Document 10eGqpkYK2ZJ1pnN32dqvDYGm
U-50
96-4080
APPENDIX U (CONT.)
VINYL CHLORIDE COMBINED INHALATION TWO-GENERATION
REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CD RATS
TERMINAL ORGAN AND BODY WEIGHTS, ORGAN/BODY WEIGHT AND ORGAN/BRAIN WEIGHT RATIOS
TERMINAL SACRIFICE - P2 GENERATION - MALES
TERMINAL
AN BODY WT. WT.
NO (G)
(G)
INDIVIDUAL VALUES EPIDIDYMID
ORG/TBW ORG/BRN (X 1000) (X 10)
WT. (G)
TESTES
ORG/TBW ORG/BRN
(X 1000) (X
1)
GROUP I - 0 PPM
1031 1032 1033 1035 1037 1039 1041 1043 1045 1047 1048 1052 1054 1056 1057
511.1 494.6 570.8 530.6 413.6 446.6 404.6 451.8 491.2 447.7 413.7 470.3 504.3 454.8 480.3
1.5015
1.4652 1.6422 1.3356 1.3697
.8429 1.2828 1.3140 1.6937 1.3248 1.3384 1.6338 1.3814 1.5093 1,5060
2.94 2.96 2.88 2.52 3.31 1.89 3.17 2.91 3.45 2.96 3.24 3.47 2.74 3.32 3.14
7.04 6.63 7.31 5.76 6.84 3.59 6.68 5.82 7.74 6.24 6.13 8.18 6.61 7.07 6.88
3.921 3.689 3.521 3.330 3.100 1.813 2.925 3.322 3.445 3.933 3.293 3.190 2.741 3.749 3.259
7.67 7.46 6.17 6.28 7.50 4.06 7.23 7.35 7.01 8.78 7.96 6.78 5.44 8.24 6.79
1.84 1.67 1.57 1.44 1.55
.77 1.52 1.47 1.57 1.85 1.51 1.60 1.31 1.76 1.49
MEAN
S.D.
N
MIN. MAX.
472.4
46.3
15
404.6 570.8
1.4094
.2039
15
.8429 1.6937
2.99
.40
15
1.89 3.47
6.57
1,05
15
3.59 8.18
3.282
.529
15
1.813 3.933
6.98
1.17
15
4.06 8.78
1.53
.26
15
.77 1.85
BFG 003113
U-51
96-4080
APPENDIX U (CONT.)
VINYL CHLORIDE COMBINED INHALATION TWO-GENERATION
REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CD RATS
TERMINAL ORGAN AND BODY WEIGHTS, ORGAN/BODY WEIGHT AND ORGAN/BRAIN WEIGHT RATIOS
TERMINAL SACRIFICE - P2 GENERATION - MALES
TERMINAL
AN BODY WT. WT.
NO (G)
(G)
INDIVIDUAL VALUES
THYMUS
ORG/TBW ORG/BRN
(X 10000) (X
10)
GROUP I - 0 PPM
1031 1032 1033 1035 1037 1039 1041 1043 1045 1047 1048 1052 1054 1056 1057
511.1 494.6 570.8 530.6 413.6 446,6 404.6 451.8 491.2 447.7 413.7 470.3 504.3 454.8 480.3
.234 .181 .317 .245 .281 .158 .261 .271 .290 .287 .248 .230 .246 .276 .182
4.58 3.66 5.55 4.62 6.79 3.54 6.45 6.00 5.90 6.41 5.99 4.89 4.88 6.07 3.79
1.10 .82
1.41 1.06 1.40
.67 1.36 1.20 1.32 1.35 1.14 1.15
1.18 1.29
.83
MEAN
S.D.
N
MIN. MAX.
472.4
46.3
15
404.6 570.8
.247
.045
15
.158 .317
5.28
1.08
15
3.54 6.79
1.15
.23
15
.67 1.41
BFG 003114
U-52
96-4080
APPENDIX U (CONT.)
VINYL CHLORIDE COMBINED INHALATION TWO-GENERATION
REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CD RATS
TERMINAL ORGAN AND BODY WEIGHTS, ORGAN/BODY WEIGHT AND ORGAN/BRAIN WEIGHT RATIOS
TERMINAL SACRIFICE - P2 GENERATION - MALES
TERMINAL
AN BODY WT. WT.
NO IS)
(G)
INDIVIDUAL VALUES
BRAIN
ORG/TBW ORG/BRN
(X 1000) (X
1)
WT. (G)
ADRENALS ORG/TBW ORG/BRN 1[X 10000) (X 100)
GROUP II - 10 PPM
2031 2033 2034 2036 2037 2038 2040 2042 2044 2046 2048 2050 2052 2054 2056
452.7
652.4 488.6 614.4 537.7 446.0 405.1 473.4 464.9 510.0
520.1 501.1 381.2 486.6 550.1
2.041
2.289 2.355 2.374 2.321 2.245 2.174 2.115 2.265 2.236 2.378 2.225 2.053 2.237 2.314
4.51
3.51 4.82 3.86 4.32 5.03 5.37 4.47 4.87 4.38 4.57 4.44 5.39 4.60 4.21
1.00
1.00 1.00 1.00 1.00 1.00 1.00 1.00 1.00 1.00 1.00 1.00 1.00 1.00 1.00
.0755 .0892 .0883 .0692 .0559 .0405 .0505 .0459 .0597 .0623 .0948 .0711
c .0664 .0601
1.67 1.37 1.81 1.13 1.04
.91 1.25
.97 1.28 1.22 1.82 1.42
1.36 1.09
3.70 3.90 3.75 2.91 2.41 1.80 2.32 2.17 2.64 2.79 3.99 3.20
2.97 2.60
MEAN
S.D.
N
MIN. MAX.
499.0
71.3
15
381.2 652.4
2.241
.107
15
2.041 2.378
4.56
.50
15
3.51 5.39
1.00
.00
15
1.00 1.00
.0664
.0163
14
.0405 .0948
1.31
.29
14
.91 1.82
2.94
.68
14
1.80 3.99
BFG 003115
U-53
96-4080
APPENDIX U (CONT.) VINYL CHLORIDE COMBINED INHALATION TWO-GENERATION
REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CD RATS
TERMINAL ORGAN AND BODY WEIGHTS, ORGAN/BODY WEIGHT AND ORGAN/BRAIN WEIGHT RATIOS
TERMINAL SACRIFICE - P2 GENERATION - MALES
TERMINAL
AN BODY WT. WT.
NO (G)
(6)
INDIVIDUAL VALUES
KIDNEYS
ORG/TBW ORG/BRN
(X 1000} (X
1)
WT. (G)
LIVER
ORG/TBW ORG/BRN
(X 100} (X
1}
GROUP II - 10 PPM
2031 2033 2034 2036 2037 2038 2040 2042 2044 2046 2048 2050 2052 2054
2056
452.7 652.4 488.6 614.4 537.7 446.0 405.1 473.4 464.9 510.0 520.1 501.1 381.2 486.6
550.1
3.948 4.974 4.574 5.149 4.555 3.948
3.034 4.069 4.381 4.027 4.407 3.929 3.186 4.727
4.889
8.72 7.62 9.36 8.38 8.47 8.85 7.49 8.60 9.42
7.90 8.47 7.84 8.36 9.71
8.89
1.93 2.17 1.94 2.17 1.96 1.76
1.40 1.92 1.93 1.80 1.85 1.77 1.55 2.11
2.11
11.936 20.812 13.240 19.094 16.053 13.403 12.781 13.900 14.077 16.505 16.450 14.403 10.950 14.303
18.177
2.64 3.19 2.71 3.11 2.99 3.01 3.16 2.94 3.03 3.24 3.16 2.87 2.87 2.94
3.30
5.85 9.09 5.62 8.04
6.92 5.97 5.88 6.57 6.22 7.38 6.92 6.47 5.33 6.39
7.86
MEAN
S.D.
N
MIN. MAX.
499.0
71.3
15
381.2 652.4
4.253
.609
15
3.034 5.149
8.54
.65
15
7.49 9.71
1.89
.22
15
1.40 2.17
15.072
2.742
15
10.950 20.812
3.01
.19
15
2.64 3.30
6.70
1.03
15
5.33 9.09
BFG 003116
U-54
96-4080
APPENDIX U (CONT.)
VINYL CHLORIDE COMBINED INHALATION TWO-GENERATION
REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CD RATS
TERMINAL ORGAN AND BODY WEIGHTS, ORGAN/BODY WEIGHT AND ORGAN/BRAIN WEIGHT RATIOS
TERMINAL SACRIFICE - P2 GENERATION - MALES
TERMINAL
AN BODY WT. WT.
NO (G)
(G)
INDIVIDUAL VALUES LUNGS ORG/TBW ORG/BRN (X 1000) (X 10)
WT. (G)
PROSTATE ORG/TBW ORG/BRN (X 1000) (X 10)
GROUP II - 10 PPM
2031 2033 2034 2036 2037 2038 2040 2042 2044
2046 2048 2050 2052 2054 2056
452.7 652.4 488.6 614.4 537.7 446.0 405.1 473.4 464.9 510.0 520.1 501.1 381.2 486.6 550.1
1.560 2.073 2.016 1.967 1.980 1.510 1.538 1.806 1.814 1.574 1.953 1.619 1.382 2.042
2.250
3.45 3.18 4.13 3.20 3.68 3.39 3.80 3.81 3.90
3.09 3.76 3.23 3.63 4.20 4.09
7.64 9.06 8.56 8.29 8.53 6.73 7.07 8.54 8.01 7.04 8.21 7.28
6.73 9.13 9.72
.866 1.435
.868 1.085
.758 .897 .728 .596 .967 .408 1.050 .732 .989 .627
1.91 2.20 1.78 1.77
1.41 2.01 1.80 1.26 2.08
.80 2.02 1.46 2.59 1.29
4.24 6.27 3.69 4.57 3.27 4.00 3.35 2.82 4.27
1.82 4.42 3.29
4.82 2.80
MEAN
S.D.
N
MIN. MAX.
499.0
71.3
15
381.2 652.4
1.806
.258
15
1.382 2.250
3.63
.37
15
3.09 4.20
8.04
.93
15
6.73 9.72
.858
.251
14
.408 1.435
1.74
.46
14
.80 2.59
3.83
1.08
14
1.82 6.27
BFG 003117
U-55
96-4080
APPENDIX U (CONT.)
VINYL CHLORIDE COMBINED INHALATION TWO-GENERATION
REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CD RATS
TERMINAL ORGAN AND BODY WEIGHTS, ORGAN/BODY WEIGHT AND ORGAN/BRAIN WEIGHT RATIOS
TERMINAL SACRIFICE - P2 GENERATION - MALES
TERMINAL
AN BODY WT. WT.
NO (G)
(G)
INDIVIDUAL VALUES
SEMIN VESI
ORG/TBW ORG/BRN
(X 1000) (X
1)
WT. (G)
SPLEEN ORG/TBW ORG/BRN i[X 1000) (X 10)
GROUP II - 10 PPM
2031 2033 2034 2036 2037 2038 2040 2042 2044 2046 2048 2050 2052 2054 2056
452.7 652.4 488.6 614.4 537.7 446.0 405.1 473.4 464.9 510.0 520.1 501.1
381.2 486.6 550.1
2.1472 2.1508 2.4449 2.5329 1.6337
1.5075 1.9104 2.4999 2.7441 2.8180 2.9327 1.9890
.9535 2.9977 2.9209
4.74 3.30 5.00 4.12 3.04 3.38 4.72 5.28 5.90 5.53 5.64 3.97 2.50 6.16 5.31
1.05 .94
1.04 1.07
.70
.67 .88 1.18 1.21 1.26 1.23 .89 .46 1.34 1.26
.735 1.130
.766 .770 .794
.568 .617 .845 .673 .586 .704 .675 .746 .889 1.334
1.62 1.73 1.57 1.25 1.48 1.27 1.52 1.78 1.45 1.15 1.35 1.35 1.96 1.83 2.43
3.60 4.94 3.25 3.24 3.42 2.53 2.84 4.00 2.97 2.62 2.96 3.03 3.63 3.97 5.76
MEAN
S.D.
N
MIN. MAX.
499.0
71.3
15
381.2 652.4
2.2789
.5992
15
.9535 2.9977
4.57
1.13
15
2.50 6.16
1.01
.25
15
.46 1.34
.789
.204
15
.568 1.334
1.58
.33
15
1.15 2.43
3.52
.88
15
2.53 5.76
BFG 003118
U-56
96-4080
APPENDIX U (CONT.)
VINYL CHLORIDE COMBINED INHALATION TWO-GENERATION
REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CD RATS
TERMINAL ORGAN AND BODY WEIGHTS, ORGAN/BODY WEIGHT AND ORGAN/BRAIN WEIGHT RATIOS
TERMINAL SACRIFICE - P2 GENERATION - MALES
TERMINAL
AN BODY WT. WT.
NO (G)
(G)
INDIVIDUAL VALUES EPIDIDYMID ORG/TBW ORG/BRN (X 1000) (X 10)
WT. (G)
TESTES
ORG/TBW ORG/BRN
(X 1000) (X
i:
GROUP II - 10 PPM
2031 2033 2034 2036 2037 2038 2040 2042 2044 2046
2048 2050 2052 2054 2056
452.7 652.4 488.6 614.4 537.7 446.0 405.1 473.4 464.9 510.0 520.1 501.1 381.2 486.6 550.1
1.5752 1.3679 1.7404 1.5357 1.3614 1.4678 1.3757 1.4488
1.6135 1.4306 1.6206 1.2787 1.2908 1.7032 1.5068
3.48 2.10 3.56 2.50 2.53 3.29 3.40 3.06
3.47 2.81 3.12 2.55 3.39 3.50 2.74
7.72 5.98 7.39 6.47 5.87 6.54 6.33 6.85
7.12 6.40 6.81 5.75 6.29 7.61 6.51
3.428 3.353 3.795 3.831 3.401 3.494 3.135 3.461 3.299 3.746 3.585 3.118 2.888 3.551 3.112
7.57
5.14 7.77
6.24 6.33 7.83 7.74 7.31
7.10 7.35 6.89 6.22
7.58 7.30 5.66
1.68 1.46 1.61
1.61 1.47 1.56 1.44 1.64 1.46 1.68
1.51 1.40
1.41 1.59 1.34
MEAN
S.D.
N
MIN. MAX.
499.0
71.3
15
381.2 652.4
1.4878
.1426
15
1.2787 1.7404
3.03
.46
15
2.10 3.56
6.64
.61
15
5.75 7.72
3.413
.272
15
2.888 3.831
6.93
.83
15
5.14 7.83
1.52
.11
15
1.34 1.68
BFG 003119
U-57
96-4080
APPENDIX U (CONT.)
VINYL CHLORIDE COMBINED INHALATION TWO-GENERATION
REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CD RATS
TERMINAL ORGAN AND BODY WEIGHTS, ORGAN/BODY WEIGHT AND ORGAN/BRAIN WEIGHT RATIOS
TERMINAL SACRIFICE - P2 GENERATION - MALES
TERMINAL
AN BODY WT. WT.
NO (G)
(G)
INDIVIDUAL VALUES THYMUS ORG/TBW ORG/BRN (X 10000) (X 10)
GROUP II - 10 PPM
2031 2033 2034 2036 2037 2038 2040 2042 2044 2046 2048 2050
2052 2054 2056
452.7 652.4 488.6 614.4 537.7 446.0 405.1 473.4 464.9 510.0 520.1 501.1 381.2 486.6
550.1
.190 .284 .283 .355 .338 .208 .212 .243 .257 .199 .379 .445 .313 .360 .378
4.20 4.35 5.79 5.78 6.29 4.66 5.23 5.13 5.53 3.90 7.29 8.88 8.21 7.40
6.87
.93 1.24 1.20 1.50 1.46
.93 .98 1.15 1.13 .89 1.59 2.00
1.52 1.61 1.63
MEAN
S.D.
N
MIN. MAX.
499.0
71.3
15
381.2 652.4
.296
.078
15
.190 .445
5.97
1.50
15
3.90 8.88
1.32
.33
15
.89 2.00
BFG 003120
U-58
96-4080
APPENDIX U (CONT.)
VINYL CHLORIDE COMBINED INHALATION TWO-GENERATION
REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CD RATS
TERMINAL ORGAN AND BODY WEIGHTS, ORGAN/BODY WEIGHT AND ORGAN/BRAIN WEIGHT RATIOS
TERMINAL SACRIFICE - P2 GENERATION - MALES
TERMINAL
AN BODY WT. WT.
NO (GJ
(G)
INDIVIDUAL VALUES
BRAIN
ORG/TBW ORG/BRN
(X 1000} (X
1}
WT. (GJ
ADRENALS
ORG/TBW ORG/BRN I[X 10000) (X 100)
GROUP III - 100 PPM
3031
3032 3033 3034 3035 3037 3039 3041 3042 3043 3045 3046 3047 3048 3049
580.1 546.3 433.2 459.7 496.8 503.8 444.4 501.7 491.6 518.9 475.8 478.1 512.3 548.2 508.4
2.214 2.284 2.042 2.111 2.309 2.308 2.207 2.335 2.179 2.129 2.260 2.223 2.157 2.128 2.241
3.82 4.18 4.71
4.59 4.65 4.58 4.97 4.65 4.43 4.10 4.75 4.65 4.21
3.88 4.41
1.00 1.00 1.00 1.00 1.00 1.00 1.00 1.00 1.00 1.00 1.00 1.00 1.00 1.00 1.00
.0465
.0672 .0409 .0608 .0672 .0755 .0573 .0691 .0647 .0721 .0634 .0714 .0633 .0702 .0600
.80 1.23
.94 1.32 1.35 1.50 1.29 1.38 1.32 1.39 1.33 1.49 1.24 1.28 1.18
2.10 2.94 2.00 2.88 2.91 3.27 2.60 2.96 2.97 3.39
2.81 3.21 2.93 3.30
2.68
MEAN
S.D.
N
MIN. MAX.
500.0
39.5
15
433.2 580.1
2.208
.084
15
2.042 2.335
4.44
.33
15
3.82 4.97
1.00
.00
15
1.00 1.00
.0633
.0094
15
.0409 .0755
1.27
.19
15
.80 1.50
2.86
.40
15
2.00 3.39
BFG 003121
U--59
96-4080
APPENDIX U (CONT.)
VINYL CHLORIDE COMBINED INHALATION TWO-GENERATION
REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CD RATS
TERMINAL ORGAN AND BODY WEIGHTS, ORGAN/BODY WEIGHT AND ORGAN/BRAIN WEIGHT RATIOS
TERMINAL SACRIFICE - P2 GENERATION - MALES
TERMINAL
AN BODY WT. WT.
NO (GJ
(G)
INDIVIDUAL VALUES
KIDNEYS
ORG/TBW ORG/BRN
(X 1000) (X
1)
WT. (G)
LIVER
ORG/TBW ORG/BRN
(X 100) (X
1)
GROUP III - 100 PPM
3031 3032 3033
3034 3035 3037 3039 3041 3042 3043 3045 3046 3047 3048 3049
580.1 546.3 433.2 459.7 496.8 503.8 444.4 501.7 491.6 518.9 475.8 478.1 512.3 548.2 508.4
4.426
4.139 3.706 3.676 4.128 3.978 3.887 4.057 4.132 4.159 4.780 4.443
4.900 5.311 4.017
7.63 7.58 8.55 8.00 8.31
7.90 8.75 8.09 8.41
8.02 10.05
9.29 9.56
9.69 7.90
2.00 1.81 1.81 1.74 1.79 1.72 1.76 1.74 1.90 1.95 2.12 2.00 2.27 2.50 1.79
19.282 16.360 13.984
12.790 16.399 16.560 14.132 14.625 19.275 18.319 17.538 16.455 20.482 18.421 14.657
3.32 2.99 3.23 2.78 3.30 3.29 3.18 2.92 3.92 3.53 3.69 3.44 4.00 3.36 2.88
8.71 7.16 6.85 6.06 7.10 7.18 6.40 6.26 8.85 8.60 7.76 7.40 9.50 8.66 6.54
MEAN
S.D.
N
MIN. MAX.
500.0
39.5
15
433.2 580.1
4.249
.453
15
3.676 5.311
8.51
.79
15
7.58 10.05
1.93
.22
15
1.72 2.50
16.619
2.265
15
12.790 20.482
3.32
.36
15
2.78 4.00
7.54
1.08
15
6.06 9.50
BFG 003122
U-60
96-4080
APPENDIX U (CONT.)
VINYL CHLORIDE COMBINED INHALATION TWO-GENERATION
REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CD RATS
TERMINAL ORGAN AND BODY WEIGHTS, ORGAN/BODY WEIGHT AND ORGAN/BRAIN WEIGHT RATIOS
TERMINAL SACRIFICE - P2 GENERATION - MALES
TERMINAL
AN BODY WT. WT.
NO (G)
(G)
INDIVIDUAL VALUES LUNGS ORG/TBW ORG/BRN (X 1000) (X 10)
WT. (G)
PROSTATE ORG/TBW ORG/BRN (X 1000) (X 10)
GROUP III - 100 PPM
3031 3032 3033 3034 3035 3037 3039 3041 3042 3043 3045 3046 3047 3048 3049
580.1 546.3 433.2 459.7 496.8 503.8 444.4 501.7 491.6 518.9 475.8 478.1
512.3 548.2 508.4
1.686 2.303 1.623 1.894 1.890 1.588 1.606 2.134 1.736 2.073 1.847 1.817
1.808 1.830 1.823
2.91 4.22 3.75 4.12 3.80 3.15 3.61 4.25 3.53 3.99 3.88 3.80 3.53 3.34 3.59
7.62 10.08
7.95 8.97
8.19 6.88 7.28 9.14 7.97 9.74 8.17 8.17 8.38 8.60 8.13
.551 .602 .554 1.184 .613 .793 .787 .887 .847 1.423 .822 1.128 .817 1.043 .793
.95 1.10 1.28 2.58 1.23 1.57 1.77 1.77 1.72
2.74 1.73 2.36 1.59 1.90 1.56
2.49 2.64 2.71 5.61 2.65 3.44 3.57 3.80 3.89 6.68 3.64 5.07 3.79 4.90 3.54
MEAN
S.D.
N
MIN. MAX,
500.0
39.5
15
433.2 580.1
1.844
.200
15
1.588 2.303
3.70
.38
15
2.91 4.25
8.35
.86
15 6.88 10.08
.856
.248
15
.551 1.423
1.72
.51
15
.95 2.74
3.89
1.20
15
2,49 6.68
BFG 003123
U-61
96-4080
APPENDIX U (CONT.)
VINYL CHLORIDE COMBINED INHALATION TWO-GENERATION
REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CD RATS
TERMINAL ORGAN AND BODY WEIGHTS, ORGAN/BODY WEIGHT AND ORGAN/BRAIN WEIGHT RATIOS
TERMINAL SACRIFICE - P2 GENERATION - MALES
TERMINAL
AN BODY WT. WT.
NO (G)
(G)
INDIVIDUAL VALUES
SEMIN VESI
ORG/TBW ORG/BRN
(X 1000) (X
1)
WT. (G)
SPLEEN ORG/TBW ORG/BRN 1[X 1000) (X 10)
GROUP III - 100 PPM
3031 3032 3033 3034 3035 3037 3039 3041 3042 3043 3045 3046 3047 3048 3049
580.1 546.3
433.2 459.7 496.8 503.8 444.4 501.7 491.6 518.9 475.8
478.1 512.3
548.2 508.4
2.8737 1.4407 2.5208 2.2408 2.2838 2.0022 1.9718 2.3692 2.5255 3.0409 2.7585 2.3833 2.3363 2.6049 1.7142
4.95 2.64
5.82 4.87 4.60 3.97 4.44 4.72 5.14 5.86 5.80
4,98 4.56
4.75 3.37
1.30 .63
1.23 1.06
.99 .87 .89 1.01 1.16 1.43 1.22 1.07
1.08 1.22
.76
1.129 1.546
.677 .791 .782 .919 .761 .777 .882 .883 .801 .792 .915
.980 .882
1.95 2.83 1.56 1.72 1.57 1.82 1.71 1.55 1.79 1.70 1.68 1.66 1.79 1.79
1.73
5.10 6.77
3.32 3.75 3.39 3.98 3.45 3.33 4.05 4.15 3.54 3.56 4.24
4.61 3.94
MEAN
S.D.
N
MIN. MAX.
500.0
39.5
15
433.2 580.1
2.3378
.4271
15
1.4407 3.0409
4.70
.88
15
2.64 5.86
1.06
.21
15
.63 1.43
.901
.209
15
.677 1.546
1.79
.31
15
1.55 2.83
4.08
.90
15
3.32 6.77
BFG 003124
U-62
96-4080
APPENDIX U (CONT.)
VINYL CHLORIDE COMBINED INHALATION TWO-GENERATION
REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CD RATS
TERMINAL ORGAN AND BODY WEIGHTS, ORGAN/BODY WEIGHT AND ORGAN/BRAIN WEIGHT RATIOS
TERMINAL SACRIFICE - P2 GENERATION - MALES
TERMINAL
AN BODY WT. WT.
NO (6)
(G)
INDIVIDUAL VALUES
EPIDIDYMID ORG/TBW ORG/BRN (X 1000) (X 10)
WT. (G)
TESTES
ORG/TBW ORG/BRN
(X 1000) (X
1
GROUP III - 100 PPM
3031 3032 3033 3034 3035 3037 3039 3041 3042 3043 3045 3046 3047 3048 3049
580.1 546.3 433.2 459.7 496.8 503.8 444.4 501.7 491.6 518.9 475.8 478.1 512.3 548.2 508.4
1.2965 1.4290 1.1813 1.4550 1.4460 1.2608 1.1497 1.4530 1.5672 1.5310 1.4678 1.3673 1.6734 1.4861 1.4098
2.23 2.62 2.73 3.17 2.91 2.50 2.59 2.90 3.19 2.95 3.08 2.86 3.27 2.71 2.77
5.86 6.26 5.79
6.89 6.26 5.46 5.21 6.22 7.19 7.19 6,49 6.15 7.76 6.98 6.29
3.158 3.328 3.057 3.506 3.044 3.259 2.963 3.373 3.393 3.607 3.756 3.898 4.143 4.060 3.412
5.44 6.09 7.06 7.63 6.13 6.47 6.67 6.72 6.90 6.95 7.89 8.15 8.09 7.41 6.71
1.43 1.46 1.50 1.66 1.32 1.41 1.34 1.44 1.56 1.69 1.66 1.75 1.92 1.91 1.52
MEAN
S.D.
N
MIN. MAX.
500.0
39.5
15
433,2 580.1
1.4116
.1415
15
1.1497 1.6734
2.83 .28
15
2.23 3.27
6.40
.70
15
5.21 7.76
3.464
.366
15
2.963 4.143
6.95
.78
15
5.44 8.15
1.57
.19
15
2.32 1.92
BFG 003125
U-63
96-4080
APPENDIX U (CONT.)
