6
10.6
Erythrocytes, xlO^/cmm.
0
6.63
6.38
6.23
6.51
1
7.13
6.82
6.51
6.30
2
6.74
6.81
6.57
5.44
3
6.64
6.82
6.21
5.54
Leucocytes, xlO'Y cmm.
0
12.64
13.72
11.73
11.72
1
9.41
.7.40
9.08
11.53
2
11.76
9.27
8.76
8.67
3
10.96
9.04
10 il4
11.38
Neutrophils, % Seg., %
Non-Seg., %
.
0
14 11
14
11
1
15 17
14
15
2
15 13
17
12
3
11 20
11
8
0
00
0
0
1
00
0
0
2
00
0
0
3
10
0
0
Lymphocytes, "L
0
83 87
84
88
1
81 81
84
84
2
'82 83
79
87
3
85 77
88
90
Monocytes, %
0
12
1
1
1
21
1
1
2
22
2
1
3
22
0
1
Eosinophils, 7
0
10
1
0
1
21
1
0
2
12
2
0
3
11
1
1
Basophils, 7=
0
00
0
0
1
00
0
0
2
00
0
0
3
00
0
0
* Dosage level in this group increased to 1000 ppm. in the 5th week of study. ** Dosage level in this group increased to 5000 ppm. in the 5th week of study.
,mpany Sanif2ed- Does no! contain TS CA CBi
Ninety-Day Feeding Study in the Rat,
TABLE 14. Rat
^dividual Rat Hematologic Values during Control Period.
No. & Hematocrit Hemoglobin Erythrocvtes t Ttal ------- - --
ex ______ Y______ gms./lQQ ml. (xl06/cmm.)
^ " `Z - S a g . z
Control:
------ --- -- -- ------ ----- Z--------
14163M 14167M 14173M 14175M 14178M 14181M Mean
14143F 14146F 14150F 14154F 14157F 14160F Mean
100 ppm.
46 50 45 46 48 45 47
48 48 48 50 49 49 49
12.6 14.0 12.3 12.7 12.6
12.0 12.7
13.2 12.5 13.2 13.9 13.1 13.6 13.3
6.09 6.90 6.42 6.01 6.94 5.91 6.38
6.14 6.14 6.89 6.98 6.40 7.22 6.63
7.29 14.00 12.82 10.32 11.52 8.57 10.75
16.18 12.34 14.18 13.03
9.74 10.38 12.64
7 13 31
9 21
9 15
9 19 20
8 7 21 14
1 0 0 2 1 0 1
0 0 0 0 0 0 0
92 84 69 85 78 91 83
90 80 75 91 92 78 84
14204M 14208M 14210M 14205M 14216M 14220M Mean
14184F 14189F 14191F 14194F 14198F 1420 If
Mean
49 43 44 43 45 46 45
46 41 45 46 45 49 45
13.4 13.4 12.1 12.2 12.0 12.9
12.7
12.1 11.1
12.0 12.6 11.7 14.1
12.3
6.50 5.40 6.20 5.81 6.10 6.23
6.04
6.02 5.55 6.07 6.25 6.02 8.36 6.38
9.65 8.63 12.96 7.36 6.44 14.36 9.90
25.67 14.31 10.55 10.63
9.78 11.40 13.72
16 15 16 19 13 8 15
15 14
6 5 11 14 11
0 0 2 1 0 0 1
0 0 0 0 0 0 0
78 84 81 78 87 90 82
81 84 92 95 85 84 87
'bompany Sanitized. Does not contain T S C A B
Company San^zcd. l o . . z c : ia t
*osinc,pillla Basoph L% %
000 300 000 400 000 000 10 0 10 0 10 0 320 100 010 0 10 110
420 10 0 0 10 110 00 0 110 110 400 110 200 000 310 20 0 26 0
TTpnO>>3 LO CTv
Ninety-Day Feeding Study in the Rat
500 ppm
14244M 14247M 14249M 14251M 14255M 14257M Mean
14225F 14227F 1423IF 14233F 14236F 14241F Mean
2500 ppm.:
14284M 14288M 14290M 14295M 14298M 14301M Mean
14264F 14267F 14269F 14276F 14278F 14281F Mean
44 46 44 43 42 44 44
46 46
45 51 43 45 46
12.5 12.9 12.4 12.3 12.0 12.0 12.4
13.0 12.9 12.2 13.7 12.2 13.4 12.9
6.03 6.48 6.01
56..2722
5.77 6.04
6.25 6.58
6.13 6.76 7.16 6.20 6.51
15.14 10.32 13.88 8.92 10.30 9.21 11.30
11.62 11.10 8.96 11.35 17.47 9.84 11.72
18 12 10 11 13 8 12
13 7
11 9 8
18 11
1 0 1 0 1 0 1
1 0 0 1 0 0 0
79 88 87 86 85 90 85
85 91 87 89 90 81 88
2 0 1 2 0 2 1
1 2 1 0 2 1 1
0 0 1 1 1 0 1
0 0 1 1 0 0 0
0 0 0 0 0 0 0
0 0 0 0 0 0 0
Company Sanitized. Does not contain TSCA CBI
in n> to
Ninety-Day Feeding Study in the Rat.
TABLE 15. Individual Rat Hematologic Values at One Mpnth.
Rat No. & Hematocrit Sex %
Control:
Hemoglobin gms./lOO ml
Total
Erythrocytes Leucocytes
Neutrophils
(xlO /cmm.) (xl03/cmm.) Seg.% Non-Seg.%
Differential LympHocytes Monocytes Eosinophils Basophil^
7 % %
14162M I4165M 14168M 1417LM 14174M 14177M Mean
14142F 14144F 14146F 14148F 14150F 14153F Mean
50 46 47 47 48 47 48
48 48 50 51 47 49 49
15.4 13.9 14.8 14.5 14.4 14.5 14.6
7.18 6.66 6.80 6.22
6.44 6.30 6.60
14.40 14.75
9.27 14.34 10.88
7.08 11.79
8 6 6 5 7 10 7
0 0 0 0 0 0 0
86 91 90 94 92 88 90
5 3 3 1 1 1 2
14.7 15.2 15.5 15.2 14.3 15.4 15.1
6.87 7.04 8.12 7.27 6.61 6.89 7.13
7 .82 8..80 11,.60 10,,53 7,,00 10,,72 9.,41
14 19 18 17 14
9 15
0 0 0 0 0 0 0
82 77 77 80 80 89 81
1 1 3 1 3 1 2
1 0 1 0 0 1 1
3 3 2 1 3 1 2
0 0 0 0 0 0 0
0 0 0 1 0 0 0
100 ppm.:
14202M 14205M 14208M 14211M 14214M 14217M Mean
14182F 14185F 14188F 14191F 14194F 14197F Mean
44 48 47 45 49 45 46
47 44 46 48 45 46 46
13.6 14.8 14.6 13.7 13.8 14.1 14.1
6.32 6.73 7.08 6.54 7.03 6.72 6.74
19.70 7.10 8.22 6.78
11.69 13.77 11.21
7 25 30
9 23
7 17
0 0 0 0 0 0 0
90 74 69 88 76 92 82
1 o 0 l o l o
14.2
13.6 14.3 14.8 13.9
14.4 14.4
6.69 6.68 6.91 7.10 7.28 6.30 6.82
9.15 3.97 8.64 6.98 6.53 9.15 7.40
6 46 11 18 11
8 17
0 91 3 49 0 87 0 81 0 86 0 91 0 81
1 l 0 1 2 1 1
2 1 1 2 1 0 1
2 1 2 0 1 0 1
0 0 0 0 0 0 0
0 0 0 0 0 0 0
Company Sanitized. Do< not contain T S C A CB1
'MT) O(PD to
f)
NinetyDay Feeding Study in the Rat,
TBLt
Rat No, Sex
Continued. Individual Rat Hematologic Value s at One Month,
Hematocrit %
u , ..
Total
Hemoglobin Erythrocytes Leucocytes
gtBS,/100 m ! , (xioe/c^.) (*l03/L..)
Neutroohois
14242M 14245M 14248M 14251M
14254m .4257M Mean
14222F 1422.5F 14228F 14231F 14234F 14237F Mean
51 45 47 46 47 48 47
45 46 45 45 46 45 45
2500 ODm.:
14282M 14285M 14288M 14291M 14294M 14297M Mean
14262F 14265F 14268F 14271F 14274F 14277F Mean
42 44 42 45 41 45 43
44 42 46 41 40 44 43
15.9 13.6 14.6 13.9 14.7 14.5 14.5
14.4 14.3 14.4 14.2 14.4 14.5 14.4
13.2 13.9 12.6 13.7 12.5 13.9 13.3
13.6 13.3 14.6 13.0 12.9 13.8 13.5
7.07 6.03 6.77 6.17 5.99 6.55 6.43
6.55 6.83 6.20 6.42 6.69 6.35 6.51
6.02 6.57 5.93 6.68 6.14 6.50 6.31
6.12 6.07 7.19 5.96 5.95 6.53 6.30
7.48 7.84 9.75 11.62 8.16 8.13 8.83
11.49 9.65 7.68 9.95 5.79 9.90 9.08
17 14
9 12 10 ' 20 14
8 10 11 21 20 14 14
9.79 11.49 8.82 6.71 6.54 8.34 8.62
19.29 9.08 6.28
13.43 8.84 12.23 11.53
8 ii
9 18 11 10 11
9 16 14 18 16 16 15
0 1 0 0 0 0 0
0 0 0 1 0 0 0
0 0 0 0 0 0 0
0 0 0 0 0 1 0
Differential Lymphocytes Monocytes Eosinoph 1
%
82 0 84 1 90 1 87 1 90 0 79 0 85 1
90 2 89 1 87 0 77 1. 79 1 83 1 84 1
1 0 0 0 0 1 0
0 0 2 0 0 2 1
91 0 88 1 90 1 82 0 85 3 89 0
87 1
1 0 0 0 1 1 1
88 3
0
83 1 - 0
85 0
1
80 1
1
83 1
0
81
2'
0
84 1
0
C o m p ly
Doss not contain T S C A CB|
T
0 0 0 0 0 0 0
0 0 0 0 0 0 0
0 0 0 0 0 0 0
0 0 0 0 0 0 0
Page 3
TABLE 16
Individual Rat Hematologic Values at Two Months
Rat
No. &
bex
Hematocrit
/,,
Hemoglobin Erythrocytes gnmnsn .//1l5A r5t mH. " .(' xn fK fi j w ).
Total
Leucocytes ( Qo. VJ c ^ O
Control :
14164m 14167 m 14170M 14174M 14178M 14181M Mean
14I43F 14147F 14149F 14152F 14154F 14158F Mean
47 49 52 47 47 48 48
47 48 49 41 50 42 46
100 pom.:
14204M 14210M 14213M 14217M 14220M 14221M Mean
50 44 41 42 50 40 45
14184F
14190F 14193F 14194F
14196F
14200F Mean
45
45 41 44 43
43 44
15.4 1^.5 16.6 15.6 16.0 15.4 15.9
15.4 16.2 16.4 15.2 15.8 16.0 15.8
16.0 14.9 14.8 14.9 15.8 14.5 15.2
15.2 15.0 13.6 15.1 15.1 14.5 14.8
7.02 7.43 7.47 7.07 7.00 7.24 7,21
6.67 6.78 7.26 6.36 7.03 6.31 6.74
7 .84 7 .55 7 .87 6 .84 8,.02 7,.20 7,.55
6,.85 6,,74 6.,12 6.,71 6..98 7. 47 6. 81
11.44 13.95 11.11
9.73 11.22
9.88 11.22
11.86 15.15 10.64 10.92 12.83
9.16 11.76
10 .75 9 .29
12 .15 7 .30 9,.37 7,.56 9,.40
10..00 6..42 7,,11 6,,23
13.,75 12. 12
9. 27
7 12
5 31 19
8 14
32 9 9
22 7 8
15
19 8 14 8 15 12 13
7 22 10 12 14 10 13
^ m o a n y Sanitized. Poes no! eonfain T S G A GBI
Differential Lymphocytes Monocytes Eosinophils Basophils
0 90 2
0 83
5
0 93 1
1 0 1
0 0 0
0 64 5 0 0
0 81 0
0 90 2
0 83
3
0 0 0
0 0 0
0 67
1
0
0
0 87 3 1 0
0 88
1
2
0
0 78 0 0 90 3
0 0
0 0
0 90 2 0 82 2
0 1
0 0
0 75 3 3 0
0 90 1 1 0
0 84
1
0 91 1
1 0
0 0
0 82
2
1
0
0 85 3 0 84 2
0 1
0 0
0 90 1 2 0
2 69 4 0 87 2
0 83
3
0 85 0
0 90 0
0 83 2
3 1 2
1 0 2
0 0
0 0 0 0
t;
cu
0rQd
Ninety-Day Feeding Study in the Rat.
TABLE 16. Continued. Individual Rat Hematologic Values at Two Months.
