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1810 FRONTAGE ROAD NORTHBROOK, ILLINOIS 60062
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REPORT TO
MONSANTO COMPANY THREE-GENERATION REPRODUCTION STUDY WITH
AROCLOR 1242 IN ALBINO RATS NOVEMBER 1, 1971
IBT NO. B7297
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1810 FRONTAGE ROAD NORTHBROOK, ILLINOIS 60062
November 1, 1971
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Mr. Elmer Wheeler Monsanto Company 800 N. Lindbergh Boulevard St. Louis, Missouri 63166
Dear Mr. Wheeler:
Re: 1BT No. B7297 - Three-Generation ReproductionStudy With Aroclor 1242 In Albino Rats
We are submitting herewith our laboratory report dated
November 1, 1971, prepared in connection with the above study.
Very truly yours,
JCC:sjn
J. C. Calandra President
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REPORT TO MONSANTO COMPANY THREE-GENERATION REPRODUCTION STUDY WITH
AROCLOR 1242 IN ALBINO RATS NOVEMBER 1, 1971
IBT NO. B7297
I. Introduction At the request of Monsanto Company, a reproduction study was \.
( initiated in order to ascertain potential toxicological effects of subacute oral administration of Aroclor 1242, Lot No, AK-255, upon the fertility and offspring of three consecutive generations of albino rats. This report presents the data collected from the initiation of the investigation to the weaning of the second (F3b) litters obtained from the third (F2) parental generation.
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II. Summary A three-generation reproduction study employing albino rats fed
diets containing 1, 10 or 1 00 ppm Aroclor 1242 was conducted. The fol lowing results were obtained during the investigation.
A. Parental Animals 1. Body Weights Body weights and body weight gains revealed no differences
between test and control animals which could be attributed to the ingestion of Aroclor 1242.
2. Mortality and Reactions Several animals succumbed during each of the three
generations. None of these deaths could be attributed to the ingestion of Aroclor 1 242.
3. Pathologic Studies Gross pathologic examination revealed no differences
between test and control rats. The absolute liver weights and liver to body weight or brain
weight ratios were significantly elevated in both FI males and females fed 100 ppm Aroclor 1242. Statistical evaluations of other organ weights, organ to body weight and organ to brain weight ratios disclosed several randomly occurring intergroup differences. The lack of any consistent dose or generation related response and the absence of any deleterious histopathologic change confirm that these differences were not related to the ingestion of Aroclor 1242.
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All lesions noted during histopathologic studies were those
of spontaneous disease.
4. Reproductive Performance
Reproductive indices of rats fed 1 or 10 ppm did not
differ from those of the controls during any of the three generations.
During the second generation (F2a and F2b litters), rats fed 100 ppm
had lowered mating indices and a reduced incidence of pregnancy.
Because only two T-III females produced F2b litters, it was not possible
to continue this level through the third generation.
B. Progeny
1. Population Data
The number of live pups born per litter and the avejage
number of pups weaned were not affected at any level of Aroclor 1242
tested. No external abnormalities were present that could be attributed
to treatment. No untoward behavioral reactions were observed among
test or control progeny.
2. Survival
Twenty-four hour and five day survival indices and the
lactation index were normal for all groups.
3. Body Weights
Body weights for all progeny were normal at weaning.
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( 4. Pathologic Studies
At autopsy of the F3b weanlings no gross or microscopic tissue changes were present which could be associated with the ingestion of Aroclor 1242.
Respectfully submitted, INDUSTRIAL BIO-TEST LABORATORIES, INC.
Report prepared by:
Sandra Haley Assistant Toxicologist Rat Toxicity
/
Report approved by:
Jhjfnes B. Plank Senior Group Leader Rat Toxicity
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Paul L. Wright, *Pn. D. Section Head, Toxicology
November 1, 1971 Jg:6jn;psh
M. L, Kepling^r, Ph.^T Manager, Toxicology
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HI. Procedure A. Experimental Animals The animals employed were weanling Charles River albino
rats*. A total of 96 weanling rats (32 males and 64 females) was selected to form three test groups and a control group of Fo generation animals. Parental animals were allowed to reach maturity, mate and produce two litters. Eight males and 16 females from the second litters of each dietary group (Fib and F2b) were selected at weaning as parental animals for the succeeding generations. The study terminated following the weaning of the F3b litters.
B. Organization of Groups A structural outline of the experiment is given in Table I. A
flow chart depicting the three generations is shown in Figure 1.
* Charles River Breeding Laboratories, Inc., North Wilmington, Mass, 0365395
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( TABLE I
TEST MATERIAL: Aroclor MM
Three-Generation Reproduction Study - Albino Rats
Outline of Experiment
G r oup
Dietary Level (ppm)
Number of Animals
Male
F emale
Control
None
8 16
T-I
1 8 16
T -II
10 8 16
T -III
100
8 16
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FIGURE 1 TEST MATERIAL: Aroclor 1242
Design of Experiment
Fo Parental Animals
G e n e ra tio n G e n e ra tio n G e n e ra tio n
F irs t
Fla Progeny Wean Sacrifice
Fib Progeny Wean Select the FI Parental Animals
Second
F2a Progeny Wean Sacrifice
F2b Progeny Wean Select the F2 Parental Animals
( F3a Progeny F3b Progeny
Wean
W ean
Sacrifice
Histopathology
T h ird
Gross and histopathologic examinations were conducted upon parental animals of all three generations following the weaning of the second (b) litters.
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/ C. Diets and Feeding Diets were prepared in the central diet room of this laboratory.
The diet for any given test group was prepared by incorporating a calculated weight of Aroclor 1242 into a standard pulverized stock ration*, so that the final concentrations of test material in the diets were 1, 10 and 100 parts per million respectively. The animals in the control group were fed the basic ration without test material. Animals in all groups were maintained on their respective diets without interruption until their sacrifice, which followed the weaning of the second litters. Feeding was conducted on an ad libitum basis with fresh, diets prepared weekly,
D. Body Weights and Weight Gains ^ Initially, the body weight of each rat was determined and recorded
at 21 days of age. All animals were then weighed weekly until mating trials commenced. No further body weight data were obtained until the sacrifice of each parental generation, at which time final body weights were recorded.