VINYL CHLORIDE COMBINED INHALATION TWO-GENERATION
REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CD RATS
TERMINAL ORGAN AND BODY WEIGHTS, ORGAN/BODY WEIGHT AND ORGAN/BRAIN WEIGHT RATIOS
TERMINAL SACRIFICE - P2 GENERATION - MALES
TERMINAL
AN BODY WT. WT.
NO (G)
(G)
INDIVIDUAL VALUES THYMUS ORG/TBW ORG/BRN (X 10000) (X 10)
GROUP III - 100 PPM
3031
3032 3033 3034 3035 3037 3039 3041 3042 3043 3045 3046 3047
3048 3049
580.1 546.3 433.2 459.7 496.8 503.8 444.4 501.7 491.6 518.9 475.8 478.1 512.3 548.2 508.4
.271 .276 .192 .207 .262 .290 .334 .377 .261 .217 .170 .242 .229 .318 .370
4.67 5.05 4.43 4.50 5.27 5.76 7.52 7.51 5.31 4.18 3.57
5.06 4.47 5.80 7.28
1.22 1.21
.94 .98 1.13 1.26 1.51
1.61 1.20 1.02
.75 1.09 1.06 1.49 1.65
MEAN
S.D.
N
MIN. MAX.
500.0
39.5 15
433.2 580.1
.268
.062
15
.170 .377
5.36
1.22
15
3.57 7.52
1.21
.26
15
.75 1.65
BFG 003126
U-64
96-4080
APPENDIX U (CQNT.)
VINYL CHLORIDE COMBINED INHALATION TWO-GENERATION
REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CD RATS
TERMINAL ORGAN AND BODY WEIGHTS, ORGAN/BODY WEIGHT AND ORGAN/BRAIN WEIGHT RATIOS
TERMINAL SACRIFICE - P2 GENERATION - MALES
TERMINAL
AN BODY WT. WT.
NO (G)
(G)
INDIVIDUAL VALUES
BRAIN
ORG/TBW ORG/BRN
(X 1000) (X
I)
WT. (G)
ADRENALS ORG/TBW ORG/BRN 1[X 10000) (X 100)
GROUP IV - 1100 PPM
4031 4033 4035 4037 4039 4041
4043 4045 4046 4047 4049 4050 4052 4054 4056
544.8 497.0 561.4 575.2 497.8 488.4
483.5 494.8 482.7 486.6 514.7 490.5
487.2 462.9 487.2
2.275 2.440 2.119 2.192 2.295 2.099 2.226 2.106 2.106 2.291 2.299 1.945 2.329
2.218 2.108
4.18 4.91
3.77 3.81 4.61 4.30
4.60 4.26 4.36 4.71 4.47 3.97 4.78 4.79 4.33
1.00 1.00 1.00 1.00 1.00 1.00 1.00 1.00 1.00 1.00 1.00 1.00 1.00 1.00 1.00
b
.0522 .0917 .0589 .0683 .0806 .0572 .0501 .0769 .0648 .0792 .0649 .0733 .0769 .0630
1.05 1.63 1.02 1.37 1.65 1.18 1.01 1.59 1.33 1.54 1.32 1.50
1.66 1.29
2.14
4.33 2.69 2.98 3.84
2.57 2.38 3.65 2.83 3.44 3.34 3.15 3.47 2.99
MEAN
S.D.
N
MIN. MAX.
503.6
31.8
15
462.9 575.2
2.203
.124
15
1.945 2.440
4.39
.35
15
3.77 4.91
1,00
.00
15
1.00 1.00
.0684
.0119
14
.0501 .0917
1.37
.24
14
1.01 1.66
3.13
.60
14
2.14 4.33
BFG 003127
U-65
96-4080
APPENDIX U (CONT.)
VINYL CHLORIDE COMBINED INHALATION TWO-GENERATION
REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CD RATS
TERMINAL ORGAN AND BODY WEIGHTS, ORGAN/BODY WEIGHT AND ORGAN/BRAIN WEIGHT RATIOS
TERMINAL SACRIFICE - P2 GENERATION - MALES
TERMINAL
AN BODY WT. WT.
NO (G)
(G)
INDIVIDUAL VALUES
KIDNEYS
ORG/TBW ORG/BRN
(X 1000) (X
1)
WT. (G)
LIVER
ORG/TBW ORG/BRN
(X 100) (X
1
GROUP IV - 1100 PPM
4031 4033 4035 4037 4039 4041 4043 4045 4046 4047 4049 4050
4052 4054 4056
544.8 497.0 561.4 575.2 497.8 488.4 483.5 494.8 482.7 486.6 514.7 490.5 487.2 462.9 487.2
4.446 3.999 4.336 4.657 4.451 4.081 4.047 4.679 4.073 4.265 4.775 3.910 4.466 3.944 3.413
8.16 8.05 7.72 8.10 8.94 8.36 8.37 9.46 8.44 8.76 9.28 7.97
9.17 8.52 7.01
1.95 1.64 2.05 2.12 1.94 1.94 1.82 2.22 1.93 1.86 2.08 2.01
1.92 1.78 1.62
18.645 16.533 18.976 19.946 16.646 15.341 16.077 17.479 17.951 17.023
17.708 15.797 16.620 16.346 14.109
3.42 3.33 3.38 3.47 3.34 3.14 3.33 3.53 3.72 3.50 3.44 3.22
3.41 3.53 2.90
8.20 6.78 8.96 9.10 7.25 7.31 7.22 8.30 8.52 7.43 7.70 8.12 7.14 7.37 6.69
MEAN
S.D.
N
MIN. MAX.
503.6
31.8
15
462.9 575.2
4.236
.361
15
3.413 4.775
8.42
.64
15
7.01 9.46
1.93
.17
15
1.62 2.22
17,013
1.494
15
14.109 19.946
3.38
.19
15
2.90 3.72
7.74
.75
15
6.69 9.10
BFG 003128
U-66
96-4080
APPENDIX U (CONI.)
VINYL CHLORIDE COMBINED INHALATION TWO-GENERATION
REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CD RATS
TERMINAL ORGAN AND BODY WEIGHTS, ORGAN/BODY WEIGHT AND ORGAN/BRAIN WEIGHT RATIOS
TERMINAL SACRIFICE - P2 GENERATION - MALES
TERMINAL
AN BODY WT. WT.
NO (G)
(G)
INDIVIDUAL VALUES LUNGS ORG/TBW ORG/BRN (X 1000) (X 10)
WT. (G)
PROSTATE ORG/TBW ORG/BRN (X 1000) (X 10)
GROUP IV - 1100 PPM
4031 4033 4035 4037 4039 4041 4043 4045 4046 4047 4049 4050
4052 4054 4056
544.8 497.0 561.4 575.2 497.8 488.4 483.5 494.8 482.7 486.6 514.7 490.5 487.2
462.9 487.2
1.874 2.139 2.220 2.132 1.834 1.915 1.770 2.000 2.105
1.842 1.597 1.595 1.784 1.589 1.450
3.44 4.30 3.95 3.71 3.68 3.92 3.66 4.04 4.36 3.79 3.10 3.25 3.66 3.43 2.98
8.24 8.77 10.48 9.73 7.99 9.12 7.95 9.50 10.00 8.04 6.95 8.20 7.66 7.16 6.88
1.003 .425
1.082 1.220
.881 .993 .558 .728 1.100 .767 1.058 .882 .639 1.021 1.019
1.84 .86
1.93 2.12 1.77 2.03 1.15 1.47 2.28 1.58 2.06 1.80 1.31
2.21 2.09
4.41 1.74 5.11 5.57 3.84 4.73 2.51 3.46 5.22 3.35 4.60 4.53 2.74
4.60 4.83
MEAN
S.D.
N
MIN. MAX.
503,6
31.8
15
462.9 575.2
1.856
.233
15
1.450 2.220
3.69
.40
15
2.98 4.36
8.44
1.12
15
6.88 10.48
.892
.225
15
.425 1.220
1.77
.41
15
.86 2.28
4.08
1.11
15
1.74 5.57
003129
U-67
96-4080
APPENDIX U (CONT.)
VINYL CHLORIDE COMBINED INHALATION TWO-GENERATION
REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CD RATS
TERMINAL ORGAN AND BODY WEIGHTS, ORGAN/BODY WEIGHT AND ORGAN/BRAIN WEIGHT RATIOS
TERMINAL SACRIFICE - P2 GENERATION - MALES
TERMINAL
AN BODY WT. WT.
NO (G)
(G)
INDIVIDUAL VALUES
SEMIN VESI
ORG/TBW ORG/BRN
(X 1000) (X
1)
WT. (G)
SPLEEN ORG/TBW ORG/BRN
(X 1000) (X 10)
GROUP IV - 1100 PPM
4031 4033 4035 4037 4039 4041 4043 4045 4046 4047 4049 4050 4052
4054 4056
544.8 497.0 561.4 575.2 497.8 488.4 483.5 494.8 482.7 486.6 514.7 490.5 487.2 462.9
487.2
3.1406 2.5453 2.6035 2.0727 1.5318 1.6065 1.9450 2.4959 1.9460 2.1381 1.8817 2.3152 2.4456 1.2807 1.4616
5.76 5.12 4.64 3.60 3.08 3.29 4.02 5.04 4.03 4.39 3.66 4.72 5.02 2.77
3.00
1.38 1.04 1.23
.95 .67 .77 .87 1.19 .92 .93 .82 1.19 1.05 .58 .69
.969 1.273
.949 .951 1.342 .847 .808 1.620 .927 1.074 .874 .865 .827 .755
.725
1.78 2.56 1.69 1.65 2.70 1.73 1.67 3.27 1.92 2.21 1.70 1.76 1.70 1.63
1.49
4.26 5.22 4.48 4.34 5.85 4.04 3.63 7.69 4.40 4.69 3.80 4.45 3.55 3.40 3.44
MEAN
S.D.
N
MIN. MAX.
503.6
31.8
15
462.9 575.2
2.0940
.5071
15
1.2807 3.1406
4.14
.90
15
2.77 5.76
.95
.23
15
.58 1.38
.987
.246
15
.725 1.620
1.96
.50
15
1.49 3.27
4.48
1.11
15
3.40 7.69
BFG 003130
U-68
96-4080
APPENDIX U (CONT.)
VINYL CHLORIDE COMBINED INHALATION TWO-GENERATION
REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CD RATS
TERMINAL ORGAN AND BODY WEIGHTS, ORGAN/BODY WEIGHT AND ORGAN/BRAIN WEIGHT RATIOS
TERMINAL SACRIFICE - P2 GENERATION - MALES
TERMINAL
AN BODY WT. WT.
NO (G)
(G)
INDIVIDUAL VALUES EPIDIDYMID ORG/TBW ORG/BRN (X 1000) (X 10)
WT. (G)
TESTES
ORG/TBW ORG/BRN
(X 1000) (x
i;
GROUP IV - 1100 PPM
4031 4033
4035 4037 4039 4041 4043 4045 4046 4047 4049 4050 4052 4054 4056
544.8 497.0 561.4 575.2 497.8 488.4 483.5 494.8 482.7 486.6 514.7 490.5 487.2 462.9 487.2
1.4564 1.2880 1.6885 1.3653
1.4459 1.5775 1.4360
.6551 1.6071 1.4006 1.3446 1.4926 1.2744 1.5443 1.2914
2.67 2.59 3.01 2.37 2.90 3.23 2.97 1.32 3.33 2.88 2.61 3.04 2.62 3.34 2.65
6.40 5.28 7.97 6.23 6.30 7.52 6.45 3.11 7.63 6.11 5.85 7.67 5.47 6.96 6.13
3.372 3.060 3.460 3.509 3.306 3.461 3.141
1.714 3.275 3.128 3.324 3.304 4.430 3.487 3.519
6.19 6.16 6.16 6.10 6.64 7.09 6.50 3.46 6.78 6.43 6.46 6.74
9.09 7.53 7.22
1.48 1.25 1.63 1.60 1.44 1.65 1.41
.81 1.56
1.37 1.45 1.70 1.90 1.57 1.67
MEAN
S.D.
N
MIN. MAX.
503.6
31.8
15
462.9 575.2
1.3912
.2378
15
.6551 1.6885
2.77
.49
15
1.32 3.34
6.34
1.21
15
3.11 7.97
3.299
.540
15
1.714 4.430
6.57
1.15
15
3.46 9.09
1.50
.25
15
.81 1.90
BFG 003131
U-69
96-4080
APPENDIX U (CONT.)
VINYL CHLORIDE COMBINED INHALATION TWO-GENERATION
REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CD RATS
TERMINAL ORGAN AND BODY WEIGHTS, ORGAN/BODY WEIGHT AND ORGAN/BRAIN WEIGHT RATIOS
TERMINAL SACRIFICE - P2 GENERATION - MALES
TERMINAL
AN BODY WT. WT.
NO (G)
(G)
INDIVIDUAL VALUES
THYMUS
ORG/TBW ORG/BRN
1;x ioooo) (X
io)
GROUP IV - 1100 PPM
4031 4033 4035 4037 4039 4041
4043 4045 4046 4047 4049 4050
4052 4054 4056
544.8 497.0 561.4 575.2 497.8 488.4 483.5 494.8 482.7 486.6 514.7 490.5 487.2 462.9 487.2
.433 .215 .415 .358 .314 .294 .269 .519 .422 .183 .320 .115 .246 .269 .153
7.95 4.33 7.39 6.22 6.31 6.02 5.56 10.49 8.74 3.76 6.22 2.34 5.05 5.81 3.14
1.90 .88
1.96 1.63 1.37 1.40 1.21 2.46 2.00
.80 1.39
.59 1.06 1.21
.73
MEAN
S.D.
N
MIN. MAX.
503.6
31.8
15
462.9 575.2
.302
.113
15
.115 .519
5.96
2.14
15
2.34 10.49
1.37
.54
15
.59 2.46
bfg 003132
U-70
96-4080
APPENDIX U (CONT.)
VINYL CHLORIDE COMBINED INHALATION TWO-GENERATION
REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CD RATS
TERMINAL ORGAN AND BODY WEIGHTS, ORGAN/BODY WEIGHT AND ORGAN/BRAIN WEIGHT RATIOS
TERMINAL SACRIFICE - P2 GENERATION - FEMALES
TERMINAL
AN BODY WT. WT.
NO (G)
(G)
INDIVIDUAL VALUES
BRAIN
ORG/TBW ORG/BRN
(X 1000) (X
1)
WT. (G)
ADRENALS ORG/TBW ORG/BRN (X 10000) (X 100)
GROUP I - 0 PPM
1531 1533 1538 1540 1541 1543 1551 1553 1555 1557 1558 1563 1568 1574 1578
260.3 303.4 306.4 281.1 234.8 198.9 320.4 323.8 277.1 266.8 280.1 257.6 261.5 273.9 265.4
2.184 2.068 2.059 1.831 2.169 2.194 2.230 2.120 1.957 2.090 2.069 1.994
2.062 2.014 1.957
8.39 6.82 6.72 6.51 9.24 11.03 6.96 6.55 7.06 7.83 7.39 7.74 7.89 7.35 7.37
1.00 1.00 1.00 1.00 1.00 1.00
1.00 1.00 1.00 1.00 1.00 1.00
1.00 1.00 1.00
.0719 .0749 .0592 .0610 .0631 .0785 .0660 .0902 .0557 .0686
.0877 .0651 .0826 .0739 .0756
2.76 2.47 1.93 2.17 2.69 3.95 2.06 2.79 2.01 2.57
3.13 2.53
3.16 2.70 2.85
3.29 3.62 2.88 3.33 2.91 3.58 2.96 4.25 2.85 3.28
4.24 3.26 4.01 3.67 3.86
MEAN
S.D.
N
MIN. MAX.
274.1
32.2
15
198.9 323.8
2.067
.106
15
1.831 2.230
7.66
1.19
15
6.51 11.03
1.00
.00
15
1.00 1.00
.0716
.0103
15
.0557 .0902
2.65
.52
15
1.93 3.95
3.47
.48
15
2.85 4.25
BFG 003133
U-71
96-4080
APPENDIX U (CONT.)
VINYL CHLORIDE COMBINED INHALATION TWO-GENERATION
REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CD RATS
TERMINAL ORGAN AND BODY WEIGHTS, ORGAN/BODY WEIGHT AND ORGAN/BRAIN WEIGHT RATIOS
TERMINAL SACRIFICE - P2 GENERATION - FEMALES
TERMINAL
AN BODY WT. WT.
NO (G)
(G)
INDIVIDUAL VALUES
KIDNEYS
ORG/TBW ORG/BRN
(X 1000) (X
1)
WT. (G)
LIVER
ORG/TBW ORG/BRN
{X 100) (X
1
GROUP I - 0 PPM
1531 1533 1538 1540 1541 1543 1551 1553 1555 1557 1558 1563
1568 1574
1578
260.3 303.4 306.4 281.1 234.8 198.9 320.4 323.8 277.1
266.8 280.1
257.6 261.5 273.9 265.4
2.551 2.774 2.555 2.577 2.055 2.520 2.601 3.011 2.368 2.384 2.344 2.048 2.047
2.269 2.282
9.80 9.14 8.34
9.17 8.75 12.67 8.12 9.30 8.55 8.94 8.37 7.95
7.83 6.28 8.60
1.17 1.34 1.24 1.41
.95 1.15 1.17 1.42 1.21 1.14 1.13 1.03
.99 1.13 1.17
10.671
7.963 12.722 10.118
6.948 10.622
9.317 11.159
9.344 10.102
9.076 8.117 10.011
9.136 8.534
4.10 2.62 4.15 3.60 2.96 5.34 2.91 3.45 3.37 3.79 3.24 3.15 3.83
3.34 3.22
4.89 3.85 6.18 5.53 3.20 4.84 4.18 5.26 4.77 4.83 4.39 4.07 4.85
4.54 4.36
MEAN
S.D.
N
MIN. MAX.
274.1
32.2
15
198.9 323.8
2.426
.272
15
2.047 3.011
8.92
1.17
15
7.83 12.67
1.18
.14
15
.95 1.42
9.589
1.433
15
6.948 12.722
3.54
.66
15
2.62 5.34
4.65
.71
15
3.20 6.18
BFG 003134
U-72
96-4080
APPENDIX U (CONT.)
VINYL CHLORIDE COMBINED INHALATION TWO-GENERATION
REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CD RATS
TERMINAL ORGAN AND BODY WEIGHTS, ORGAN/BODY WEIGHT AND ORGAN/BRAIN WEIGHT RATIOS
TERMINAL SACRIFICE - P2 GENERATION - FEMALES
TERMINAL
AN BODY WT. WT.
NO (G)
(G)
INDIVIDUAL VALUES LUNGS ORG/TBW ORG/BRN (X 1000) (X 10)
WT. (G)
OVARIES ORG/TBW ORG/BRN (X 10000) (X 100)
GROUP I - 0 PPM
1531
1533 1538 1540 1541 1543 1551 1553 1555 1557 1558 1563 1568
1574 1578
260.3 303.4
306.4 281.1 234.8 198.9 320.4 323.8 277.1 266.8 280.1 257.6 261.5
273.9 265.4
1.541 1.243 1.267
a
1.229 1.449 1.335 1.494 1.231 1.298 1.293 1.147 1.388 1.230 1.194
5.92 4.10 4.14
-
5.23 7.29 4.17 4.61 4.44 4.87 4.62 4.45 5.31 4.49 4.50
7.06 6.01 6.15
-
5.67 6.60 5.99 7.05 6.29 6.21 6.25 5.75 6.73 6.11 6.10
.1353 .1042 .0901 .1328 .0714 .1271 .1134 .1406 .0968 .1170 .1140 .0687 .1219 .0978
.0842
5,20 3.43 2.94 4.72 3.04 6.39 3.54 4.34 3.49 4.39 4.07 2.67 4.66
3.57 3.17
6.20 5.04
4.38 7.25 3.29 5.79 5.09 6.63 4.95 5.60 5.51 3.45 5.91
4.86 4.30
MEAN
S.D.
N
MIN. MAX.
274.1
32.2
15
198.9 323.8
1.310
.117
14
1.147 1.541
4.87
.86
14
4.10 7.29
6.28
.43
14
5.67 7.06
.1077
.0226
15
.0687 .1406
3.98
.99
15
2.67 6.39
5.22
1.10
15
3.29 7.25
BFG 003135
U-73
96-4080
APPENDIX U (CONT.)
VINYL CHLORIDE COMBINED INHALATION TWO-GENERATION
REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CD RATS
TERMINAL ORGAN AND BODY WEIGHTS, ORGAN/BODY WEIGHT AND ORGAN/BRAIN WEIGHT RATIOS
TERMINAL SACRIFICE - P2 GENERATION - FEMALES
TERMINAL
AN BODY WT. WT.
NO (G)
(G)
INDIVIDUAL VALUES
SPLEEN
ORG/TBW ORG/BRN
(X 1000)
10)
WT. (G)
THYMUS ORG/TBW ORG/BRN (X 10000) (X 10)
GROUP I - 0 PPM
1531 1533 1538 1540 1541 1543 1551 1553 1555 1557 1558 1563 1568 1574 1578
260.3 303.4 306.4 281.1 234.8 198.9 320.4 323.8 277.1 266.8 280.1 257.6 261.5 273.9 265.4
.547 .614 .565 .504 .535 .538 .561 .642 .486 .689 .538 .394 .959 .608 .505
2.10 2.02 1.84 1.79 2.28 2.70 1.75 1.98 1.75 2.58 1.92 1.53 3.67 2.22 1.90
2.50 2.97 2.74 2.75 2.47 2.45 2.52 3.03 2.48 3.30 2.60 1.98 4.65 3.02 2.58
.196 .188 .238 .458 .161 .236 .323 .266 .162 .329 .180 .174 .344 ,190 .295
7.53 6.20 7.77
16.29 6.86
11.87 10.08
8.21 5.85 12.33 6.43 6.75 13.15 6.94 11.12
.90 .91 1.16 2.50 .74 1.08 1.45 1.25 .83 1.57 .87 .87 1.67 .94 1.51
MEAN
S.D.
N
MIN. MAX.
274.1
32.2
15
198.9 323.8
.579
.126
15
.394 .959
2.14
.53
15
1.53 3.67
2.80
.60
15
1.98 4.65
.249
.086
15
.161 .458
9.16
3.14
15
5.85 16.29
1.22
.47
15
.74 2.50
BFG 003136
U-74
96-4080
APPENDIX U (CONT.)
VINYL CHLORIDE COMBINED INHALATION TWO-GENERATION REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CD RATS
TERMINAL ORGAN AND BODY WEIGHTS, ORGAN/BODY WEIGHT AND ORGAN/BRAIN WEIGHT RATIOS
TERMINAL SACRIFICE - P2 GENERATION - FEMALES
TERMINAL
AN BODY WT. WT.
NO (G)
(G)
INDIVIDUAL VALUES UTERUS ORG/TBW ORG/BRN (X 1000) (X 10)
GROUP I - 0 PPM
1531 1533 1538 1540 1541 1543 1551 1553 1555 1557 1558 1563 1568 1574 1578
260.3 303.4 306.4
281.1 234.8 198.9 320.4 323.8 277.1 266.8 280.1 257.6
261.5 273.9 265.4
.929 .630 .573
.772 .995 .584 .743 1.131 .661 .595 .795 .656 .607 .484 .677
3.57 2.08 1.87 2.75 4.24 2.94
2.32 3.49 2.39 2.23 2.84 2.55 2.32 1.77 2.55
4.25 3.05 2.78
4.22 4.59 2.66 3.33 5.33 3.38 2.85 3.84 3.29 2.94 2.40 3.46
MEAN
S.D.
N
MIN. MAX.
274.1
32.2
15
198.9 323.8
.722
.177
15
.484 1.131
2.66
.68
15
1.77 4.24
3.49
.81
15
2.40 5.33
BFG 003137
U-75
96-4080
APPENDIX U (CONT.)
VINYL CHLORIDE COMBINED INHALATION TWO-GENERATION
REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CD RATS
TERMINAL ORGAN AND BODY WEIGHTS, ORGAN/BODY WEIGHT AND ORGAN/BRAIN WEIGHT RATIOS
TERMINAL SACRIFICE - P2 GENERATION - FEMALES
TERMINAL
AN BODY WT. WT.
NO (G)
(G)
INDIVIDUAL VALUES
BRAIN
ORG/TBW ORG/BRN
(X 1000) (X
1)
WT. (G)
ADRENALS ORG/TBW ORG/BRN
![X 10000) (x ioo;
GROUP II - 10 PPM
2532 2533 2536 2538 2540
2543 2544 2546 2550 2552 2553 2554 2558 2569 2575
295.5 288.3 302.9 279.7 285.7 295.6 268.6 302.7 253.5 266.5 292.4 296.2 282.4 272.6 276.6
2.014 1.971 2.227 2.061 2.038 2.056 2.234 2.270 2.007 1.880 2.077 2.146
2.027 1.857
2.048
6.82 6.84 7.35 7.37 7.13 6.96 8.32 7.50 7.92 7.05 7.10 7.25
7.18 6.81 7.40
1.00 1.00 1.00 1.00 1.00 1.00 1.00 1.00 1.00 1.00 1.00 1.00 1.00 1.00 1.00
.0713 .0752 .0867 .0773 .0572 .0699 .0662 .0377 .0767 .0853 .0713 .0799 .0744 .0671 .0820
2.41 2.61 2.86 2.76 2.00 2.36 2.46 1.25 3.03 3.20 2.44 2.70 2.63 2.46 2.96
3.54 3.82 3.89 3.75 2.81 3.40 2.96 1.66 3.82 4.54 3.43 3.72 3.67 3.61 4.00
MEAN
S.D.
N
MIN. MAX.
283.9
14.4
15
253.5 302.9
2.061
.119
15
1.857 2.270
7.27
.41
15
6.81 8.32
1.00
.00
15
1.00 1.00
.0719
.0122
15
.0377 .0867
2.54
.47
15
1.25 3.20
3.51
.66
15
1.66 4.54
BFG 003138
U-76 APPENDIX U (CONT.)
96-4080
VINYL CHLORIDE COMBINED INHALATION TWO-GENERATION REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CD RATS
TERMINAL ORGAN AND BODY WEIGHTS, ORGAN/BODY WEIGHT AND ORGAN/BRAIN WEIGHT RATIOS
TERMINAL SACRIFICE - P2 GENERATION - FEMALES
TERMINAL
AN BODY WT. WT.