Rat No. 6 Hematocrit oex %
1000 ppm.
Hemoglobin Erythrocytes gms./100 ml. (xl06/cmm.)
Total ---------------------- Differential
Leucocytes
(xlC)3/cmm, )
-- Neutrophils Seg.% Non-Seg.%
Lymphocytes Monocytes %y
Eosinophils Basophils % ?/o
14243M .14246M 14251M 14253M 14257M 14261M Mean
14223F 14226F 14230F 14234F 1423-7F 14240F Mean
42 46 47 46 46 42 45
42 43 41 37 43 38 41
5000 ppm.
15.4 15.2 15.4 14.8 15.9 15.1 15.3
7.71 7.11 7.42 6.94 8.03 6.89 7.35
9.97 12.04 12.47 8.86 10.67. 13.43 11.24
23 13 11 15
6 13 14
0 0 0 1 0 1 0
75 84 87 82 93 82 84
1 1 l l o 2 l
15.5 14.2 14.3 13.6 15.8 12.4 14.3
7.28 6.63 6.28 6.63 6.85 5.77 6.57
8.34 6.64 10.28 6.17 13.43 7.68 8.76
16 18
8 24 28
6 17
1 0
0 0 0 0 0
81 72 92 74 62 94 79
o 5 0 1 8 0 2
1 2 1 1 1 2 1
2 5 0 1 2 0 2
0 0 0 0 0 0 0
0 0 0 0 0 0 0
14283M 14289M 14293M 14295M 14297M 14300M Mean
14263F
14270F 14273F 14275F 14279F 14281F Mean
42 34 35 36 38 44 38
37 29 35 33 30 33 33
13.3 12.0 12.3 12.7 13.6 15.0 13.2
6.33 6.12 6.09 6.13 6.08 6.96 6.29
11.96 17.50 11.20
6.97 14.49
9.46 11.93
7 23 17
8 4 9
11
0 0 0 0 0 1
0
92 0 76 1 81 1 91 * 0 94 1 87 3 87 1
13.0
11.2 12.1 11.8
10.4 11.7 11.7
5.60
5.31 5.64 5.47 4.93 5.68 5.44
11.57 5.16 9.55 8.90 6.78
10.07 8.67
10
14 8 8
17 17 12
1 87
0 84 0 91
0 92
0 81 0 82 0 87
2 2 1 o 1 o 1
1 0 1 1 1 0 1
0 0 0 0 1 1 0
0 0 0 0 0 0 0
0 0 0 0 0 0 0
Company Sanitized. Does not contain TSCA CB S
PS TCOD
Ninety-Pay Feeding Study in the Rat.
TABLE 17. Individual Rat Hematologic Values at Three Months.
Rat No.6, He,toctit
Control :
i
JJmoglobtn Erythrocytes L e o c o c y L gms./OOml. "ciloE^cTM" (xl03/cTM!>
~-- -- ------
14164M 14169M 14172M 14176M 14179M 14181M Mean
14147F 14151F 14154F 14156F
14158F 14161F Mean
53 46 47 48 47 50 48
46 43 45 41 47 45 45
100 ppm.:
16.1 16.0 15.6 15.6 15.2 15.6 15.7
16.9 15.1 15.2 15.1 16.0 15.2 15.6
7 .52 6 .68 7 .14 6..79 7,.53 7,.10 7,.16
6..64 6..52 6.,66 6. 33 7. 02 6. 69 6. 64
17 .93 21 .59 14,,62 13,.86 10,.06 13,.45 15,.25
13..71 7.,16
12.,03 7. 12
11. 53 14. 18 10. 96
15 6
23 15 17 24 17
7 18 15
9 5 13 11
14203M 14206M 14210M 14215M 14218M 14219M Mean
14183F 14186F 14190F 14195F 14197F 14200F Mean
45 50
47 46 46 50 47
49 50 38 49 50 46 47
14.5 15.2
14.8 15.1 14.6 15.6 15.0
15.6 15.3 12.0 15.9 16.0 14.8 14.9
6.60 7.47 6.91 6.80 6.90 7-.60 7.05
6.89 7.26 6.09 6.89 6.77 7.03 6.82
13.85 10.73
9.58 7.47 12.35 7.71 10.28
12.16 10.83
6.65 5.57 11.79 7.25 9.04
40 24
7 20 16 12 20
13 29 28 ii 15 26 20
Company Sanitized. Does not contain TSCA CBS
<9
Differential
Eycphocytes Monocytes Eosinophils Basophils'
s'
/o
to
%
yo
0 82 3 0 94 0
0 70 5
0
0 0
0 84
1 '0
0 80 1
9
0 74 2
i
0 80 2
l
1 89 2
2 80 0
1 79
1
1 88
1
0 91 2
0 84 2
1 85
1
0 4 1 9
1 2
1 58
1
0 73 0
0 91 0
1 78 0
0 82 0
0 87 0
0 78 0
0 85 2
0 69 1
3 63 3
0 87
1
0 85 0
0 73 1
0 77 2
n
3 2 1 2 1
2
0 n 2 1
0 0 1
o 0 u 0 0 0 0
0 0 0 0 0 0 0
0 o 0 u
u 0 n 1 1 0 0 0 0
0f0lQ)> 4r>o
Ninety-Day Feeding Study in the Rat.
TABLE 17. Continued. Individual Rat Hematologic Values at Three Months.
, ...... No. & Hematocrit Hemoglobin Erythrocytes Sex_______ ^______ gms./lQQ ml. (xl06/cmm.)
500 ppm.:
Total Leucocytes
Neutrophils ' ____ D i f f e r e n t i a l ______________ _____
Lymphocytes Monocytes Eosinophils Basophils
(xl03/cmm.) Seg.% Non-Seg.%
7 7o %
7o
14244M 14247M 14252M 14255M 14257M 14260M Mean
48 45 47 44 46 43 45
15.6 14.4 15.1 13.9 15.0 14.0 14.7
7.59 6.91 7.28 6.48 7.27 6.82 7.06
8.18 10.44
8.53 11.35 12.50 15.89 11.15
7 23
9 12 31 13 16
0 0 0 0 0 0 0
92 74 90 86 68 84 82
0 0 0 0 1 2 1
1 3 1 2 0 1 1
0 0 0 0 0 0 0
14224F 14227F 14232F 14236F 14238F 14240F Mean
43 36 41 45 39 38
40
14.2 12.7 14.6 14.6 12.8 12.6
6.14 6.07 6.52 6.39 6.22 5.90
9.40 12.13 12.63
7.02 9.94 9.70
6 18 16 13
6 8
0 0 0 0 0 0
93 82 84 87 94 89
0 0 0 0 0 1
13.6
6.21
10.14
11
0 88
0
1 0 0 0 0 2 1
0 0 0 0 0 0 0
2500 ppm.:
14283M
14287M 14291M 14294M 14297M 14300M Mean
38
35 37 35 41 41 38
12.1
6.20
13.87
6
0 93
1
11.8 11.9
5.29 5.82
8.41 10.18
8 7
0 91 0 92
0 1
11.0
5.15
12.18
11
1 84
0
11.8
6.19
13.55
4
0
94
1
13.4
6.73
11.12
13
1
79
4
12.0
5.90
11.55
8
0 89
1
0
1 0 4 1 3 2
0
0 0 0 0 0 0
14266F
14269F 14272F 14276F 14278F 14281F Mean
31
34 36 34 30 36 33
9.7
10.5 11.6 10.5
9.5 12.0 10.6
5.25
5.04 6.38 5.54 5.42 5.63 5.54
13.37
13.63 8.95 9.45
14.55 8.35 11.38
8
8 10
8 2 10 8
0 91
1 89 0 88 1 89 0 95 0 88 0 90
0
2 2 1 2 1 1
1
0 0 1 1 1 1
0
0 0 0 0 0 0
Company Sanitized. Does notcontain T S C A CB1
oT0ItP)1J CFO-
Page 44
Ninety-Day Feeding Study in the Rat.
TABLE 18. Individual and Mean Results of Biochemical Studies During Control Period
Group
Rat No.
Alkaline Phosphatase
SGOT^
SGPT^
Control, Female Mean
14142 14145 .14149 14153 14156 14154 14144 14147 14152 14155 14158 14160
78 78 75 105 93 45
79
34 24 27 24 29 23 28 23 28 23 30 25 29 24
Control, Male
14162
99
14164
93
14166
57
14172
93
14177
93
14179
99
14170
29 23
14168
30 22
14174
31 24
14176
27 22
14180
32 23
14171
29 26
Mean
89 30 23
100 ppm., Female 14183
36
14188
48
14192
39
14199
48
14182
90
14196
45
14185
26 22
14190
29 23
14193
29 22
14200
29 25
14197
29 24
14195
29 24
Mean
51 29 23
Serum Glutamic Oxalacetic Transaminase Serum Glutamic Pyruvic Transaminase
Company Sanitized. Does not contain TSCA CB1
Ninety-Day Feeding Study in the Rat
TABLE 18. Continued. Individual and Mean Results of Biochemical Studies During Control Period.
Group
Rat No.
Alkaline Phosphatase SGOT^
SGPT^
100 ppm., Male Mean
14202
14209 14211 14219 14214 14221 14203 14206 14212 14215 14218 14217
500 ppm., Female 14230
14224
14222
14240
- 14235
14232
14229
14228
14223
14239
14237
Mean
14234
500 ppm., Male Mean
14242
14245 14248 14252 14254 14258 14243 14246 14250 14253 14256 14259
57 87 63 93 96 36
72 90 87 84 96 99 90
91 51 57 54 93 39 87
64
29 23 27 23 30 23 29 23 26 24 30 26 29 23
29 24 25 22 29 22 30 22 28 25 27 22 28 23
27 22 29 22 26 24 29 22 27 22 25 23 27 22
Serum Glutamic Oxalacetic Transaminase Serum Glutamic Pyruvic Transaminase
Company Sanitizes. Does no! co.,,, J'SCA
Page 46
Ninety-Day Feeding Study in the Rat.
TABLE 18. Continued. Individual and Mean Results of Biochemical
Studies During Control Period
Group
Rat No.
2500 ppm., Female 14271 14266 14262 14273 14274 14277 14268 14265 14263 14272 14275 14280
Mean
2500 ppm. , Male Mean
14282 14286 14296 14283 14289 14297 14287 14291 14300 14285 14292 14299
Alkaline Phosphatase 39 75 57 99 78 69
70 90 90 51 51 93 48
71
SGOT1
27 32 28 31 28 29 29
32 27 26 29 29 27 28
SGPT2
22 24 21 24 23 23 23
27 25 24 22 23 21 24
Serum Glutamic Oxalacetic Transaminase O
Serum Glutamic Pyruvic Transaminase
Company Sanitized. Does not contain TSCA C9!
%
] i ! ; ! ^ | :
fi)
Page 47
NinetyDay Feeding Study in the Rat.
TABLE 19. Individual and Mean Results of Biochemical Studies at One Month.
Group
Rat No.
Control, Female Mean
14143 14145 14147 14149 14151 14154
Control, Male Mean
14163 14166 14169 14172 14175 14178
100 ppm., Female Mean
14183 14186 14189 14192 14195 14198
100 ppm., Male Mean
14203 14206 14209 14212 14215 14218
500 ppm., Female Mean
14223 14226 14229 14232 14235 14238
Alkaline Phosphatase
60 84 ' 90 78 96 72 80
72 53 129 63 114 129 . 93
45 75 117 54 108 114 86
84 129 132 105 105 126 114
52 99 84 117 123 102 96
SGOT1
26 28 25 26 24 28 26
25 24 25 28 27 24 26
26 26 25 25 25 25 25
25 27 27 26 26 25 26
28 28 26 27 28 26 27
SGPT2
24 25 23 25 23 25 24
24 21 24 23 24 24 23
23 24 24 22 23 24 23
24 25 24 23 24 23 24
25 25 23 23 26 25 25
Serum Glutamic Oxalacetic Transaminase Serum Glutamic Pyruvic Transaminase
Company Sanitized. Does not contain TSCA CBP
t
i i
Page 48
Ninety-Day Feeding Study in the Rat.
TAB.LE 19. Continued. Individual and Mean Results of Biochemical Studies at One Month.
Group
Rat No.
500 ppm., Male .
. Mean
14243 14246 14249 14252 14255 14258
2500 ppm., Female 14263 14266 14269 14272 14275 14278
Mean
2500 ppm., Male Mean
14283 14286 14289 14292 14295 14298
Alkaline Phosphatase
72 132 132 . 96 87 132 109
84 51 60 72 84 45 66 .
72 117 117 69 105 81 94
SGOT1
27 27 26 26 25 25 26
28 27 26 28 28 28 28
28 27 24 25 26 25 26
SGPT
23 25 24 24 23 25 24
24 24 23 24 24 25 24
23 24 23 23 23 24 24
Serum Glutamic Oxalacetic Transaminase Serum Glutamic Pyruvic Transaminase
Company Sanitized. Doss not contain TSCA CBi
Ninety-Day Feeding Study in the Rat.