E. Mortality, Reactions and General Observations Observations among animals of each generation for mortality and
abnormal behavioral reactions were made daily. In addition, these animals were observed for fertility, length of gestation and lactation performance,
* Special Mix Mouse Chow, Ralston Purina Company, St. Louis, Missouri,
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^ All pups were examined for physical abnormalities at birth and the numbers of viable and stillborn members of each litter were recorded. Records of survival at designated intervals during the lactation period were maintained and a final examination for physical abnormalities was made at the weaning of each litter. Litters of more than ten pups were reduced to that number by random sacrifice on the fifth day of the lactation period. F. Mating Procedure Mating trials were initiated when the parental animals were 100 days old. Females were caged in pairs and mated with a male from within the same treatment group. Daily examinations were conducted
^ to determine if copulation had occurred. Males were rotated within their dietary group at ten day intervals until conception was confirmed or until each female had been paired with a maximum of three males. The first litters (Fla, F2a and F3a) obtained were weaned at 21 days post-partum. The parental females were then given a ten-day rest period and again mated, the above procedure being repeated in order to obtain second litters (Fib, F2b and F3b). Females failing to become pregnant during the first mating trials were not rebred. Eight males and 16 females from the second litters of each group were selected at weaning on the basis of health and body weight as parental animals for each succeeding generation.
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C, Gross and Microscopic Pathologic Studies Whenever a parental animal succumbed during the test period,
a gross autopsy was performed. In those instances when postmortem changes were not advanced, representative tissues were taken for microscopic study.
After the second litters were weaned, all surviving males and eight feinales from each group were sacrificed and subjected to gross pathologic examination. The weights of the liver, kidneys, spleen, gonads, heart and brain were recorded, along with the final body weight of each rat.
Statistical analyses were conducted upon the absolute organ weights of the sacrificed animals and upon the corresponding organ to body weight and organ to brain weight ratios. An Analysis of Variance was conducted first and significant effects disclosed by that treatment were further studied by 'V-tests.
Microscopic pathologic studies wore conducted upon five males and five females (Fo and FI) from the control and T-III groups; the T-II and control groups were examined following sacrifice of the F2 generation.
The following tissues and organs were examined:
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( Tissues and Organs ' Examined Grossly
Skin
Heart
Trachea
Lungs
Liver
Pancreas
Esophagus
Stomach
Intestinal Tract
Spleen
Lymph Nodes
Kidneys
Urinary Bladder
Testes
Ovaries
Prostate
Seminal Vesicles
Uterus
Vagina
,
( Pituitary Gland
Adrenal Glands Salivary Glands Thyroid Gland Skeletal Muscle Bone Peripheral Nerve Eyes Brain Thymus Optic Nerve Aorta
11
Tissues and Organs Examined Microscopically
Heart (right and left ventricles)
Trachea
Lung Liver
Pancreas
.
Stomach (cardiac, fundic and
pyloric regions)
Small Intestine (duodenum, jejunum
and ileum)
Caecum
Colon
Spleen
Lymph Node (cervical and mesenteric)
Kidney
Urinary Bladder
Testis Ovary
Prostate
Uterus
Pituitary Gland
-
Adrenal Gland
Salivary Gland (submaxillary)
Thyroid Gland
Parathyroid Gland
Skeletal Muscle
Bone Marrow (sternum and femur)
Peripheral Nerve (sciatic)
Brain (cerebrum, cerebellum and pons)
Seminal Vesicles
Esophagus
Spinal Cord
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iv. Results
A. Parental Animals 1. Body Weights Body weight data are presented in Tables II and III.
Included in the data on these tables are total weight gains over the first 77 days of the feeding period.
There were no differences between test and control animals which could be related to the ingestion of Aroclor 1242.
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Fo FI 47 F2 49
I ppm) '
Fo F1 F2
48 58
-II Fo
0 ppm)
FI
50
F2 52
-HI 00 ppm)
Fo FI
45
TABLE II
TEST MATERIAL: Aroclor 1242
Three-Generation Reproduction Study - Albino Rats
Parental Male Rats
Mean Body Weight (grams) Day Number:
7 14 21 2S 35 42 49 56 63 70 77
95 142 202 253 309 354 393 47.6 456 480 492 77 112 152 192 234 271 316* 349 382 416 438 77 108 140 164 200 234 265 295 319 345 354
95 137 192 242 292 336 374 409 435 458 475 76 115 164 212 259 297 335 371 393 421 444 98 149 195 234 280 327 357 390 408 436 455
95 141 200 249 297 341 366 394 422 447 466 85 123 169 221 271 306 346 394 422 438 455 92 136 176 221 262 285 313 341 362 380 394
95 139 196 224 292 340 375 400 433 461 474 73 112 153 194 245 291 339 366 409 432 450
Total Weight Gain
(grams)
Final Body Weight at Sacrifice
397
391 305
709 636
592
380 396 397
707 639 680
371 405 342
661 636 574
379 405
720 652
ote: All animals were 28 days old at day number seven.
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TABLE III
TEST MATERIAL: Aroclor 1242
Three-Generation Reproduction Study - Albino Rats
Parental Female Rats
Mean Body Weight (grams) Day Number:
rup Generation 0 7 14 21 28 35 42 49 56 63 70 77
jpm)
I ppm)
in 0 ppm)
Fo FI F2
Fo FI F2
Fo FI F2
Fo FI
93 127 158 182 203 220 233 240 250 257 266
45 73 104 134 156 180 197 220 229 237 246 248
44 66
89 113 134 152 163 178 183 193 199 212
. 93 126 155 179 203 221 232 243 252 262 270 4b 75 107 140 156 176 196 216 225 229 248 252 48 76 104 134 144 169 177 186 191 205 213 214
. 93 127 158 181 200 219 230 241 248 256 263 49 78 107 138 167 176 204 222 237 249 256 263 49 79 116 137 160 177 189 200 212 223 231 237
. 93 127 160 184 207 224 236 247 254 264 272 42 69 103 136 160 182 206 223 237 252 261 270
iet All animals were 28 days old at day number seven.