NO (G)
(G)
INDIVIDUAL VALUES
KIDNEYS
ORG/TBW ORG/BRN
(X 1000)
1)
WT. (G)
LIVER
ORG/TBW ORG/BRN
(X 100) (X
1)
GROUP II - 10 PPM
2532 2533 2536 2538 2540 2543 2544 2546 2550 2552 2553 2554 2558 2569
2575
295.5 288.3 302.9 279.7 285.7 295.6 268.6 302.7
253.5 266.5
292.4 296.2 282.4 272.6 276.6
2.379 2.466 2.218 2.503 2.795 2.563 2.634 2.599 2.082 2.201 2.481 2.498 2.380 2.421 2.465
8.05 8.55 7.32 8.95 9.78 8.67 9.81 8.59
8.21 8.26 8.48 8.43 8.43 8.88 8.91
1.18 1.25 1.00 1.21 1.37 1.25 1.18
1.14 1.04 1.17 1.19 1.16 1.17 1.30 1.20
9.115 10.796 8.901
9.407 7.960 9.393 10.303 9.656
8.107 7.843 10.312 9.418 9.273 11.346 11.351
3.08 3.74 2.94 3.36 2.79 3.18 3.84 3.19 3.20 2.94 3.53 3.18 3.28 4.16 4.10
4.53 5.48 4.00 4.56 3.91 4.57 4.61 4.25 4.04 4.17 4.96 4.39 4.57 6.11 5.54
MEAN
S.D.
N
MIN. MAX.
283.9
14.4
15
253.5 302.9
2.446
.181
15
2.082 2.795
8.62
.62
15
7.32 9.81
1.19
.09
15
1.00 1.37
9.545
1.117
15
7.843 11.351
3.37
.42
15
2.79 4.16
4.65
.63
15
3.91 6.11
BFG 003i:
U-77
96-4080
APPENDIX U (CONT.)
VINYL CHLORIDE COMBINED INHALATION TWO-GENERATION
REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CD RATS
TERMINAL ORGAN AND BODY WEIGHTS, ORGAN/BODY WEIGHT AND ORGAN/BRAIN WEIGHT RATIOS
TERMINAL SACRIFICE - P2 GENERATION - FEMALES
TERMINAL
AN BODY WT. WT.
NO (G)
(G)
INDIVIDUAL VALUES
LUNGS
ORG/TBW ORG/BRN
(X 1000) (X
10)
WT. (G)
OVARIES ORG/TBW ORG/BRN i[X 10000) (X 100)
GROUP II - 10 PPM
2532 2533 2536 2538 2540 2543 2544 2546 2550 2552 2553 2554 2558 2569 2575
295.5 288.3 302.9 279.7 285.7 295.6 268.6 302.7 253.5 266.5 292.4 296.2 282.4 272.6 276.6
1.371 1.355 1.352 1.443 1.286 1.395 1.369 1.487 1.058 1.390 1.539 1.403 1.382 1.242 1.458
4.64 4.70 4.46 5.16 4.50 4.72 5.10 4.91 4.17 5.22 5.26 4.74 4.89 4.56 5.27
6.81 6.87 6.07 7.00 6.31 6.79 6.13 6.55 5.27 7.39 7.41 6.54 6.82 6.69
7.12
.0972 .0872 .1395 .0990 .0840 .0655 .1335 .1050 .0813 .0676 .1059 .1198 .0791
.0968 .0894
3.29 3.02 4.61 3.54 2.94
2.22 4.97 3.47 3.21 2.54
3.62 4.04 2.80
3.55 3.23
4.83 4.42 6.26 4.80 4.12 3.19 5.98 4.63 4.05 3.60 5.10
5.58 3.90 5.21 4.37
MEAN
S.D.
N
MIN. MAX.
283.9
14.4
15
253.5 302.9
1.369
.113
15
1.058 1.539
4.82
.33
15
4.17 5,27
6.65
.55
15
5.27 7.41
.0967
.0216
15
.0655 .1395
3.40
.73
15
2.22 4.97
4.67
.86
15
3.19 6.26
BFG 003140
U-78
96-4080
APPENDIX U (CONT.)
VINYL CHLORIDE COMBINED INHALATION TWO-GENERATION
REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CD RATS
TERMINAL ORGAN AND BODY WEIGHTS, ORGAN/BODY WEIGHT AND ORGAN/BRAIN WEIGHT RATIOS
TERMINAL SACRIFICE - P2 GENERATION - FEMALES
TERMINAL
AN BODY WT. WT.
NO (G)
(G)
INDIVIDUAL VALUES
SPLEEN
ORG/TBW ORG/BRN
(X 1000) (X
10)
WT. (G)
THYMUS
ORG/TBW ORG/BRN
(X 10000) (X
10)
GROUP II - 10 PPM
2532 2533 2536 2538 2540 2543 2544 2546 2550
2552 2553 2554 2558 2569 2575
295.5 288.3 302.9 279.7 285.7 295.6 268.6 302.7 253.5 266.5 292.4 296.2 282.4 272.6
276,6
.453 .432 .611 .499 .502 .620 .491 .546 .438 .607 .550 .560 .573 .675 .510
1.53 1.50 2.02 1.78 1.76 2.10 1.83 1.80 1,73
2.28 1.88 1.89 2.03 2.48 1.84
2.25 2.19 2.74 2.42 2.46 3.02 2.20 2.41 2.18 3.23 2.65 2.61 2.83 3.63 2.49
.257 .224 .184 .169 .209 .168 .200 .295 .261 .208 .177 .248 .195 .201
.262
8.70 7.77 6.07 6.04 7.32 5.68 7.45 9.75 10.30 7.80 6.05 8.37
6.91 7.37 9.47
1.28 1.14
.83 .82 1.03 .82 .90 1.30 1.30
1.11 .85
1.16 .96
1.08 1.28
MEAN
S.D.
N
MIN. MAX.
283.9
14.4
15
253.5 302.9
.538
.072
15
.432 .675
1.90
.26
15
1.50 2.48
2.62
.42
15
2.18 3.63
.217
.039
15
.168 .295
7.67
1.43
15
5.68 10.30
1.06
.19
15
.82 1.30
BFG 003141
U--79
96-4080
APPENDIX U (CONT.)
VINYL CHLORIDE COMBINED INHALATION TWO-GENERATION
REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CD RATS
TERMINAL ORGAN AND BODY WEIGHTS, ORGAN/BODY WEIGHT AND ORGAN/BRAIN WEIGHT RATIOS
TERMINAL SACRIFICE - P2 GENERATION - FEMALES
TERMINAL
AN BODY WT. WT.
NO (G)
(G)
INDIVIDUAL VALUES
UTERUS
ORG/TBW ORG/BRN
(X 1000) (X
10)
GROUP II - 10 PPM
2532 2533 2536 2538 2540 2543 2544 2546 2550 2552 2553 2554 2558 2569 2575
295.5 288.3 302.9 279.7 285.7 295.6 268.6 302.7 253.5 266.5 292.4 296.2 282.4 272.6 276.6
.599 .614
.680 .852 1.249 .589 .651 .650 .643 .446 .553 .700 1.300 .422 .959
2.03 2.13 2.24 3.05 4.37 1.99 2.42 2.15 2.54 1.67 1.89 2.36 4.60 1.55 3.47
2.97 3.12 3.05 4.13 6.13 2.86 2.91 2.86 3.20 2.37 2.66 3.26 6.41
2.27 4.68
MEAN
S.D.
N
MIN. MAX.
283.9
14.4
15
253.5 302.9
.727
.259
15
.422 1.300
2.56
.92
15
1.55 4.60
3.53
1.27
15
2.27 6.41
BFG 003142
U-80
96-4080
APPENDIX U (CONT.)
VINYL CHLORIDE COMBINED INHALATION TWO-GENERATION
REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CD RATS
TERMINAL ORGAN AND BODY WEIGHTS, ORGAN/BODY WEIGHT AND ORGAN/BRAIN WEIGHT RATIOS
TERMINAL SACRIFICE - P2 GENERATION - FEMALES
TERMINAL
AN BODY WT. WT.
NO (G)
(G)
INDIVIDUAL VALUES
BRAIN
ORG/TBW ORG/BRN
(X 1000) (X
1)
WT. (G)
ADRENALS ORG/TBW ORG/BRN 1[X 10000) (X 100)
GROUP III - 100 PPM
3531 3532 3533 3534 3535 3536 3541 3543 3555
3556 3557 3559 3560 3562 3564
292.7 286.5 261.5 275.6 282.0 275.6 260.4 282.3 282.0 240.3 270.4 329.2 325.2 320.2 306,7
1.958 1.984 1.523 1.871 2.152 2.086 1.904
2.038 2.053 1.862 2.048 2.238 2.088 2.146 2.166
6.69 6.92 5.82 6.79 7.63 7.57 7.31
7.22 7.28 7.75 7.57 6.80 6.42 6.70 7.06
1.00 1.00 1.00 1.00 1.00 1.00 1.00 1.00 1.00 1.00 1.00 1.00 1.00 1.00 1.00
.0786 .0889 .0730 .0702 .0696 .0671
.0577 .0849 .0510
.0490 .0828 .0882 .0869 .0709 .0848
2.69 3.10 2.79 2.55 2.47 2.43 2.22 3.01 1.81 2.04 3.06 2.68 2.67 2.21 2.76
4.01 4.48 4.79 3.75 3.23
3.22 3.03 4.17
2.48 2.63
4.04 3.94 4.16 3.30 3.92
MEAN
S.D.
N
MIN. MAX.
286.0
25.2
15
240.3 329.2
2.008
.174
15
1.523 2.238
7.04
.52
15
5.82 7.75
1.00
.00
15
1.00 1.00
.0736
.0132
15
.0490 .0889
2.57
.38
15
1.81 3.10
3.68
.67
15
2.48 4.79
BFG 003143
U-81
96-4080
APPENDIX U (CONT.)
VINYL CHLORIDE COMBINED INHALATION TWO-GENERATION
REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CD RATS
TERMINAL ORGAN AND BODY WEIGHTS, ORGAN/BODY WEIGHT AND ORGAN/BRAIN WEIGHT RATIOS
TERMINAL SACRIFICE - P2 GENERATION - FEMALES
TERMINAL
AN BODY WT. WT.
NO (G)
(G)
INDIVIDUAL VALUES
KIDNEYS
ORG/TBW ORG/BRN
{X 1000) (X
1)
WT. (G)
LIVER
ORG/TBW ORG/BRN
(X 100) (X
i;
GROUP III - 100 PPM
3531 3532 3533 3534 3535 3536 3541 3543 3555 3556 3557 3559 3560 3562 3564
292.7 286.5 261.5 275.6 282.0 275.6 260.4 282.3 282.0 240.3 270.4 329.2 325.2
320.2 306.7
2.394 2.694 2.230 2.274 2.919 2.473 2.253 2.597 2.613 2.372 2.190 2.928 2.501
2.821 2.660
8.18 9.40 8.53 8.25 10.35 8.97 8.65 9.20 9.27 9.87 8.10 8.89 7.69
8.81 8.67
1.22 1.36 1.46 1.22 1.36 1.19 1.18 1.27 1.27 1.27 1.07 1.31 1.20
1.31 1.23
9.171 9.482 9.621 9.614 12.573 9.917 9.557 10.982 9.449 10.386
8.173 10.264 12.007
9.870 12.663
3.13 3.31 3.68 3.49 4.46 3.60 3.67 3.89 3.35 4.32 3.02 3.12 3.69 3.08
4.13
4.68 4.78 6.32 5.14 5.84 4.75 5.02 5.39 4.60 5.58 3.99 4.59 5.75
4.60 5.85
MEAN
S.D.
N
MIN. MAX.
286.0 25.2
15
240.3 329.2
2.528
.246
15
2.190 2.928
8.86
.70
15
7.69 10.35
1.26
.09
15
1.07 1.46
10.249
1.285
15
8.173 12.663
3.60
.45
15
3.02 4.46
5.13
.64
15
3.99 6.32
BFG 003144
U-82 APPENDIX U (CONT.)
96-4080
VINYL CHLORIDE COMBINED INHALATION TWO-GENERATION REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CD RATS
TERMINAL ORGAN AND BODY WEIGHTS, ORGAN/BODY WEIGHT AND ORGAN/BRAIN WEIGHT RATIOS
TERMINAL SACRIFICE - P2 GENERATION - FEMALES
TERMINAL
AN BODY WT. WT.
NO (6)
(G)
INDIVIDUAL VALUES LUNGS ORG/TBW ORG/BRN (X 1000) (X 10)
WT. (G)
OVARIES ORG/TBW ORG/BRN (X 10000) (X 100)
GROUP III - 100 PPM
3531 3532 3533 3534 3535 3536 3541 3543 3555 3556 3557 3559 3560 3562 3564
292,7 286.5 261.5 275.6 282.0 275.6 260.4 282.3 282.0 240.3 270.4 329.2 325.2 320.2 306.7
1.260 1.292 1.193 1.310 1.329 1.287 1.254 1.214 1.405 1.178 1.329 1.578 1.422 1.887 1.419
4.30 4.51 4.56
4.75 4.71 4.67
4.82 4.30 4.98 4.90 4.91 4.79 4.37 5.89 4.63
6.44 6.51 7.83 7.00 6.18 6.17 6.59 5.96 6.84 6.33 6.49 7.05 6.81 8.79 6.55
.1133 .1223 .0589 .1114 .1127
.1214 .0994 .1390 .0926 .0866 .0668 .1070 .1122 .0883 .0968
3.87 4.27 2.25
4.04 4.00 4.40
3.82 4.92 3.28 3.60 2.47 3.25 3.45 2.76 3.16
5.79 6.16 3.87 5.95 5.24 5.82 5.22 6.82 4.51 4.65 3.26 4.78 5.37 4.11 4.47
MEAN
S.D.
N
MIN. MAX.
286.0
25.2
15
240.3 329.2
1.357
.180
15
1.178 1.887
4.74
.38
15
4.30 5.89
6.77
.72
15
5.96 8.79
.1019
.0211
15
.0589 .1390
3.57
.73
15
2.25 4.92
5.07
.96
15
3.26 6.82
BFG 003145
U-83
96-4080
APPENDIX U (CONT.)
VINYL CHLORIDE COMBINED INHALATION TWO-GENERATION
REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CD RATS
TERMINAL ORGAN AND BODY WEIGHTS, ORGAN/BODY WEIGHT AND ORGAN/BRAIN WEIGHT RATIOS
TERMINAL SACRIFICE - P2 GENERATION - FEMALES
INDIVIDUAL VALUES
TERMINAL
SPLEEN
THYMUS
AN BODY WT. WT.
ORG/TBW ORG/BRN
WT. ORG/TBW ORG/BRN
NO (G)
(G) (X 1000) (X
10)
(G) 1[X 10000) (X
10)
GROUP III - 100 PPM
3531 3532 3533 3534 3535
3536 3541 3543 3555 3556 3557 3559
3560 3562 3564
292.7 286.5 261.5 275.6 282,0 275.6 260.4 282.3 282.0 240.3 270.4 329.2 325.2 320.2 306.7
.602 .656 .424 .571 .501
.502 .473 .672 .552 .560 .459 .564
.744 .684 .599
2.06 2.29 1.62 2.07 1.78 1.82 1.82 2.38 1.96 2.33 1.70 1.71
2.29 2.14 1.95
3.07 3.31 2.78 3.05 2.33 2.41 2.48 3.30 2.69 3.01 2.24 2.52 3.56 3.19 2.77
.234 .222 .337 .291 .261 .201 .266 .228 .254 .236 .344 .377
.224 .266 .236
7.99 7.75 12.89 10.56 9.26 7.29 10.22 8.08 9.01 9.82 12.72 11.45
6.89 8.31 7.69
1.20 1.12 2.21 1.56 1.21
.96 1.40 1.12 1.24 1.27 1.68 1.68 1.07 1.24 1.09
MEAN
S.D.
N
MIN. MAX.
286.0
25.2
15
240.3 329.2
.571
.091
15
.424 .744
1.99
.25
15
1.62 2.38
2.85
.40
15
2.24 3.56
.265
.051
15
.201 .377
9.33
1.91
15
6.89 12.89
1.34
.33
15
.96 2.21
BFG 003146
U-84
96-4080
APPENDIX U (CONT.)
VINYL CHLORIDE COMBINED INHALATION TWO-GENERATION
REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CD RATS
TERMINAL ORGAN AND BODY WEIGHTS, ORGAN/BODY WEIGHT AND ORGAN/BRAIN WEIGHT RATIOS
TERMINAL SACRIFICE - P2 GENERATION - FEMALES
TERMINAL
AN BODY WT. WT.
NO (G)
(G)
INDIVIDUAL VALUES
UTERUS
ORG/TBW ORG/BRN
(X 1000) (X
10)
GROUP III - 100 PPM
3531 3532 3533 3534 3535 3536 3541
3543 3555 3556 3557 3559 3560 3562 3564
292.7 286.5 261.5 275.6 282.0 275.6 260.4
282.3 282.0 240.3 270.4 329.2 325.2 320.2 306.7
.678 .854 .711 .570 .617 .584 .859 1.089 .531 .762 .945 .626 .587 .549 .633
2.32 2.98 2.72 2.07 2.19 2.12 3.30 3.86 1.88 3.17 3.49 1.90 1.81 1.71 2.06
3.46 4.30 4.67 3.05 2.87 2.80 4.51 5.34 2.59 4.09 4.61 2.80 2.81 2.56 2.92
MEAN
S.D.
N
MIN. MAX.
286.0
25.2
15
240.3 329.2
.706
.164
15
.531 1.089
2.51
.69
15
1.71 3.86
3.56
.93
15
2.56 5.34
BFG 003147
U-85
96-4080
APPENDIX U (CONT.)
VINYL CHLORIDE COMBINED INHALATION TWO-GENERATION
REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CD RATS
TERMINAL ORGAN AND BODY WEIGHTS, ORGAN/BODY WEIGHT AND ORGAN/BRAIN WEIGHT RATIOS
TERMINAL SACRIFICE - P2 GENERATION - FEMALES
TERMINAL
AN BODY WT. WT.
NO (G)
(G)
INDIVIDUAL VALUES
BRAIN
ORG/TBW ORG/BRN
(X 1000} (X
1)
WT. (G)
ADRENALS ORG/TBW ORG/BRN 1[X 10000) (X 100)
GROUP IV - 1100 PPM
4531 4538 4545 4546 4549 4555 4556 4557 4558 4560 4562 4563 4566 4574 4577
305.1 303.5
231.2 268.3 316.2 276.9 281.0 293.0 293.6 324.7 270.1 243.4 305.0 254.5
228.5
2.227
2.013 1.838 2.034 2.100 1.974 1.978 2.029 2.151 2.039 2.208 1.914
2.065 1.920
1.663
7.30 6.63 7.95 7.58 6.64 7.13 7.04 6.92 7.33 6.28 8.17 7.86 6.77 7.54
7.28
1.00 1.00 1.00 1.00 1.00 1.00 3.00 1.00 1.00 1.00
1.00 1.00 1.00
1.00 1.00
.0791 .0738 .0600 .0763 .0722 .0729 .0707 .0731 .0768 .0920 .0662 .0720 .0867 .0661 .0656
2.59 2.43 2.60 2.84 2.28 2.63 2.52 2.49 2.62 2.83 2.45 2.96 2.84 2.60
2.87
3.55 3.67 3.26 3.75 3.44 3.69 3.57 3.60 3.57 4.51 3.00 3.76 4.20 3.44 3.94
MEAN
S.D.
N
MIN. MAX.
279.7
30.2
15
228.5 324.7
2.010
.144
15
1.663 2.227
7.23
.54
15
6.28 8.17
1.00
.00
15
1.00 1.00
.0736
.0082
15
.0600 .0920
2.64
.19
15
2.28 2.96
3.66
.36
15
3.00 4.51
BFG 003148
U-86
96-4080
APPENDIX U (CONT.)
VINYL CHLORIDE COMBINED INHALATION TWO-GENERATION
REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CD RATS
TERMINAL ORGAN AND BODY WEIGHTS, ORGAN/BODY WEIGHT AND ORGAN/BRAIN WEIGHT RATIOS
TERMINAL SACRIFICE - P2 GENERATION - FEMALES
TERMINAL
AN BODY WT. WT.
NO (G)
(G)
INDIVIDUAL VALUES
KIDNEYS
ORG/TBW ORG/BRN
(X 1000) (X
1)
WT. (G)
LIVER
ORG/TBW ORG/BRN
(X 100) (X
1
GROUP IV - 1100 PPM
4531 4538 4545 4546 4549 4555 4556 4557 4558 4560 4562 4563 4566 4574
4577
305.1 303.5 231.2 268.3 316.2 276.9 281.0 293.0 293.6 324.7 270.1 243.4 305.0 254.5
228.5
2.628 2.792 2.323 2.427 2.901 2.354 2.405 2.532 2.262 2.917 2.287 2.005 2.378 2.275 2.391
8.61
9.20 10.05
9.05 9.17 8.50 8.56 8.64 7.70 8.98 8.47 8.24 7.80 8.94 10.46
1.18 1.39 1.26 1.19 1.38 1.19 1.22 1.25 1.05 1.43 1.04 1.05 1.15 1.18 1.44
11.930 11.307
8.836 11.437 10.844 10.025 11.194 10.555
9.652 12.037
9.248 8.352 10.397 9.663
10.853
3.91 3.73 3.82 4.26 3.43 3.62 3.98 3.60 3.29 3.71 3.42 3.43
3.41 3.80 4.75
5.36 5.62 4.81 5.62 5.16 5.08 5.66 5.20 4.49 5.90 4.19 4.36 5.03 5.03
6.53
MEAN
S.D.
N
MIN. MAX.
279.7
30.2
15
228.5 324.7
2.458
.254
15
2.005 2.917
8.83
.74
15
7.70 10.46
1.23
.13
15
1.04 1.44
10.422
1.108
15
8.352 12.037
3.74
.38
15
3.29 4.75
5.20
.62
15
4.19 6.53
BFG 003149
U-87
96-4080
APPENDIX U (CONT.)
VINYL CHLORIDE COMBINED INHALATION TWO-GENERATION
REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CD RATS
TERMINAL ORGAN AND BODY WEIGHTS, ORGAN/BODY WEIGHT AND ORGAN/BRAIN WEIGHT RATIOS
TERMINAL SACRIFICE - P2 GENERATION - FEMALES
TERMINAL
AN BODY WT. WT.
NO (G)
(G)
INDIVIDUAL VALUES
LUNGS
ORG/TBW ORG/BRN
(X 1000)
10)
WT. (G)
OVARIES ORG/TBW ORG/BRN (X 10000) (X 100)
GROUP IV - 1100 PPM
4531 4538 4545 4546 4549 4555 4556 4557 4558 4560 4562 4563 4566 4574 4577
305.1 303.5
231.2 268.3 316.2 276.9 281.0 293.0 293.6 324.7 270.1 243.4 305.0 254.5 228.5
1.353 1.597 1.375 1.239 1.507 1.255 1.288 1.470 1.295 1.330 1.576 1.319 1.381
1.251 1.272
4.43 5.26 5.95 4.62 4.77 4.53 4.58 5.02 4.41 4.10 5.83 5.42 4.53 4.92 5.57
6.08 7.93 7.48 6.09 7.18 6.36 6.51 7.24 6.02 6.52 7.14 6.89
6.69 6.52 7.65
.1000 .1090 .0736 .1075 .1646
.0984 .1147 .1012 .0959 .0464 .1221 .0662 .1179 .0950 .1010
3.28 3.59
3.18 4.01 5.21 3.55 4.08 3.45 3.27 1.43 4.52 2.72 3.87 3.73 4.42
4.49 5.41 4.00 5.29 7.84 4.98 5.80 4.99 4.46 2.28 5.53 3.46 5.71 4.95 6.07
MEAN
S.D.
N
MIN. MAX.
279.7
30.2
15
228.5 324.7
1.367
.118
15
1.239 1.597
4.93
.56
15
4.10 5.95
6.82
.60
15
6.02 7.93
.1009
.0268
15
.0464 .1646
3.62
.87
15
1.43 5.21
5.02
1.26
15
2.28 7.84
BFG 003150
U-88 APPENDIX U (CONT.)
96-4080
VINYL CHLORIDE COMBINED INHALATION TWO-GENERATION
REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CD RATS
TERMINAL ORGAN AND BODY WEIGHTS, ORGAN/BODY WEIGHT AND ORGAN/BRAIN WEIGHT RATIOS
TERMINAL SACRIFICE - P2 GENERATION - FEMALES
TERMINAL
AN BODY WT. WT.
NO <G)
(G)
INDIVIDUAL VALUES
SPLEEN
ORG/TBW ORG/BRN
(X 1000) (X
10)
WT. (G)
THYMUS
ORG/TBW ORG/BRN
1[X 10000) (X
10)
GROUP IV - 1100 PPM
4531 4538 4545 4546 4549 4555 4556 4557 4558 4560 4562 4563 4566 4574 4577
305.1 303.5 231.2 268.3 316.2 276.9 281.0 293.0 293.6 324.7 270.1 243.4 305.0 254.5 228.5
.632 .594 .469
.588 .718 .501 .552 .656 .708 .641 .674 .570 .665 .505 .582
2.07 1.96 2.03 2.19 2.27 1.81 1.96 2.24 2.41 1.97 2.50 2.34
2.18 1.98 2.55
2.84 2.95 2.55 2.89 3.42 2.54 2.79 3.23 3.29 3.14 3.05 2.98 3.22 2.63 3.50
.362 .180 .176
.164 .234 .323 .175
.245 .234 .244 .301 .302 .193 .223 .162
11.86 5.93 7.61 6.11 7.40
11.66 6.23 8.36 7.97
7.51 11.14 12.41
6.33 8.76 7.09
1.63 .89 .96 .81
1.11 1.64
.88
1.21 1.09 1.20 1.36 1.58
.93 1.16
.97
MEAN
S.D.
N
MIN. MAX.
279.7
30.2
15
228.5 324.7
.604
.076
15
.469 .718
2.16
.22
15
1.81 2.55
3.00
.30
15
2.54 3.50
.235
.063
15
.162 .362
8.43
2.25
15
5.93 12.41
1.16
.28
15
.81 1.64
BFG 003151
U-89
96-4080
APPENDIX U (CONT.)
VINYL CHLORIDE COMBINED INHALATION TWO-GENERATION
REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CD RATS
TERMINAL ORGAN AND BODY WEIGHTS, ORGAN/BODY WEIGHT AND ORGAN/BRAIN WEIGHT RATIOS
TERMINAL SACRIFICE - P2 GENERATION - FEMALES
TERMINAL
AN BODY WT. WT.
NO (G)
(G)
INDIVIDUAL VALUES
UTERUS
ORG/TBW ORG/BRN
(X 1000) (X
10)
GROUP IV - 1100 PPM
4531 4538 4545 4546 4549 4555 4556 4557 4558 4560 4562 4563 4566 4574 4577
305.1 303.5 231.2 268.3 316.2 276.9 282.0 293.0 293.6 324.7 270.1 243.4 305.0 254.5 228.5
.612 .551 .351 .635 .775 .612 .627 .596 .651 .856
1.138 .741 .842 .620 .696
2.01 1.82 1.52 2.37 2.45 2.21 2.23 2.03 2.22 2.64
4.21 3.04 2.76 2.44 3.05
2.75 2.74 1.91 3.12 3.69 3.10 3.17 2.94 3.03 4.20 5.15 3.87 4.08 3.23 4.19
MEAN
S.D.
N
MIN. MAX.