TABLE 20.
Individual and Mean Results of Biochemical Studies at Two Months.
Group
Rat No.
Control, Female Mean
14144 14148 .14150 14151 14153 14155
Control, Male Mean
14163 14166 14169 14171 14172 14173
100 ppm., Female Mean
14183 14186 14187 14192 14195 14198
100 ppm., Male Mean
14203 14206 14209 14211 14216 14219
1000 ppm., Female 14224 14227 14229 14232 14235 14236
Mean
Alkaline Phosphatase
60 73 59 56 67 67 64
54 38 79 98 78 78 71
31 47 58 39 36 37 41
56 36 111 64 33 46 58
62 58 64 63 46 27 53
SGOT1
SGPT'
27 21 26 24 25 - 22 19 22 25 22 26 22 25 22
28 20 28 23 26 23 27 24 24 24 25 22 26 23
24 21 23 23 25 22 24 21 30 22 29 22 26 22
25 24 28 21 27 22 27 22 29 24 29 23 28 23
26 21 27 22 29 24 26 22 31 22 25 21 27 22
Serum Glutamic Oxalacetic Transaminase Serum Glutamic Pyruvic Transaminase
Company Sanitized. Doesno.conmin t s c a c b ,
Page 50
Ninety-Day Feeding Study in the Rat.
TABLE 20. Continued. Individual and Mean Results of Biochemical Studies at Two Months.
Group
Rat No.
1000 ppm., Male .
Mean
14242 14247 14249 14254 14256 14259
5000 ppm., Female 14264
14267 14269 14271 14274 14277 Mean
5000 ppm., Male Mean
14284 14289 14292 14294 14296 14298 '
Alkaline Phosphatase
39 45 . 53 41 38 70 48
64 32 32 36 28 37 40
47 49 82 27 50 88 57
SGOT1
26 27 29 26 29 28 28
27 27 26 27 29 28 27
26 27 27 27 29 28 27
SGPT2
23 22 21 23 21 22 22
20 21 21 21 21 22 21
23 21 21 20 24 23 22
Serum Glutamic Oxalacetic Transaminase Serum Glutamic Pyruvic Transaminase
Company Sanitized. Does not contain TSCACBi
! j
i 1
<t>
i
Page 51
TABLE 21.
Ninety-Day Feeding Study in the Rat.
Individual and Mean Results of Biochemical Studies at Three Months.
Group
Rat No.
Alkaline Phosphatase
SGOT1
SGPT2
Control, Female Mean
14144 14248 14155 14157 14159 14160
Control, Male Mean
14174
14171 14173 14175 14177 14180
TOO ppm., Female .
Mean
14187 14189 14192 14196 14198 14199
100 ppm., Male Mean
14204
14207 14209 14211 14213 14216
1000 ppm., Female 14226
14229
14233
14235
14237
Mean
14239
26 59 21 20 31 28 31
24 30 32 79 77 107 58
22 29 18 14 68 32 31
16 25 47 25 35 41 32
39 53 73 55 50 22 49
30 . . 23
26 28 27 28 27
26 26 27 25 27 28 27
' 25 26 25 22 23 24 24
24 23 26 25 24 22 24
23 26 25 25 25 23 25
23 24 22 22 23 26 23
21 23 22 25 24 27 24
22 23 21 21 22 21 22
22 21 20 21 21
9?
21
24 24 23 25 22 20 23
Serum Glutamic Oxalacetic Transaminase
2
Serum Glutamic Pyruvic Transaminase
Company Sanitized. Does not contain TSCA CK
Page 52
Ninety-Day Feeding Study in the Rat.
TABLE 21. Continued.
Individual and Mean Results of Biochemical Studies at Three Months.
Group
Rat No
Alkaline Phosphatase
SG0T*
SGPT2
1000 ppm., Male Mean
14243 14250 14254 14256 14259 14261
5000 ppm., Female 14264
14277
14271
14274
14280
Mean
14279
5000 ppm., Male Mean
14284 14286 14290 14292 14296 14298
41 43 15 26 87 34 41
26 19 18 18 26 16 21
49 66 37 75 45 33
51
29 25 26 23 23 22 25
25 25 25 26 28 25 26
27 25 24 24 24 24 .
25
27 22 19 20 23 22 22
22 21 20 22 22 19 21
24 24 21 22 22 21
22
Serum Clutamic Oxalacetic Transaminase Serum Glutamic Pyruvic Transaminase
Company Sanitized. Does not contain TSCA CBl
Sex
Volume (ml. )
Appear ance
pH
Specific Gravity
Albumin
Bili- Glu- Occ.
Epi.
rubin cose Blood' WBC RBC Cells
Amor. Urates
Amm. Triple Urates Phos.
Calcium Bact-
Ox. eria
Blae dei
Worn
L43 F
5 S;C 7.0 1.028 N
146 F 12 LS; cl 6.9 1.030 N
150 F
3 S;cl 6.3 1.032 N
.54 F
5 S;C 6.8 1.032 N
.57 F .60 F
6 S;C 7.0 1.032 N 6 S;C 7.2 1.030 N
N N N N N N
N N OCC NN NN NN N
NN
.63 M 21 LS;C 6.5 1.030 N
.67 M .73 M
1 Am; C 6.4 1.063 3+
1
LAm;C 6 . 2
1.065
N
.75 M .78 M
4 S;cl 6.8 1.040 N 2 S ;cl 6.4 1.045 N
.81 M 12 LS;C 9.0 1.030 N
N N N N N N
NN N N occ NN N N occ NN
NN
1 ppm. :
occ 1-3
F F F M F FM
F
F F F F
F M M F M F
F F F M M F
84 F 89 F 91 F 94 F 98 F 01 F 04 M 08 M 10 M 05 M 16 M 20 M
*
6 LS; cl 6.8 7 LS ;cl 8.8 4 S;C 6.5 3 S;cl 8.8 13 LS;C 9.0 3 LAm;C 6.8
6 LS;cl 8.5 3 S ;C 6. 2 2 S;C 6.5 4 S;cl 6.8 4 LS ;C 7.0 9 LS;cl 9.0
Straw
Light Straw Amber
Light Amber
1.030 1.030 1.030 1.040 1.030 1.045
1.030 1.055 1.042 1.030 1.032 1.030
Clear Cloudy
N N N N o.cc N N NN N N N N occ N N NN N N NN N N NN
N - Negative 1H-- Trace-to-Slight 2+ - Slight-to-Moderate 3+ - Moderate 4+ - Marked
F
F F
occ M F occ F
FF
occ
M occ F
F M F F M M
F F M F F F
M F F F F F
Few Many Occasional
emoany Sanfflzed. Does not contain TSC CB!
Page 53
Ninety-Day Feeding Study in the Rat. LE 22. continued. Urinalysis Values for Male and Female Rats during Control Period';
41 F
44* M 47 M 49 M 51 M 55 M 57 M
ppm.
54 F 57 F 59 F 76 F 78 F 51 F
54 M ?8 M 0 M >5 M 18 M 1 M
S LS DS
* Am LAm
1 S;C 6.3
3 Sjcl 8.8
3 S;C 6.3 3 S;cl 8.0 7 LS;cl 6.5 3 LAm;C 6 .0
4 S;C 6 . 2 4 S ;cl 9.0 5 S;cl 8.3 4 S;cl 6.7 6 LS;cl 6.7 4 S;cl 6.5
1 AmjC 6 S;cl 21 LS;C 4 S; cl 4 S;C 2 DS;C
2 S;C 2 S;cl 5 S;cl 10 LS;cl 12 S; cl 1 Am;C
Straw
Light Straw Dark Straw Amber
Light Amber
6.5 6.9 7.0 7.3 7.4 9.0
7.0 9.0 9.0 9.0 6.9 6.2
G cl
1.045 1.042 1.045 1.040 1.030 1.045
1.040 1.035 1.032 1.045 1.030 1.042
1.065 1.030 1.030 1.030 1.033 1.042
1.048 1.053 1.037 1.030 1.030 1.055
Clear Cloudy
N N NN N N NN N N NN N N NN N N NN N N NN
N N NN N N NN N N NN N N NN N N NN N N NN
N N NN N N NN N N NN N N NN N N NN N N NN
N N NN N N NN N N NN N N NN N N NN N N N.N
N - Negative 1+ - Trace-to- Slight 2+ - Siight-to-Moderate 3+ - Moderate 4+ - Marked
CM r1H
occ F M F
F F FM F
FF
FF
FMF occ M M
F F OCC
occ occ
occ M
F
F M F M F F
F M M M M M
occ
occ occ F
F F
MM F occ
O C C occ M occ MM FF
F M F M F F
F occ
M occ M
occ occ
occ 2-3
M
.F M F
M M F
M M F
M L F
F - Few
M - Many L - Loaded
* Occasional uric acid
occ - Occasion
,1 contain T S C ftC B I
Comp!m, S 3 * e d . D o n o
03 0(QD Ln -O
\
LE 23.
Ninety-Day Feeding Study in the Rat, Urinalysis Values for Male and Female Rats at One Month.
t Volume Appear- Specific . Sex (ml.) ance pH Gravity
trol :
62 M 12 LS;cl 8.5 1.013
65 M 12 LS;cl 7.9 1.016 6 8 M 17 LS-;cl 8.9 1.014
71 M
4 LS;cl 7.2 1.048
74 M 15 LS ;cl 7.0 1.013
77 M
9 LS ;cl 6.9 1.020
42 F 10 LS ;cl 6.5 1.017
45 F
7 S;cl 9.0 1.041
46 F 15 LS; cl 7.1 1.012
.48 F
6 DAm;C 8.9 1.031
50 F 12 LS;cl 6.2 1.011
53 F
7 S;cl 6.9 1.035
t ppm. :
:02 M
7 S;cl 7.0 1.044
:05 M 26 LS;cl 7.3 1.008
:08 M 10 S;cl 6.9 1.021
'.11 M 16 LS;cl 9.0 1.009
:i4 M 14 S;cl 6.5 1.013
-17 M 10 S;cl 6.3 1.021
.82 F
4 S;cl 7.0 1.042
.85 F 13 LS; cl 7.1 1.011
.88 F 14 LS;C 9.0 1.007
.91 F 12 LS;cl 6.8 1.016
.94 F
7 S;cl 9.0 1.019
.97 F
9 S ;cl 6.5 1.017
Le: S - Straw LS - Light Straw
DAm - Dark .Amber
C - Clear cl - Cloudy
m It
Microscopic_________ ____________
Albu- Bili-- Glu- Occ.
Epi. Amor. Amm.
Oai-
Blad-
Triple cium Bact- der
min rubin cose Blood WBC RBG Gells Urates Urates Phos. Ox. eria Worm:
NN N .N NN NN NN NN
NN NN NN NN NN NN
NN NN NN NN NN NN
NN NN NN NN NN NN
CM
r--11
CM
r--1
occ 1-2
F
OCC
1-2
F F
F F
F F occ F
FF M occ M M FF FM M FF
F
M MF FF FF
M FM
N N NN N N NN N N NN N N NN N N NN N N NN
N N NN N N NN N N NN N N NN N N NN N N N. N
N - Negative 1+ - Trace-to- Slight 2+ - Slight-to-Moderate 3+ - Moderate 4+ " Marked
FFF
FM
F
occ M
1-2 F
occ F
F
FL
occ F
FF
F
occ F M
occ F
F
M F F M M M
F F F M F M
F - Few
M - Many
L - Loaded
occ
-
Occasional
Gompany
Sanitized.
Does
n
ot
contain
T
S
C
A
C03
OCC
occ occ
Q>
U0L>ni
Ninety-Day Feeding Study in the Rat TABLE 23. Continued Urinalysis Values for Male and Female Rats at One Month.
Rat
Volume Appear-
Specific Albu-
No. Sex (ml.) ance pH Gravity min
Billrubin
________________________ Microscopic __________________
Cal-
Blad-
Glu- Occ.