Total Weight Gain
(grams)
Final Body Weight at Sacrifice
173 203 168
388 349 316
177 206 166
388 304 318
170 214 188
387 338 360
179 228
372 392
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2. Mortality
'
Mortality data are presented in Tables IV and V.
Gross autopsy performed on animals which succumbed
during the test period failed to reveal any relationship between the
ingestion of Aroclor 1242 and the death of the animal.
0365405
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TABLE IV TEST MATERIAL: Aroclor 1242 Three-Generation Reproduction Study - Albino Rats
Mortality Data Parental Generation Males
Group Generation
C Fo FI F2
T-I (1 ppm)
Fo FI F2
T -II (10 ppm)
Fo FI F2
T -III
Fo
(100 ppm) FI
r'irst Mating Pre-M M Post-M
000 000 000
000 0 0 0 000
000 000 000
1 00 000
Second Mating
M
Post-M
Total
000 000 01 1
000 01 1 000
000 0 0 -o 01 1
00 1 0 1 .1
Pre-M = Pre-Mating Period M = Mating Period
Post-M = Post-Mating Period
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TABLE V TEST MATERIAL: Aroclor 1242 Three-Generation Reproduction Study - Albino Rats
Mortality Data Parental Generation Females
Group Generation
C Fo FI F2
T-I (1 ppm)
Fo FI F2
T-II (10 ppm)
Fo FI F2
T -III
Fo
(100 ppm) FI
Pre-M
0 0 0
0 0 0
0 0 0
0 0
First Mating
MG
P
001 000 000
000 000 000
000 000 000
000 000
Pre-M = Pre-Mating Period M = Mating Period G = Gestation Period P = Parturition L = Lactation Period R = Resting Period
Post-W = Post-Weaning Period
LR
00 00 01
0 .0' 00 00
00 00 00
00 00
Second Mating
M G 'P
L Post-W T otal
00000 1
000000 000001
0001 01 00001 1 00 00 00
000000 00 0 000 000000
000000 000000
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3. Reactions
No untoward reactions were noted among the parental ani
mals during the investigation.
4. Pathologic Findings
a. Gross Pathologic Findings
There were no gross pathologic findings which could be
correlated with ingestion of the test material. Findings among test animals
were comparable to those noted among control animals.
b Organ 'Weights and Ratios
Mean organ weights, organ to body weight ratios and
organ to brain weight ratios are assembled in Tables VI through XIII,
The absolute liver weights and liver to body weight or
brain weight ratios were significantly elevated in both FI males and females
fed 100 ppm Aroclor 1242. Statistical evaluations of the other organ weights and
ratios revealed several intergroup differences. There was no consistent
dose or generation related response and these differences were not attributed
to the ingestion of Aroclor 1242.
-
TOXSTUDIES1166
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Group
Generation
C.
To FI F2
T-I (1 ppm)
Fo FI F2
T-II
(10 ppm)
o
o-
T-III
(100 ppm]
c
Fo FI F2
Fo FI
TABLE VI
TEST MATERIAL: Aroclor 1242 Three-Generation Reproduction Study - Albino Rats
Mean Organ Weights and Ratios
Parental Animals
Organ: Liver
Organ Weight
(g)
Males
F emales
28. 0 24.7 23. 6
16.3 15. 2 12.2
Organ/Body Weight Ratio
(g/100 g)
Males
Females
3. 96 3. 90 3.97
4.26 4.41 3.87
Organ/Brain Weight Ratio
(g/g)
Males
Females
12. 9 11.9 11.6
8. 68 7. 92 6. 97
00
26.8 24.4 22.7
26.5 26. 7 22. 5
16.8 13.4** 12.0
16. 0 16. 1 15. r
3. 80 3. 87 3.38**
4. 02 4. 20* 3. 94
4.33 4.45 .
4. 18 4. 78 4.25
.
12. 6 11. 8 10. 5
12. 0 -12.4
10. 6
7. 06* 6. 02
7. 77 8. 36 7. 80
29.9 30. 8*
17. 6 18.3**
4. 18 4.75* `
4.75 4.73
14.4* 15.8**
7. 90 10.30**
* Statistically significant difference at the 95 percent confidence level. ** Statistically significant difference at the 99 percent confidence level.
TOXSTUDIES1167
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Group
Generation
C Fo FI F2
T-I (1 ppm)
Fo FI F2
T -II (10 ppm)
T-m (100 ppm)
Fo FI F2
Fo FI
TEST MATERIAL: Aroclor 1242 Three-Generation Reproduction Study - Albino Rats
Mean Organ Weights and Ratios Parental Animals Organ: Kidneys
Organ Weight
(g)
Males
Females
4. 82 4.44 4. 01
2. 77 2. 68 2. 43
4. 30 4.47 4. 03
2. 72 2. 65 2. 37
4. 59 4. 56 3. 71
2. 95 2. 74 2. 68
4. 26 4. 09
3. 02 2. 74
Organ/body Weight Ratio
(g/100 g)
Males '
Females
Organ/Brain Weight Ratio
(g/g)
Males
Females
-
0. 680 0. 709 0.681
0. 724 0. 771 0. 774
2. 22 2. 14 1.99
1.48 1.40 1. 39
0.610* 0. 709 0.601**
0.704 0.882** 0.755
.
2. 02 2. 17 1.87
1.39 1. 39 1. 19
0. 693 0.723* 0. 647
0. 771 0. 813 0. 755
2. 08 2. 13 1.74
1.44 1.42 1. 38
0.593** 0. 6?6*
0.816** 0.711
2. 05 2. 09
1.33 1. 55
* Statistically significant difference at the 95 percent confidence level, ** Statistically significant difference at the 99 percent confidence level.
TOXSTUDIES1168
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Group
Generation
C Fo FI F2
T-I (1 ppm)
Fo FI F2
T-H
Fo
(10 ppm) o FI
Cf F2
t-iii (100 ppm)
Fo FI
TABLE VIII
TEST MATERIAL: Aroclor 1242 Three-Generation Reproduction Study - Albino Rats
Mean Organ "Weights and Ratios Parental Animals Organ: Spleen
Organ Weight
(g)
Males
Females
0. 83 0. 74 0.96
0. 63 0. 61 0. 63
0. 85 0.73 0.83*
0. 89 0. 78 0.76*
0. 59 0.53 0. 57
0. 59 0. 64 0. 62
.