279.7
30.2
15
228.5 324.7
.687
.175
15
.351 1.138
2.47
.64
15
1.52 4.21
3.41
.79
15
1.91 5.15
003152
bfg
APPENDIX V
BFG 003153
Huntingdon Life Sciences Reproduction Study
96-4080
Page 1 Draft Final Report
Terminal Organ and Body Weights and Organ/Body Weight Ratios - Terminal
Sacrifice - Pups
Appendix V
Key to Abbreviations
TBW ORG/TBW
General
= -
Terminal Body Weight Organ/Terminal Body Weight Ratio
Due to technician error, greater than 15 pups were processed in some groups.
BFG 003154
Huntingdon Life Sciences 96-4080 Reproduction Study
Appendix V Terminal Organ and Body Weights and Organ/Body Weight Ratios
Terminal Sacrifice - FI Male Pups
Page 2
Female No.
Terminal Pup Body No. Weigh*
<g)
Adrenal Weight
(8)
Adrenal/ TBW
(XI000)
Brain Weight
<E)
Brain/ TBW (XI00)
Group 1 - 0 ppm
1501 2
1505 4
1506 2
1508 3
1510 3
1514 7
1516 2
1517 3
1518 3
1519
1
1520 2
1521 8
1522 3
1524 7
1525 3
1528 2
1529 5
62.3 54.2 58.3 58.2 48.9 58.5 58.3 45.0 46.2 57.0 45.7 50.0 62.6 61.3 45.8 70.2 54.9
0.0223 0.0183 0.0185 0.0188 0.0227 0.0201 0.0144 0.0100 0.0181 0.0271 0.0141 0,0187 0.0234 0.0155 0.0078 0.0214 0.0173
0.3579 0.3376 0.3173 0.3230 0.4642 0.3436 0.2470 0.2222 0.3918 0.4754 0.3085 0.3740 0.3738 0.2529 0.1703 0.3048 0.3151
1.4305 1.4801 1.4328 1.5695 1.2965 1.5871 1.4860 1.4647 1,5207 1.4836 1.5613 1.4805 1.6183 1.6386 1.4689 1.6558 1,5050
2.2961 2.7308 2.4576 2.6967 2.6513 2.7130 2.5489 3.2549 3.2916 2.6028 3.4164 2.9610 2.5851 2.6731 3.2072 2.3587 2.7413
Kidneys Weight
(8)
0.8362 0.7630 0.9100 0.8690 0.7664 0.8837 0.7333 0.6273 0.7210 0.7691 0.6812 0.7139 0.9168 0.8907 0.7255 1.0384 0.7750
Kidneys/ TBW (XI00)
(g)
Liver Weight
(g)
1.3422 1.4077 I.S609 1.4931 1.5673 1.5106 1.2578 1.3940 1.5606 1.3493 1.4906 1.4278 1.4645 1.4530 1.5841 1.4792 1.4117
2.6186 2.1530 2.9605 2.6056 2.3539 2.8784 2.6093 1.8964 2.0633 2.2307 2.7290 2.2357 2.9369 2.7975 2.1364 3.2573 2.3862
Liver/ TBW (xlOO)
4.2032 3.9723 5.0780 4.4770 4.8137 4.9203 4.4756 4.2142 4.4660 3.9135 5.9716 4.4714 4.6915 4.5636 4.6646 46400 4.3464
Spleen Weight
(g)
Spleen^ TBW (xlOO)
Testes Weight
(g>
Testes/ TBW (xlOO)
Tliymus Weight
(g)
Thymus/ TBW (xlOO)
0.3014 0.3663 0.3571 0.2924 0.4134 0.2967 0.3024 0.2768 0.2288 0.3815 0.2402 0.2580 0.3888 0.3002 0.281! 0.3817 0.3129
0.4838 0.6758 0.6125 0.5024 0.8454 0.5072 0.5187 0.6151 0.4952 0.6693 0.5256 0.5160 0.6211 0.4897 0.6138 0.5437 0.5699
0.3310 0.2510 0.2652 0.3146 0.2651 0.3083 0.2651 0.2105 0.2395 0.2753 0.2309 0.2757 0.3319 0.3096 0.1769 0.4046 0,2693
0.5313 0.4631 0.4549 0.5405 0.5421 0.5270 0.4547 0.4678 0.5184 0.4830 0.5053 0.5514 0.5302 0.5051 0.3862 0.5764 0.4905
0.2342 0.2112 0.2008 0.2202 0.1881 0.2330 0.2381 0.1986 0.1511 0.2045 0.1694 02093 0.2832 0.2545 0.2291 0.2693 0.2000
0.3759 0.3897 0.3444 0.3784 0.3847 0.3983 0.4084 0.4413 0.3271 0.3588 0.3707 0.4186 0.4524 0.4152 0.5002 0.3836 0.3643
BFG 003155
Huntingdon Life Sciences 96-4080 Reproduction Study
Appendix V Terminal Organ and Body Weights and Organ/Body Weight Ratios
Terminal Sacrifice - FI Male Pups
Page 3
Terminal Femule Pup Body Adrenol
No. Nu. Weight Weight
(g> <S>
Adrenal/ TBW
(X1000)
Brain Weight
<g)
Group II 2503 2504 2506 2510 2515 2516 2518 2522 2523 2524 2525 2527 2528 2530 2531
10 ppm 4 2 9 1 11 2 3 12 4 2 3 4 6 5 7
54.0 60.9 62.6 59.2 54.9 58.7 64.3 50.6 55.5 59.3 47,0 50.4 61.0 51.7 61.0
0.0188 0.0177 0.0106 0.0302 0.0203 0.0266 0.0227 0,0117 0.0187 0.0181 0.0226 0.0339 0.0189 0.0288 0.0162
0.3481 0.2906 0.1693 0.5101 0.3698 0.4532 0.3530 0.2312 0.3369 0.3052 0.4809 0.6726 0.3098 0-5571 0.2656
1.5498 I.SI18 1.5454 1.5528 1.4896 1.5605 1.5390 1.4909 1.4718 1.4510 1.4758 1.5107 1.5862 1.5416 1.5903
Brain/ TBW (X100)
2.8700 2.4824 2.4687 2.6230 2.7133 2.6584 2.3935 2.9464 2.6519 2.4469 3.1400 2.9974 2.6003 2.9818 2.6070
Kidneys Weight
(e)
0.7778 0.8484 0.9084 0.9026 0,8032 0.8158 0.9364 0.7291 0.7502 0.8135 0.7411 0.7057 0.9052 0.6910 0.8601
Kidneys/ TBW (XI00)
<g)
Liver Weight
(g)
1.4404 1.3931 1.4511 1.5247 1.4030 1.3898 1.4563 1.4409 1.3517 1.3718 1.5768 1.4002 1.4839 1.3366 1.4100
2.1145 2.5660 3.1826 2.7993 2.4118 2.7395 2.9362 2.2227 2.4552 2.7424 2.1621 2.3223 2.8987 2.3562 2.4501
Liver/ TBW (xlOO)
3.9157 4.2135 5.0840 4.7285 4.3931 4.6670 4.5664 4.3927 4.4238 4.6246 4.6002 4.6077 4.7520 4.5574 4.0166
Spleen Weight
(g)
Spleen/ TBW (xlOO)
0.2900 0.3422 0.3063 0.2637 0.3405 0.4099 0.2563 0.2942 0.2645 0.2863 0.1874 0.2573 0.3301 0.2560 0.3745
0.5370 0.5619 0.4893 0.4454 0.6202 0.6983 0.3986 0.5814 0.4766 0.4828 0.3987 0.5105 0.5411 0.4952 0.6139
Testes Weight
<g)
Testes/ TBW (xlOO)
Thymus Weight
(e)
Thymus/ TBW (xlOO)
0.2328 0.2694 0.3826 0.3181 0.2419 0.2949 0.3099 0.2805 0.3590 0.3773 0.2496 0.2503 0.3087 0.2818 0.2896
0.4311 0.4424 0.6112 0.5373 0.4406 0.5024 0.4820 0.5543 0.6468 0.6363 0.5311 0.4966 0.5061 0.5451 0.4748
0.2127 0.2634 0.2480 0.1772 0.2475 0.2483 0.1897 0.1883 0.1875 0.2894 0.1729 0.1958 0.2521 0.2107 0.2972
0.3939 0.4325 0.3962 0.2993 0.4508 0.4230 0.2950 0.3721 0.3378 0.4880 0.3679 0.3885 0.4133 0.4075 0.4872
BFG 003156
Huntingdon Life Sciences 96-4080 Reproduction Study
Appendix V Terminal Organ and Body Weights and Organ/Body Weight Ratios
Terminal Sacrifice - FI Male Pups
Page 4
Terminal Female Pup Body
No. No. Weight <g)
Adrcnul Weight
(g)
Adrenal/ TBW (XI00)
Drain Weight
(8)
Brain/ TBW (XI00)
roup III - 100 ppm
3502 1
59.7
3506 2
60.4
3507 2
39.4
3509 6
66.3
3511
69.2
3512 4
70.8
3515
1
48.1
3516 3
63.3
3517 3
61.7
3518 2
56.3
3519 5
70.0
3521 7
56.3
3523 6
46.1
3524 2
72.5
3528 7
60.0
0.0135 0.0194 0.0127 0.0092 0.0166 0.0183 0.0164 0.0187 0.0197 0.0177 0.0209 0.0246 0.0142 0.0181 0.0263
0.2261 0.3212 0.3223 0.1388 0.2399 0.2585 0.3410 0.2954 0.3193 0.3144 0.2986 0.4369 0.3080 0.2497 0.4383
1.4267 1.5227 1.3371 1.6463 1.6121 1 6549 1.5013 1.6836 1.6016 1.5216 1.5913 1.6126 1.5632 1.7474 1.4738
2.3898 2 5210 3.3937 2 4831 2 3296 2.3374 3.1212 2.6597 2.5958 2.7027 2.2733 2.8643 3.3909 2.4102 2.4563
Kidneys Weight
(g)
0.8595 0.8980 0 6083 0.9211 0.9222 0.9981 0.7617 0.8848 0.8861 0.7788 1.1382 0.7860 0.6695 0.9890 08686
Kidneys/ TBW (XI00)
(S)
Liver Weight
(g)
1.4397 1.4868 l 5439 1.3893 1 3327 1.4097 1.5*36 1.3978 1.4361 1.3833 1.6260 1.3961 1.4523 1.3641 1.4477
2.6355 3.1553 1.7052 3.1098 3.3301 3.2219 2.3497 3.2332 2.6983 2.3090 3.5341 2.3950 1.6902 3.9753 2.6058
Liver/ TBW (xlOO)
4.4146 5.2240 4.3279 4.6905 4 8123 4.5507 4.8850 5.1077 4.3733 4.1012 5.0487 4.2540 3.6664 5.4832 4.3430
Spleen Weight
(R)
Spleen/ TBW (xlOO)
Testes Weight
(S)
Testes/ TBW (xlOO)
Thymus Weight
(*)
Thymus/ TBW (xlOO)
0.3567 0.3382 0.2842 0.3293 0.3563 0.3422 0.3064 0.4026 0,3077 0.3374 0.3442 0.2997 0.2616 0.2854 0.3644
0.5975 0.5599 0.7213 0.4967 0.5149 0.4833 0.6370 0.6360 0,4987 0.5993 0.4917 0.5323 0.5675 0.3937 0.6073
0.3570 0.3440 0.1531 0.351* 0.4199 0.3613 0.2436 0.2773 0.3647 0.2637 0.4025 0.2447 0.2184 0.46*6 0.3552
0.5980 0.5695 0.38*6 0.5306 0.6068 0.5103 0.5064 0.4381 0.5911 0.4684 0.5750 0.4346 0.4738 0.6463 0.5920
0.2255 0.2395 0 1951 0.2932 0.3021 0.3229 0.2064 0.2282 0.3160 0.2534 03328 0.2172 0.2017 0.3163 0.2365
0.3777 0.3965 0.4952 0.4422 0.4366 0.4561 0.4291 0.3605 0.5122 0.4501 0.4754 0.3858 0.4375 0.4363 0.3942
BFG 003157
Huntingdon Life Sciences 96-4080 Reproduction Study
Appendix V Terminal Organ and Body Weights and Organ/Body Weight Ratios
Terminal Sacrifice - FI Male Pups
Page 5
Terminal Female Pup Body
No. No. Weight (S)
Adrenal Weight
(s)
Adrenal/ TBW (X100)
Brain Weight
(e)
Brain/ TBW (XI00)
Group IV - 1100 ppm
4501 2
62.7
4502 2
56.6
4503 2
38.3
4504 2
55.9
4506 9
54.0
4509 3
60.8
4511
5
57.1
4512 2
72,5
4515 2
56.0
4518 6
64.2
4519 5
47.1
4521 4
76.3
4522 l
50.9
4524 1
65.7
4528 2
51.5
4529 3
33.7
4530 5
50.2
0.0176 0.0134 0.0150 0.018.3 0.0155 0.0279 0.0202 0.0305 0.0247 0.0227 0.0131 0.0373 0.0173 0.0254 0.0190 0.0192 0.0182
0.2X07 0.2367 03916 0.3274 0 2X70 0.4589 03538 0.4207 0.4411 0.3536 0.2781 0.4889 0.3399 0.3866 0.3689 0.5697 0.3625
1.6097 1.5286 1.3623 1.4380 1.6007 1.6784 1.6106 1.7145 1.5930 1.5887 1.5202 1.7400 1.3701 1.5238 1.4940 1.3667 1.5558
2.5673 2.7007 3.5569 2 5725 2.9643 2.7605 2.8207 2.3648 2.8446 2.4746 3.2276 2.2805 2.6917 2.3193 2.9010 4.0555 3.0992
Kidneys Weight
(g)
0.8700 08132 0 5233 0.8413 0 8754 0.8527 0.8011 1.1625 0.7839 0.9646 0,6757 1.1036 0.7216 0.9741 0.7683 0.5120 0.7649
Kidneys/ TBW (XtOO) <g)
Liver Weight
(g)
1.3876 1.4367 1.3663 1.5050 1 6211 1.4025 1.4030 1.6034 1.3998 1.5025 1.4346 1.4464 1.4177 1.4826 1.4918 1.5193 1.5237
2.7832 2.8104 1 3766 2.8006 2.5741 2.8924 2.5014 3.2616 2.3558 3.3276 1.9845 3.9687 2.2481 3.2112 2.1060 1.2345 2.2144
Liver/ TBW (xlOO)
4.4389 4.9654 3.5943 5.0100 4.7669 4.7572 4.3807 4.4988 4.2068 5.1832 4.2134 5.2014 4.4167 4.8877 4.0893 3.6632 4.4112
Spleen Weight
(S)
Spleen/ TBW (XlOO)
Testes Weight
(e)
Testes/ TBW (xlOO)
Thymus Weight
(g)
Thymus/ TBW (xlOO)
0.4045 0.3360 0 1724 0 2339 03357 0.4063 0.3320 0.3991 0.2206 0.3390 0.2655 0.3846 0.3217 0.3677 0.2893 0.1763 0.2795
0.6451 0.5936 0.4501 0.4184 0.6217 0 6683 0.5814 0.5505 0.3939 0.5280 0.5637 0.5041 0.6320 0.5597 0.5617 0.5231 0.5568
0.3122 0.2522 0.1892 0.2598 0.2160 0.3583 0.2760 0.3976 0.3483 0.3470 0.2306 0.3938 0.2231 0.3382 0.2394 0.1138 0.2433
0.4979 0.4456 0.4940 0.4648 0.4000 0.5893 0.4834 0.5484 0.6220 0.5405 0.4896 0.5161 0.4383 0.5148 0.4649 0.3377 0.4847
0.3970 0.2687 0.1877 0.2249 1.9555 0.2615 0.2394 0.2410 0.2287 0.2881 0.1716 0.2563 0.1843 0.2298 0.2082 0.1500 0.2231
0.6332 0.4747 0.4901 0.4023 3.6213 0.4301 0.4193 0.3324 0.4084 0.4488 0.3643 0.3359 0.3621 0.3498 0.4043 0.4451 0.4444
BFG 003158
Huntingdon Life Sciences 96-4080 Reproduction Study
Appendix V Terminal Organ and Body Weights and Organ/Body Weight Ratios
Terminal Sacrifice - FI Female Pups
Page 6
Terminal Female Pup Body Adrenal
No. No. Weight Weight
(s> (g)
Adrenal/ TBW
(X1000)
Drain Weight
(g)
Brain/ TBW (XlOO)
Group 1 0 ppm IS01 3 1505 7 1500 13 1508 7 1510 10 1513 4 1514 14 1516 12 1517 10 1518 11 1519 9 1520 9 1521 14 1522 9 1524 8 1525 14 1528 5 1529 7
57.5 45.1 58.7 55.6 42.6 59.7 57.2 42.4 50.2 42.0 49.7 48.2 42.3 55.6 56.4 48.6 57.0 48.9
0.0186 0.0160 0.0233 0.0185 0.0129 0.0150 00244 0.0211 0.0161 0.0183 0.0241 0.0192 0.0104 0.0101 0.0143 0.0125 0.0200 0.0134
0.3235 0.3548 0.3969 0.3327 0.3028 0.2513 0.4266 0.4976 0.3207 0.4357 0.4849 0.3983 0.2459 0.1817 0.2535 0.2572 0.3509 0.2740
1.4092 14118 1.4080 1.4502 1.2906 1.4646 1.4830 1.4631 1.5817 1.3767 1.3857 1.4414 1.4642 1.5965 1.6360 1.4760 1.6248 1.4691
2.4508 3.1304 2.3986 2.6083 3.0296 2.4533 2.5927 3.4507 3.1508 3.2779 2.7881 2.9905 3.4615 2.8714 2.9007 3.0370 2.8505 3.0043
Kidneys Weight
(g)
0.8546 0.7364 0.9002 0.8612 0.6549 0.8508 0.8758 0.6032 0.7119 0.6485 0.6580 0.7300 0.6748 0.8152 0.9048 0.8474 0.8605 0.6406
Kidneys/ TBW (X100) (g)
Liver Weight
(8)
1.4863 1.6328 1.5336 1.5489 1.5373 1.4251 1.5311 1.4226 1.4181 1.5440 1 3239 1.5145 1.5953 1.4662 1.6043 1.7436 1.5096 1.3100
2.5134 2.1767 2.9315 2.7498 1.9900 2.2876 3.0669 1.8530 2.3659 1.8108 2.4982 2.1068 2.1657 2.4240 2.681] 2.4675 2.7833 1.9712
Liver/ TBW (xlOO)
4.3711 4.8264 4.9940 4.9457 4.6714 3.8318 5.3617 4.3703 4.7129 4.3114 5.0266 4.3710 5.1199 4.3597 4.7537 5.0772 4.8830 4.0311
Ovaries Weight
(g)
Ovaries/ TBW (xlOO)
Spleen Weight
(g)
Spleen/ TBW (XlOO)
Thymus Weight
(g)
Thymus/ TBW (xlOO)
0.0213 0.0253 0.0479 0.0300 0.0176 0.0144 0.0186 0.0209 0.0193 0.0117 0.0183 0.0157 0.0170 0.0220 0.0193 0.0186 0.0217 0.0281
0.0370 0.0561 0.0816 0.0540 0.0413 0.0241 0.0325 0.0493 0.0384 0.0279 0.0368 0.0326 0.0402 0.0396 0.0342 0.0383 0.0381 0.0575
0.3074 0.2624 0.3700 0.2784 0.3235 0.2677 0.5648 0.2558 0.3374 0.2107 0.2591 0.2144 0.2376 0.3038 0.2890 0.3447 0.2963 0.2080
0.5346 0.5818 0.6303 0.5007 0.7594 0.4484 0.9874 0.6033 0.6721 0.5017 0.5213 0.4448 0.5617 0.5464 0 5124 0.7093 0.5198 0.4254
0.2747 0.2142 0.2342 0.1461 0.2246 0.2717 0.2986 0.1998 0.2287 0.0153 0.2135 0.2165 0.1496 0.3118 0.2798 0.2749 0.2661 0.2217
0.4777 0.4749 0.3990 0.2628 0.5272 0.4551 0.5220 0.4712 0.4556 0.0369 0.4296 0.4492 0.3537 0.5608 0.4961 0.5656 0.4668 0.4534
BFG 003159
Huntingdon Life Sciences 96-4080 Reproduction Study
Appendix V Terminal Organ and Body Weights and Organ/Body Weight Ratios
Terminal Sacrifice - FI Female Pups
Page 7
Female No.
Terminal Pup Body No. Weight
(g)
Adrenal Weight
(g)
Adrenal/ TBW
(X1000)
Drain Weight
(e)
Brain/ TBW (XI00)
Group II 2503 2504 2506 2510 2515 2516 2518 2522 2523 2524 2525 2527 2528 2530 2531
10 ppm 7 8 10 10 13 6 6 13 12 7 11 6 8 13 12
54.8 44.6 57.9 57.6 43.5 53.1 66.8 50.4 49.4 53.3 45.8 62.6 57.1 53.7 59.5
0.0096 0.0129 0.0158 0.0199 0.0170 0.0190 0.0281 0.0063 0.0149 0.0121 0.0236 0.0357 0.0203 0.0131 0.0158
0.1752 0.2892 0.2729 0.3455 0.3908 0.3578 0.4207 0.1250 0.3016 0.2270 0.5153 0.5703 0.3555 0.2439 0.2655
1.3425 1.3615 1.6082 1.4463 1.5552 1.4293 1.5321 1.4919 1.3834 1.3892 1.2930 1.5885 1.4376 1.5359 1.5191
2.4498 3.0527 2.7775 2.5109 3.5752 2.6917 2.2936 2.9601 2.8004 2.6064 2.8231 2.5375 2.5177 2.8601 2.5531
Kidneys Weight
(8)
0.8323 0.7127 0.8916 0.9028 0.6433 0.7421 0.9400 0.7391 0.6557 0.7296 0.6794 0.9825 0.8914 0.8376 0.8515
Kidneys/ TBW (XI00) (8)
Liver Weight
(8)
1.5188 1.5980 1.5399 1.5674
1.4789 1.3976 1.4072 1.4665 1.3273 1.3689 1.4834 1.5695 1.5611 1.5598 1.4311
2.6008 1 8458 3.2997 ' 2.7478 1.8668 2.3362 3.5616 2.3690 1.9216 2.3714 2.0743 3.0526 2.8528 2.5064 2.5569
Liver/ TBW (xlOO)
4.7460 4.1386 5.6990 4.7705 4.2915 4.3996 5.3317 4.7004 3.8899 4.4492 4.5290 4.8764 4.9961 4.6674 4.2973
Ovaries Weight
(8)
Ovaries/ TBW (xlOO)
Spleen Weight
(8)
Spleen/ TBW (XlOO)
Thymus Weight
(8)
Thymus/ TBW (xlOO)
0.0189 0.0037 0.0224 0.0389 0.0155 0.0213 0.0344 0.0175 0.0141 0.0217 0.0196 0.0231 0.0387 0.0203 0.0230
0.0345 0.0083 0.0387 0.0675 0.0356 0.0401 0.0515 0.0347 0.0285 0.0407 0.0428 0.0369 0.0678 0.0378 0.0387
0.3608 0.3181 0.2562 0.2994 0,3032 0.2784 0.3289 0.2819 0.2587 0.2510 0.1951 0.3020 0.2650 0.2594 0,3167
0.6584 0,7132 0.4425 0.5198 0.6970 0.5243 0.4924 0.5593 0.5237 0,4709 0.4260 0.4824 0.4641 0.4831 0.5323
0.2772 0.1839 0.2653 0.2324 0.1957 0,2341 0.2455 0.2217 0.2102 0.2978 0.2030 0.2752 0.2626 0.2307 0.2806
0.5058 0.4123 0,4582 0.4035 0.4499 0.4409 0.3675 0.4399 0.4255 0.5587 0.4432 0.4396 0.4599 0.4296 0.4716
BFG 003160
Huntingdon Life Sciences 96-4080 Reproduction Study
Appendix V Terminal Organ and Body Weights and Organ/Body Weight Ratios
Terminal Sacrifice - FI Female Pups
Page
Female Pup No. No,
Terminal Body
Weight (fi)
Adrenal Weight
(S)
Adrenal/ TBW
(X1000)
Brain Weight
<g)
Brain/ TBW (XI00)
Llroup III -100 ppm
3502 14
55.6
3506 13
50.2
3507 10
41.2
3509 10
53.9
3511
8
61.1
3512 7
63.0
3515 9
54.0
3516 10
56.6
3517 fl
50.7
3518 14
57.5
3519 7
62.9
3521 8
60.6
3523 9
59.5
3524 8
64.9
3528 13
55.6
0.0153 0.0365 0.0194 0.0187 0.0147 0.0127 0.0171 0.0139 0.0106 0.0200 0.0175 0.0351 0.0201 0.0150 0.0058
0.2752 0.7271 0.4709 0.3469 0.2406 0.2016 0.3167 0.2456 0.2091 0.3478 0.2782 0.5792 0.3378 0.2311 0.1043
1.5336 1.4328 1.3277 1.5638 1,4778 1.5848 1.4964 1.5660 1.5328 1.5180 1.5449 1.5717 1.5730 1.6362 1.5782
2.7583 2.8542 3.2226 2.9013 2.4187 2.5156 2.7711 2.76 6 8 3.0233 2.6400 2.4561 2,5936 2.6437 2.5211 2.8385
Kidneys Weight
<g>
0.7950 0.7360 0.6382 0.7980 0.7924 0.8695 0.7936 0.7637 0.6975 0.7494 1.0843 0.8433 0.8621 0.9319 0.8641
Kidneys/ TBW (X100)
(e)
Liver Weight
(g)
1.4299 1.4661 1.5490 1.4805 1.2969 1.3802 1.4696 1.3493 1.3757 1.3033 1.7238 1.3916 1.4489 1.4359 1.5541
2.6815 2.6635 1.7363 2.7005 2.9106 2.9656 2.7168 3,1270 2.7311 2.4714 3.1425 2.5540 2.5920 3.5279 2.3337
Liver/ TBW (x100)
Ovaries Weight
(g)
Ovaries/ TBW (xlOO)
Spleen Weight
(fi)
Spleen/ TBW (XlOO)
Thymus Weight
(E)
Thymus/ TBW (xlOO)
4.8228 5.3058 4.2143 5.0102 4.7637 4.7073 5.0311 5.5247 53868 4.2981 4.9960 4.2145 4.3563 5.4359 4.1973
0.0325 0.0225 0.0175 0.0222 0.0279 0.0103 0.0206 0.0236 0.0159 0.0258 0.0193 0.0265 0.0206 0.0201 0.0179
0.0585 0.0448 0.0425 0.0412 0.0457 0.0163 0.0381 0.0417 0.0314 0.0449 0.0307 0.0437 0.0346 0.0310 0.0322
0.2897 0.2117 0.2648 0.2554 0.2134 0.3870 0.2996 0.3494 0.2222 0.3335 0.2908 0.3669 0.3331 0.2161 0.3750
0.5210 0.4217 0.6427 0.4738 0.3493 0.6143 0.5548 0.6173 0.4383 0.S800 0.4623 0.6054 0.5598 0,3330 0.6745
0.2398 0.2280 0.2259 0.2375 0.1928 0.3108 0.2570 0.2692 0.2351 0.2379 0.3150 0.2994 0.2779 0.2972 0.2387
04313 0.4542 0.5483 0.4406 0.3155 0.4933 0.4759 0.4756 0.4637 0.4137 0.5008 0.4941 0.4671 0.4579 0.4293
Terminal Organ and Body Weights and Organ/Body Weight Ratios
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BFG 003162
Huntingdon Life Sciences 96-4080 Reproduction Study
Appendix V Terminal Organ and Body Weights and Organ/Body Weight Ratios
Terminal Sacrifice - F2 Male Pups
Page 10
Terminal Female Pup Body Adrenal
No. No. Weight Weight
(0 (8>
Adrenal/ TBW
(X1000)
Bruin Weight
<g>
Brain/ TBW (XI00)
Group I - Oppm
1535 9
1537 4
1538 5
1540 2
1542 7
1543 4
1551 3
1553 6
1558 2
1561
1
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1570 5
1572 7
1578 3
1580 1
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0.0180 0.0073 0.0138 0.0116 0.0168 0.0134 0.0150 0.0132 0.0156 0.0143 0.0201 0.0141 0.0206 0.0123 0.0133
0.3758 0.3120 0.2987 0.2473 0.4138 0.3418 0.3676 0.4190 0.4262 0.3695 0.4696 0.3106 0 4310 0.2971 0.3491
1.5380 1.3373 1.5687 1.5415 1.5671 1.5102 1.5191 1.3866 1.4489 1.5714 1.4407 1.6119 1.5101 1.4167 1.5221
3.2109 5.7150 3.3955 3.2868 3.8599 3.8526 3.7233 4.4019 3.9587 4.0605 3.3661 3.5504 3.1592 3.4220 3.9950
Kidneys Weight
(e)
0.8221 0.3730 0.6909 0.7215 0.5408 0.5297 0.6602 0.4295 0.5359 0.5602 0.6333 0.6258 0.6804 0.5809 0.5968
Kidneys/ TBW (XI00) (E)
1.7163 1.5940 1.4955 1.5384 1.3320 1.3513 1.6181 1.3635 1.4642 1.4475 1.4797 1.3784 1.4234 1.4031 1.5664
Liver Weight
(e)
2.6870 0.9669 2.1872 2.4812 1.6145 1.2803 1,8760 1.2141 1 6136 1.6716 1.9363 1.8290 1.8616 1.6201 1.7342
Liver/ TBW (xlOO)
5.6096 4.1321 4.7342 5.2904 3.9766 3.2661 4.5980 3.8543 4.4087 4.3194 4.5241 4.0286 3.8946 3.9133 4.5517
Spleen Weight
(E)
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(8)
Testes/ TBW (xlOO)
Thymus Weight
(>
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0.2220 0.0552 0.2493 0.1836 0.1458 0.0902 0,1447 0.1303 0.1465 0.3313 0.1692 0.1723 0.2014 0.1559 0.1040
0.4635 0.2359 0.5396 0.3915 0.3591 0.2301 0.3547 0.4137 0.4003 0.8561 0.3953 0.3795 0.4213 0.3766 0.2730
0.2163 0.0833 0.1995 0.1818 0.1806 0.1481 0.1884 0.1190 0.1608 0.1687 0.1978 0.2104 0.2055 0.1574 0.1449
0.4516 0.3560 0.4318 0.3876 0.4448 0.3778 0.4618 0.3778 0.4393 0.4359 0.4621 0.4634 0.4299 0.3802 0.3803
0.2591 0.0733 1.21 SO 0.1991 0.1909 0.1070 0,1878 0.1572 0.1217 0.1367 0.1328 0.1730 0.2598 0.1388 0.1027
0.5409 0,3132 2.6299 0.4245 0.4702 0.2730 0.4603 0.4990 0.3325 0.3532 0,3103 0.3811 0.5435 0.3353 0.2696
BFG 003163
Terminal Organ and Body Weights and Organ/Body Weight Ratios
43
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BFG 003164
Huntingdon Life Sciences 96-4080 Reproduction Study
Appendix V Terminal Organ and Body Weights and Organ/Body Weight Ratios
Terminal Sacrifice - F2 Male Pups
Page 12
Terminal
Female Pup No. No.