Epi. Amor. Amm. Triple cium Bact- der
cose Blood WBC RBG Cells Urates Urates Phos. Ox. eria Worm;
500 ppm.:
14242 14245 14248 14251 14254 14257
M M M M M M
14222 14225 14228 14231
14234 14237
F F F F
F F
12 10 12 13 16 17
8 4 6 14 3 16
LS; cl LS; cl LS; cl LS;cl LS; cl LS; cl
7.1 9.0 9.0 6.1 6.8 8.9
S;cl S; cl S;cl S;cl
DS; cl LS; cl
6.5 6.5 6.6 7.2
6.1 8.8
1.012 1.023 1.011 1.015 1.011 1.012
1.024 1.048 1.034 1.012 1.050 1.010
N N N N N N
N N N N N N
N NN N NN N NN N NN N NN N NN
N NN N N N N NN N NN N N N OCC N NN
CM
T--1<
F 1-2 F M
F 1-2 F F
FF FM
FF occ F
F occ F M
F FL
F F M occ M M M occ
M F F F F F
2500 ppm.:
14282 M 14 LS;C 7.1 1.023 N N N N 14285 M 7 LS; cl 7.3 1.035 N N N N 14288 M 17 LS; cl 8.8 1.015 N N N N 14291 M 14 LS; cl 9.0 1.012 N N N N 14294 M 4 DS; cl 8.9 1.042 N N N N 14297 M 17 S;cl 6.9 1.014 N N N N
14262 F 4 S;cl 7.0 1.044 N N N N 14265 F 4 S;cl 6.1 1.040 N N N N 2-3 14268 F 6 S;cl 6.5 1.025 N N N N 14271 F 15 LS;cl 7.0 1.011 N N N N 14274 F 14 S;cl 6.7 1.013 N N N N 14277 F 8 S;cl 7.1 1.017 N N N N
FM 1-2 F F
L FF occ M FF
occ F
F
FF
FF
OCC
F
occ F M
Code: S - Straw LS - Light Straw DS - Dark !Straw
C - Clear cl - Cloudy
N - Negative 1 + - Trace-to- Slight 2+ - Slight-to-Moderate 3+ - Moderate 4+ - Marked
F - Few
M - Many L - Loaded occ - Occasion!
F F OCC F F OCC F F OCC
F M F M M M
T<D) ((TDO Ln
ON
Company Sanitized. Does not contain T S C A CBI
Ninety-Day Feeding Study in the Rat.
TABLE 24.
Urinalysis Values for Male and Female Rats at- Two Months.
Microscopic
Cal-
Blad"
Rat
Volume Appear-
Specific Albu- Bili- Glu- Occ.
Epi. Amor. Amm. Triple eium Bact- der
No. Sex (ml.) ance pH Gravity min rubin cose Blood WBC BBC Cells Urates Urates Phos. Ox. eria Wcrrmf
Control:
14164 M 28 LS;cl 7.0 1.015 N N N N 14167 M 16 LS;cl 7.1 1.022 N N N N 14170 M 12 LS; cl 7.0 1.028 N N N N 14174 M 25 LS;cl 9.0 1.014 N N N N 14178 M 24 LS;cl 7.5 1.012 N N N N 14181 M 30 LS;cl 8.0 1.009 N N N N
OCC
F
14143 F 6 LS;cl 7.5 1.030 N N N N
14147 F 13 LS;C 7.7 1.022 N N N N
14149 F 6 S;cl 9.0 1.030 N N N N
14152 F 11 LS;cl 9.0 1.024 N N N N
14154 F 3 S;C 6.2 1.065 N N N N F
14158 F
4 S;C 6.0 1.047 N
N
N N :f
occ
MM MF MF F MF
F
FF FM FM FL occ M FF
M IF
M
M IF
F M M 1?
M M
F
F
F
F
100 D D m . :
14204 14210 14213
14217 14220 14221
M M M M M M
14184 14190 14193 14194 14196 14200
F F F F F F
30 18 21 17 30 23
4 20 24
6 5 8
LS ;C , LS;cl LS;cl
S;cl LS;cl LS;cl
7.8 8.8 9.0
9.0 8.0 9.0
S;cl LS;cl LS;cl S;cl S;cl S;cl
7.5 8.4 6.4 9.0
6.8 6.2
1.016 1.022 1.016 1.015 1.008 1.011
1.044 1.008 1.006 1.028 1.028 1.030
Code: S - Straw
- C - Clear
LS - Light Straw cl - Cloudy
N N NN N N N .N N N NN N N NN N N NN N N NN
N N NN N N NN N N NN N N NN N N NN N N NN
N - Negative 1+ - Trace-to-Slight 2H-- Slight-to-Moderate 3+ - Moderate 4+ - Marked
OCC occ occ
F F F
M
F - Few
M - Many L - Loaded occ - Occasional
MM FF MF
F FF FF
MM FM M OCC FM FF F
FF
MT
FF
FF M IF F
F F M M M F
0) O(QD
t_n
Company Sanitized. Does not contain T S C A CBt
XNinety-Day Feeding Study in the Rat.
TABLE 24. Continued. Urinaysis Values for Male and Female Rats at Two Months
Microscopic______________________
Cal-
Blad-
Rat Volume Appear- Specific Albu- Bili- Glu- Occ.
Epi- Amor. Amm. Triple cium Bact- der
No. Sex (ml.) ance pH Gravity min rubin cose Blood WBC RBC Cells Urates Urates Phos. Ox. eria Worm:
1000- ppm. :
14243 M 24 LS;cl 9.0 1.013 N N N N
F
14246 M 16 LS;cl 6.8 1.017 N N N N
14251 M 12 LS;cl 6.0 1.026 N N N N occ F
14253 M 30 LS;C 7.8 1.010 N N N 1+
mu M M
l
LS:cl LSjcl
hi
1.013 1.015
N N
N N
NN NN
14223 F 11 S;cl 7.2 1.013 N N N N
F
14226 F 10 S;cl 9.0 1.030 N N N N
14230 F 12 LS;cl 8.8 1.016 N N N N
F
14234 F 7 S;cl 6.4 1.023 N N N N
F
14237 F 14 LS;C 7.5 1.010 N N N N
14240 F 15 LS;cl 7.8 1.009 N N N N
FF FM FF FF FF FF M OCC FM FF FF F f: FM
F
F F F
M M F M F
M M
E M
5000 ppm. :
14283 M 14 LS;cl 9.0 1.021 N N N N 14289 M 27 LS;cl 9.0 1.013 N N N N 14293 M 10 S;cl 9.0 1.034 N N N N 14295 M 40 LS;cl 9.0 1.006 N N N N 14297 M 27 LS;cl 9.0 1.012 N N N N 14300 M 23 LS;cl 6.7 1.010 N N N N
14263 F 12 S;cl 7.0 1.020 N N N N 14270 F 10 S;cl 7.2 1.017 N N N N 14273 F 14 LS;cl 9.0 1.013 N N N N 14275 F 5 Am;cl 8.5 1.024 N N N N 14279 F 8 S;C 6.0 1.026 N N N N 14281 F 4 S;C 8.2 1.028 N N N N
occ F
Code: S - Straw
C - Clear
LS - Light Straw c \ - Cloudy
Am - Amber
N - Negative 1+ - Trace-to- Slight 2+ - Slight-to-Moderate 3+ - Moderate 4+ - Marked
F - Few
M - Many L - Loaded occ - Occasional
occ F
M F F F F F
F F F M F
F
F F F M
F F M M F F
FF FF FF FM FF FF
F F F M F F
0> (D Ln OO
Company Sanitized. Does not contain T S C A C B l
Ninety-Day Feeding Study in the Rat. Urinalysis Values for Male and Female Rats at Three Months
Microscopic
Cal-
Blad-
Rat
Vo lume Appear-
Specific Albu- Bili- Glu- Occ.
Epi. Amor. Amm. Triple cium Bact- der
No. Sex (ml.) ance pH Gravity min rubin cose Blood WBC RBC Cells Urates Urates Fhos. Ox. eria Worm,
Control:
14164 M 8 LS;cl 6.8 1.053 N N N N 14169 M 7 S;cl 7.3 1.055 N N N N 14172 M 11 LS;cl 9.0 1.035 N N N N 14176 M 5 S;cl 6.5 1.066 N N N N 14179 M 4 S;cl 7.8 1.058 N N N N 14181 M 7 S;cl 6.9 1.052 N N N N
14147 F 1 S;C 6.1 1.080 N N N N 14151 F 2 S;C 6.3 1.069 N N N N 14154 F 2 S;cl 7.4 1.065 N N N N 14156 F 2 S;cl 6.1 1.065 N N N N 14158 F 1 S;C 6.0 1.080 N N N N 14161 F 2 S;C 6.7 1.065 N N N N occ
FM FFM FF 1-2 F M FFM
FM
FF FM occ F M FFF 1-2 F F occ F M
M J? F ;F M :f FT FT F 3?
F F M F F F
100 ppm.:
14203 M 7 S;cl 6.7 1.058 N N N N 14206 M 7 LS;cl 7.0 1.048 N N N . N 14210 M 6 S;cl 9.0 1.055 N N N N 14215 M 3 DS;cl 6.0 1.080 N N N N 14218 M 9 S;cl 9.0 1.045 N N N N 14219 M 6 LS;cl 6.3 1.049 N N N N
14183 F 1 S;C 6.0 1.080 N N N N 14186 F 6 LS;cl 8.0 1.045 N N N N 14190 F 6 S;cl 7.0 1.035 N N N N 14195 F 6 LS;cl 6.2 1.035 N N N N 14197 F 1 S;C 7.7 1.072 N N N N 14200 F 2 S;cl 6.0 1.065 N N N N O C C
FF FFF 2-3 F
FF FF occ M
FF
FL
1-2 F
F
FF
MF
FM
M M FF MF F :f F
F F M M F F
Code: S - Straw LS - Light Straw DS - Dark :Straw
9
C - Clear cl - Cloudy
N - Negative 1+ " Trace-to-Slight 2+ - Slight-to-Moderate 3+ - Moderate 4+ - Marked
F - Few M - Many L - Loaded occ - Occasional
Company Sanitized. Does not contain T S C A CBI
JD
O<QD
Ln
K Ninety-Day Feeding Study in the Rat. TABLE 25. Continued. Urinalysis! Values" for Mle, and: Female :Rats at Three Months.
Microscopic
Cal-
Blad-
Rat
Volume Appear-
Specific Albu- Bili- Glu- Occ.
Epi. Amor. Amm. Triple cium Bact- der
No. Sex (ml.) ance pH Gravity min rubin cose Blood WBC RBC Cells Urates Urates Phos. Ox. eria Woxmi
1000 ppm; :
14244 M 10 LS; cl 7.0 i.035 N N N 3+*
14247 M 6 S;cl 6.8 1.057 N N N N 14252 M 5 S;cl 6.6 1.065 N N N N 14255 M 4 S;C 6.0 1.065 N N N N 14257 M 10 LS;cl 9.0 1.037 .N N N 14260 M 3 S;cl 6.7 1.073 N N N N
OCC F F
F 2-3 F F
OCC F F F 2-3 F M
1-2 F M
14224 F 5 S;cl 9.0 1.045 N N N N 14227 F 2 S;C 6.7 1.068 N N N N 14232 F 3 S;cl 5.9 1.057 N N N N OCC 14236 F 2 S;C 6.0 1.075 N N N N 1-2
14238 F 2 S;cl 6.5 1.065 N N N N 14240 F 1 S;C 6.2 1.078 N N N N
FF FF
FF FF
FF FF
MW M :f F ,F F MH F
M F M F F F
5000 ppm.:
14283 14287 14291 14294 14297 14300
M M M M M M
14266 14269 14272 14276 14278 14281
F F F F F F
2 4 6 2 4 4
1 2 1 1 2 1
Am; Cl S;cl S;cl DS;cl DS;C S ;cl
S;C S;cl DS;C DS;C S;C DS;C
6.2 6.8 8.8 7.7 6.1 6.8
7.0 6.2 5.8 6.6 6.3 6.0
1.075 1.073 1.045 1.080 1.075 1.065
1.080 i.068 1.065 1.065 1.065 1.080
Code:
S - Straw LS - Light Straw DS - Dark ,Straw Am - Amber
C - Clear cl - Cloudy
)
N N NN N N NN 2+ N N 'N N N NN N N NN N N NN
N N NN N N NN N N NN N N NN N N NN N N NN
N - Negative 1+ - Trace-to-Slight 2+ - Slight-to-Moderate 3+ - Moderate 4+ - Marked
occ F F F FF FM FM
OCC F F FFF
FF occ F M
OCC F F M 1-2 F M 1-2 F M 1-2 F F
F - Few M - Many L - Loaded OCC - Occasional * Repeat 3+
F F
m
F F F
F F F F F M
U OQ
F :f F :f M
O
Company Sanitized. Does not contain T S C A CBI
Ninety-Day Feeding Study in the Rat.
Rats were normal except as noted below:
Control: 14165 14146
M F
100 PESI: 14202 14208 14185
M M F
2500 DDm. : 14288 14262
M F
thymus uterus
lung lung uterus
spleen spleen
Few petechial hemorrhages. Mild hydrouterus.
Moderate pneumonia. Mild pneumonia. Mild hydrouterus.
Slightly enlarged. Slightly enlarged.
<* m )
Company Sanitized. Does not contain TSCA CBI
Page 62 %
Ninety-Day Feeding Study in the Rat.
TABLE-26- Continued.
Necropsy Observations. Sixty-Day Interim Sacrifice.
Animal Number
Sex Organ
Comment
Rats were normal except as noted below:
Control: 14149
F
lung
Few scattered gray areas.
100 D D m . : 14221
M
liver lung
Pale. Gray pinpoint areas scattered throughout.