0. 82 0.82
0.58 0. 60
Organ/Body Weight Ratio
(g/100g)
Males '
Females
0. 12 0. 12 0. 16
0. 16 0. 18 0. 20
0. 12 0. 12 0.12**
0. 14 0. 12 0. 13*
0. 15 0. 18 0. 18
0. 15 0. 19 0. 18
0. 11 0. 13
'
0.16 0.15
Organ/Brain Weight Ratio
(g/g)
Males
F emales
0. 38 0. 36 0.48
0. 33 0. 32 0. 36
0.40 0. 35 0.38**
0.41 0. 36 0.35**
0. 30 0. 28 0. 28
0. 29 0. 33 0. 32
0.40 0.42
0. 25 0. 34
* Statistically significant difference at the 95 percent confidence level. ** Statistically significant difference at the 99 percent confidence level.
TOXSTUDIES1169
BIO -TEST j*
Group
Generation
C-
Fo FI F2
T-I (1 ppm)
Fo FI F2
T -II (10 ppm)
Fo ,
c FI
O vn
F2
T-IH (100 ppm)
Fo FI
TEST MATERIAL,: Aroclor 1242
Three-Generation Reproduction Study - Albino Rats Mean Organ Weights and Ratios
Parental Animals Organ: Gonads
Organ Weight
(g)
Males
F emales
3. 62 3. 57 3. 18
0. 117 0. 099 0. 132
Organ/Body W eight Ratio
(g/100 g)
Males '
Females
0. 510 0. 576 0.530
0.0302 0.0283 0. 0424
Organ/Brain Weight Ratio
<g/g)
Males
Females
1. 67 1.72 1.57
0.0627 0.0524 0.0757
3. 59 3. 66 3. 56
0. 116 0. 080 0. Ill
0. 512 0. 581 0. 536
0. 0303 0.0263 0.0353
1.69 1.77 1.65
0.0590 0.0415 0.0561
.
3. 61 3. 78 3. 74
3. 55 3. 69
0. 131 0. 119 0. 130
0. 114 0. 102
0. 549 0. 630 0.652*
0.0338 0.0361 . 0.0375
0. 501 0. 571 '
0.0310 0.0274
1.64 1.76 1.75
1. 70 1.89
0.0637 0.0620 0.0668
0.0505 0.0579
* Statistically significant difference at the 95 percent confidence leve!
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TOXSTUDIES1170
B I O " T E S T XatuyiakviieA, ?*ic.
Group
Generation
C To FI F2`
T-I (1 ppm)
Fo FI F2
t-ii (10 ppm)
Fo FI O' F2
T-m (100 ppm)
Fo FI
TABLE X
TEST MATERIAL: Aroclor 1242 Three-Generation Reproduction Study - Albino Rats
Mean Organ Weights and Ratios Parental Animals Organ: Heart
Organ Weight
(g)
Males
Females
I. 36 1.74 1.34
1.28 1.24 1. 19
1.79 1.87 1.93
1.28 1.32 1. 12
1. 71 1. 82 1. 57
1.92 1. 83
1.25 1.10** 1. 18
1.25 1. 28
Organ/Body Weight Ratio
(E/100 g)
Males '
Females
Organ/Brain Weight Ratio
(g/g)
Males
Females
0. 261 0. 276 0.314
0. 332 0.360 0.379
0.858 0.844 0.914
0. 684 0. 647 0. 682
0. 254 0.297 0. 288
0.333
0.440**
0.355
*.
0.843 0.918 0.891
0.655 0. 695 0. 563
0. 259
0.289 0.274
0. 267 0.284
0. 331 0.328* 0. 337
0. 337 0.332
0.775 0.851 0.739
0.927 0. 944
0. 611 0.574* 0. 608
0. 561 0.727*
v*
* Statistically significant difference at the 95 percent confidence level. ** Statistically significant difference at the 99 percent confidence level.
TOXSTUDIES1171
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T-I
(1 ppm)
T-II (10 ppm)
O'
T-III (100 ppm)
Generation
Fo FI F2
Fo FI F2
Fo FI F2
Fo FI
TABLE XI
TEST MATERIAL: Aroclor 1242
Three-Generation Reproduction Study - Albino Rats
Mean Organ Weights and Ratios
Parental Animals
Organ: Brain
Organ Weight
(g)
Males
Females
Organ/Body Weight Ratio
(g/100 g)
Males
Females
2. 17 2.07 2. 01
1.90
1.93
1.74
0. 307 0. 334 0. 345
0. 509 0. 566 0. 557
2. 12 2. 07 2. 17
2. 21 , 2. 15
2. 12
. 2.08 1.95
1.96 1.91 1.99
Z. 05 1.93 1. 94
2. 01 1.77*
0. 303 0. 329 0. 328
0. 338 0. 346 0. 371
0.294 0. 302
0. 510 0. 637 0. 633
0. 542 0.577 0. 559
0. 540 0.464*
* Statistically significant difference at the 95 percent confidence level.
TOXSTUDIES1172
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Generation
c'
Fo FI F2 .
T-I (1 ppm)
Fo FI F2
T-H (10 ppm)
T-in (100 ppm)
2 ST * U1
Fo . FI F2
Fo FI
TABLE XII
TEST MATERIAL: Aroclor 1242
Three-Generation Reproduction Study - Albino Rats
Mean Organ Weights and Ratios
Parental Animals
Organ: Adrenal Glands
Organ Weight (g) Females
Organ/liody Weight Ratio
(g/100 g)
Males `
F emales
Organ/Brain Weight Ratio
(g/g)
Males
Females
0.072 0.066 0. 071
0.065 0. 063 0. 061
0. 076 0.084* 0. 063
0. 095 0. 091 0. 080
0. 102 0. 077 0. 075
0. 093 0. 088 0. 088
0. 010 0. 010 0. 012
0. 009 0. 010 0. 009
0. Oil 0.013* 0. Oil
0. 025 0. 026 0. 026
0. 026 0.026 0.024
0. 024 0. 026 0.025
.