Body Weight
Adrenal Weight
(e) (g>
Adrenal/ TBW
(X1000)
Brain Weight
(E)
Brain/ TBW (X100)
roup Hi - 100 ppm
3533 2
50.2
3534 2
44.5
3536 2
46.9
3537 1
35.9
3538 1
43.4
3543 2
41.5
3545 2
44.8
3547 1
41.4
3549 7
34.8
3551
1
37.2
3555 5
49.2
3557 7
41.5
3564 2
32.5
3565 5
27.9
3568 4
28.4
0.0160 0.0142 0.0140 0.0218 0.0153 0.0140 0.0176 0.0155 0.0120 0.0125 0.0203 0.0173 0.0148 0.0101 0.0118
0.3187 0.3191 0.2985 0.6072 0.3525 0.3373 03929 0.3744 0.3448 0.3360 0.4126 0.4169 0.4554 0.3620 0.4155
1.4966 1.4291 1.5796 1.4427 1.4846 1.5036 1.3923 1.4533 1.3271 1 3769 1.3758 1.4079 1.3842 1.4800 1.3761
2.9813 3.2115 3.3680 4.0187 3.4207 3.6231 3,1078 3,5104 3.8135 3.7013 2.7963 3.3925 4.2591 5.3047 4.8454
Kidneys Weight
<e)
0.7526 0.6262 0.6831 0.5069 0.5431 0.6118 0.6196 0.6191 0.4574 0.5483 0.7023 0.5622 0.4770 0.4235 0.3958
Kidneys/ TBW (X100)
<e)
Liver Weight
(e)
1.4992 1.4072 1.4565 1.4120 1.2514 1.4742 1.3830 1.4954 1.3144 1.4739 1.4274 1.3547 1.4677 1.5179 1.3937
2.2327 1.9026 2.2119 1.4007 1.7575 1.8664 1.9J4J 1.7517 1.3172 1 5159 2.1714 1 6676 1.3800 1.2377 1.0161
Liver/ TBW (xIOO)
4.4476 4.2755 4.7162 3.9017 4.0495 4.4973 4.2725 4.2312 3.7851 4.0750 4.4134 4.0183 4.2462 4.4362 3.5778
Spleen Weight
(t)
Spleen/ TBW (xIOO)
Testes Weight
(e)
Testes/ TBW (xIOO)
Thymus Weight
(e)
Thymus/ TBW (xIOO)
0.2280 0.1912 0.1976 0.0875 0.1750 0.1289 0.1854 0.1527 0.1107 0.1328 0.2092 0.1237 0.1245 0.0907 0.1078
0.4542 0.4297 0.4213 0.2437 0.4032 0.3106 0.4J38 0.3688 0.3181 0.3570 0.4252 0.2981 0.3831 0.3251 0.3796
0.2114 0.1784 0.1924 0.1646 0.1779 0.2007 0.2099 0.1909 0.1570 0.1669 0.1862 0.1544 0.1534 0.1214 0.0928
0.4211 0.4009 0.4102 0.4585 0.4099 0.4836 0.4685 0.4611 0.4511 0.4487 0.3785 0.3720 0.4720 0.4351 0.3268
0.2752 0.2008 0.1790 0.1987 0.1986 0.1983 0.1387 0.1641 0.0983 0.1565 0.1726 0.1486 0.1335 0.0865 0.1668
0.5482 0.4512 0.3817 0.5535 0.4576 0.4778 0.3096 0.3964 0.2825 0.4207 0.3508 0.3581 0.4108 0.3100 0 5873
BFG 003165
Huntingdon Life Sciences 96-4080 Reproduction Study
Appendix V Terminal Organ and Body Weights and Organ/Body Weight Ratios
Terminal Sacrifice - F2 Male Pups
Page 13
Terminal
Female Pup Body No. No. Weight
Adrenal Weight
(E> <e)
Adrenal/ TBW
(XI000)
Brain Weight
()
Brain/ TBW (XI00)
Group IV - 1100 ppm
4531
7
43.7
4535 4542 4548 4551 4554 4555 4556 4557 4564 4566 4568 4575 4577 4579
2 7 1 9 2 3 1 5 6 8 2 4 6 3
41.4 53.7 44.9 34.1 42.4 52.9 43.2 42.7 35.5 37.9 30.9 37.1 32.9 44.1
0.0155
0.0100 0.0179 0.0130 0.0150 0.0182 0.0170 0.0098 0.0138 0.0134 0.0144 0.0167 0.0133 0.0102 0.0180
0.3547
0.2415 0.3333 0,2895 0.4399 0.4292 0.3214 0.2269 0.3700 0.4338 0.3799 0.540S 0.3585 0.3100 0.4082
1.5198
1.5192 1.6129 1.4517 1.5325 1.4215 1.5621 1.4643 1.5038 1.3777 1.3927 1.1827 1.5263 1.3549 1.5408
3.4778
3.6696 3.0035 3.2332 4.4941 3.3526 2.9529 3.3896 3 5218 3.8808 3.6747 3.8275 4.1140 4.1182 3.4939
Kidneys Weight
(8)
0.5930 0.5705 0.7566 0.5676 0.5030 0.5843 0.6742 0.5913 0.6098 0.5545 0.4841 0.4364 0.6171 0.4935 0.6255
Kidneys/ TBW (XI00) (E)
1.3570 1.3780 1.4089 1 2641 1.4751 1.3781 1.2745 1.3688 1.4281 1.5620 1.2773 1.4123 1.6633 1.5000 1.4184
Liver Weight
(E)
1.9245 1.7620 2.5416 1.8943 1.2053 1.7323 2.2573 2.1617 1.8778 1.7072 1.4774 1.2177 1.5326 1.2452 2.0171
Liver/ TBW (xlOO)
4.4039 4.2560 4.7330 4.2189 3.5346 4.0856 4.2671 5.0039 4.3977 4.8090 3.8982 3.9408 4.1310 3.7848 4.5739
Spleen Weight
(b)
Spleen/ TBW (XlOO)
Testes Weight
(e)
Testes/ TBW (XlOO)
Thymus Weight
(E)
Thymus/ TBW (xlOO)
0.2013
0.1495 0.3308 0.1668 0.1034 0.1447 0.1720 0.2231 0.1960 0.1410 0.1389 0.1014 0 1518 0.1000 0.2614
0.4606
0.3611 0.6160 0.3715 0.3032 0.3413 03251 0.5164 0.4590 0.3972 0.3665 0.3282 0.4092 03040 0.5927
0 1839
0.1660 0.2113 0.1880 0.1212 0.1872 01952 0.1872 0.1767 0.1428 0.1239 0.1310 0.1585 0.1196 0.1640
0.4208
0.4010 0.3935 0.4187 0.3554 0.4415 0.3690 0.4333 0.4138 0.4023 0.3269 0.4239 0.4272 0.3635 0.3719
0.1817
0.1572 0.1825 0.1730 0.1159 0 1397 0.2250 0.1198 0.1270 0.1208 O.I359 0.1050 0.1436 0.1541 0.1512
0.4158
0.3797 0.3399 0.3853 0.3399 0.3295 0.4253 0.2773 0,2974 0,3403 0.4113 0.3398 0.3871 0.4684 0.3429
Huntingdon Life Sciences 96-4080 Reproduction Study
Appendix V Terminal Organ and Body Weights and Organ/Body Weight Ratios
Terminal Sacrifice - F2 Female Pups
Page 14
Terminal Female Pup Body
No. No. Weight (g)
Adrenal Weight
(8)
Adrenal/ TBW
(X1000)
Brain Weight
(E)
Brain/ TBW (X100)
Group 1 - 0 ppm 1535 15 1537 9 1538 10 1540 7 1542 14 1543 8 1551 16 1553 14 1558 6 1561 14 1565 12 1570 14 1572 11 1578 10 1580 4
48.2 24.2 43.4 43.0 37.5 43.6 40.3 32.3 37.2 32.9 45.2 42.1 47.8 45.8 43,2
0.0127 0.0077 0.0169 0.0100 0.0146 0.0149 0.0166 0.0098 0.0139 0.0129 0.0167 0.0138 0.0188 00138 0.0177
0.2635 0.3182 0 3894 0.2326 0.3893 0.3417 0.4119 0.3034 0.3737 0.3921 0.3695 0.3278 0.3933 0.3013 0.4097
1.5278 1.1128 1.4808 1.4529 1.4446 J.519I 1.4206 1.4079 1.4435 1.4692 1.4816 1.4687 1.4670 1.5145 1.5746
3 1697 4 59X3 3 412CJ 3 37KX 3.X523 3 4842 3.5251 4.3588 3.8804 4.4657 3.2779 3.4886 3.0690 3.3068 3.6449
Kidneys Weight
(g)
0.7273 0.3748 0.6607 0.6160 0 495X 0.6903 0.6005 0.4536 0.5857 0.5472 0.6339 0.7045 0.7443 0.6201 0.7158
Kidneys/ TBW (XI00)
(S)
Liver Weight
(g)
1.5089 1.5488 1.5224 1 4326 1.3221 1.5833 1.4901 1.4043 1.5745 1.6632 1.4024 1.6734 1.5571 1.3539 1.6569
2.4504 0.9628 2.0097 1.7664 1.4380 2.0102 1.7639 1.4268 1.5834 1.5208 1.8858 2.1447 2.2165 1.9303 2.3735
Liver/ TBW (xlOO)
Ovaries Weight
(g)
Ovaries/ TBW (xlOO)
Spleen Weight
(g)
Spleen/ TBW (xlOO)
Thymus Weight
(g)
Thymus/ TBW (xlOO)
5.0838 3.9785 4.6306 4.1079 3 8347 4.6106 4.3769 4.4173 4.2565 4.6225 4.1721 5.0943 4.6370 4.2146 5.4942
0.0173 0.0037 0.0139 0 0151 0.0170 0.0113 0.0147 0.0116 0.0137 0.0120 0.0227 0.0109 0.0175 0.0186 0.0179
0.0359 0.0153 0.0320 0.0351 0.0453 0.0259 0.0365 0.0359 0.0368 0.0365 0.0502 0.0259 0.0366 0.0406 0.0414
0.2335 0.0777 0.2580 0.1948 0.1726 0.1979 0.1913 0.1224 0 1115 0.1301 0.2217 0.2067 0.2143 0.0778 0.1600
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0.4089 0.3773 0.4850 0.4367 0.5261 0.3255 0.4124 0.4514 0.4067 0.3581 0.4487 0.3952 0.4701 0.3985 0.3368
BFG 003167
Terminal Organ and Body Weights and Organ/Body Weight Ratios
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Huntingdon Life Sciences 96-4080 Reproduction Study
Appendix V Terminal Organ and Body Weights and Organ/Body Weight Ratios
Terminal Sacrifice - F2 Female Pups
Page 16
Terminal Female Pup Body Adrenal
No. No. Weight Weight
is) (S)
Adrenal/ TBW
(X1000)
Brain Weight
()
Brain/ TBW (XI00)
Group (II 100 ppm
3533 13
47.7
3534 8
45.0
3536 7
44.6
3537 9
35.1
3538 9
39.7
3543 4
42.1
3545 10
47.9
3547 10
43.7
3549 9
43.0
3551 6
34.5
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39.4
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41.5
3564 13
22.6
3565 11
43.2
3368 6
33.8
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0.2516 0.3444 0.2085 0.4786 0.4282 0.2850 0.4134 0.4233 0.2581 0.3884 0.3503 0.4771 0.4381 0.3621 0.3876
1.4362 1.4438 1.4236 1.3083 1.4068 1.4326 1.4133 1.4085 1.3746 1.2747 1.2721 1.4944 1.2146 1.4636 1.3664
3.0109 3.2084 3.1919 3.7274 3.5436 3.4029 2.9505 3.2231 3.1967 3.6948 3.2287 3.6010 5.3743 3.3880 4.0426
Kidneys Weight
(fi)
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Kidneys/ TBW (X100) (r)
1.6568 1.3556 1.5590 1.6185 1.4441 1.5188 1.3858 1.3174 1.4693 1.3629 1.5398 1.3181 1.5765 1.6023 1.4964
Liver Weight
is)
2.2751 2.0296 2.0246 1.3778 1.7292 1.8845 1.9031 1.7507 1.8746 1.5040 1.7715 1.5781 1.0042 2.1045 1.2519
Liver/ TBW (xlOO)
4.7696 4.5102 4.5395 3.9254 4.3557 4.4762 3.9731 4.0062 4.3595 4.3594 4.4962 3.8027 4.4434 4.8715 3.7038
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(e)
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is) J
Spleen/ TBW (xlOO)
Thymus Weight
is)
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0.5585 0.3729 0.3942 0.4749 0.4154 0.4394 0.3238 0.3815 0.5358 0.4913 0.4726 0.4908 0.4283 0.5845 0.4950
BFG 003169
Huntingdon Life Sciences 96*4080 Reproduction Study
Appendix V Terminal Organ and Body Weights and Organ/Body Weight Ratios
Terminal Sacrifice - F2 Female Pups
Page 17
Female No.
Terminal Pup Body No. Weiglil
(g)
Adrenal Weight
(b)
Adrenal/ TBW
(X1000)
Bruin Weight
<g>
Brain/ TBW (XI00)
Group IV -1100 ppm
4531
9
44.1
4535 10
46.6
4542
9
50.9
4548 9
43.2
4549 2
21.7
4551 11
36.1
4554 6
44.4
4555 13
44.6
4556 12
46.1
4557 12
41.9
4564 12
46.0
4566 12
35.9
4568 7
40.5
4575
9
42.4
4577 11
26.4
4579 11
47.6
0.0129 0.0188 0.0230 0.0163 0.0108 0.0147 0.0155 0.0162 0.0109 0.0203 0.0224 0.0137 0.0176 0.0139 0.0070 0.0155
0.2925 0.4034 0.4519 0.3773 0.4977 0.4072 0.3491 0.3632 0.2364 0.4845 0.4870 0.3816 0.4346 0.3278 0.2652 0.3256
1.5231 1.4749 1.5945 1.4308 1.2359 1.2722 1.4812 1.4443 1.2891 1.4311 1.4769 1.3753 1.4628 1.5011 1.2844 1.5439
3.4537 3.1650 3.1326 3.3120 5.6954 3.5241 3.3360 3.2383 2.7963 3.4155 3.2107 3.8309 3.6119 3.5403 4.8652 3.2435
Kidneys Weight
(e)
0.7115 0.6518 0.7634 0.6542 0.3327 0.5201 0.7282 0.6115 0.6770 0.5932 0.6552 0.5128 0.6305 0.6553 0.4040 0.6793
Kidneys/ TBW (X100) <g)
Liver Weight
(g)
1.6)34 1.3987 1.4998 1.5144 1.5332 1.4407 1.6401 1.3711 1.4685 1.4158 1.4243 1.4284 1.5568 1.5455 1.5303 1.4271
1.9081 2.2046 2.1955 2.0272 0.8532 1.4235 2.1211 2.0122 2.4884 1.8800 2.1163 1.4185 1.7056 1.9915 1.0004 2.1238
Liver/ TBW (xlOO)
Ovaries Weight
(E)
Ovaries/ TBW (xlOO)
Spleen Weight
(g)
Spleen/ TBW (xlOO)
Thymus Weight
(e)
Thymus/ TBW (xlOO)
4.3268 4.7309 4.3134 4.6926 3.9318 3.9432 4.7773 4.5117 5.3978 4.4869 4.6007 3.9513 4.2114 4.6969 3.7894 4.4618
0.0098 0.0152 0.0205 0.0169 0.0140 0.0180 0.0105 0.0166 0.0139 0.0210 0.0185 0.0141 0.0215 0.0230 0.0042 0.0191
0.0222 0.0326 0.0403 0.0391 00645 0.0499 0.0236 0.0372 0.0302 0.0501 0.0402 0.0393 0.0531 0.0542 0.0159 0.0401
0.1977 0.1948 0.2375 0.2004 0.0611 0.1058 0.1631 0.1648 0.1965 0.1733 0.2225 0.1630 0.1455 0.1758 0.0780 0.2504
0.4483 0.4180 0.4666 0.4639 0.2816 0.2931 0.3673 0.3695 0.4262 0.4136 0.4837 0.4540 0.3593 0.4146 0.2955 0.5261
0.2350 0.2284 0.1779 0.1625 0.0652 0.1237 0.1962 0.1926 0.2123 0.2237 0.2405 0.1440 0.1345 0 1708 0.1225 0.1867
0.5329 0.4901 0.3495 0.3762 0.3005 0.3427 0.4419 0.4318 0.4605 0.5339 0.5228 0.4011 0.3321 0.4028 0.4640 0.3922
BFG 003170
APPENDIX W
BFG 003171
Pathology Associates International
A Company of Science Applications International Corporation
An EmptoyBfrOwntd Company
APPENDIX W
SPERM ANALYSIS REPORT FOR
VINYL CHLORIDE COMBINED INHALATION TWO-GENERATION REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CD RATS HLS STUDY NUMBER: 96-4080
PREPARED FOR
HUNTINGDON LIFE SCIENCES (HLS) METTLERS ROAD
EAST MILLSTONE, NJ 08875-2360
PREPARED BY
PATHOLOGY ASSOCIATES INTERNATIONAL. (PAI)
15 WORMAN'S MILL COURT, SUITE I
FREDERICK, MD
21701
BFG 003172
15 Worman's Mill Court, Suite I Frederick, Maryland 21701 (301) 663-1644 (301) 663-8994 FAX
Draft Report HLS Study No.: 96-4080
TABLE OF CONTENTS
Section
Page No.
I. QUALITY ASSURANCE STATEMENT .................................................................................
4
II. MATERIALS AND METHODS ......................................................................................................... 5
A. Sample Collection .................................................................................................... B. Sperm Motility Evaluation ............................................................................ C. Total Sperm Count Determination.......................................................... D. Sperm Morphology Evaluation ...................................................................... E. Statistical Analyses ........................................................................................
5 5 5 6 6
III. RESULTS .............................................................................................................................................
6
A. Sperm Motility .......................................................................................................... B. Total Sperm Count ................................................................................................. C. Sperm Morphology ....................................................................................................
6 6 7
IV. DISCUSSION AND CONCLUSIONS .......................................................................................
7
V. REFERENCES ....................................................................................................................................
7
2
BFG 003173
Draft Report HLS Study No.: 96-4080
INDEX OF TABLES AND APPENDICES
Table
Page No.
1. Summary of Px Sperm Analysis Parameters .................................................. 8
2. Summary of P2 Sperm Analysis Parameters .................................................. 9
Appendix
Page No.
A. Individual P2 Sperm Motility and Total Count Data ................... 10
B. Individual P2 Sperm Motility and Total Count Data.................... 12
C. Individual Px Sperm Morphology Data ......................................................... 14
D. Individual P2 Sperm Morphology Data............................................................. 18
3 BFG 003174
Pathology Associates International
A Company of Science Applications International Corporation
An Employee-Owned Company
Sperm Analysis Report
Vinyl Chloride Combined Inhalation Two-Generation Reproduction and Developmental Toxicity Study in CD Rats
HLS Study Number: 96-4080
QUALITY ASSURANCE STATEMENT
This sperm analysis project has been inspected and audited by the PA1 Quality Assurance Unit (QAU) as required by the Good Laboratory Practice (GLP) regulations promulgated by the U.S. Food and Drug
Administration (FDA), Environmental Protection Agency (EPA) and the Organization for Economic Co operation and Development (OECD). The sperm analysis report is an accurate reflection of the recorded data. The following table is a record of the inspections/audits performed and reported by the QAU.
Date of Inspection
05/09/97 11/24,25/97 11/24,25/97
Phase inspected
Date Findings Reported to Management/ Study Teratoloqist
Sperm Motility Study Data and Supporting Documentation Draft Sperm Analysis Report
05/09/97 11/25/97 11/25/97
Sharon E. Abel Quality Assurance Specialist
Date
4 BFG 003175
I . RESERVED FOR QUALITY ASSURANCE STATEMENT
4
BFG 003176
Draft Report HLS Study No.: 95-4080
Vinyl Chloride Combined Inhalation Two-Generation Reproduction and Developmental Toxicity Study in CD Rats
II. MATERIALS AND METHODS
A. Sample Collection
After the last Fx and F2 litters were delivered, the first 15
surviving P1 and P2 males, respectively, were euthanized by carbon
dioxide asphyxiation followed by exsanguination.
The P1 males
were sacrificed on April 28-29, 1997, and the P2 males were
sacrificed on September 15-16, 1997.
For all animals, the
abdominal cavity was opened and the reproductive organs exposed.
For motility assessment, the right vas deferens was dissected away
from the testis and immediately placed in a petri dish containing
10 ml of a solution consisting of 1% Bovine Serum Albumin
dissolved in Phosphate Buffered Saline. The solution was prewarmed
to a temperature of approximately 38C. A minimum 3 minute period
was allowed for the sperm to swim out.
The right epididymis was then removed and placed on dry ice. The frozen epididymides were then transferred to Pathology Associates International, Frederick, MD. and stored frozen at -70C or lower until evaluation for total sperm count.
B. Sperm Motility Evaluation
Following the swim out period, a sperm sample was obtained
using a 100 ^im deep cannula. The cannula was immediately loaded
into the prewarmed stage of the Hamilton Thorne IVOS automated sperm analyzer. Five fields were automatically selected by the
analyzer and each motion image was recorded and stored on an
optical disk.
The images were subsequently analyzed and the
percent motility determined for each animal.
C. Total Sperm Count Determination
Each frozen epididymis was removed from the freezer, thawed
and the caudal section was trimmed and weighed.
The cauda
epididymis was homogenized and the suspension was transferred to a
plastic test tube and vortexed. A 100 \il sample was transferred
to a vial containing a dye which uniquely stains the head of the
sperm. A sample of the stained sperm was placed into a 20 jam deep
glass slide which was loaded into the analyzer.
Twenty fields
were automatically selected by the analyzer for each animal and
total sperm counts determined. The counts were reported adjusted
for caudal epididymal weight.
5 BFG 003177
Draft Report HLS Study No.: 96-4080
D. Sperm Morphology Evaluation
Two Eosin stained slides were prepared for each animal from the caudal epididymis total count preparation. The slides were evaluated and a minimum of 200 sperm cells/animal were examined for morphological development.
E. Statistical Analyses
The means and standard deviations for the sperm motility, total count and sperm morphology data were calculated and compared across groups using the Kruskal-Wallis nonparametric ANOVA test. If a significant effect occurred {p<0.05), the Wilcoxon (MannWhitney U) test was used for pair-wise comparisons of each treated group to the control group. Statistical analyses were performed using an IBMTM compatible computer with SAS computer programs (SAS/STAT User's Guide, 1989).
III. RESULTS
A. Sperm Motility
Table 1 (Pj_ Summary Data) Table 2 (P2 Summary Data) Appendix A (P1 Individual Appendix B (P2 Individual
Data) Data)
No apparent treatment-related effects were observed for the
sperm motility data in either the P. or P2 males. Group mean
values were comparable between the study groups.