5000 ppm.:
14289
M
14293 14295
M M
liver testes
liver liver
Slightly pale. Left testis approximately twice the size of right.
Pale.
Pale yellow in color.
Company Sanitized. Does not contain T S C A CBI
Page 63
Ninety-Day Feeding Study in the Rat.
TABLE 26. Continued.
Necropsy Observations. Ninety-Day Terminal Sacrifice.
Animal Number
Sex Organ
Comment
Rat were normal except as noted below:
Controlr 14175 14153
M F
100 DDm.: 14214
M
1000 DDm. : 14252 14254 14227
M M F-
14233 14237
F F
5000 D D m . :
14284
M
14286
.M
14291
M
14294
M
14297
M
14266
F
14274
F
lung lung
lung
liver lung abdominal
cavity lung lung
liver lung liver liver liver lung kidney
Mild pneumonia. Mild pneumonia.
Mild pneumonia.
Slightly yellowish. Mild pneumonia.
6 mm. firm hemorrhagic area in abdominal fat
Mild pneumonia.
-
Mild pneumonia.
Slight yellowish cast. Mild pneumonia. Slight yellowish cast. Slight yellowish cast. .Slight yellowish cast. Moderate pneumonia and bronchiectasis. Hydronephorsis, right kidney.
Company Sanitized. Does not contain TS CA CBI
Page 64
Animal Number
Sex Organ
Comment
Pats were normal except as noted below:
5000 ppm.: 14299 14300
M M
liver liv e r
Slightly pale. Slightly pale.
Company Sanitized. Does not contain TSCA CBI
age 65
Ninety-Day Feeding Study in the Rat.
27. Mean Actual (Grams) and Relative (X Body Weight) Organ Weights.
Terminal
Dietary
Body Wt.
Level Sex ,,Gm,,.__
Gm.
30-Day Interim Sacrifice:
0 0 100 100 500 500 2500 2500
M 315 0.97 F 202 0.70 M 268 0.70 F 212 0.69 M 243 0.62 F 188 0.47 M 277 1.12 F 173 0.59
60-Dav Interim Sacrifice:
0 M 355 0.76
0 F 233 0.52
100 M 338 0.79
100 F 230 0.52
j|000
M 355 0.74
^000
F 210 0.54
5000
M 412 0.90
5000
F 232 0.62
90-Day Terminal Sacrifice:
0 M 495 1.08
0 F 270 0.71
100 M 469 1.14
100 F 284 0.81
1000
M 452 0.97
1000
F 284 0.77
5000
M 425 0.98
5000
F 237 0.81
21-Day Compound Withdrawal:
0 M 490 0.70
0 F 297 0.56
1000
M 507 0.91
1000
F 287 0.61
5000
M 440 0.61
5000
F 277 0.57
% Gm.
% Gm.
% Gm.
% Gm.
0.308 0.347 0.261 0.326 0.255 0.250 0.404 0.341
14.11 8.74
11.65 7.28
10.06 8.26
15.68 8.65
4.479 4.327 4.347 3.434 4.136 4.394 5.661 5.000
0.039 0.069 0.044 0.054 0.037 0.054 0.044 0.068
0.010 0.034 0.020 0.025 0.015 0.029 0.016 0.039
2.66 1.73 2.22 1.56 2.30 1.86 2.80 1.85
0.844 0.856 0.828 0.736 0.946 0.990 1.011 1.069
2.99 0.949 0.089 0.040 2.69 1.003 0.092 0.040 2.74 1.127 0.097 0.050 2.74 0.989 0.123 0.070
0.214 0.22 0.234 0.226 0.208 0.257 0.218 0.267
13.02 8.25
10.91 8.00
12.94 7.89
21.71 12.04
3.668 0.062 3.541 0.070 3.228 0.048 3.478 0.065 3.645 0.046 3.757 0.075 5.269 0.071 5.190 .0.067
0.017 0.030 0.014 0.028 0.013 0.036 0.017 0.029
2.62 1.72 2.53 1.70 2.70 1.92 3.46 2.36
0.738 0.738 0.749 0.739 0.761 0.914 0.840 1.017
3.07 0.865 0.133 0.060 3.30 0.976 0.132 0.060 3.08 0.868 0.162 0.080 3.82 0.927 0.145 0.060
0.218 0.263 0.243 0.285 0.215 0.271 0.231 0.342
14.12 8.17
14.19 8.27
15.02 10.59 20.38 10.95
2.853 3.026 3.026 2.912 3.323 3.729 4.795 4.620
0.066 0.075 0.057 0.071 0.060 0.087 0.057 0.072
0.013 0.028 0.012 0.025 0.013 0.031 0.013 0.030
2.87 1.73 2.95 1.87 3.05 2.30 3.33 2.25
0.580 0.641 0.629 0.658 0.675 0.810 0.783 0.949
3.32 0.670 0.154 0.057 3.39 0.723 0.171 0.060 3.39 0.750 0.155 0.055 3.37 0.793 0.142 0.060
0.143 0.189 0.179 0.213 0.139 0.206
14.82 9.17
17.41 9.35
16.55 10.75
3.024 3.087 3.434 3.258 3.761 3.881
0.056 0.073 0.065 0.077 0.058 0.083
0.014 0.025 0.013 0.027 0.013 0.030
2.97 2.09 3.36 2.25 3.18 2.45
0.606 0.704 0.663 0.784 0.723 0.884
3.36 0.686 0.224 0.080 3.59 0.709 0.177 0.060 3.32 0.755 0.162 0.060
D
Company Sanitized. Does not contain T S C A CBI
Thymus Gm. 1
Heart
Gm. .
1
Lung Gm.
Thyroid
Brain
% Gm.
% Gm..
1
Pituitary Gm. %
0 .90 0 .68 0 .73 0 .47 0 .67 0 .71 0 .74 0 .59
0 .286 0 .337 Q,.272 0,.222 0..276 0,.378 0,.267 0,.341
1 .15 0 .78 0 .98 0 .69 0 .94 0 .77 1.06 0 .68
0. 365 0. 386 0.,366 0.,325 0. 386 0.410 0. 383 0. 393
1.63 1.32 1.56 1.25 1.58 1.28 1.65 1.34
0.517 0.653 0.582 0.590 0.650 0.681 0.596 0.774
0.023 0.021 0.027 0.018 0.024 0.024 0.018 0.018
0.007 0.010 0.010 0.008 0.010 0.013 0.006 0.010
1.86 1.79 1.74 1.74 1.84 1.74 1.96 1.80
0.591 0.886 0.649 0.820 0.757 0.926 0.708 1.040
0.009 0.007 0.009 0.009 0.008 0.008 0.006 0.004
0.003 0.003 0.003 0.004 0.003 0.004 0.002 0.002
0,.64 0 .57 0 .79 0,.50 0..66 0,.56 0,.90 0..56
0..180 0,.244 0..234 0,.217 0..186 0,.267 0..218 0..241
1.41 0 .86 1 .17 0 .76 1 .09 0 .81 1 .36 0 .85
0.,397 0.,369 0.,346 0.,330 0.,307 0.,386 0.,330 0.,366
1.91 1.16 1.70 1.44 1.92 1.41 2.06 1.34
0.538 0.498 0.503 0.626 0.501 0.671 0.500 0.578
0.026 0.024 0.027 0.036 0.022 0.033 0.030 0.025
0.007 0.010 0.008 0.016 0.007 0.016 0.007 0.011
1.61 1.79 1.88 1.75 2.00 1.87 1.98 1.86
0.454 0.768 0.556 0.761 0.563 0.890 0.481 0.802
0.014 0.011 0.010 0.012 0.010 0.010 0.012 0.013
0.004 0.005 0.003 0.005 0.003 0.005 0.003 0.006
0..66 0,.51 0.,64 0. 52 0. 59 0. 50 0. 66 0. 50
0. 130 0.,189 0.,136 0. 183 0. 131 0. 176 0. 155 0. 211
1 .37 0 .84 1 .42 0,.87 1,.32 0..98 1,.29 0..85
0. 277 0. 311 0. 303 0. 306 0. 292 0. 345 0. 304 0. 359
2.02 1.37 2.11 1.40 2.08 1.48 1.91 1.54
0.408 0.507 0.450 0.493 0.460 0.521 0.449 0.650
0.028 0.025 0.027 0.024 0.028 0.031 0.025 0.022
0.006 0.009 0.006 0.008 0.006 0.011 0.006 0.009
1.92 1.82 1.99 1.87 1.96 1.89 2.00 1.85
0.388 0.674 0.424 0.658 0.434 0.665 0.471 0.781
0.014 0.013 0.011 0.013 0.013 0.013 0.010 0.010
0.003 0.005 0.002 0.005 0.003 0.005 0.002 0.004
0. 79 0. 52 0. 84 0. 58 0. 67 0. 62
0. 161 0. 175 0. 166 0. 202 0. 152 0. 224
1..32 0..89 1.,51 0.,84 1.,28 0.,93
0. 269 0. 300 0. 298 0. 293 0. 291 0. 336
2.47 1.53 2.29 1.63 1.82 1.60
0.504 0.515 0.452 0.568 0.414 0.578
0.035 0.026 0.036 0.029 0.030 0.030
0.007 0.009 0.007 0.010 0.007 0.010
2.07 1.87 2.12 1.95 2.01 1.90
0.422 0.630 0.418 0.680 0.457 0.686
0.010 0.012 0.014 0.014 0.012 0.012
0.002 0.004 0.003 0.005 0.003 0.005
Company Sanitized. Does not contain T S C A CB!
Ninety-Day Feeding Study in the Rat
TABLE 28. Organ Weights, Grams
Animal
Terminal
No. &
Weight Soleen
GrouD Sex Grams
30-DAY INTERIM SACRIFICE:
Control: 14162 M 14165 M 14168 M 14142 F 14145 F 14146 F
270 360 315 205 175 225
1.09 0.92 0.89 0.52 0.99 0.60
100 D D m . 14202 14205 14208 14182 14185 14188
M M M F F' F
275 300 230 280 190 165
0.94 0.67 0.50 0.57 1.10 0.40
500 onm, 14242 M
14245 M 14248 M 14222 F 14225 F 14228 F
225 270 235 205 160 200
0.49 0.79 0.59 0.50 0.40 0.50
2500 DDm.: 14282 M 14285 M 14288 M 14262 F 14265 F 14268 F
255 290 285 195 170 155
0.71 0.90 1.76 0.99 0.47 0.32
, Liver Adrenals
12.02 17.02 13.30
8.63 8.11 9.49
0.024 0.051 0.043 0.079
0.056 0.071
12.51 13.42
9.02 7.75 7.81 6.28
0.044 0.050
0.038 0.060 0.053 0.048
9.49 11.02 9.66
9.20 7.08 8.51
0.028
0.046 0.036 0.052 0.051 0.060
14.75 15.29 16.99 10.35
7.78 7.82
0.061 0.051 0.019 0.079 0.056 0.068
Kidnevs
2.35 3.11 2.52 1.79 1.50 1.91
2.39 2.41 1.86 1.61 1.67 1.42
2.16 2.52 2.21 1.96 1.59 2.04
2.49 2.90 3.00 2.12 1.70 1.74
Testes/ Ovaries
3.06 2.81 3.10 0.084 0.063 0.120
2.76 3.11 2.19 0.110 0.092 0.075
2.83 2.82 2.56 0.084 0.083 0.123
2.29 2.83 3.10 0.100 0.117 0.153
Thymus
0.75 0.93 1.01 0.79 0.53 0.71
0.81 0.69 0.70 0.60 0.41 0.39
0.50 0.93 0.58 0.80 0.45 0.87
0.65 0.88 0.70 0.67 0.61 0.50
Heart
0.90 1.43 1.12 0.79 0.71 0.85
0.93 1.07 0.93 0.72 0.65 0.70
0.99 1.03 0.79 0.81 0.70 0.80
0.96 1.02 1.20 0.76 0.65 0.63
Lune Thyroid
1.44 1.68 1.76 1.30 1.22 1.45
0.020 0.024 0.025 0.022 0.020 0.021
1.84 1.47 1.37 1.30 1.36 1.08
0.025 0.027 0.029 0.030 0.012 0.012
1.76 1.60 1.38 1.31 1.14 1.38
0.033 0.023 0.016 0.028 0.026 0.018
1.46 1.40 2.08 1.41 1.14 1.47
0.026 0.019 0.010 0.021 0.013 0.020
Brain
1.84 1.83 1.92 8.80 1.78 1.80
1.90 1.72 1.61 1.70 1.72 1.79
1.73 2.00 1.78 1.71 1.71 1.79
1.93 2.01 1.94 1.81 1.75 1.83
Pituitary
0.007 0.010 0.008 0.008 0.006 0.007
0.009 0.008 0.010 0.010 0.010 0.007
0.006 0.010 0.007 0.007 0.007 0.009
0.005 0.006 0.007 0.003 0.002 0.006
Page 67
Company Sanitized. Does not contain TSCA CBI
Ninety-Day Feeding Study in the Rat.