0.033 0. 032 0.035
0.030 0.031 0.028
0.034 0.039** 0. 030
0. 050 0. 047 0. 046
0. 052 0. 040 0. 038
0. 045 0.045 0. 045
0. 063 0. 069
0. 090 0. 078
0. 008 0.011 '
0. 024 0. 020
0.030 0. 035
0. 039 0.044
^Statistically significant difference at the 95 percent confidence level. ^Statistically significant difference at the 99 percent confidence level.
TOXSTUDIES1173
B IO - T E S T JtaL&iaiMuiA., Site.
Group
Generation
C Fo FI F2
T-I (1 ppm)
Fo FI F2
T-n (10 ppm)
T-III (100 ppm)
c cO' *
Fo , FI F2
Fo FI
TEST MATERIAL: Aroclor 1242
Three-Generation Reproduction Study - Albino Rats
Mean Organ Weights and Ratios
Parental Animals
Organ: Thyroid Gland
Organ Weight
(g)
Males
F emales
0. 035 0. 025 0. 034
0.028 0.025 0. 028
Organ/Body Weight Ratio
(g/100 g)
Males `
Females
0.0050 0.0040 0.0056
0.0075 0.0074 0.0089
Organ/Brain Weight Ratio
(g/g)
Males
Females
0.016 0. 012 0. 016
0. 015 0. 013 0. 016
0. 036 0.034** 0. 038
0. 042 0.043** 0. 040
0. 031 0. 026 0. 030
0. 026 0.029* 0. 035
0.0051 0.0054** 0.0059
0.0081 0.0087
0.0095
0.0063* 0.0069** 0. 0070
0. 0067 0.0087 0.0099
,
0. 017 0.016** 0. 017
0. 019 0.020** 0. 019
0. 016 0. 014 0.015
0. 013
0. 018
o o *
0. 041 0.037*
0. 028 0.032*
0.0057 0.0p57* '
0.0077 0.0082
0. 020 0.019**
0. 014 0. 018**
* Statistically significant difference at the 95 percent confidence level. ** Statistically significant difference at the 99 percent confidence level.
TOXSTUDIES1174
. -StiduAi/Ual B 1 O T E S T akvuit&iie4; Unc,
27
c. Histopathologic Findings Histopathologic findings among sacrificed animals are
summarized in Tables XIV through XVI. Table XVII summarizes the histopathologic examination of the urinary bladder conducted on all animals sacrificed from the final generation.
No tissue changes were observed microscopically which could be correlated with ingestion of test material. Findings among treated animals were essentially the same as those of control animals.
0365417 TOXSTUDIES1175
'fm yvwfo?- 1 S 3 1 " 0 1 9
Organ T rachea
Lung
Pancreas Kidney
Adrenal gland
EST MATERIAL: Aroclor 1242
Three-Generation Reproduction Study - Albino Rats
Histopathologic Changes
Control Group - Fo Generation
Number of Animals Examined
Findings
Incidence
5 Males 5 Females
Focal inflammation T racheitis Focal inflammation
3 1 1
5 Males 5 Females
Focal inflammation Hyperemia
Focal inflammation Hyperemia
2 5 2 5
5 Males
Prominent islands of Lange rhans
1
5 Males 5 Females
Focal inflammation Hyperemia Hyperemia
1 1 2
5 Females
Hyperemia '
3
Average Grade
0. 5 2. 0 1.0
1.0 2. 0 0. 5 1.0
1. 0
0. 5 0.5 1.0
1.0
fs> co
0 3 6 5 *il8
TOXSTUDIES1176
BI 0 -T EST
Hoc.
Organ Trachea Lung
Liver
TABLE XIV continued
TEST MATERIAL: Aroclor 1242 Three-Generation Reproduction Study - Albino Rats
Histopathologic Changes Test Group III - Fo Generation
Number of Animals
Examined 5 Males 5 Females , 5 Males
5 Females
5 Males 5 Females
Findings
Focal inflammation T racheitis Focal inflammation
Focal inflammation Brown macrophages Hyperemia Focal inflammation Hyperemia
Focal vacuolization Focal pericholangitis Hyperemia
Incidence
2 2 3
1 1 1 1 -4
1 1 2
Average Grade
1.0 2.0 0.5
1.0 1.0 1.0 1.0 2. 0
0. 5 0. 5 1.0
TOXSTUDIES1177
i*4a l B I O - T E S T 2abo4aiMi&i, mP .
Organ Kidney
Adrenal gland
TABLE XIV continued
TEST MATERIAL: Aroclor 1242
Three-Generation Reproduction Study - Albino Rats
Histopathologic Changes
Test Group III - Fo Generation
Number of Animals Examined 5 Males
5 Females
Findings
Focal inflammation Nephritis Hyperemia Nephritis Hyperemia
'
Incidence
1 1 2 1 2
5 Males 5 Females
Hyperemia Hyperemia
1 1
All other tissues and organs examined were normal.
Grading System 0.5= Minimal 1.0 = Slight 2.0 = Mild 3. 0 = Moderate 4. 0 = Severe 5.0 = Extreme
' ^
Average Grade
0. 5 0. 5 0. 5 0. 5 .1.0
0. 5 0. 5
TOXSTUDIES1178
B IO - T E S T JedotauMiet, 9ftc.
Orean Trachea
Lung
Liver Kidney
Prostate
TABLE XV TEST MATERIAL: Aroclor 1242 Three-Generation Reproduction Study - Albino Rats
Histopathologic Changes Control Group - FI Generation
Number of Animals
Examined 5 Males 5 Females 5 Males 5 Females
5 Females 5 Males 5 Females 5 Males
Findings
Incidence
Average Grade
T rachcitis F ocal inflammation T racheitis
3 2. 0 3 ' 1.0 3 2. 0
Focal inflammation
Focal inflammation
Focal inflammation with abscess
Hyperemia
.
5 4 1 1
2. 0 1. 0 5. 0 2. 0
Hyperemia
1 0. 5
Nephrosis Nephritis Nephrosis
2. 1 1
0. 5 0. 5 0. 5
Focal inflammation
1 0. 5
T?*S9fO
TOXSTUDIES1179
B 1O - T E S T
TABLE XV continued TEST MATERIAL: Aroclor 1242
Three-Generation Reproduction Study - Albino Rats Histopathologic Changes
Test Group III - FI Generation
Organ
Number of Animals Examined
Findings
Incidence
Trachea
5 Males 5 Females
T racheitis T racheitis Focal inflammation
Lung
. 5 Males 5 Females
Focal inflammation
Hyperemia
Focal inflammation
Focal inflammation with abscess
Hyperemia
.