Group mean
values ranged from 88.5% to 96.5% and 89.3% to 97.3% for the Pa
and P2 males, respectively. No evidence of reduced motility due
to treatment with Vinyl Chloride was observed in either
generation.
B. Total Sperm Count
Table 1 (Px Summary Data) Table 2 (P2 Summary Data) Appendix A (Pi Individual Appendix B (P2 Individual
Data) Data)
The number of sperm/gram of cauda epididymis was comparable between the study groups. Mean values ranged from 819.9 to 947.2 and 850.1 to 1063.9 million sperm/gram for the P1 and P2 males,
6 BFG 003178
respectively. No treatment-related differences were observed.
Draft Report HLS Study No.:
96-4080
C. Sperm Morphology
Table 1 (Pi Summary Data) Table 2 (P2 Summary Data) Appendix C {Px Individual Appendix D (P2 Individual
Data) Data)
A low incidence of head/tail abnormalities was observed for animals in all treatment groups. Group mean values ranged from 0.03 to 5.13 and 0.07 to 0.27 percent abnormal sperm for the Px and P2 males, respectively. No treatment related differences were observed.
IV.DISCUSSION AND CONCLUSIONS
Mean percent motility, total sperm count and morphology were
not affected by treatment with Vinyl Chloride in either generation
at dosage levels of 0, 10, 100 and 1100 ppm.
No biologically
meaningful differences were observed between the study groups.
__________________________________________ Michael D. Mercieca, B.S. Reproductive Toxicologist Pathology Associates International
Date:
V. REFERENCES
SAS Institute Inc., SAS/STAT User's Guide, Version 6, Fourth Edition, Cary, NC:SAS Institute Inc., 1989. Vol. 2 p. 1195-1210.
7 BFG 003179
HLS STUDY NO.: 96-4080
TABLE 1 VINYL CHLORIDE COMBINED INHALATION TWO-GENERATION REPRODUCTION
AND DEVELOPMENTAL TOXICITY STUDY IN CD RATS SUMMARY OF Pt SPERM ANALYSIS PARAMETERS
MOTILITY (PERCENT)
Group:
12
3
Level: VINYL CHLORIDE (PPM) 0 10 100
Mean SD N
91.5 11.4
15
88.5 24.9
15
NONE SIGNIFICANTLY DIFFERENT FROM CONTROL
96.5 2.9 15
4 1100
91.4 14.9
14
TOTAL SPERM COUNT (MILLION SPERM/GRAM)
Group:
12 3 4
Level: VINYL CHLORIDE (PPM) 0
10
100
1100
Mean SD N
826.5 197.9
15
947.2 313.8
15
NONE SIGNIFICANTLY DIFFERENT FROM CONTROL.
872.2 222.2
16
819.9 313.5
15
SPERM MORPHOLOGY (PERCENT ABNORMAL)
Group:
12 3 4
Level: VINYL CHLORIDE (PPM) 0
10
100
1100
Mean SD N
0.03 0.13
15
0.23 0.50
15
5.13 19.70
16
0.86 2.65
14
MEAN AND STANDARD DEVIATIONS WERE CALCULATED USING THE TOTAL NUMBER OF ABNORMAL SPERM AS A PERCENTAGE OF THE NUMBER OF SPERM EXAMINED. NONE SIGNIFICANTLY DIFFERENT FROM CONTROL.
8
BFG 003180
HLS STUDY NO.: 96-4080
TABLE 2 VINYL CHLORIDE COMBINED INHALATION TWO-GENERATION REPRODUCTION
AND DEVELOPMENTAL TOXICITY STUDY IN CD RATS SUMMARY OF P2 SPERM ANALYSIS PARAMETERS
MOTILITY (PERCENT)
Group:
1
Level: VINYL CHLORIDE (PPM) 0
23 10 100
Mean SD N
96.2 2.3 13
97.3 1.9 15
NONE SIGNIFICANTLY DIFFERENT FROM CONTROL
94.5 9.0 15
4 1100
89.3 17.8
13
TOTAL SPERM COUNT (MILLION SPERM/GRAM)
Group:
1
Level: VINYL CHLORIDE (PPM) 0
23 4
10
100
1100
Mean SD N
1063.9 231.1 15
1053.1 340.1 15
NONE SIGNIFICANTLY DIFFERENT FROM CONTROL.
850.1 223.2
15
1025.4 396.1 15
SPERM MORPHOLOGY (PERCENT ABNORMAL)
Group:
1
Level: VINYL CHLORIDE (PPM) 0
23 4
10
100
1100
Mean SD N
0.07 0.18
14
0.27 0.46
15
0.20 0.41
15
0.23 0.65
15
MEAN AND STANDARD DEVIATIONS WERE CALCULATED USING THE TOTAL NUMBER OF ABNORMAL SPERM AS A PERCENTAGE OF THE NUMBER OF SPERM EXAMINED. NONE SIGNIFICANTLY DIFFERENT FROM CONTROL.
9
BFG 003181
WT.fi STUDY NO. : 96-4080
APPENDIX A
VINYL CHLORIDE COMBINED INHALATION TWO-GENERATION REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CD RATS
INDIVIDUAL Pj, SPERM MOTILITY AND TOTAL COUNT DATA
Group 1:
0 PPM (VINYL CHLORIDE)
Animal No.
1001 1002 1003 1004 1005 1006 1007 1008 1009 1010 1011 1012 1013 1023 1027
% Motility
94 89 98 74 97 97 94 90 96 97 57 98 94 99 98
Total Count {million sperm/gram)
759.8 1004.1
678.5 1048.8
626.8 921.4 729.0 904.2 123S.4 1033.4 844.2 479.4 651.3 732.8 748.5
Group 2:
10 PPM (VINYL CHLORIDE)
2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 2013 2014 2020
97 98 88 96 97
83 97 97 96 88 100* 98
0a 98 94
a=ONLY 4 SPERM PRESENT FOR MOTILITY EVALUATION.
784.6 1254.1
529.4 1025.9
942.2 821.5 1753.4 718.1 752.1 903.3 1085.3 658.3 640.0 1276.4 1062.8
10 003182
HLS STUDY NO.: 96-4080
APPENDIX A
VINYL CHLORIDE COMBINED INHALATION TWO-GENERATION REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CD RATS
INDIVIDUAL Px SPERM MOTILITY AND TOTAL COUNT DATA
Group 3:
100 PPM (VINYL CHLORIDE)
Animal No.
% Motility
Total Count (million sperm/gram)
3001 3002 3003 3004 3005 3006 3007 3008 3009 3010 3014 3020 3022 3026 3029 3030
94 97 95 99 88 98 99 98 99 96 96 98 99 97 95
a
a=NO SPERM PRESENT FOR MOTILITY EVALUATION.
961.0 1091.8
790.7 1105.7
654.2 1009.8
646.4 1179.0
531.5 869.6 574.6 908.7 1136.4 731.1 1123.5 641.7
Group 4:
1100 PPM (VINYL CHLORIDE)
4001 4002 4003 4004 4005 4006 4007
4008 4009 4010 4011 4012 4013 4014 4027
79 99 95 93 95 94 98
a 93 98 99 98 43b 98 98
a=NO SPERM PRESENT FOR MOTILITY EVALUATION. b=ONLY 7 SPERM PRESENT FOR MOTILITY EVALUATION.
782.7 1310.1
981.7 764.3 719.4 1015.2 671.9 154.3 1028.5 1094.8 603.3 723.2 451.8 1325.0 657.9
II
BFG 003183
HLS STUDY NO.: 96-4080
APPENDIX B
VINYL CHLORIDE COMBINED INHALATION TWO-GENERATION REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CD RATS
INDIVIDUAL P2 SPERM MOTILITY AND TOTAL COUNT DATA
Group 1:
0 PPM (VINYL CHLORIDE)
Animal No.
% Motility
Total Count (million sperm/gram)
1031 1032 1033 1035 1037 1039 1041 1043 1045 1047
1048 1058 1068 1071 1078
94 92 97 95 98
a 93 95 97 98 100
a 96 97 98
841.5 1247.1 1065.9 1033.9 1161.7
400.5 1077.0 1360.7 1295.9 1148.5
930,7 1148.8
920.8 1164.1 1160.9
a=NO SPERM PRESENT FOR ANALYSIS.
Group 2:
2031 2033 2034 2036 2037 2038 2040 2042 2044 2046 2048 2050 2052 2054 2066
10 PPM (VINYL CHLORIDE)
98 99 99 96 94 99 99 98 97 95 99 95 94 99 98
770.2 1182.8
759.8 1198.1 1492.2
806.6 972.0 1034.1 1434.0 1152.8
820.5 754.0 1851.3 978.3 590.5
12
BFG 003184
KLS STUDY NO.: 96-4080
APPENDIX B
VINYL CHLORIDE COMBINED INHALATION TWO-GENERATION REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CD RATS
INDIVIDUAL P2 SPERM MOTILITY AND TOTAL COUNT DATA
Group 3:
100 PPM (VINYL CHLORIDE)
Animal No.
% Motility
Total Count (million sperm/gram)
3031 3032 303 3 3034 3035 3037 3039 3041 3042 3043 3045 3046 3047 3048 3049
99 98 63a 93 96 100 94 99 98 95 99 96 93 99 95
740.5 425.6 870.3 763.7 698.5 769.9 1015.7 993.1 1191.4 699.8 847.2 747.7 1364.6 850.0 772.8
a=ONLY 7 SPERM PRESENT FOR MOTILITY EVALUATION.
Group 4:
1100 PPM (VINYL CHLORIDE)
4031 4033 4035 4037 4039 4041 4043 4045 4046 4047 4049 4050 4052 4054 4056
94 96 98 94 98 98
a a 97 100 33b 90 97 84 82
a=NO SPERM PRESENT FOR ANALYSIS. Q=ONLY 12 SPERM PRESENT FOR MOTILITY EVALUATION.
1208.5 1370.2 1120.1 1099.2
907.6 710.0 654.0 315.6 1406.3 1148.2 606.5 765.7 1660.2 1654.2 754.4
13
BFG 003185
HLS STUDY NO.: 96-4080
APPENDIX C
VINYL CHLORIDE COMBINED INHALATION TWO-GENERATION REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CD RATS
GROUP 1: 0 PPM (VINYL CHLORIDE)
Animal No.
Normal
Amorphous
1001 1002 1003 1004 1005 1006 1007 1008 1009 1010 1011 1012 1013 1023 1027
200 200 200 200 200 200 200 200 200 199 200 200 200 200 200
0 0 0 0 0 0 0 0 0 1 0 0 0 0 0
INDIVIDUAL p! SPERM MORPHOLOGY DATA
Small
0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
Enlarged
0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
Double
0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
Tail-
Coiled
Bent Double
000 00 0 00 0 00 0 00 0 00 0 00 0 000 00 0 000 000 000 000 000 000
Other
0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
BFG 003186
14
HLS STUDY NO.: 96-40B0
APPENDIX C
VINYL CHLORIDE COMBINED INHALATION TWO-GENERATION REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CD RATS
INDIVIDUAL Pj SPERM MORPHOLOGY DATA
GROUP 2: 10 PPM (VINYL CHLORIDE)
Animal No.
2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 2013 2014 2020
Normal
200 200 200 198 200 197 200 200 200 198 200 200 200 200 200
-------- H e a d----------------------
Amorphous
Small
Enlarged
0 00 0 00 0 00 2 00 0 00 3 00 0 00 0 00 0 00 2 00 0 00 0 00 0 00 0 00 0 00
Double
0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
-Tail-
Coiled
Bent Double
000 00 0 000 00 0 00 0 00 0 00 0 00 0 00 0 00 0 00 0 00 0 00 0
00 0 00 0
Other
0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
% c
L8XS00
15
HLS STUDY NO.: 96-4080
APPENDIX C
VINYL CHLORIDE COMBINED INHALATION TWO-GENERATION REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CD RATS
INDIVIDUAL PL SPERM MORPHOLOGY DATA
GROUP 3: 100 PPM (VINYL CHLORIDE)
Animal No.
Normal
--------H e a d----------------------
Amorphous
Small
Enlarged
Double
-Tail-
Coiled
Bent Double
3001 3002 3003 3004 3005 3006 3007 3008 3009 3010 3014 3020 3022 3026 3029 3030
200 200 199 200 200 200 200 200 199 199 200 200 200 200 197
42
0 0 0 0 0 0 0 0 1 0 0 0 0 0 1 158
00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00
0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
00 0 00 0 10 0 00 0 00 0 000 00 0 00 0 00 0 01 0 000 000 000 00 0 02 0 00 0
Other
0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
BFG 003188
16
HLS STUDY NO.: 96-4080
APPENDIX C
VINYL CHLORIDE COMBINED INHALATION TWO-GENERATION REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CD RATS
INDIVIDUAL
SPERM MORPHOLOGY DATA
GROUP 4: 1100 PPM (VINYL CHLORIDE)
Animal No.
Normal
-------- H e a d-------- v..............
Amorphous
Small
Enlarged
4001 4002 4003 4004 4005 4006 4007
4008 4009 4010 4011 4012 4013 4014 4027
200 200 200 198 200 199 200 a 200 200 200 199 b 180 200 200
0 00 0 00 0 00 2 00 0 00 0 00 0 00
0 00 0 00 0 00 1 00 20 0 0 0 00 0 00
Double
0 0 0 0 0 0 0
0 0 0 0 0 0 0
-Tail-
Coiled
Bent Double
000 000 0 00 000 000 010 000
000 000 000 000 000 000 000
a=Too few cells (less then 200) to evaluate. b=Excessive fragmentation.
Other
0 0 0 0 0 0 0
0 0 0 0 0 0 0
BFG 003189
17
HLS STUDY NO.: 96-4080
APPENDIX D
VINYL CHLORIDE COMBINED INHALATION TWO-GENERATION REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CD RATS
INDIVIDUAL P2 SPERM MORPHOLOGY DATA
GROUP 1: 0 PPM (VINYL CHLORIDE)
Animal No.
Normal
Amorphous
Small
Enlarged
Double
Coiled
1031
200
1032
200
1033
200
1035
200
1037
200
1039 a
1041
200
1043
199
1045
199
1047
200
1048
200
1058
200
1068
200
1071
200
1078
200
0 00 0 0 00 0 0 00 0 0 00 0 0 00 0
0 00 0 1 00 0 0 00 0 0 00 0 0 00 0 0 00 0 0 00 0 0 00 0 0 00 0
0 0 0 0 0
0 0 1 0 0 0 0 0 0
a=Too few cells (less then 200) to evaluate.
Bent
0 0 0 0 0
0 0 0 0 0 0 0 0 0
Double
0 0 0 0 0
0 0 0 0 0 0 0 0 0
Other
0 0 0 0 0
0 0 0 0 0 0 0 0 0
BFG 003190
18
HLS STUDY NO.: 96-4080
APPENDIX D
VINYL CHLORIDE COMBINED INHALATION TWO-GENERATION REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CD RATS
GROUP 2: 10 PPM (VINYL CHLORIDE)
Animal NO.
Normal
Amorphous
2031 2033 2034 2036 2037 2038 2040 2042 2044 2046 2048 2050 2052 2054 2066
200 200 199 200 198 200 200
199 200 200 200 200 199 197 200
0 0 1 0 0 0 0 1 0 0 0 0 1 3 0
INDIVIDUAL P2 SPERM MORPHOLOGY DATA
Small
0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
Enlarged
0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
Double
0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
Coiled
0 0 0 0 2 0 0 0 0 0 0 0 0 0 0
Bent
0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
Double
0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
Other
0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
BFG 003191
19
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V IN Y L CHLORIDE COMBINED IN H A LA TIO N TWO-GENERATION REPRODUCTION
AND DEVELOPMENTAL T O X IC IT Y STUDY IN CD RATS
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BFG 003192
HLS STUDY NO.: 96-4080
APPENDIX D
VINYL CHLORIDE COMBINED INHALATION TWO-GENERATION REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDY IN CD RATS
INDIVIDUAL P2 SPERM MORPHOLOGY DATA
GROUP 4: 1100 PPM {VINYL CHLORIDE)
Animal No.
Normal
Amorphous
-------- H e a d----------------------
Small
Enlarged
Double
-Tail-
Coiled
Bent Double
4031 4033 4035 4037
4039 4041 4043 4045 4046 4047 4049 4050 4052 4054 4056
200 200 195 200 200 200 200 200 200 199 200 200 199 200 200
0 00 0 0 00 0 2 00 0 0 00 0 0 00 0 0 00 0 0 00 0 0 00 0 0 00 0 1 00 0 0 00 0 0 00 0 1 00 0 0 00 0 0 00 0
000 0 00 2 10 0 00 000 0 00 000 000 000 000 000 0 00 000 0 00 000
Other
0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
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APPENDIX X
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Appendix X
1. INTRODUCTION.................................................................................................. 2
2. MATERIAL AND METHODS 2.1. Husbandry During Exposure Periods......................................................................2 2.2. Test Material Preparation....................................................................................... 3 2.3. Test Material Administration and Chamber Operation........................................... 3 2.4. Exposure Chamber Sampling.................................................................................. 5
EXPOSURE GENERATION SYSTEM...................................................................................... 7
EQUIPMENT LIST........................................................................................................................ 8
MIRAN AMBIENT AIR ANALYZER Procedure and Methodology...................................................................................10 Miran Ambient Air Analyzer Setup....................................................................... 13 Calibration Curve - Groups II and III.................................................................... M Calibration Curve - Group IV................................................................................15
SUMMARY OF DISTRIBUTION TRIAL SAMPLES.............................................................16
CUMULATIVE EXPOSURE RECORD....................................................................................17
IN-CHAMBER OBSERVATIONS.............................................................................................62
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Appendix X
1. INTRODUCTION This appendix presents the methodology for exposure atmosphere generation, monitoring and results.
2. MATERIAL AND METHODS
2.1. HUSBANDRY DURING EXPOSURE PERIODS
2.1.1. HOUSING
Animals were individually housed in stainless steel, wire mesh cages within a 6m3 stainless steel and glass whole-body exposure chamber. The placement of the animals in the whole-body exposure cages was rotated at each exposure to ensure uniform exposure of the animals. A description of the animal rotation is included in the raw data.
2.1.2. FOOD None was provided during exposure.
2.1.3. WATER
Water was available without restriction via an automated watering system (Elizabethtown Water Company, Westfield, New Jersey).
2.1.4. ENVIRONMENTAL CONDITIONS
Chamber temperature and relative humidity were recorded every half-hour during exposure and maintained, to the maximum extent possible, within the ranges presented below.
Temperature
Desired: Actual:
20 to24C 16 to28C
Relative Humidity
Desired: Actual:
40 to60% 29 to79%
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2.2. TEST MATERIAL PREPARATION The test material was used as received.
Appendix X
2.3. TEST MATERIAL ADMINISTRATION AND CHAMBER OPERATION
2.3.1. ROUTE OF ADMINISTRATION Inhalation, whole body.
2.3.2. ROUTE JUSTIFICATION
The inhalation route is one of the potential routes of human exposure to this test material.
2.3.3. EXPOSURE LEVELS 10, 100 and 1100 ppm
2.3.4. FREQUENCY OF EXPOSURES 6 hours per day.
2.3.5. DURATION Animals were exposed
2.3.6. DATES OF EXPOSURES Pi Generation: 7 January 1997 to 5 June 1997
Fi Generation: 20 May 1997 to 3 October 1997
2.3.7. PRE-STUDY TRIALS
Trials were performed, prior to the start of the study, to evaluate the optimal set of conditions and equipment to generate a stable atmosphere at the targeted exposure levels.
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2.3.8. CHAMBER OPERATION
The exposure chambers were operated dynamically under slight negative pressure at a minimum airflow rate of 1200 liters per minute (Lpm), This flow rate was calculated to provide one complete air change every 5.0 minutes and a 99% equilibrium time (T99) of 23 minutes. This chamber size and airflow rate was considered adequate to maintain the animal loading factor below 5% and oxygen above 19%. The chamber was exhausted through a system consisting of a coarse filter, a HEPA filter and a MOCO fume incinerator (on days when the fume incinerator was not functioning, a charcoal filter was used along with the coarse filter and HEPA filter).
2.3.9. EXPOSURE PROCEDURE
Group I:
House supply air was fed through the turret of a 6m3 glass and stainless steel whole-body exposure chamber, at a rate of 1329 Lpm, with a static pressure of-0.15 in. H2O. The airflow and static pressure were maintained at these settings throughout the 360 minute exposures. The animals remained in the chamber for a minimum of 30 minutes following the exposures to allow the chamber to clear at the same airflow rate used during exposures.
Groups H through IV:
House supply air was fed through the turret of a 6m3 glass and stainless steel whole-body exposure chamber at flow rates of 1267 Lpm, 1257 Lpm and 1239 Lpm for Groups II, III and IV, respectively. The airflow and static pressure were maintained at these settings throughout the 360 minute exposures. The test material was delivered from a compressed gas cylinder via Vi' tubing to a Scott Specialty Gases regulator (equipped with inlet and outlet backpressure gauges). From the regulator, the test material flowed to a purge/vent system, which was attached to the inlet side of an electronic solenoid valve. The electronic solenoid valve was intended to shut-off the test material flow if electrical power or
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Appendix X
chamber airflow was interrupted. The outlet of the solenoid valve was attached to a stainless steel cross union, from which 14" tubing branched to the three generation flowmeters. The test material exited the flowmeters via V" tubing at flow rates of 12.36 mL/min, 128.3 mL/min and 1312 mL/min for Groups II, III and IV respectively, and was directed into the turret of each of the 6m3 exposure chambers, where it mixed with the house supply air. The generation system from the regulator through the flowmeters, was contained within a separate 6m3 glass and stainless steel chamber. This containment chamber was exhausted through the in-house filtering system, which consisted of a charcoal filter, a coarse filter and a HEPA filter.
All animals remained in the chamber for a minimum of 30 minutes at the end of each exposure to allow for clearing of the chamber. During this time, the chamber operated at the same airflow rate as during the exposure.
Refer to Diagram and equipment list (pages 7-9 of Appendix X) for equipment details.
2.4. EXPOSURE CHAMBER SAMPLING
2.4.1. CHAMBER SAMPLING (ER)
Measurements of airborne concentrations of the test material were made using a MIRAN Ambient Air analyzer equipped with a strip chart recorder. The test atmosphere samples were drawn hourly during the exposures through a filter or a Drierite drying tube (Groups I and II only) and then through the MIRANT and measurements were recorded. Samples were drawn through a filter attached to 14" tubing, and into the inlet of the MIRAN. A vacuum pump was used to pull the chamber air through the MIRANT. The pump was exhausted into the exhaust pipe of the 6m3 exposure chamber, via 14" plastic tubing. The exposure levels were determined by comparison of the measured absorbance to a calibrated response curve constructed using the same instrument settings.
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Appendix X
Refer to pages 10-15 of Appendix X equipment details.
2.4.2. CHAMBER SAMPLING (GC)
GC (gas chromatography) sampling was performed twice during this study on one day per week with approximately two weeks between analysis. GC analyses of the chamber atmospheres were performed along with the IR (Miran infrared spectrophotometer) analyses in each exposure group at each hourly interval. The procedure for sampling is included in Appendix Z.
2.4.3. PARTICLE SIZE DISTRIBUTION ANALYSIS
Particle size distribution measurements were performed once weekly from the chambers and room air using a TSI Aerodynamic Particle Sizer. The samples were drawn for 20 seconds at a flowrate of 5 Ipm. A computer was used to program the system to the appropriate settings prior to sampling. The mass median aerodynamic diameter, geometric standard deviation and Total Mass Concentration were calculated by the computer and printed out.
2.4.4. NOMINAL CONCENTRATION
To calculate the nominal concentrations (ppm), the flow of test material and air through the chamber was monitored using appropriate calibrated equipment. The test material (liters) consumed during the exposure was then divided by the total volume of air (liters) passing through the chamber [volumetric flow rate (L) X total exposure time (min)] X 106pl/L.
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Exposure Generation System
Appendix X
PresaureSwtch
NOTE: The generation system, ercmtnQ the carprcsscd gas vfftda was housed
a SnPeapoang chamber.
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Equipment List
Appendix X
Exposure Chamber Haiford 6000 liter glass and stainless steel chamber.
Compound Reservoir Compressed gas cylinder (Sponsor supplied Ton cylinder)
Flowmeters Gilmont Flowmeter/Micrometer, size micro (range 0-100% of scale), size 11 (range 0250 mL/min), size 12 (range 0-2000 mL/min), Gilmont Industries, Inc. The flowmeters were calibrated prestudy with a Gilibrator (range 1-250 cc), P/N D800287, SN6675-2 with a sensor block P/N D800290 or with a Gilibrator (range 20 cc-6 Lpm), P/N D800286, SN 569-S with a flow cell P/N A800266; Gilian Instrument Corp.
Dwyer, 0-20 Lpm.
Pressure/Vacuum Gauge(s) Dwyer Magnehelic gauge, 0 - 2 in. and a 0 + 1 in. (center zero) 0-30 in. Hg Gast vacuum gauge
Regulator(s) Scott Specialty Gases regulator (equipped with a 0-100 psi inlet backpressure gauge and a 0-100 psi outlet backpressure gauge)
MG Industries stainless steel Purge/Vent System
Solenoid Valves Allenair *6 electronic solenoid valve
Pressure Switch Dwyer Instruments Inc. (ID# 1950-0).
Connector Stainless steel cross union.
Tubing
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Equipment List
Appendix X
Size 14" plastic (American Scientific Products). Size VS" plastic (Baxter Scientific Products. Size 14" and 14" Teflon. Size Vi" stainless steel.
Filters PALL Corp. (HC9020F UP4H) filter PTI Tecnologies (B129327044) filter
Vacuum Pumps Thomas Industries Inc., Model 707CM 50.
Air Analyzer Wilks, MIRAN 1A Ambient Air Analyzer with a Fisher Recordall Series 5000, Model D5117-SAQ and a Micronta LCD Benchtop Digital Multimeter No. 22-195.
Particle Sizer/Analyzer TSI Aerodynamic Particle Sizer, Model 3310A, and a DELL computer (model #A86P125) equipped with an Epson LQ-578+ Dot matrix printer
Thermometer and Humidity Gauge Springfield Precision Instruments, Temperature/Humidity gauges calibrated before use with a Fischer Digitial Hygrometer/Thermometer.
Chamber Air-flow Gauge Dwyer Magnehelic gauge, 0-2 in. H2O; calibrated prestudy with a Sierra Acumass Flowmeter (model 730-N8-2) with a Sierra Instruments Digital meter (model 831-N2).
Chamber Static Pressure Gauge Dwyer Magnehelic gauge, 0-+ 1 in. H2O (center zero); calibrated prestudy with a Dwyer Mark II Manometer (model 25).