"t a b l e 2.8. Continued. Organ Weights , Grams.
Animal
Terminal
No. &
Weight Soleen
GrouD Sex Grams
21-DAY COMPOUND WITHDRAWAL:
Control: 14177 M 14179 M 14180 M 14158 F 14159 F 14161 F
420 520 530 280 320 290
/ 0.60
0.65 0.85 0.42 0.53 0.73
1000 DDm. 14258 M 14259 M 14260 M 14238 F 14239 F 14240 F
5000 DDm, 14298 M 14299 M 14300 M 14278 F 14279 F 14280 F
560 470 490 280 290 290
340 535 445 280 260 290
1.05 0.63 1.05 0.68 0.57 0.59
0.55 0.78 0.50 0.57 0.53 0.62
Liver Adrenals
11.80 14.98 17.68
8.48 9.34 9.70
0.050 0.064 0.055 0.071 0.072 0.075
18.65 17'.40 16.17
8.90 9.63 9.52
0.064 0.068 0.062 0.081 0.069 0.081
11.10 22.95 15.61 11.10 10.13 11.01
0.051 0.074 0.048 0.087 0.085 0.077
Kidnevs
2.67 3.02 3.22 1.98 2.15 2.15
3.65 3.20 3.23 2.26 2.40 2.09
2.80 3.75 2.98 2.30 2.52 2.52
Testes/ Ovaries
3.30 3.29 3.50 0.185 0.248 0.239
3.80 3.55 3.41 0.180 0.192 0.160
3.32 3.40 3.25 0.124 0.160 0.203
Thymus
0.58 0.88 0.90 0.41 0.64 0.51
0.90 0.83 0.80 0.52 0.61 0.60
0.58 0.75 0.68 0.61 0.60 0.65
Heart
1.18 1.41 1.38 0.93 0.90 0.85
1.70 1.41 1.41 0.80 0.91 0.82
1.05 1.60 1.20 0.88 0.92 1.00
Lung Thyroid
2.43 2.23 2.75 1.57 1.50 1.52
0.030 0.034 0.042 0.041 0.018 0.020
2.23 2.30 2.34 2.11 1.42 1.35
0.035 0.034 0.038 0.027 0.023 0.037
1.64 2.09 1.72 1.70 1.32 1.78
0.018 0.044 0.028 0.029 0.034 0.028
Brain
2.21 2.07 1.93 1.80 1.92 1.90
2.15 2.00 2.22 1.98 1.81 2.06
2.01 2.13 1.90 1.78 1.93 1.98
Pituitary
0.010 0.010 0.010 0.011 0.010 0.014
0.014 0.015 0.012 0.015 0.010 0.017
0.012 0.014 0.010 0.009 0.014 0.013
Page 68
Company Sanitized. Does not contain TSCA CBI
,Ninety-Day Feeding Study in the Rat. TABLE 28. Continued. Organ Weights, Grams.
-
Animal
Terminal
No. &
Weight Spleen
Group Sex Grams
60-DAY INTERIM SACRIFICE:
Control: 14167 M 14170 M 14178 M 14143 F 14149 F 14152 F
340 385 340 200 260 240
0.81 0.71 0.75 0.49 0.47 0.59
100 ppm. : 14217 M 14220 M 14221 M 14184 F 14193 F 14194 F
1000 ppm,; 14246 M 14251 M 14253 M 14223 F 14230 F 14234 F
325 0.79 340 0.79 350 0.79 215 0.41 235 0.54 240 0.61
320 0.62 360 0.79 385 0.81 215 0.55 220 0.65 195 0.41
5000 ODDI , J 14289 M 14293 M 14295 M 14263 F 14270 F 14275 F
450 355 430 265 200 230
0.71 1.34 0.66 0.50 0.55 0.80
Liver Adrenals
13.13 14.70 11.24
7.28
8.88 8.58
0.058 0.069 0.059 0.059 0.071 0.080
11.78 10.52 10.44
8.29 7.70
0.051 0.053 0.041 0.062 0.064 0.069
11.75 14.00 13.08
8.24 8.01 7.42
0.050 0.048 0.041 0.081 0.076 0.068
26.05 16.75 22.33 13.71 10.29 12.11
0.070 0.067 0.075 0.074 0.063 0.065
Kidnevs
2.60 2.90 2.36 1.55 1.90 1.71
2.69 2.31 2.59 1.61 1.66 1.82
2.57 3.09 2.45 1.89 2.01 1.85
3.49 3.33 3.56 2.46 2.20 2.41
Testes/ Ovaries Thvmus
3.14 2.89 3.19 0.170 0.100 0.130
0.69 0.70 0.52 0.49 0.69 0.53
3.32 3.31 3.27 0.144 0.135 0.118
0.83 0.96 0.59 0.45 0.47 0.58
2.70 3.17 3.37 0.138 0.200 0.149
0.60 0.62 0.77 0.58 0.50 0.60
1.69, 2. 95 1.00
3.32
0.91
3.49
0.78
0.168 0.68
0.079 0.50
0.188 0.50
Heart
1.16 1.48 1.58 0.75 0.98 0.84
1.13 1.22 1.15 0.70 0.80 0.78
1.12 1.11 1.05 0.89 0.88 0.66
1.40 1.38 1.29 0.87 0.80 0.89
Lune Thvroid
1.67 2.03 2.02 1.07 1.22 1.19
0.027 0.027 0.025 0.015 0.031 0.027
1.60 1.81 1.69 1.15 1.78 1.38
0.037 0.025 0.019 0.044 0.023 0.042
1.95 1.81 2.01 1.40 1.62 1.21
0.024 0.029 0.014 0.042 0.038 0.018
1.89 2.19 2.11 1.29 1.44 1.30
0.029 0.036 0.025 0.021 0.033 0.022
Brain
1.81 1.20 1.81 1.87 1.74 1.75
2.01 1.71 1.92 1.79 1.73 1.73
1.91 1.99 2.09 1.82 1.90 1.90
1.90 1.96 2.08 1.80 1.88 1.90
Pituitarv
0.014 0.017 ' 0.011 0.01 0.009 0.014
0.010 0.009
-
0.012 0.013 0.010
0.010 0.012 0.008 0.010 0.009 0.010
0.014 0.013 0.009 0.019 0.012 0.007
Page 69
Company Sanitized. Does not contain TSCA CBI
Ninety-Day Feeding Study in the Rat.
TABLE 28. Continued
Organ Weights, Grams.
Animal
Terminal
No. &
Weight Spleen
Group Sex Grams
90-DAY TERMINAL SACRIFICE:
Control ; 14163 M 14164 M 14166 M 14169 M 14171 M 14172 M 14173 M 14174 M 14175 M 14176 M 14144 F 14147 F 14148 F 14150 F 14151 F 14153 F 14154 F 14155 F 14156 F 14157 F
410 545 420 460 430 490 800 450 545 400 325 255 280 300 250 255 275 255 290 210
1.10 1.22 0.91 1.11 1.32 1.10 0.99 1.00 1.28 0.75 1.00 0.51 0.76 0.75 0.71 0.69 0.72 0.81 0.78 0.39
Liver Adrenals
11.63 17.92 12.83 14.18 13.81 15.47 11.91 15.12 17.71 10.48
9.90 7.11 8.62 9.80 7.50 7.88 8.39 8.32 8.63 5.58
0.061 0.059 0.053 0.063 0.066 0.078 0.058 0.080 0.065 0.081 0.096 0.065 0.060 0.084 0.051 0.080 0.078 0.090 0.090 0.055
Kidneys
2.29 3.71 2.51 3.10 2.79 3.10 2.39 3.02 3.12 2.65 2.49 1.52 1.70 1.92 1.61 1.58 1.72 1.60 1.89 1.23
Testes/ Ovaries
2.80 3.58 3.22 3.65 3.37 3.19 3.15 3.31 3.49 3.42 0.242 0.134 0.155 0.167 0.104 0.147 0.140 0.70 0.154 0.123
Thvmus
0.52 1.09 0.43 0.71 0.59 0.95 0.41 0.69 0.60 0.58 0.60 0.52 0.39 0.51 0.60 0.60 0.51 0.53 0.38 0.41
Heart
1.22 1.90 1.13 1.23 1.40 1.38 1.12 1.38 1.58 1.39 1.05 0.80 0.71 0.98 0.75 0.83 0.78 0.85 0.89 0.73
Lung Thvroid
2.00 2.38 1.64 1.78 2.09 2.07 2.03 1.60 2.92 1.68 1.71 1.00
1.35 1.52 1.21 1.61 1.48 1.37 1.40
1.05
0.040 0.051 0.019 0.036 0.021 0.024 0.020 0.019 0.026 0.025 0.031 0.015 0.024 0.031 0.031 0.023 0.030 0.024 0.023 0.018
Brain Pituitary
1.88 2.02 1.88 2.01 1.81 1.91 1.80 1.85 2.00 2.08 1.85 1.70 1.80 1.92 1.65 1.85 1.82 1.80 1.89 1.89
0.009 0.017 0.014 0.012 0.014 0.013 0.014 0.015 0.015 0.012
0.014 0.013
0.013 0.013
4.
0.014 0.016 0.012 0.008
Company Sanitized. Does not contain T S C A CBI
Ninety-Day Feeding Study in the Rat.
FABLE 28 . Continued. Organ Weights, Grams.
Animal
Terminal
Sto. &
Weight Spleen
SrouD Sex Grams
90-DAY TERMINAL SACRIFICE:
LOO ppm.: L4203 M
1.4204 M 14206 M 14207 M 14209 M 14210 M 14211 M 14213 M. 14214 M 14215 M 14216 M 14218 M 14219 M 14183 F 14186 F 14187 F 14189 F 14190 F 14191 F 14192 F 14195 F 14196 F 14197 F 14198 F 14199 F 14200 F
14201 F
455 560 465 435 400 520 470 380 485 420 535 520 450 310 345 280 265 255 290 245 280 270 260
295 280 285 310
1.49 0.99 1.20 1.20 1.21 1.24 1.48 1.03 1.02 0.70 0.90 1.41 1.00 0.64 0.81 0.81 1.10 0.70 1.22 0.68 0.71 0.89
0.54 1.00 0.76 0.81 0.68
Liver Adrenals
1.4.08 17.48 14.60 12.02 12.0/ 15.48 13.78 11.20 14.03 12.49 15.90 17.65 13.65
8.78 9.62 8.00 8.40 7.58 7.51 7.58 8.50 8.59 7.32 8.40 8.83 8.80 7.88
0.051 0.061 0.067 0.060 0.054 0.053 0.035 0.051 0.061. 0.056 0.055 0.081 0.055 0.076 0.093 0.074 0.081 0.067 0.061 0.069 0.093 0.064
0.049 0.055 0.050 0.077 0.084
Kidneys
2.50 3.38 3.25 3.05 2.72 2.79 3.10 2.61 2.89 2.80 3.29 3.02 2.95 1.93 2.15 1.77 1.91 1.58 1.96 1.80 2.01 1.80
1.72 1.79 1.81 1.98 1.99
Testes/ Ovaries
3.05 3.70 3.50 3.93 3.19 3.10 3.42 3.43 3.50 3.33 3.32 3.74 2.85 0.210 0.203 0.186 0.183 0.165 0.168 0.161 0.161 0.177 0.116 0.181 0.170
0.119 0.198
Thvmus
0.41 0.60 0.60 0.82 0.44 1.11 0.36 0.58 0.60 0.90 0.59 0.72 0.54 0.50 0.58 0.44 0.81 0.33 0.56 0.30 0.60 0.48 0.49 0.42
0.61 0.71 0.48
Heart
1.43 1.73 1.38 1.22 1.28 1.39 1.43 1.20 1.46 1.30 1.50 1.71 1.40 0.80 1.14 0.79 0.83 0.71 0.92 0.72 0.93 0.89 0.88 0.79
1.01 0.81 0.93
Lung Thyroid
2.28 2.10 2.72 1.74 1.90 2.20 1.95 1.62 2.71 2.08 2.02 2.21 1.90 1.52 1.34 1.21 1.42 1.29 1.43 1.43 1.30 1.53 1.28
1.60 1.41 1.37 1.50
0.019 0.025 0.024 0.023 0.025 0.021 0.039
0.027 0.028 0.036 0.022 0.029 0.028 0.034 0.026 0.027 0.023 0.016 0.023 0.026 0.028 0.022 0.014 0.019 0.023 0.020
Brain
1.85 1.93 2.08 2.08 1.82 1.90 2.19 2.09 2.09 2.00 1.97 1.83 2.08 1.78 2.02 1.90 1.73 1.75 1.89 1.91 1.88 1.92 1.77 1.92
1.81 1.87 2.09
Pituitary
0.007 0.014 0.011 0.009 0.009 0.010 0.011 0.009 0.013 0.011 0.013 0.015 0.010 0.014 0.014 0.018 0.015 0.011 0.012 0.011 0.014 0.008
0.012 0.013 0.015 0.014 0.013
Page 71
Company Sanitized. Does not contain TSCA CBI
'mm9\ Ninety-Day Feeding Study in the Rat
''TABLE 28. Continued. Organ Weights, Grams.