Liver
5 Males 5 Females
Hyperemia Hyperemia
Kidney
5 Males 5 Females
Nephrosis Nephritis Nephrites
Adrenal gland
5 Females
Hyperemia
All other tissues and organs examined were normal.
Grading System
0.5 = Minimal
4.0 = Severe
1.0 = Slight
5.0 = Extreme
2. 0 = Mild
3 2 2
5 3 4 1 4
1 1
1 1 1
1
.
Average Grade
2. 0 1. 0 0. 5
2. 0 1.0 0. 5 3. 0 2. 0
1.0 1.0
0. 5 0.5 0. 5
1.0
.
TOXSTUDIES1180
7V<*9 0
<( fonvjVK'jo-f J. S 3 1 O I a
Organ Trachea
Lung
TABLE XVI
' TEST MATERIAL: Aroclor 1242
Three-Generation Reproduction Study - Albino Rats
Histopathologic Changes
Control Group - F2 Generation
Number of Animals Examined
Findings
Incidence
5 Males 5 Females 5 Males 5 Females
Focal inflammation Inflammation Focal inflammation Inflammation
Focal inflammation Inflammation with abscess Hyperemia Focal inflammation Inflammation with abscess Hyperemia
1 2 1 1
4 1 2 1 1 3
Average Grade
0. 5 3. 0 0. 5 1.0
1.0 3. 0 1.0 2. 0 4. 0 2. 0
T0XSTUDIES1181
B IO - T E S T la l& ia t& iio l, 2+tc.
Orean Colon Liver Kidney
TABLE XVI continued TEST MATERIAL: Aroclor 1242 Three-Generation Reproduction Study - Albino Rats
Histopathologic Changes Control Group - FZ Generation
Number of Animals
Examined
5 Males
5 Females
5 Males 5 Females
Findings Focal inflammation
Hyperemia
Focal inflammation NephrocalcinosLs
Incidence 2
1
1 1
Average Grade
0. 5
0. 5
0. 5 0. 5
TOXSTUDIES1182
duAbual B I O - T EST
Sue.
TABLE XVI continued
TEST MATERIAL: Aroclor 1242
Three-Generation Reproduction Study - Albino Rats
Histopathologic Changes Test Group II - F2 Generation
Organ
Number of Animals Examined
Findings
T rachea
5 Males 5 Females
Focal inflammation Focal inflammation
Inflammation
Lung
5 Males 5 Females
Focal inflammation Focal hype'remia Hyperemia Focal inflammation Hyperemia
Colon
5 Males
Focal inflammation
All other tissues and organs examined were normal.
Grading System 0. 5 = Minimal 1.0= Slight 2. 0 = Mild 3.0 = Moderate 4.0= Severe 5.0 = Extreme
Incidence
4 2 1
2 1 2 3 3
1
Average Grade
1.0 0.5 2.0
1.0 1.0 1.0 1.0 Z. 0
1.0
42V59C0
TOXSTUDIES1183
9?fc 59 CO
v isa i-o ia
Group C
T-I (1 ppm) T-II (10 ppm)
Sex M F
M F M
F
TABLE XVII
TEST MATERIAL: Aroclor 1242
Three-Generation Reproduction Study - Albino Rats
Histopathologic Changes of the Urinary Bladder
F2 Generation
Number Examined
Findings*
Incidence
7 None
10
Focal epithelia hyperplasia
1
associated with focal
cystitis (11)
7 Proteinaceous plug (30)
15
None
^
5 Proteinaceous plug (55) Focal epithelial hyperplasia (69)
13 None
1 -
1 1
-
* Individual animal numbers are shown in parenthesis.
Grading System . 1.0 = Minimal or Trace 2.0 = Mild 3.0 = Moderate 4.0 = Severe 5.0 = Extreme
Average Grade
1.0
.
-
1.0 "
TOXSTUDIES1184
$'nd*uUial BIO-TEST JahrtabvU&i, 9tic.
37
5. Reproductive Data
Reproductive data for parental animals are presented in
Table XVIII, The indices employed are defined below:
Mating Index
Number of Copulations51* ~ Number of Estrus Cycles Required
X 100
Fertility Index
Number of Pregnancies Number of Copulations
X 100
Incidence of Pregnancy
Number of Pregnancies Number of Females Mated
X 100
Incidence of Parturition _ Number of Parturitions Number of Pregnancies
X 100
The addition of 1 or 10 ppm Aroclor 1242 to the diet did not
affect the reproductive performance of rats during the three-generation
study. During the second generation (F2a and F2b litters) rats fed 100 ppm
(T-III) had lowered mating indices and a reduced incidence of pregnancy.
Because only two T-III females produced F2b litters it was not possible
to continue this level through the third generation.
* Only one copulation counted per estrus cycle. Five days equal one
estrus cycle.
.