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Appendix X
Miran Ambient Air Analyzer Procedure and Methodology Procedure
Hourly samples for determination of the levels of exposure to Vinyl Chloride were analyzed for Groups I-IV, using a MIRAN Ambient Air Analyzer equipped with a strip chart recorder and multimeter. The test atmospheres were drawn continuously through a glass fiber filter in a filter holder, and then through 1/4" Teflon tubing to the inlet of the Miran. A vacuum gauge was connected to the outlet of the Miran. The gauge was connected, via 1/4" Teflon tubing, to a flowmeter equipped with a metering valve. A pump was used to pull chamber air through the Miran. When the Mran cell was considered equilibrated, the pump was turned off and the absorbance was read off the multimeter. The absorbances and flowmeter settings were recorded. The pump was exhausted into the in-house filtering system consisting of a coarse and HEPA filters and activated charcoal. The exposure levels were determined by comparison of the measured absorbance to a calibrated response curve (see pages 14 and 15 of Appendix N) constructed using the same instrument settings.
Settings. The instrument settings for the unit are summarized below:
wavelength, microns pathlength, dial setting slit width, mm range, absorbance response, seconds gain chart speed, cm/min chart volts
11.1 (Groups I, II, III); 10.9 (Group IV) 11.5 (Groups I, II, III); 4.48 (Group IV) 1 0.25A (Groups I, II, III); 1A (Group IV) 1 High 1 1
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Appendix X
Calibrations. The MIRAN was turned on and allowed to warm up for approximately 20 minutes. The cell was flushed with room air for approximately one minute. The loop (5.64 Liters) was closed, the unit was zeroed and the injection series was performed as shown below. The resultant data was plotted to obtain separate calibration curves for Groups I and II, for Group IH and for Group IV.
Groups I, II and HI:
Iniection Volume
(HL) 28 56 140 280 560 850
Calculated Concentration*
(ppm) 5.0a 9.9a 25"'b 50a'b 99b IS lb
ABSORBANCE Observer I Observer 2 Average
0.0313 0.0600 0.2160 0.350 0.599 0.833
0.0321 0.0610 0.2265 0.357 0.645 0.923
0.0317 0.0605 0.2213 0.354 0.622 0.878
Group IV:
ABSORBANCE
Iniection Volume
Calculated Concentration*
Observer 1 Observer 2 Average
(HL)
(ppm)
560
99
0.0680
0.0666
0.0673
2800
496
0.312
0.306
0.309
4500
798
0.472
0.464
0.468
6200
1099
0.626
0.612
0.619
7500
1330
0.730
0.731
0.731
"ppm = Volume of Vinyl Chloride(jjL) / Volume of Air (L) * These concentrations were used to prepare the calibration curve for Groups I and II. b These concentrations were used to prepare the calibration curve for Group III.
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Appendix X
Calibration Checks. A three-point calibration check of the MTRAN* was performed for
each trial/exposure day prior to sampling the chambers as shown below:
INJECTION VOLUME
(ML)
56 560 6200
CALCULATED CONCENTRATION
(ppm)
9.9 99 1099
EXPECTED ABSORBANCE
READING
(v)
0.0605
0.622 0.619
ACCEPTABLE ABSORBANCE
RANGE
(v)
0.0514-0.0696 0.529- 0.715 0.526-0.712
Injections were made with a 100 \XL Precision Sampling Corp. syringe, a 1000 pL Hamilton syringe or a 10 mL Hamilton syringe (model 1001 and 1010). The absorbance was recorded after each injection. The absorbance must be within 15% of the original calibrations series. If any of the absorbance values fell outside the 15% range, the injection was rechecked as follows: the volume for the value that was out of range was reinjected twice. The two closer pair of the three injections were averaged and the results compared with the original curve. If the value of the average was outside the 15% range, the Study Director or Inhalation Toxicologist decided if a new graph was to be prepared.
Significant Figures. Sample concentrations and daily means were reported to two significant figures.
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Appendix X
Prom chamber
1
Strip Chart Recorder
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Calibration Curve - Groups I and II
40.0 -r
35.0
30.0 Faa 25.0 0 20.0 e V 15.0 S V
10.0
-295.82x* + 178.4x R1 - 0.9989
5.0 -
0.0 0.0000
Calibration Curve - Group III
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Inhalation Report Calibration Curve - Group IV
Appendix X
1400 1200 - -
y - -301.17x4 + 133.59x3 + 616.48x2 + 1415.5x R2 0.9997
1000 - Eaa eo 800 -
oceuco 600 400 --
Coefficients
200 -
0.0000 0.1000 0.2000 0.3000 0.4000 0.5000 0.6000 0.7000 0.8000 Absorbance (Volts)
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Appendix X
GROUPn 23 Dec 96 23 Dec 96 23 Dec 96 23 Dec 96 23 Dec 96 23 Dec 96 23 Dec 96 23 Dec 96 23 Dec 96 23 Dec 96 23 Dec 96
GROUPm 23 Dec 96 23 Dec 96 23 Dec 96 23 Dec 96 23 Dec 96 23 Dec % 23 Dec 96 23 Dec 96 23 Dec 96 23 Dec 96 23 Dec 96 23 Dec 96
GROUP IV 23 Dec 96 23 Dec 96 23 Dec 96 23 Dec 96 23 Dec 96 23 Dec % 23 Dec 96 23 Dec 96 23 Dec 96 23 Dec 96 23 Dec 96
23 Dec 96
SUMMARY OF DISTRIBUTION TRIAL SAMPLES
ANALYTICAL (JR)
RATIO
SAMPLE
PORT
CONCENTRATION
DISTRIBUTION
PATENUMBERLD.(PPM)SAMPLE/H-1
223 H-l 223 H-4 223 H-6 223 H-7 224 H-l 224 H-9
224 H-I2 224 H-14 225 H-l 225 H-15 225 H-17
10 11 1.10 10 1.00
11 1.10 11 11 1.00 11 1.00 11 1.00 11 10 0.91 11 1.00
322 H-l 322 H-4 322 H-6 323 H-l 323 H-12 323 H-14 324 H-l 324 H-15 324 H-17 325 H-l 325 H-7 325 H-9
100 110 1.10 100 1.00
100 100 1.00 100 1.00 100 97 0.97 95 0.97 100 100 1.00 100 1.00
422 H-l 422 H-4 422 H-6 423 H-l 423 H-12 423 H-14 423 H-7 424 H-l 424 H-9 424 H-5
425 H-l
425 H-17
1100 1100 1100 1100 1100 1100 1100 1100 1100 1200 1100
1100
-
1.00 1.00
-
1.00 1.00 1.00
-
1.00 1.09
-
1.00
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Cumulative Exposure Records Preface
Appendix X
Footnotes:
Bold values indicate GC confirmation of IR sample. bDue to equipment problems, GC sample was not taken. c Sample taken before a leak in the sample line or a fitting was
repaired. dDue to equipment problems, Miran sample was not taken. "Due to elevated chamber humidity, a valid Miran sample could not
be taken. fDue to equipment problems, accurate temperature readings could not
be taken. g A second exposure (4-hours) was run on this date to expose animals
that were erroneously not loaded in the morning. h Sample not taken due to technician error. `Mean and SD of all individual IR samples. JMean and SD of all individual GC samples.
<LOQ = Less than the limits of quantification.
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Cumulative Exposure Record Chamber Monitoring Results
Appendix X
Week
2 3 4
Date
7-Jan-97 8-Jan-97 9-Jan-97 10-Jan-97 13-Jan-97 14-Jan-97 15-Jan-97 16-Jan-97 17-Jan-97 20-Jan-97 21-Jan-97 22-Jan-97 23-Jan-97 24-Jan-97 27-Jan-97 28-Jan-97 29-Jan-97 30-Jan-97 31-Jan-97 3-Feb-97
Exposure
Number Mean (ppm)
1 0.0 2 0.0 3 00/0.90 4 0.0 5 0.0
6 0.0 7 0.0 8 0.0 9 0.0/0.099 10 0.0 11 0.0 12 0.0
13 o.o/o.o 14 00
15 0.0
16 0.0 17 0.0
18 0.0/0.0
19 0.0
20 0.0
0.0 0.0 0.0/1.2 0.0 0.0 0.0 0.0 0.0 0.0/0.593' 0.0 0.0 0.0
o.o/o.o
0.0 0.0 0.0 0.0
o.o/o.o 0.0
0.0
Miran (IR)'
Individual
(ppm)
0.0 0.0 0.0
0.0 0.0 0.0
0.0/1.2
0.0 b
0.0
0.0 0.0 0.0
0.0 0.0 0.0
0.0 0.0 o.o
0.0
0.0
o.o/o.o* 0.0
0.0 0.0
o.o/o.o'
0.0
0.0
0.0
00/0.0' 0.0
0.0 0.0 0.0
0.0 O.O/O.O
0.0 0.0
0.0
o.o/o.o
0.0 0.0
d
0 0/0.0
0.0 0.0
0.0
0.0
0.0/0.0
0.0
0.0
0.0 0.0
o.o/o.o
0.0 0.0
0.0 0.0 o.o/o.o 0.0 0.0
0.0 0.0
0.0/1.2
0.0
0.0 0.0 0.0
00
o.o/o.o 0.0 0.0
d
o.o/o.o 0.0 0.0 0.0 0.0
o.o/o.o 0.0 0.0
0.0 0.0 o.o/o.o 0.0 0.0
0.0 0.0 0.0 o.o/o.o 0.0 0.0
d
o.o/o.o 0.0
0.0
0.0 0.0 o.o/o.o 0.0 0.0
Particle Size
Determinations
MMAD GSD TMC
(pm)
(mg/m3)
3.114 1.714 5.41B-04
1.812 2.271 1.29E-03
3.798 2.192 2.00E-03
7.101 2.014 1.19E-03
Chamber Environment
Mean
Temoerature Humiditv
(C) 22 22 23 22 23
(%) 41 39 42 49 48
22 41
22 40 23 53 22 42 22 39
22 38 23 40 23 42 22 34 22 34
22 45 21 34 20 32 20 37 21 40
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Appendix X
Week 5 6 7
a
Date
4-Feb-97 5-Feb-97 6-Feb-97 7-Feb-97 10-Feb-97 11-Feb-97 12-Feb-97 13-Feb-97 14-Feb-97 17-Feb-97 18-Feb-97 19-Feb-97 20-Feb-97 21-Feb-97 24-Feb-97 25-Feb-97 26-Feb-97 27-Feb-97 28-Feb-97 3-Mar-97
Exposure Number
21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40
Mean (ppm)
0.0 0.0 0.0 0.0 0.0 0.0 0.0
o.o/o.o
0.0 0.0 0.0 0.0 0.0 0.0 0.0
0.0 0.0
o.o/o.o
0.0 0.0
0.0 0.0 0.0 0.0 0.0 0.0 0.0 00/0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0
o.o/o.o
0.0 0.0
Mlran (IR)*
Individual
(ppm)
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
o.o/o.o
0.0
o.o/o.o
0.0 0.0
0.0 0.0
0.0 0.0
0.0 0.0
00 0.0
0.0 0.0
00 0.0
0.0 0.0
0.0
o.o/o.o
0.0
o.o/o.o
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 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0
o.o/o.o
0.0 0.0
0.0 0.0 0.0 0.0 0.0 0.0 0.0
o.o/o.o
0.0 0.0 00 0.0 0.0 0.0 0.0 0.0 0.0
o.o/o.o
0.0 0.0
0.0 0.0 0.0 0.0 0.0 0.0 0.0
o.o/o.o
0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0
o.o/o.o
0.0 0.0
Particle Size
Determinations
MMAD GSD TMC
(pm)
(mg/m3)
6.641 2.072 3.42E-04
2.851 2.128 2.58E-03
2.843 1.878 1.37E-03
0.9951 1.945 4.46E-03
Chamber Environment
Mean
Temoerature Humidity
CC)
(%)
21 39
20 39
22 39
22 41
21 41
21 42
21 35
21 33
20 47
21 40
21 41
22 39
22 40
22 47
22 39
22 41
22 46
25 62
23 50
21 48
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Appendix X
Week 9
to
II
12
Date
4-Mar-97 5-Mar-97 6-Mar-97 7-Mar-97 IO-Mar-97 11-Mar-97 !2-Mar-97 13-Mar-97 M-Mar-97 17-Mar-97 18-Mar-97 19-Mar-97 20-Mar-97 21-Mar-97 22-Mar-97 2 3-Mar-97 24-Mar-97 25-Mar-97 26-Mar-97 27-Mar-97 28-Mar-97 29-Mar-97 30-Mar-97 31-Mar-97
Exposure Number
41 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60 61 62 63 64
Mean (ppm)
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 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 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 0.0 0.0 0.0 0.0 0.0/0.0 0.0 0.0 0.0 0.0
Miran <IR)a
Individual
(ppm)
0.0 0.0
0.0 0.0
0.0 0.0
0.0 0.0
0.0 0.0
0.0
o.o/o.o
0.0
o.o/o.o
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
0.0 0.0
0.0 0.0
0.0 0.0
0.0 0.0
0.0
o.o/o.o
0.0
o.o/o.o
0.0 e
0.0 0.0
0.0 0.0
0.0 0.0
0.0 0.0 0.0 0.0 0.0
0.0
o.o/o.o
0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0
0.0 0.0
o.o/o.o
e 0.0 0.0 0.0
e 0.0 0.0 0.0 0.0
0.0
o.o/o.o
0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0
o.o/o.o
e 0.0 0.0 0.0
e 0.0 0.0 0.0 0.0
0.0
o.o/o.o
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
e 0.0 0.0 0.0
Particle Size
Determinations
MMAD GSD TMC
(pm)
(mg/m3)
0.9153 1.314 9.97E-03
1.740 1.847 1.81E-03
1.218 1.509 2.40E-03
1.748 1.922 1.89E-03
Chamber Environment
Mean
Temoerature Humidity
CC)
21
(%) 49
21 50 21 54 21 39
20 53
19 54
19 51
19 46
19 54
19 51
19 52
20 55
20 58
20 57
20 61
16 50
21 48
22 46
21 51
21 51
21 47
21 53
21 49 20 64
BFG 003214
Huntingdon Life Sciences Reproduction Study
96-4080
Page 21 Draft Final Report
Group 1 - 0 ppm
Cumulative Exposure Record Chamber Monitoring Results
Appendix X
Week 13
14
15
Date
1-Apr-97 2-Apr-97 3-Apr-97 4-Apr-97 5-Apr-97 6-Apr-97 7-Apr-97 8-Apr-97 9-Apr-97 10-Apr-97 11 -Apr-97 12-Apr-97 13-Apr-97 14-Apr-97 15-Apr-97 16-Apr-97 l7-Apr-97 18-Apr-97 19-Apr-97 20-Apr-97 21-Apr-97
Exposure Number
65 66 67 68 69 70 71 72 73 74 75 76 77 78 79 80 81 82 83 84 85
Mean (ppm)
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 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 0.0 0.0 0.0
o.o/o.o
0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 <LOQ 0.0
Miran (UR)"
Individual
(ppm)
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
0.0 0.0
o.o/o.o
0.0 0.0
o.o/o.o
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
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 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 0.0 0.0
0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0
o.o/o.o
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 0.0 0.0 0.0 0.0 0.0 0.0 0 0/0.0 0,0 0.0 0.0 0.0 00 0.0 0.0 0.0 0.0 0.0 0.0
Particle Size
Determinations
MMAD OSD TMC
(pm)
(mg/m3)
2.633 1.794 3.96E-03
1.257 1.365 5.28E-04
2.025 2.16) 2.45E-03
Chamber Environment
Mean TemnerBture Humiditv
CC) (%)
20 54 18 49 20 53 19 55 19 55 19 58 22 63 22 54 21 48 21 52 20 48 20 54 20 62 20 36 20 42 22 44 21 46 20 44 20 43 21 43 22 42
BFG 003215
Huntingdon Life Sciences Reproduction Study_____
96-4080
Page 22 Draft Final Report
Group 1 - 0 ppm
Cumulative Exposure Record Chamber Monitoring Results
Appendix X
Week 16
17
18
Date
22-Apr-97 23-Apr-97 24-Apr-97 25-Apr-97 26-Apr-97 27-Apr-97 28-Apr-97 29-Apr-97 30-Apr-97 1-May-97 2-May-97 3-May-97 4-May-97 5-May-97 6-May-97 7-May-97 8-May-97 9-May-97 lO-May-97 11-May-97 12-May-97
Exposure Number
86 87 88 89 90 91 92 93 94 95 96 97 98 99
100
101 102 103 104 105 106
Mean (ppm)
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 00 0.0
0.0
0.0/0.0 00
0.0 0,0 0.0
0.0 0.0
o.o/o.o
00 0.0 0.0 0.0
0.0 0.0 0.0 0.0 0.0 0.0 0.0
0.0 0.0
o.o/o.o 0.0 0.0
0.0 0.0
Mlran (IR)*
Individual
(ppm)
0.0 0.0
0.0 0.0
o.o/o.o 00/<LOQ
00 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 0.0
0.0 0.0 0.0 0.0
0.0 0.0
0.0 0.0
0.0
o.o/o.o
0.0
o.o/o.o
0.0 0.0
0.0 0.0
0.0 0.0
0.0 0.0
0.0 0.0
o.o/o.o
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
o.o/o.o 0.0
0.0
00 0.0
0.0 0.0
o.o/o.o
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
o.o/o.o 0.0 0.0 0.0
0.0
0.0 0.0
o.o/o.o
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
o.o/o.o
0.0 0.0 0.0 0.0
Particle Size
Determinations
MMAD GSD TMC
(pm)
(mg/m5)
0.769 1.710 7.48E-03
1.175 2.57 1.73E-03
8.335 1.59 5.67E-03
Chamber Environment
Mean
Temperplpre Humiditv
CC) (%)
22 46 20 46 20 45
21 44
20 40 21 36 24 54
22 42 22 54 25 50 22 38 25 55 23 43 20 37
21 44 19 36 19 42 19 51
21 55
22 46
21 50
BFG 003216
Huntingdon Life Sciences Reproduction Study_____
96-4080
Page 23 Draft Final Report
Group 1 - 0 ppm
Cumulative Exposure Record Chamber Monitoring Results
Appendix X
Week 19
20 21 22
Date
13-May-97 M-May-97 15-Mav-97 16-May-97 17-May-97 18-May-97 ] 9-May-97 20-May-97 21-May-97 22-May-97 23-May-97 26-May-97 27-May-97 28-May-97 29-May-97 30-May-97 2-Jun-97 3-Jun-97 4-Jun-97 5-Jun-97 6-Juii-97 9-Jun-97
Exposure Number
107 108 109
no
1)1 112 113 114 115 116 117 120 121 122 123 124 125 126 127 128 129 130
Mean (ppm)
0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 O.O/O.O 0.0 0.0 0.0 0.0 0.0 0.0 0.0 00/0.0 00 0.0 0.0 0.0
0.0 0.0 0.0 0.0 0.0 0.0 0.0
0.0 0.0 00/0.0 0.0 0.0
0.0 0.0 0.0 0.0 0.0
0.0/0.Q 0.0 0.0 0.0 0.0
Mfran (!R)"
Individual
(ppm)
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
0.0 0.0
0.0 0.0
o.o/o.o
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
0.0 0.0
o.o/o.o o.o/o.o
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 0.0 0.0 0.0 00/0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 00/0.0 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 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 0.0
0.0 0.0 0.0 0.0 0.0 0.0 0.0
0.0 0.0
o.o/o.o
0.0 0.0 0.0 0.0 0.0 0.0 0.0
00/0.0 0.0 0.0 0.0 0.0
Particle Size
Determinations
MMAD GSD TMC
(pm)
(mg/m3)
1.278 2.58 2.63E-03
1.949 2.74 1.81E-03 2.058 2.53 1.36E-03 1.796 2.34 1.39E-03
Chamber Environment
Mean
Temperature Humiditv
(C)
<%)
20 54
19 58
19 55
21 50
19 57
21 51
20 62
19 62
18 55
19 49
20 52
f 63
20 49
20 47
20 47
20 56
22 62
22 58
22 54
22 52
21 59
22 53
BFG 003217
Huntingdon Life Sciences Reproduction Study
96-4080
Page 24 Draft Hngl Report
Group 1 - 0 ppm
Cumulative Exposure Record Chamber Monitoring Results
Appendix X
Week 23 24 25 26
Date
10-Jun-97 1 l-Jun-97 12-Jun-97 13-Jun-97 16-Jun-97 17-Jun-97 l S-Jun-97 19-Jun-97 20-Jun-97 23-Jun-97 24-Jun-97 25-Jun-97 26-Jun-97 27-Jun-97 30-Jun-97 l-Jul-97 2-Jul-97 3-Jul-97 4-Jul-97 7-Jul-97
Exposure Number
131 132 133 134 135 136 137 138 139 140 141 142 143 144 145 146 147 148 149 150
Mean (ppm)
0.0 0.0 0.0 0,0 0.0
o.o/o.o
0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0
o.o/o.o
0.0 0.0 0.0
0,0 0.0 0.0 0.0 0.0
o.o/o.o
0.0 0.0 0.0 0.0
0.0 0.0 0.0 0.0 0.0 0.0
o.o/o.o
0.0 0.0 0.0
Mi ran (IR)"
Individual
(ppm)
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
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
0.0 0.0
0.0 0.0
0.0
o.o/o.o
0.0 00/0.0
0.0 0.0
0.0 0.0
0.0 0.0
0.0 0.0 0.0 0.0 0.0
o.o/o.o
00 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
0.0 0.0 0.0 0.0 0.0
o.o/o.o
0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 00/0.0 0.0 0.0 0.0
0.0 0.0 0.0 0.0 0.0
o.o/o.o
0.0 0.0 0.0 0.0
0.0 0.0 0.0 0.0 0.0 0.0 00/0.0 0.0 0.0 0.0
Particle Size
Determinations
MMAD OSD TMC
(pm)
(mg/m5)
1.100 2.01 1.52E-03
0.990 1.62 8.00E-03
0.665 1.32 5.22E-03
1,513 2.41 2.93E-03
Chamber Environment
Mean
Temperature (C)
22
Humidity (%) 55
24 54
22 58
21 58
22 51
21 58
22 56
22 60 22 57 23 60
23 63 23 66
23 68
22 65
23 63
24 63
24 67
23 67
23 65 23 64
bFG 003218
LO
x
X T3 C
CL
a.
<
o </)
8i
a
a
3C
oCO
V> w oo
o a. .ts
I CD
^i
05 s ~
'5
.
11
ou
a o c
w"o I
c .2 -g U 05
|1
3 X cd
a Q. O
a. 3 OW o
os oso t-- s<5 c--
OWN' IsNn fWsN i/NC IsNo Tso 7sO
wi \0 ^ in 3m sr i-**. in -- cs -- f| -- -- <N in v n pi in in n
IN N fS N IN N IN N (N N M N IN N IN N N IN IN M IN IN
sa
OsO'
?
W
I*NT
qrIN
'T
o 5
d d d d
d
5
O
odd
d
d
d
d
o' d
S
5
d
d
d
d
5
d
ddd dd d
d
d
d
dd
5
odd d d d d
d
i *
5 e
dddod d d d d d d d d d c
w--\
Ii/N*>
mI'Ni
urnf mmii
ici
r- moo vOi' ic
r oo -- c r* f~
a
r.
t*
Os
rs
r- r
t"
Os
r*>
pOs-
tO**s r>
t
3 3333 3 3 3 3 3 3 3 3
oo oo ao e
3 3 3=
-- mi sc r~
OfNs
m
--C*N
<:-<:< - IN Pi N
V r
in
00
IN
m
BFG 003219
Mean Humiditv (% )
21 22 22 21 22 22 21 21 21 21 21 21
20 22 23 62 23 54 23 66 23 69 21 65 23 65 23 64 23 73
P article Size D e te rm in a tio n s MMAD GSD (pm)
1.488 1,74 9.70E-04 I
0.823 2.40 i
8S
g,
g'oc
^ <0
c
S3
O
x
x TD
C
CL Q.
<
s Ea
>o
\n 'O
ov
co-
t*~
fpi-
e'Oo
Voi
>o
N9O
o
frS-
Or--
to*t
B? bd
Akw
E xQll oW
U
|f
H J,
g
J3 JS JS
0*0
00 00 00 0 0 /0 0 00 00 00 00 00 00 00 00 00 00
0*0
00 00 00
0*0/00
00 00 00 00 00 00 00 00 00 00
*o to
oo
o I?
oCO
CO
CoO wo LoxU. .cOti
ii03 .it
sco ^
s
oo
S
Individual (ppm)
00 00 0*0 0 0
0*0 0*0 0*0 0*0
0*0 0 0
0*0 0*0
00 00
0*0
0*0
00
0*0
0*0
0*0
00 00
O'O
0*0/00
0*0
00 00 00 00 00 00 00 00 00
00
0*0
0*0
0*0
00
0*0
0*0 0*0
0*0
0*0
00 0*0/00
0*0
0*0
00 00 00 00 00 00 00 00
00 00
0*0
00 00 00 00 00
0*0
00 00
0*0/00
0*0
00 00 00
00
00 00 00 00 00
00 00
0*0
0*0
00
0*0 0*0
00 00
0*0
00
0*0/00
0*0
00 00 00 00 00 00 00 00 00
Mean (ppm)
I
!
!
|
0*0 0*0
00
0*0/00
0*0 0*0 0*0
00 00 00 00 00 00 00
V)
oc
`3 to ^ C0|
'-I c co .2*
o y g-i S 2
cc
3
X cn
E QOl. O
Q.