Animal No. & Group
Terminal Weight
Sex Grams
, Spleen Liver
Adrenals
Kidneys
Testes/ Ovaries
Thymus
Heart
Lung Thyroid
Brain
Pituitary
90-DAY TERMINAL SACRIFICE:
1000 ppm.: 14243 M 14244 M. 14247 M 14249 M 14250 M
14252 M 14254 M 14255 M L4256 M 14257 M 14224 F 14226 F 14227 F 14229 F 14231 F 14232 F 14233 F 14235 F 14236 F 14237 F
455 535 475 470 440 470 460 410 385 415 290 270 295 305 320 280 230
325 275 250
1.09 0.97 0.99 1.17 0.89 0.79 1.18 1.00 1.01 0.63 0.69 0.51 0.50 0.89 0.77 0.77 1.22 0.84
0.61 0.88
12.68 17.13 16.20 15.88 16.13 16.61 15.50 12.80 12.39 14.90 12.38
8.91 9.40 10.75 11.55 11.00 14.39 8.14 10.52 8.81
0.054 0.065 0.053 0.082 0.057 0.067 0.058 0.053 0.055 0.055 0.107 0.066 0.073 0.075 0.097 0.096 0.116 Missed
0.074 0.077
2.87 3.51 3.00 3.21 3.01 3.42 3.23 2.60 2.58 3.03 2.60 2.21 2.49 2.10 2.55 2.17 2.89
1.73 2.21 2.08
3.39 3.60 3.40 3.58 3.30 3.80
3.41 3.30 2.81
3.29 0.172 0.097 0.127 0.186 0.206
0.201
0.171 0.130 0.144 0.117
0.27 0.98 0.41 0.68 0.42 0.60 0.59 0.79 0.35 0.78 0.40 0.22 0.35 0.61 0.37 0.80 0.68 0.31
0.50 0.75
1.30 1.50 1.31 1.51 1.32 1.39 1.31 1.21 1.10
1.21 0.90 1.40 0.85 0.98 1.09
0.88 1.12 0.70 0.91 1.00
1.92 2.94 2.21 1.65 1.98 1.93 2.75 2.00 1.71 1.68 1.49 1.39 1.52 1.35 1.83 1.24 1.65 1.20
1.33 1.79
0.019 0.026 0.031 0.034 0.031 0.029 0.017 0.026 0.024 0.040 0.027 0.037 Missed Missed
0.026 0.040 0.031 0.022 0.028 0.034
1.82 1.98 2.25 1.93 1.91 1.89 1.81 2.01 1.98 1.99 1.81 1.89 1.90 1.91 2.08 1.90 1.99
1.68 1.92 1.85
0.030 0.012 0.010 0.012 0.013 Missed 0.012 0.012 0.008 0.009
0.011 0.005 0.009 0.012 0.010 0.014 0.019 0.014 0.017 0.016
Page 72
Company Sanitized. Does not contain T S C A CBI
Ninety-Day Feeding Study in the Rat.
`TABLE 28. Continued. Organ Weights , Grams.
7
Animal
Terminal
No. &
Weight Spleen
Group Sex Grams
90-DAY TERMINAL SACRIFICE:
1.000 D D m . : 14293 M 14244 M 14247 M 14249 M 142.50 M 14252 M 14254 M 14235 M 1.4256 M 14257 M 14224 F 14226 F 14227 F 14229 F 14231 F 14232 F 14233 F 14235 F 14236 F 14237 F
455 535 4 75 470 440
470 460 410 .385
415 290
270 295 305 .320 280 230 325 275 250
1.09
0.97 0.99 1.17 0.89
0.79 1.18 1.00 1.01 0.63 0.69 0.51 0.50 0.89 0.77 0.77 1.22 0.84 0.61 0.88
Liver Adrenals
12.68
17.13 16.20 15.88 16.13 16.61 15.50 12.80 12 .'39 14.90 12.38
8.91 9.40 10.75 11.55 11.00
14.39 8.14
10.52 8.81
0.054 0.065 0.053 0.082 0.057 0.067 0.058 0.053 0.055 0.055 0.107 0.066 0.073 0.075 0.097 0.096 0.116 Missed 0.074 0.077
Kidneys
2.87 3.51 3.00 3.21 3.01 3.42 3.23 2.60 2.58 3.03 2.60 2.21 2.49 2.10 2.55 2.17 2.89 1.73 2.21 2.08
Testes/ Ovaries
3.39 3.60 3.40 3.58 3.30 3.80 3.41 3.30 2.81 3.29 0.172 0.097 0.127 0.186 0.206 0.201 0.171 0.130 0.144 0.117
Thvmus
0.27 0.98 0.41 0.68 0.42 0.60 0.59 0.79 0.35 0.78 0.40 0.22 0.35 0.61 0.37 .0.80 0.68 0.31 0.50 0.75
Heart
1.30 1.50 1.31 1.51 1.32 1.39 1.31 1.21 1.10 1.21 0.90 1.40 0.85 0.98 1.09 0.88 1.12 0.70 0.91 1.00
Lung Thvroid Brain
1.92 2.94 2.21 1.65 1.98 1.93 2.75 2.00 1.71 1.68
1.49 1.39 1.52 1.35 1.83 1.24 1.65 1.20 1.33 1.79
0.019 0.026 0.031 0.034 0.031 0.029 0.017 0.026 0.024 0.040
0.027 0.037 Missed Missed 0.026 0.040
0.031 0.022 0.028 0.034
1.82 1.98 2.25 1.93 1.91 1.89 1.81 2.01 1.98 1.99 1.81 1.89 1.90 1.91 2.08 1.90 1.99 1.68 1.92 1.85
Pituitary
0.030 0.012 0.010 0.012 0.013 Missed 0.012 0.012 0.008 0.009
0 .011
0.005 0.009 0.012 0.010 0.014 0.019 0.014 0.017 0.016
Page 72
Company Sanitized. Does not contain T S C A CBI
Ninety-Day Feeding Study in the Rat.
TABLE 28. Continued. Organ Weights , Grams.
4
Animal
Terminal
No. &
Weight Spleen
Group Sex Grams
90-DAY TERMINAL SACRIFICE:
5000 d o d i . : 14283 M
14284 M 14286 M 14287 M 14290 M 14291 M 14292 M 14294 M 14296 M 14297 M 14264 F 14266 F 14267 F 14269 F 14271 F 14272 F 14273 F 14274 F 14276 F 14277 F
420
525 345 425 430 410 390 395 430 480 220 225 250 220 270 215 240 240 250 235
1.30 1.02 0.98 1.11 0.90 0.51 1.19 0.77 1.12 0.91 0.90 0.83 0.48 0.58 1.08 0.67 0.70 1.51 0.48 0.83
Liver Adrenals
19.57 0.058 25.68 0.065 15.13 0.059 20.11 0.050 21.49 0.059 21.65 0.060 19.82 0.050 18.30 0.054 19.82 0.054 22.19 0.058
9.84 0.063 11.40 0.077 10.85 0.067 11.01 0.068 11.91 0.072
9.57 0.083 11.75 0.062 10.41 . 0.059 11.30 0.085 11.41 0.079
Kidnevs
3.30 3.91 2.62 3.30 3.38 3.18 3.20 3.30 3.31 3.80 2.00 2.03 2.28 2.25 2.78 1.80 2.38 2.45 2.12 2.40
Testes/ Ovaries
3.30 2.87 3.21 3.39 3.60 3.20 3.49 3.40 3.60 3.61 0.146 0.122 0.178 0.092
0.130 0.180 0.107 0.144 0.182
Thvmus
0.58 1.32 0.69 0.80 0.42 0.59 0.63 0.30 0.79 0.51 0.41
0.58 0.53 0.57 0.58 0.42 0.51 0.43 0.48
Heart
1.21 1.43 0.91 1.30 1.58 1.17 1.20 1.38 1.42 1.28 0.78 0.80 0.72 0.83 0.98 0.70 0.90 0.83 1.03 0.95
Lung Thyro id
1.88
2.35 2.18 1.98 1.61 2.02 1.42 2.09 1.60 1.92 1.38 2.93 1.28 1.13 1.40 1.32 1.21 1.60 1.61 1.51
0.024 0.035 0.023 0.029 0.027 0.031 0.019 0.021 0.023 0.017 0.020 0.018 0.019 0.024 0.018 0.032 0.018
0.015 0.031 0.025
Brain
2.04 2.09 2.08 2.10 1.92 1.83 2.02 1.90 1.92 2.05 1.78 1.88 1.80 1.91 1.79 1.91 1.98 1.81 1.81 1.78
Pituitary
0.010
0.015 ' 0.008
0.011 0.012 0.010 0.009 0.008 0.010 0.011 0.010 0.011 0.012 0.011
.
0.010 0.007 0.008 0.013
Page 73
Company Sanitized. Does not contain TSCA CBI
:Page 74
Ninety-Day Feeding Study in the Rat.
TABLE 29. Incidence of Histopathologic Lesions.
brain - no lesion - glial nodules
spinal cord - no lesion peripheral nerve - no lesion eye - no lesion pituitary - no lesion thyroid - no lesion parathyroid - no lesion adrenal - no lesion
- ossification lung - no lesion
- chronic respiratory disease heart - no lesion
- arteritis spleen - no lesion
- hematopoiesis lymph node - no lesion thymus - no lesion bone marrow - no lesion saliv'ary gland - no lesion stomach - no lesion small intestine - no lesion large intestine - no lesion
- nematodes
30 Day Interim Sacrifice
60 Day Interim Sacrifice
Control 2500 ppm. Control 5000 ppm.
M FM FM FMF
3/3 3/3 3/3 3/3 3/3 3/3 3/3 3/3
3/3 3/3 2/2 3/3 3/3 3/3 3/3 3/3 3/3 3/3 3/3 3/3 3/3 3/3 3/3 3/3 3/3 3/3 3/3 3/3 3/3 3/3 3/3 2/2 2/2 3/3 2/2 1/1 3/3 2/2 3/3 2/2 3/3 3/3 3/3 3/3 3/3 3/3 3/3 3/3
1/1 3/3 3/3 2/2 1/1 3/3 3/3 3/3 3/3 3/3 3/3 3/3 3/3
3/3 2/3 3/3 2/3 3/3 2/3 3/3 3/3 1/3 1/3 1/3
3/3 3/3 3/3 3/3 3/3 3/3 3/3 3/3
3/3 3/3 2/3 3/3 3/3 3/3 3/3 3/3
1/3 3/3 3/3 3/3 3/3 2/2 3/3 3/3 3/3 3/3 3/3 3/3 3/3 3/3 3/3 3/3 3/3 3/3 3/3 3/3 3/3 3/3 3/3 3/3 3/3 3/3 3/3 3/3 3/3 3/3 2/2 3/3 3/3 3/3 3/3 3/3 3/3 3/3 3/3 3/3 3/3 3/3 3/3 3/3 3/3 3/3 3/3 3/3 3/3 3/3 3/3 3/3 3/3 3/3 3/3 2/3 3/3
1/3
_
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90 Day
Tieerminal Sacrifice_______
Control 1000 Dom.
5000 DDm.
__M__ F__ _M__ __E-- ___ n---_ J L -------
10/10 10/10
9/10 10/10
21 Day ___ Withdrawal. Control 5000 DDm,
M T? M F
3/3 3/3 3/3 3/3
1/10
8/8 9/9 9/9 9/9 10/10 9/9 9/9 3/3 10/10 9/9 : 5/5 6/6 10/10 10/10
9/9 9/9 9/9 8/8 9/9 9/9 8/8 1/1 10/10 9/9 3/3 2/2 9/10 10/10
3/3 3/3 3/3 3/3 3/3 3/3 3/3 3/3 3/3 3/3 3/3 3/3 3/3 3/3 3/3 3/3 3/3 3/3 3/3 3/3 1/1 1/1 3/3 1/1 3/3 3/3 3/3 3/3
j
5/10 9/10 5/10 1/10 9/10 10/10
1/10 7/10 7/10 3/10 3/10 10/10 10/10
2/3 1/3 2/3 1/3 1/3 2/3 1/3 2/3 3/3 3/3 3/3 3/3
1/10 10/10 10/10
9/9 10/10
3/3 3/3 3/3 3/3
9/9 9/9 10/10 9/9 10/10 10/10 10/10
8/8 9/9 10/10 9/9 10/10 10/10 10/10
8/8 10/10 9/9 8/8 9/9 10/10 9/9 ' 8/8 10/10 10/10 10/10 10/10 10/10 9/10
1/10
3/3 2/2 3/3 3/3 3/3 3/3 3/3 3/3 3/3 3/3 3/3 3/3 3/3 3/3 3/3 3/3 3/3 3/3 3/3 3/3 3/3 3/3 3/3 3/3 3/3 3/3 3/3 3/3
Company Sanitized. Does not contain TSCA CBI
Page 75
j!.age 76
Ninety-Day Feeding Study in the Rat. ^ ----
Stable 2 9 . continued.