036*427
TOXSTUDIES1185
9 7V<i`>tO
wy 'wijn>w>py l S 3 1 ' O I 9
>,"N
TABLE XVIII TEST MATERIAL: Aroclor 1242
Three-Generation Reproduction Study - Albino Rats
Parental Animals Reproductive Performance
Mating Index Group Litte r F raction Percent
Incidence of Pregnancy
F raction Percent
Fertility Index
F raction Percent
Incidence of Parturition Fraction Percent
C
Fla 17/25
68.0
16/16
100. 0
16/17
94. 1
15/16
93.8
Fib
15/20
75. 0
15/15
100. 0
15/15
100. 0
15/15
100. 0
F2a F2b
16/37 14/26
43.2 53.8
14/16 14/14
87. 5 100.0
14/16
87. 5
14/14^ 100. 0
14/14 14/14
100.0 100.0
F3a F3b
15/66 12/16
22.7 75. 0
13/16 12/12
81.2 100. 0
13/15 12/12
86.7 100. 0
11/13 11/12
84.6 91.7
T-I
Fla
(1 ppm) Fib
16/37 15/21
43.2 71.4
16/16 15/15
100. 0 100.0
16/16 15/16
100. 0 93.8
16/16 15/15
100.0 100.0
F2a F2b
F3a F3b
15/27 15/18
13/77 9/23
55. 6 83. 3
16.9 39.1
15/16 14/15
9/16 8/9
93. 8 93. 3
56.2 88. 8
15/15 14/15
9/13 8/9
100. 0 93. 3
'69. 2 88. 9
15/15 14/14
9/9 8/8
100. 0 100.0
100.0 100. 0
Gestation
Time (Days)
Mean
Range
22 19-22 22 21-22
21 20-22 22 21-23
22 21-22 22 21-22
22 21-23 22 21-24
22 20-22 22 21-23
22 21-22 21 20-22
T0XSTUDIES1186
TABLE XVIII continued
TEST MATERIAL: Aroclor 1242 Three-Generation Reproduction Study - Albino Rats
Parental Animals Reproductive Performance
Group
Mating Index Litter Fraction Percent
Incidence of Pregnancy
Fraction Percent
Fertility Index
Fraction Percent
incidence of Parturition
Fraction Percent
Gestation
Time (Days)
Mean
Range
T -II
Fla 16/43
(10 ppm) Fib 16/24
37.2 66.7
16/16 16/16
100.0 100.0
16/16 16/16
100.0 100.0
15/16 16/16
93.8 100.0
22 22
21-23 21-23
F2a 13/53 F2b 13/24
24. 5 54.2
12/16 12/12
75. 0 100.0
12/13 12/13
92.3 92. 3
12/12 12/12
100.0 100.0
22 22
21-22 21-22
F3a 16/43 F3b 16/28
T-III
Fla 15/43
(100 ppm) Fib 15/24
F2a 11/78 F2b 2/37
37. 2 57. 1
34.9 62. 5
14.1 5.4
16/16 15/16
15/16 15/15
7/16 2/7
100.0 93. 8
93. 8 100. 0
43.8 28. 6
16/16 15/16
15/15 15/15
7/11 2/2
100.0 93.8
100. 0 100. 0
63. 6 100. 0
15/16 15/15
14/15 15/15
7/7 2/2
93.8 100.0
93.3 100. 0
' 22 22
22 22
100.0 100.0
21 22
21-22 22-23
21-23 21-23
-
o u 9<9 > rv sC
B I O - T E S T lobo-iaiiyiiei; 9nc.
w
T0XSTUDIES1187
^nJuii'ual B I O - T E 5 T Jahvui&vUei, Phg.
40
B. Progeny 1. Population Data Population data for all litters are presented in Tables
XIX and XX. The number of live pups born per litter and the number of pups weaned per litter were not affected by feeding 1 , 10 or 100 ppm Aroclor 1242. All pups delivered appeared outwardly normal and dis played normal growth through the lactation period. At weaning, an exam ination of each pup for external abnormalities was conducted and all pups were judged to be free of gross external abnormalities.
0365430
TOXSTUDIES1188
1 S 3 1 - O I 9 V*3*,tf'T V
'y
Litter
Fla Fib
F2a F2b
F3a F3b
Fla Fib
F2a F2b
F3a F3b
TABLE XIX
TEST MATERIAL: Aroclorl242
Three-Generation Reproduction Study - Albino Rats
Population Data
Progeny
Number of Pups
Delivered
Total
Mean/Litter
Number of Pups Stillborn
T otal Mean /Litter
Number of Pups Cannibalized
Total Mean/Littei:
Number of Viable Pups Born
Total Mcan/Litter
178 191
147 164
102 109
11.9 12.7
10. 5 11.7
9.3 9.9
13 0.9 12 0. 8
0 1
7 0. 5
0
0 - '0
10 0.9 15 1.4
0 1
0. 1
_ _ 0. 1
165 178
140 164
92 93
11.0 11.9
10. 0 11. 7
8.4 8.5
'
184 208
158 142
86 80
11.5 13. 9
10. 5 10. 1
9.5 10. 0
9 0. 6 11 0. 7
1 4
3 0.2 2 0.1
1 0
11
1.2 ,
'0
7 0. 9
4
0. 1 0. 3
0. 1 -
0. 5
174 193
154 140
75 71
10. 9 12.9
10.3 10. 0
8. 3 8.9
TE<>99fO
TOXSTUDIES1189
tu b u h ia l B I O - T E S T J a & Q id a ile l, Hue.
Group
Litter
T -II (10 ppm)
Fla Fib
F2a FZb
F3a F3b
T-III .
Fla
(100 ppm) Fib
F2a F2b
TABLE XIX continued
TEST MATERIAL: Aroclor 1242
Three-Generation Reproduction Study - Albino Rats
Population Data
Progeny
Number of Pups
Delivered
Total
Mean/Litter
Number of Pups Stillborn
Total Mean/Littcr
Number of Pups Cannibalized
Total Mean/Litter
Number of Viable Pups Born
Total Mean/Litter
176 207
126 138
149 171
11.7 12.9
10. 5 11.5
9.9 11.4
3 4
8 5
17 8
0. 2 0. 2
0.7 0.4
1. 1 0. 5
0 0
0 0
_ -
5 0. 3 3 0. 2
173 203
118 133
127 160
11.5 12. 7
9. 8 11.1
8. 5 10. 7
168 203
12.0 13. 5
8. 3
0. 6 0. 2 .