Incidence of Histopathologic Lesions.
30 Day
60 Day
Interim Sacrifice Interim Sacrifice
Control 2500 ppm. Control 5000 ppm.
Tissue and Lesion
mfmfmfmf
pancreas - no lesion
3/3 3/3 3/3 3/3 3/3 3/3 3/3 3/3
pancreatitis, focal liver - no lesion
- portal inflammatory infiltrate - centrolobular change kidney - no lesion - focal nephritis
2/3 3/3 0/3 2/3 2/3 2/3 0/3 0/3 1/3 1/3 1/3 1/3 1/3 1/3
3/3 3/3 2/2 3/3 3/3 3/3 2/3 3/3 3/3 3/3 3/3
1/3
- hyaline droplets urinary bladder - no lesion
- siminal plug W . ..
testes or ovaries - no lesion - edema
prostate or uterus - no lesion
2/3 3/3 3/3 3/3 3/3 3/3 3/3 3/3
1/3 3/3 3/3 3/3 3/3 3/3 3/3 2/3 3/3
1/3 3/3 3/3 3/3 3/3 3/3 3/3 3/3 3/3
- hydrometra skeletal muscle - no lesion skin - no lesion bone - no lesion
3/3 3/3 3/3 3/3 3/3 3/3 3/3 3/3 3/3 3/3 3/3 3/3 3/3 3/3 3/3 3/3 3/3 3/3 3/3 3/3 3/3 3/3 3/3 3/3
Company Sanitized. Does not contain TSCA CBI
90 Day
Terumiij.nuaali Sacrifice_____
11*G 1
Control 1000 DDm.
5000
M
T? M
F
M
F
10/10 10/10
10/10 10/10
7/10 3/10 1/10 8/10
5/10 5/10
10/10
7/10 3/10
6/10 4/10
1/10 1/10 9/10 10/10
2/10 8/10 2/10 9/10 1/10
2/10 6/8 9/9 k}2/8 ^!o/io 10/10
10/10 9/9 10/10 10/10
10/10 9/10 1/10
9/9 10/10 9/9 10/10 ; L0/10 10/10
10/10 10/10
10/10 9/9 9/9 6/6
10/10 10/10
21 Day Withdrawal Control 5000 DDm, M FM F 2/3 3/3 3/3 3/3 1/3 2/3 2/3 0/3 0/3 1/3 1/3 1/3 3/3
2/3 3/3 3/3 3/3 2/3
1/3
1/2 3/3 3/3 3/3 1/2 3/3 3/3 3/3 3/3
3/3 3/3 2/2 2/2
3/3 3/3 3/3 3/3 3/3 3/3 3/3 3/3 3/3 3/3 3/3 3/3
Page 77
Company Sanitized. Does not contain TSCA CBI
Page 78
*-- V TABLE 3Q.
Ninety-Day Feeding Study in the Rat Histopathologic Observations. Thirty-Day Interim Sacrifice.
Animal Number
Sex Tissue
Comment
Control : 14162 14165 14168 14142 14145 14146
M M M F F F
2500 DDm.: 14282 14285
M M
14288
M
14262
14265 14268
F
F F
liver urinary bladder lung
Mild portal lymphocytic infiltrate. No lesion. Seminal plug. No lesion ... Small focus of pneumonic consolidation. No lesion.
liver liver
liver
spleen liver kidney lung
Slight hypertrophy of centrolobular hepatocytes.
Slight hypertrophy of centrolobular hepatocytes with loss of coarse cytoplasmic granularity.
Slight hypertrophy of centrolobular hepatocytes
with loss of usual coarse granularity.
Moderate hematopotic activity.
1
Mild portal lymphocytic infiltrate. Mild focal interstitial lymphocytic infiltrate.
Moderate peribronchial lymphoid hyperplasia.
No lesion.
*
_______
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Page 79
Ninety-Day Feeding Study in the Rat.
TABLE 30. Continued. Histopathologic Observations. Sixty-Day Interim Sacrifice.
Animal Number
Sex Tissue
Comment
Control: 14167 14170 14178 14143 14149
14152
5000 DDm. 14289
M M M F F
F
M
14293
M
14295
14263 14270 14275
M
F F F
liver
liver lung
No lesion. No lesion. Slight portal lymphocytic infiltrate.
No lesion.
Slight portal lymphocytic infiltrate.
_
Few small scattered foci of pneumonic consolidation.
No lesion.
large intestine testes liver
liver
liver
liver liver liver
Nematodes. One testis was edematous and had reduced spermatogenic activity. Hypertrophy of hepatocytes which was more pronounced in the centrolobular area; hepatocytes appeared to have higher glycogen content than controls.
Moderate hypertrophy of hepatocytes,. predominately centrolobular with loss of coarse granularity. Moderate portal lymphocytic infiltrate with scattered small nodules of proliferated reticuloendothelial cells in liver parenchyma.
Hypertrophy of hepatocytes, primarily centrolobular, hepatocytes appeared to contain more glycogen than control.
Slight hypertrophy of hepatocytes, predominately centrolobular.
Slight portal lymphocytic infiltrate.
Slight hypertrophy of centrolobular hepatocytes.
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Page 80
Ninety-Day Feeding Study in the Rat.
TABLE 39. Continued. Histopathologic Observations. Ninety-Day Terminal Sacrifice.
Animal Number
Sex Tissue
Comment
Control : 14163 14164 14166 14169
M M M M
14171 14172
14173
14174 14175
M M
M
M M
14176
14144 14147 14148
M
F F F
lung urinary bladder
kidney liver lung urinary bladder lung lung kidney
liver
lung liver heart
liver
Moderate perivascular lymphocytic cuffing.
Seminal plug.
No lesion.
Small numbers of hyaline droplets in epithelium
of convoluted tubules. Slight portal lymphocytic infiltrate and bile
duct proliferation.
,
Moderate perivascular lymphocytic cuffing with localized pneumonitis.
Seminal plug. Slight perivascular lymphocytic cuffing, peribronchial lymphoid hyperplasia.
Slight peribronchial lymphoid hyperplasia. Moderate numbers of hyaline droplets in epithelium of convoluted tubules.
No lesion.
Slight portal lymphocytic infiltrate, centrolobular hepatocytes less coarsely granular. Slight perivascular lymphocytic cuffing.
Slight portal lymphocytic infiltrate. Moderate mural necrosis and perivascular inflammatory infiltrate of a coronary vessel.
No lesion.
No lesion. Slight portal lymphocytic infiltrate and bile duct proliferation.
Company
Dpgg notaonialn TSCJ\
Page 81
Ninety-Day Feeding Study in the Rat. TABLE 30. Continued. Histopathologic Observations. Ninety-Day Terminal Sacrifice.
Animal Number
Sex Tissue
Comment
Control (cont'd):
14150 14151 14153
F
F liver
F lung liver
14154
F uterus liver
14155
F liver
14156
F
14157
F
No lesion.
Slight portal lymphocytic infiltrate.
Small area of chronic pneumonitis, Slight portal lymphocytic infiltrate.
Hydometra. Slight portal lymphocytic infiltrate.
Slight portal lymphocytic infiltrate.
No lesion. No lesion.
'
-
Con,pany Sanitized. Doesnot contain Tsca CBl
Page 82
Ninety-Day Feeding Study in the Rat.
TABLE 30. Continued. Histopathologic Observations . Ninety-Day Terminal Sacrifice.
Animal Number
Sex Tissue
Comment
1000 D D m . ,. Liver Only:
14243
M.
14244
M
14247
M
14249
M
14250
M
14252
M
14254
M
14255
M
14256
M
14257
M
14224
F
14226
F
14227
F
14229
F
14231
F
14232
F
14233
F
14235
F
14236
.F
14237
F
No lesion.
No lesion. Slight portal lymphocytic infiltrate.
No lesion.
No lesion.
No lesion.
No lesion.
No lesion. Slight portal lymphocytic infiltrate. Slight portal lymphocytic infiltrate.
No lesion.
No lesion.
No lesion. Slight portal lymphocytic infiltrate.
No lesion. Slight portal lymphocytic infiltrate. Slight portal lymphocytic infiltrate. Slight portal lymphocytic infiltrate.
No lesion.No lesion.
-
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Page 83
Ninety-Day Feeding Study in the Rat. TABLE 30. Continued. Histopathologic Observations. Ninety-Day Terminal Sacrifice.
Animal Number
Sex Tissue
Comment
5000 ppm.:
14283
M
liver
14284 14286
M liver lung
M brain lung liver
14287
M adrenal... liver
14290 14291
14292
14294 14296
M M liver
M liver lung
M liver
M liver
Centro lobular hepatocytes slightly hypertrophied cytoplasm less coarsely granular than in hepatocytes at periphery of lobules.
Centrolobular hepatocytes less coarsely granular than those at periphery. Slight peribronchial lymphoid hyperplasia.
Glial nodules in medulla, structure resembling Sarcosporidia also present. Slight perivascular lymphocytic cuffing, area of pneumonic consolidation. Centrolobular hepatocytes less granular than those at periphery of lobule, slight portal lymphocytic infiltrate.
Area of osteoid and bone in cortex of one adrenal. Cytoplasm of centrolobular hepatocytes less coarsely granular than cytoplasm of hepatocytes at periphery, slight portal lymphocytic infiltrate.
No lesion.
Cytoplasm of centrolobular hepatocytes less coarsely granular than cytoplasm of hepatocytes at periphery of lobules.
Centrolobular hepatocytes less coarsely granular than those at periphery of lobules. Slight peribronchial lymphoid hyperplasia. _
Centrolobular hepatocytes less coarsely granular than those at periphery of lobule.
Marked portal lymphocytic infiltrate, centrolobular hepatocytes slightly less granular than those at periphery of lobule.
OJWpanySanHizeti. Does no! conu*, T8CA cbi
Page 84
Ninety-Day Feeding Study in the Rat.
TABLE 30. Continued. Histopathologic Observations. Ninety-Day Terminal Sacrifice.
Animal Number
Sex Tissue
Comment
5000 D D m . Ccont'd) m
14297
M liver
14264 14266
F liver F liver
14267 14269 14271
14272 14273
14274
lung F liver
F liver
F kidney liver
F liver F liver
large intestine F liver
14276 14277
F lung F lung
Centrolobular hepatocytes less coarsely granular than those at periphery of lobule.
Moderate portal lymphocytic infiltrate.
Centrolobular hepatocytes less coarsely granular than those at periphery, mild portal lymphocytic infiltrate. Chronic murine pneumonia of moderate severity.
Mild portal lymphocytic infiltrate.
Slight portal lymphocytic infiltrate.
Moderate interstitial lymphocytic infiltrate. . Mild portal lymphocytic infiltrate.
Mild portal lymphocytic infiltrate.
Mild portal lymphocytic infiltrate. Nematodes.
Mild portal lymphocytic infiltrate, centrolobular hepatocytes less coarsely granular than those at periphery.
Moderate perivascular lymphocytic cuffing.
Moderate perivascular lymphocytic cuffing.
Company Sanitized, Does not contain ISCA CBJ
Page 85
Ninety-Day Feeding Study in the Rat. TABLE 3Q. Continued. Histopathologic Observations. 21-Day Compound Withdrawal.
Animal Number
Sex Tissue
Comment
Control: 14177 14179 1418
M M M
14158 14159 14161
F F F
5000 ppm.:
14298
M
14299
M
14300 14278
M F
14279 14280
F F
pancreas lung liver urinary bladder
lung liver lung
No lesion.
Small area of necrosis and chronic inflammation.
Moderate peribronchial lymphoid hyperplasia. Slight portal lymphocytic infiltrate. Seminal plug.
No lesion.
Moderate peribronchial lymphoid hyperplasia.
Slight portal lymphocytic infiltrate. Slight perivascular lymphocytic cuffing.
liver lung urinary bladder liver
liver
kidney
liver
lung liver
lung liver
Slight portal lymphocytic infiltrate. Mild peribronchial lymphoid hyperplasia.
Seminal plug. Centrolobular hepatocytes appeared slightly hypertrophied.
Centrolobular hepatocytes appeared slightly hypertrophied.
Slight interstitial lymphocytic infiltrate, few calcified tubules. Moderate lymphocytic inflammatory infiltrate, primarily in portal areas. Moderate peribronchial lymphoid hyperplasia.
Mild portal lymphocytic infiltrate, few scattered vacuolated hepatocytes.
Slight peribronchial lymphoid hyperplasia. Slight portal lymphocytic infiltrate.
Company Sanitized. Does not contain TSCA CBi