4 0.3 ' 0
156 200
11. 1 13. 3
53
7. 6
6
20 10.0 2
0. 9 1.0
2 0. 3 2 1. 0
45 6.4 16 8. 0
TOXSTUDIES1190
BIO -TEST Jc
TABLE XX
TEST MATERIAL: Aroclor 1242
Three-Generation Reproduction Study - Albino Rats
Population Data
Progeny
jtoud
Litter
Number of Pups at Lactation Day 1 Total Mean/Litter
Number of Pups at Lactation Day 5 T otal Mean/Litter
Number of Pups Retained at Lactation Day 5 Total Mcan/Littcr
Male
Number of "Weanlings F emale Total Mean/ Litter
Fla Fib
146 176
9.1 11.7
70 117
4.7 7. 8
66 103
4.4 6.9
34 28 31 35
62 4. 1 66 4.4
F2a F2b
132 163
9.4 11. 6
90 135
6. 4 9.6
78 115
5.6 8. 2
30 34 64 4. 6
39 46
85
6.1
F3a F3b
90 91
8. 2 8. 3
69
6. 3
65 5.9
26 25 51 4.6
79 7. 2 75 6.8 16 26 42 3.8
r-i Fla
;i ppm)
Fib'
W F2a
F2b
176 175#
152 133
11.0 12. 5
10. 1 9.5
103 148
107 100
6.4 91 5. 7 36 53 89 5.6
10. 6
IZ0
8. 6
46 40
86
6.1
7. 1 7. 1
99 6. 6 . 90 . 6-4
37 39 76 5. 1 37 30 67 4.8
F3a F3b
69 66
7. 7 8. 2
46 5. 1 39 4. 3 12 13 25 2.8
46
5.8
45 5. 6
12 11 23 2. 9
v One female died on Day 1 of lactation. Pups from this litter were sacrificed and are not included in the totals and means.
T0XSTUDIES1191
1S 31-O I9
0U(f
TABLE XX continued
TEST MATERIAL: Aroclor 1242
Three-Generation Reproduction Study - Albino Rats
Population Data
Progeny
Stovlp________Litter
Number of Pups at Lactation Day 1 Total Mean/Litter
Number of Pups at Lactation Day 5 Total Mean/Litter
Number of Pups Retained at Lactation Day 5 Total Mean/Litter
Number of Weanlings Male Female Total Mean/Litter
T-H (10 ppm)
Fla Fib
170 202 .
11.3 12. 6
133 163
8.9 10. 2
118 7.9 134 8.4
59 49 46 60
108 106
7. 2 6.6
F2a F2b
109 132
9.1 11.0
96 8. 0 ,90 7. 5 38 39 115 9.6 103 8.6 37 37
77 6.4 74 6. 2
F3a F3b
126 152
3.4 10. 1
114
7.6
105 7. 0
44 60
104 6.9
119
7.9
102 6.8
51 46
87 5.8
r-in (100 ppm)
Fla Fib
149 196
10. 6 13. 1
133
9.5
122 8. 7
44 51
133
8.9 '' 111
7.4
31 28
95 6.8 59 3. 9
F2a F2b
37 15
5.3 7.5
36 5. 1 15 7.5
36 13 .
5. 1 6.5
14 21 56
35 5.0 11 5.5
<7 s*
T0XSTUDIES1192
frndtuUial B I O - T E S T J.aimrUoAiei-, 9nc.
45
2. Survival Data
Survival data for progeny are presented in Table XXI,
Live birth, 24 hour, five day and lactation indices were normal for all
groups.
The indices employed are defined below.
Live Birth Index
Number of Viable Pups Born Total Number of Pups Born
24-Hour Survival Index
Number of Pups Viable at Lactation Day 1 x 100 Number of Viable Pups Born
5-Day Survival Index
Number of Pups Viable at Lactation Day 5 x jqq . Number of Viable Pups Born
Lactation Ind^x - Number of Pups Viable at Lactation Day 21 x jqq Number of Pups Viable at Lactation Day 5
0365*35
TOXSTUDIES1193
; jIndu&btial BIO-TEST
Hc.
46
( TABLE XXI
TEST MATERIAL: Aroclor 1242
Three-Generation Reproduction Study - Albino Rats
Survival Indices
Progeny
Group C
T-I (1 ppm)
Live Birth
Litter
Index
Fla Fib F2a F2b F3a F3b
92. 7 93.4
95.2 100. 0
90. 2 85. 3
Fla Fib F2a F2b F3a F3b
94.6 92. 3 97.5 95.5 87. 2 88. 8
24-Hour
5 -Day
Survival Index Survival Index
Lactation Index
88. 5 98.9 94. 3 99. 3 97. 8 97. 8
42.4 65. 7 64. 3 82. 3 75. 0 85.0
93.9 64.1 81.2
73.9 78. 5 56.0
98. 3 97. 2 98. 7 95.0 92. 0 93. 0
59.2 82. 2 69. 5 71.4 61.3 63.4
97.8 71.7
. 76.8 74.4 64.1 51.1
T -II (10 ppm)
Fla Fib F2a F2b F3a F3b
98. 3 98. 1 93.7 96.3 85.2 94.1
98. 3 99.5 92.4 99.2 99.2 95.0
76. 9 80.3 81.4 86.4 82. 7 74. 4
91.5 79. 1 85.6 71.8 99.0 85. 3
T -III (I 00 ppm)
Fla Fib F2a F2b
92.9 98. 5 84.9 80,8
95.5 98. 0 82. 2 93.8
85.3 66.5 80.0 93. 8
77.9 53.2 97.2 84. 6
t 0365*36
TOXSTUDIES1194
ytiduAkUal BIO TEST hyiabyueS, Hkc.
47
3, Bodv Weight Data
.
Body weight data for weanlings are presented in Table XXII.
There are no significant differences between test and con-
trol weanling body weights.
v
TOXSTUDIES1195
Jltulu&Uial B I O - T E S T Jaho'iaU'Uei., 9hc.
48
Group C
T-I (1 ppm)
T -II (10 ppm)
T -III (100 ppm)
TABLE XXII
TEST MATERIAL; Ax odor 1242
Three-Generation Reproduction Study - Albino Rats
Progeny
Weanling Body Weight Data
Litter
Mean Body W eight (grams)
Male
Female
Fla Fib F2a F2b F3a F3b
Fla Fib F2a F2b F3a F3b
Fla Fib F2a F 2b F3a F3b
Fla Fib F2a F2b
44 47 46 41 45 42
46 46 47 45 38 35
49 52 48 41 49 39
' 45 42 55 38
44 43 43 39 44 42
' 46 45
- 44 40 38 39
47 47 47 45 46 43
. 43 42 48 37
(
03640#
T0XSTUDIES1196
BIO-T E S T
$nc.
49
4, Pathologic Studies
At autopsy of the F3b weanlings no gross or microscopic
tissue changes were present which could be associated with the ingestion
of Aroclor 1242 .
(
C
0365439
TOXSTUDIES1197