3O 5
a
ti
567891011-
Exposure Number Aug-97 173 Aug-97 174 Aug-97 175 Aug-97 176 Aug-97 177 Aug-97 178 Aug-97 179
ooooooo o' 0000009
187 187 188 189 190 191 192 193
OOC - 9rs9 mOS 90 u90r oW
CP* rO*n rO-n r^- fO*n ^
e^tr-r-r-r-r-r-
ftfl 3
MQ S3
QA 3
Q3j
Q9A
BA 3
Q3f
daosBn'eao&soosoesfi&sOBsO
<<: <:<:<: <f
Nw^
Is oc S'a,o-Nw?m
rs m
BFG 003220
Huntingdon Life Sciences Reproduction Study
96-4080
Page 27 Draft Final Report
Group 1 - 0 ppm
Cumulative Exposure Record Chamber Monitoring Results
Appendix X
Week 34
35
36
Date
26-Aug-97 27-Aug-97 28-Aug-97 29-Aug-97 30-Aug-97 31 -Aug-97 1-Sep-97 2-Sep-97 3-Sep-97 4-Sep-97 5-Sep-97 6-Sep-97 7-Sep-97 8-Sep-97 9-Sep-97 10-Sep-97 11-Sep-97 12-Sep-97 13-Sep-97 14-Sep-97 15-Sep-97
Exposure Number
194 195 196 197 198 199 200 201 202 203 204 205 206 207 208 209 210 2)1 212 213 214
Mean (ppm)
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 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 0.0 0.0 o.o/o.o 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0
Mi ran (IR)" Individual (ppm)
0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 00 0.0 0.0 0.0 0.0 0.0 0.0 0.0 o.o/o.o o.o/o.o 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 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 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 0.0 0.0 0.0 0.0
0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 o.o/o.o 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 0.0 0.0 0.0 0.0 0.0 0.0 o.o/o.o 0.0 0.0 0.0 0,0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0
Particle Size
Determinations
MMAD GSD TMC
(pm)
(mg/m3)
1.363 2.47 6.17E-03
3.302 3.21 1.22E-03
0.821 1.33 6.78E-03
Chamber Environment
Mean TemDerature Humidity
(C) (%) 24 73 24 74 24 79 24 72 23 71 23 74 23 79 22 74 22 62 22 58 22 60 22 65 23 67 24 69
24 71 24 68 25 76 24 71 23 67 23 63 24 61
BFG 003221
Huntingdon Life Sciences Reproduction Study_____
96-4080
Page 28 Draft Final Report
Group 1 - 0 ppm
Cumulative Exposure Record Chamber Monitoring Results
Appendix X
Week 37
38
39
Dale
16-Scp-97 17-Scp-97 18-Sep-97 19-Sep-97 20-Sep-97 21-Sep-97 22-Sep-97 23-Sep-97 24-Sep-97 25-Sep-97 26-Sep-97 27-Sep-97 28-Sep-97 29-Sep-97 30-Sep-97 1-Oct-97 2-Oct-97 3-Oct-97
Eiposure Number
218 219 220 221 222 223 224 225 226 227 228 229 230 231 232 233 234 235
Mean (ppm)
0.0 00/0.0
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 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 0.0 0.0 0.0 0.0
0.0 0.0 0.0 0.0
Mlran <IR)* Individual (ppm)
0.0 0.0 0.0/0.0 00/0.0
0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 00 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 00 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 00/0.0
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 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 00 0.0 0.0 0.0 0.0
0.0 0.0 0.0 0.0
0.0 00/0.0
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 0.0 0.0 0.0
Panicle Size
Determinations
MMAD GSD TMC
(pm)
(mg/m3)
1.014 3.81 2.01E-03
1.573 1.90 6.13E-04
1.605 1.77 4.85E-04
Chamber Environment
Mean
Temnerature Humidity
CC) 23 23 23 24
<*) 59 62 64 64
24 69 24 50
21 47
21 54
20 50
20 48
21 55
20 49
21 55
23 66
22 58
20 56
20 49
25 48
BFG 003222
Mean: SD:
0.00 1
0.00
0.036 0.197
2.1 2.0 4.6E-03 1.8 - 7.7E-03
22 1.6
55 11
Huntingdon Life Sciences Reproduction Study
96-4080
Page 29 Draft finaL Report
Group 11-10 ppm
Cumulative Exposure Record Chamber Monitoring Results
Week 1 2 3 4
Date
7-Jan-97 8-Jan-97 9-Jan-97 10-Jan-97 13-Jan-97 14-Jan-97 15-Jan-97 16-ian-97 17-Jan-97 20*Jan*97 21-Jan-97 22-Jan-97 23-Jan-97 24-Jan-97 27-Jan-97 28-Jan-97 29-Jan-97 30-Jan-97 31-Jan-97 3*Feb-97
Exposure
Number Nominal (ppm)
1 9.8 2 9.8 3 9.8 4 9.8 5 9.8 6 9.8 7 9.8 8 9.8 9 9.4 10 9.8 11 9.7 12 9.8 13 98 14 9.8 15 9.8
16 9.8 17 9.8 18 9.8 19 9.8 20 9.8
Mean (ppm)
10 97 9.5/14 10 10 9.7 10 10 9.5/7.6 10 12 12 11/14 11 10
11 11 11/12 11 11
Chamber Concentration
11 9.2 9.4 b 9.3 10 9.3 11 9.6 7.2/0.95* 11 12 10 12/14 11 8.8
10 11 11/11 11 9.6
Mlran (IR)a
Individual
(ppm)
11 11 9.9
9.8 9.7
11
9.3/14
9.2/13
9.7/14
9.9 9.4
11
10 10 10
9.9 10
10
9.9 10
10
11 10 10
8.0/2.7* 11/2.9*
11/13
11 9.7 10
11 12 10
14 11
d
11/14
11/14
11/13
11 11 11
11 11 10
11 11 11
11 11 10
12/13
11/13
11/13
11 11 11
12 n II
9.1 9.0 10/13 II 10 9.6 10 10 10/12 10 13 d 11/13 11 11
H 10 11/10 11 11
Appendix X
8.2 9.4 9,2/14 10 11 9.6 10 10 10/14 11 12 d 11/13 11 11
n 10 10/12 u li
Particle Size
Chamber Environment
Determinations
MMAD OSD TMC
(pm)
(mg/m3)
1.755 1.887 2.21E-04
2.152 2.555 1.29E-03
1.654 2.049 1.31E-03
Mean Temperature Humidity
TO (%)
21 42 22 42 22 42 22 42 22 42 22 42 22 42 22 42 22 42 22 33 24 33 22 41 25 42 25 35 24 36
1.616 1.647 1.72E-04
24 25 24 27 25
45 35 35 29 38
BFG 003223
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11 41 10 38 12/1 32 1 2 44 11 35 12 10 1 2 /1 11 11
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| oo go oo oo oc 90 00 00 00 00 00
ooo
lS O'* O' O' O' Ov s O' O' O' O' fl\ Oi "
-
2 9
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- n w <r ^ s
oo o' o " N m v m so r** oo Os o
(N <S (S fS (N fN IN (N N n n
tn t*> r~>
r- r- r- r- r- r- r~ r- r- f" r- r~ r- r- r-
ffi ffi o\ o< ^ J> A J> J> -6
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t* Cl. U. Uh U. Urn b. u. u. u. u. u, h. b. u. ^
v o r*
-- <N fn rr r*
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r- 00
BFG 003224
Huntingdon Life Sciences Reproduction Study
96-4080
Page 31 Draft Final Report
Group II - 10 ppm
Cumulative Exposure Record Chamber Monitoring Results
Appendix X
Week 9 10 11
12
Date
4-Mar-97 5-Mar-97 6-Mar-97 7-Mar-97 10'Mar-97 11 -Mar-97 12-Mot-97 13-Mar-97 14-Mar-97 17-Mar-97 18-Mar-97 19-Mar-97 20-Mar-97 21-Mar-97 22-Mar-97 23-Mar-97 24-Mar-97 25-Mar-97 26-Mar-97 27-Mar-97 28-Mar-97 29-Mar-97 30-Mar-97 31-Mar-97
Exposure Number Nominal
(ppm)
41 10 42 10 43 10 44 9.8 45 9.8
46 9.8 47 9.8 48 9.8 49 9.8 50 9.8 51 9.8 52 9.8 53 9.8 54 9.8 55 9.8 56 9.8 57 9.8
58 9.8 59 9.8 60 9.8
61 9.1
62 8.1 63 7.9 64 8.1
Mean (ppm)
12 12 11 11 11 11 11 11/9.1 11 9.7 10 10 10 (0 10 11 11 12 12 11/10 12 11 9.1 II
12 14 10 11 10
10 10 13/9.1 10 9.1 10
to
8.2 10 II 10 10
n
12 11/9.7
11
14 8.7 12
Chamber Concentration
12 12 11 11 11 11 10 13/8,8 11 9.9 10 10 10 9.9 10 11 8.8
12 12 11/11 12 II
8.9
12
Mi ran (lR)a
Individual
(ppm)
12 12
12 12
11 11
11 II
12 12
11 11
11 II
12/9.2 98/8.6
10 10
10 9.9
10 10
10 10
10 It
10 10
10 10
11 11
10 12
12 12
12 12
11/9.7
12/11
12 13
10 10
9.1 9.2
11 10
12 12 11 11 11 11 II 9.6/9.1 10 9.4 10 9.9 11 10 10 11 12
12 13 12/11 11 10 8.9
10
13 12 11 11 11 11 12 10/9.7 12 10 10 10 10 11 10 11 13
12
13
11/10 11 9.3 9.5 11
Particle Slie
Chamber Environment
Determinations
MMAD GSD TMC
(pm)
(mg/m5)
0.9201 1.428 9.9 IE-03
1.429 1.622 1.28E-03
1.334 1.527 2.52E-03
16.95 2.588 7.27E-03
Mean
(C)
25 25 25 24 24 25 25 25 25 25 25 24 24 24 25 25 23 22 20 21 22 21 21 20
(%) 51 55 45 43 60 56 54 38 41 35 39 40 44 40
46
36 34 60 44 35 38 44 44 54
BFG 003225
BFG 003226
l
cc
3X
iOL. <
SMea U
t- t^-- r^- r* r** ^r~ ^ra tbl tba. tbL. *&1. &ll kaL <.<,<<.<.<.< - N if 1^1 ^ Is
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ll
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Week Date
; 8-Apr-97 1 9-Apr-97
10-Apr-97
-- <N V o e* 00 --
1!. C<L.
bu <.
< <: < <;
k kk k
<: <; <. <
il
CL
1Q!. .
iOi.
il
CL
r*' rC-ft r-~ rO-* rO-' r-s r- r-
Number Nominal (ppm)
65 8.8 66 8.7 67 9.2 68 9.2 69 9.2 70 9.2 71 1 9.2 72 9.2 73 9.2 74 9.2 75 1 9.2 76 | 8.2 77 1 7.8 78 9.2
79 1 9.2 80 I 9.2
81 92
82 9.2 83 9.2 84 8.5 85 10
-- -- O O -- fN
<N 0 C-* 0 0 0 --
Mean (ppm)
12 11
12/12
11
II
9.3
ll
1 11 1 11
l 11/11
1 1! 10
1 9.9 9.9
11 11 12
_^ _
fi <s 0 -- 0 --*
JR
W
NO-O-O-
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uc
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ew
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O
00
0
(N (S (N " - a 0 - in m
12 11
12/12
11
9.6
12
(0
10
II
11
12 11
I 12/12 12
11
8.0
i 11 12
to
9.8 10 10
11 12
-- -- --. Q> ^ Os *+{
11 10 12
to 9.6
10
11 12 11
12/12
11 11
9.3
11
-- -- 0 0 0 -- <-*
11
9.9 12 10 10
10 10 12 12
12/12
11
9.7 9.4
11
2
c tc
1i
a-V5)
TO i0s
Zl
01 01 01 0E
II II
* a. l
<S I5
o^ S St t/1
X
X
`S ca>
o. Cl
<
OSD
12 10 12 10
9.2 9.7 10
II
11
12/12
11
11
9.7 12
I2.57E-03
2.643 1.837
1
1
1
1 |
1.259 1.499 5.91E-04
1.116 1.445 1.21E-03
20
18
19
20
19
20 22 21 20 20 21 21 22 20
21 21 21 21 21 22 21
o
51
48 50 1 50
51 54 54
c
m
Bd
.b4sA<
2
31 Sj
Q
s
Q
c-*-T> 5sT 0f*0N Nn 90 (V*1 Sf'O-. r4 S O^O O' O O
5 5
a4 Se
Huntingdon Life Sciences Reproduction Siudv--------
96-4080
Page 33 Draft Final Report
Group II - 10 ppm
Cumulative Exposure Record Chamber Monitoring Results
Appendix X
Week 16
17
18
Date
22-Apr-97 23-Apr-97 24-Apr-97 25-Apr-97 26-Apr-97 27-Apr-97 28-Apr-97 29-Apr-97 30-Apr-97 1-May-97 2-May-97 3-May-97 4-May-97 5-May-97 6-May-97 7-May-97 8-May-97 9-May-97 IO-May-97 11-May-97 12-May-97
Exposure
Number Nominal (ppm)
86 9.8 87 9.8 88 9.6 89 9.6 90 10 91 10 92 9.5 93 9.8 94 9.6 95 9.5 96 9.5 97 9.5 98 9.5 99 9.5 100 9.6 101 9.1 102 9.1 103 9.4 104 10 105 10 106 9.1
Mean (ppm)
12 11 12/10 12 II 9.9 12 11 11 11 11 11 11 10
12 10 11/12 11 11 11 11
11 II I2/II 11 11 10 12
11 11 13 11 11 11 11 12 10 11/12 11 11 11 11
Chamber Concentration
12 12 12/11 12 11 9.7 13 II 11 11 12 12 12 10 12 11 10/12 12 11 10 12
Miran (IK)
Individual
(ppm)
12 12
11 11
12/11
11/9.4
12 12
11 12
10 9,6
13 12
n 10
10 11
ii II
u 10
n 12
12 9.8
10 10
12 12
10 10
10/U
11/12
12 11
10 11
11 I!
11 10
II 11 11/9.4 12 11 10 11 10 U 11 It 11 11 11
11 10 11/12 II 11 10 11
II II 11/9.9 II 12 10 II 10 11 11 10 11 11 10
It 10 11/12 11 12 10 11
Particle Size
Chamber Environment
Determinations
MMAD GSD TMC
(pm)
(mg/m3)
0.775 1.710 7.88E-03
Mean
Temperature Humiditv
m
<%)
22 43
20 42
20 41
20 41
20 40 20 45 22 59
1.241 2.12 2.07E-03 1.862 2.75 8.26E-04
23 23 24 23 24 23 21 20 20 20 20 21 21 22
43 44 49 35 53 42 34 49 30 32 48 43 40 42
B FG 003227
Huntingdon Life Sciences Reproduction Study
96-4080
Page 34 Draft Final Report
Group 11-10 ppm
Cumulative Exposure Record Chamber Monitoring Results
Appendix X
Week Date Exposure
Number Nominal
(ppm)
19 l3-Mav-97 107
9.1
!4-May-97 15-May-97
108 109
8.8 8.7
!6-May-97 no
9.1
17-Mav-97 111
9.5
l8-May-97 112
9.5
19-May-97 113
9,1
20 20-May-97 114
9.1
21-May-97 115
9.1
22-May-97 116
8.8
23-May-97 117
8.5
26-May-97 118
8.9
21 27-May-97 119
8.5
28-May-97 120
8.5
29-Mav-97 121
8.5
30-May-97 122
8.5
2-Jun-97
123
8.5
22 3-Jun-97
124
8.5
4-Jun-97
125
8.5
5-Jun-97
126
8.5
6-Jun-97
127
8.5
9-Jun-97
128
8.5
Mean (ppm)
11 11 12 11 11 10 11 11 11 12/11 11 11 11 10 9.8 I! 11
12/10 to 10 10 11
11 12 11 12 n u n 10 ii 11/12 10 9.7
10 10 9.5 10 11 12/10 10 10 10 11
Chamber Concentration
11 11 12 11 10 10 11 II II 12/12 II II 11 11 10 It 10
12/9.8 10 10 11 11
Miran (IR)
Individual
(ppm)
12 II
11 12
11 12
11 11
10 11
10 8.0
12 11
11 10
11 12
12/12
11/10
11 10
11 11
II 10
10 10
10 10
II 11
II 12
12/11 10
M/9.4 10
10 10
10 9.4
12 11
II 11 12 11 10 11 12 11 M 11/11 11 12 11 10 10 It 11 12/9.6 9.7 to 10 12
II 11 12 10 11 9.9 11 10 11 12/11 10 12 10 10 9.3 10 11
12/10 10 10 10 II
Particle She
Chamber Environment
Determinations
MMAD OSD TMC
(pm)
(mg/m3)
11.024 5.27 7.38E-03
Mean
Temperature Humidity CC) (%) 22 43 21 45 20 47 22 39 22 40 22 38 23 54
1.397 1.83 4.17E-04
20 21 20 21 f
54 40 37 39 56
1.458 1.84 8.12E-04
21 21 20 20 21
43 48 47 54 61
1.250 2.01 8.61E-04
21 21 20 19 21
55 46 49 50 55
BFG 003228
Huntingdon Life Sciences Reproduction Study
96-4080
Page 35 Draft Final Report
Group 11-10 ppm
Cumulative Exposure Record Chamber Monitoring Results
Appendix X
Week 23 24 25 26
Date
IO-Jun-97 11 -Jun-97 12-Jun-97 H-Jun-97 !6-Jun-97 17-Jun-97 18-Jun-97 19-Jun-97 20-Jun-97 23-Jun-97 24-Jun-97 25-Jun-97 26-Jun-97 27-Jun-97 30-Jun-97 l-Jul-97 2-Jul-97 3-Jul-97 4-Jul-97 7-Jul-97
Exposure Number Nominal
(ppm) 129 8.5 130 8.5 131 8.5 132 8.5 133 8.5 134 8.5 135 8.5 136 8.5 137 8.5 138 8 5 139 8.5 140 8.5 141 8.5 142 8.5 143 8.5 144 8.5 145 8.5 146 8.5 147 8.9 148 8.5
Mean (ppm)
12 10 10 10 11
12/11 11 10 11 10 10 9.7 10 9.9 9.7 10
10/11 11 9.8 10
10 10 10 10 10
11/10 10 12 11 10 10 9.8 9.8 9.7 8.6
10 10/10
10 9.7 8.9
Chamber Concentration
Miran (IR)1 Individual (ppm)
12 12 12 11 10 10 11 11 10 11 10 10 11 11 II
11/9.9 II 10 II 10
ll/ll 11 9.7 10 10
12/11 11 10 11 9.9
II 10 10 10 10 10 10 10 10 10 9.9 10 10 10 10
10 11/11
11 10 10
10 10/11
10 9.2 10
11 11/11
10 to 10
]] 10 10 10 II
12/11 II 10 11 11 10 8.2 10 10 10 10
10/10 11 10 10
12 10 10 11 10
12/11 II 10 11 10 10 10 10 9.5 9.7 10
10/12 11 10 11
Particle Size
Chamber Environment
Determinations
MMAD GSD TMC
(pm)
(mg/m5)
1.089 2.16 I.60E-03
1.028 1.67 9.70E-03
0.668 1.34 5.51E-03
1.227 1.74 1.09E-03
Mean Temperature Humiditv
(C) (%) 21 54 23 52 21 56 21 56 21 50
20 56 21 56 2) 60 21 56 22 56 22 61 22 64 23 67 21 62 22 60 23 60 22 64 21 75 21 60 22 60
BFG 003229
Huntingdon Life Sciences Reproduction Study_____
96-4080
Page 36 Draft Final Report
Group 11-10 ppm
Cumulative Exposure Record Chamber Monitorina Results
Appendix X
Week 27 28 29 30
Date
8-Ju)-97 9-Jul-97 10-Jul-97 ll-Jul-97 14-Jul-97 15-Jul-97 16-Jul-97 17-Jul-97 18-Jul-97 2I-M-97 22-Jul-97 23-JuI-97 24-Jul-97 25-Jul-97 28-Jul-97 29-JuI-97 30-Jul-97 3!-Jul-97 1-Aug-97 2-Aug-97 3-Aug-97 4-Aug-97
Exposure Number Nominal
(ppm) 149 8.5 150 8.9 151 8.9 152 8.9 153 8.9 154 8.9 155 8.9 156 8.9 157 8.9 158 8.9 159 8.9 160 8.9 161 8.9 162 8.9 163 8.9 164 8.5 165 8.5 166 8.5 167 8.5 168 8.9 169 8.9 170 8.9
Mean (ppm)
10 11 10 10 9.8 10 10/8.9 9.9 10 9.8
10 to 10 10 9.6
10 10 9.8 98/9.9 9.9 9.7 10
10 10 11 10 80 10 10/8.4 9.6 9.6 8.6 10 9.6 10 8.8 8.8 10 10 10 9.7/10 8.4 8.5 10
Chamber Concentration
Miran (>*
Individual
(ppm)
10 10 10
11 11 11
11 10 10
10 10 II
11 10 10
10 10 10
10/8.9
10/9.6
10/8.7
10 10 9.7
10 10 10
10 10 10
10 10 10
II 10 10
10 10 10
10 10 11
9.5 9.4
10
10 9.9 10
10 10 10
10 10 10
96/9.7
10/10
10/10
11 10 10
9.5 10 10
10 10 10
II 11 10 11 10
11 10/9.3
10 11 10
10 10 10 10 9.7
9.8 10 9.4 10/10 10 10 10
10 10 10 10 10
10 9.8/8.4
10 10 10
10 10 9.8 10 10
10 10 9.3 9.6Z9.5 10 10 10
Particle Size
Chamber Environment
Determinations
MMAD GSD TMC
(pm)
(mg/m3)
0.718 1.22 1.61E-02
Mean
TgmEsrehgs Humidity ro (%) 25 67 26 68 23 68 25 63 26 70
0.662 1.95 2.31E-02
23 22 22 20 21
70 76 70 68 73
1.147 1.61 7.31E-04
21 21 20 20 21
74 72 70 71 61
1.678 2.17 5.47E-04
20 23 24 21 21 22 22
55 47 54 56 61 61 63
003230
a
CO
a>
CO
ooaacs
-a
a Q
X
c a.
Q.
<
"O B] o 4g 83
OC
O CoO <)
g 0o9 c. UQXi. cc
a
'C i53 E3 U <-
to
cu <n^
M
*c -tSt cS -S51 c3 _
X cc
a. Q.
O
a o3 a
Particle Size
Chamber Environment
Mean Temnerahire Humidity
21 60
1.393 2.24 7.54E-04 22 62 21 64 21 63 21 68
21 72
21 65
c <o <o >o r- v
21
21
22
21
2!
0.767 22
21
uo
(mg/m3)
M M AD GSD TMC
s .c 15
oi
1
e 1
r** .c
1 <0
(pm)
rs 0 0 5^;"^ ---- ffs o O'
I
-- 0 0 0 300 --
04 3 ~ P*; '> , *'1 --
10 10 10 10 10 10 10
to
10 10 10 7.1 9.7 10
10 10 9.4 10/10 9.9 9.6 9.4
10 10
to 9.0
12 9.7 10 9.4
10 10
10 10
9.4 10 10 (0
1) 10 10
torn
9.9 10 9.7
10
J
|
w
cC
8s s
<2 I
jua<0
E
Individual (ppm)
10
10
10
10
01
98
01 01 01 01 01
00-000 0
10
11
11 11
to
10/11 10 9.7 9.0
to
10 10 10 10 9.5 9.8 10
OOOO^.f".-- ^ r*:
o -- ooo
- - O' "* ? 30 " -- -- -- <3 O' --
Exposure Number
BO
I 8.
sa
-o
^
-- -- O' O'
O'
!I
*-i Vi v*i
O' */>
06 06 60 CO 00 09 0Q
zw
IS> Vk */ WV O' O' V"l ao ao ed oe ac go ee
p6-
oO>'
O
w
Nss
W
oe
'T
r-- t-- r-~ r-~ r~- c~ t~- r- St. t-t-'.r'.r-r-r-
^ ^ ^ ^ O' 1
5oo
3
o> 3
ac
55
aco
do 3
SP
<<<<<>
32 } 5
O'
OC 3
5
v> \o r oc O' " .. P4
O' O'
O' O'
O' S' O'
9> C>
O0 06 OD 0006 W >aoat>o0eoeflcococo
S 3 S 3 3 3 3^333333
<. <. < <. <: <: *:<<:<<<<:
f*1 4T
-P' 00 O' os o
<s fn v wi
Date
185 ; 8.5 9.9 185 ; 8.9 10 186 ; 8.5 10 187 i 8.5 10 188 8.5 10 189 1 8,9 9.2 190 8.9 10
191 i 85 9.9
171 to
172 10 i 173 10 | 174 10 1 175 10 ! 176 9 . 7 1 177 10 32
Week
BFG 003231
22 56 23 54
22 68 22 73 20 70 22 65
22 61
22 66
Huntingdon Life Sciences Reproduction Study_____
96-4080
Page 38 Prgft Final Report
Group 11-10 ppm
Cumulative Exposure Record Chamber Monitoring Results
Appendix X
Week 34
35
36
Date
26-Aug-97 27-Aug-97 28-Aug-97 29-Aug-97 30-Aug-97 3 l-Aug-97
1-Sep-97 2-Sep-97 3-Sep-97 4-Sep-97 5-Sep-97 6-Sep-97 7-Sep-97 8-Scp-97 9-Sep-97 10-Sep-97 11-Sep-97 12-Sep-97 13-Sep-97 14-Sep-97 !5-Sep-97
Exposure
Number Nominal (ppm)
192 8.5 193 8.5 194 8.5 195 8.5 196 8.9 197 8.9 198 8.9 199 8.5 200 8.5 201 8.5 202 8.5 203 8.3 204 8,2 205 8.5
206 8.5 207 8.5 208 8.5 209 8.5 210 8.9 211 8.9 212 8.5
Mean (ppm)
10 10 10 9.9 10 10 10 9.9 10/9.8 9.9 10 10 9.6 10 10 9.8 10 10 9.9 10 10
10 10 9.7 10 10 10 11 10 10/9.7 9.6 10 12 9.7 10
10 10 10 10 9.4 10 10
Chamber Concentration
10 10 10 10 10 10 11 10 10/9.6 10 10 11 9.8 11 II 10 10 11 10 10 10
Miran (IR)
Individual
(ppm)
10 10
10 10
10 10
10 10
10 10 9.8 10 10 12
10 9.5
10/9.9
10/10
10 10 10 10
9.4 11
8.7 9.4
9.0 10
10 10
8.9 10
10 10
10 10
10 10
10 11
10 10
10 10 10 9.5 10 to 9.1 10 10/10 10 10 9.1 11 10
10 10 10 11 10 9.6 10
10 10 10 10 10 10 9.8 10 10/9.7 10 10 7.6 8.8 10 10 10 11 10 10 10 10
Particle Size
Chamber Environment
Determinations
MMAD GSD TMC
(pm)
(mg/m3)
0.776 2.11 2.70E-03
1.551 2.48 6.25E-04
0.796 1.34 6.98E-03
Mean
ISiPRgstMS Humiditv (C) (%) 21 69 22 69 23 79 22 71 21 71 21 72 22 73 21 76 21 60 21 52 21 58 22 65 22 71 22 68
23 67 22 66 23 76 23 74 22 67 22 61 22 61
BFG 003232
Huntingdon Life Sciences Reproduction Study_____
96-4080
Page 39 Draft Final Report
Group 11-10 ppm
Cumulative Exposure Record Chamber Monitoring Results
Appendix X
Week 37
38
39
Date
16-Sep-97 l7-Sep-97 18-Sep-97 19-Sep-97 20-Sep-97 21-Sep-97 22-Sep-97 23-Sep-97 24-Sep-97 25-Sep-97 26-Sep-97 27-Sep-97 28-Sep-97 29-Sep-97 30-Sep-97 1 -Oct-97 2-Oct-97 3-Oct-97
Exposure Number Nominal
(ppm) 218 8.5 219 8.5 220 8.5 221 8.5 222 8.9 223 8.9 224 8.5 225 8.5 226 8.5 227 8.5 228 8.9 229 8.9 230 8.9 231 8.5 232 8.5 233 8.9 234 8.9 235 9.1
Mean (ppm)
10 10/8.7
9,9 99 9.3 9.4 10 9.8 9.9 9.9 10 10 10 10 10 10 10 10
10 10/7.4
9.6 9.3 92 9.6 10
9.6 9.2 10 10 10 9.7 10 10 10 9.8 10
Chamber Concentration
10 10/8.9
10 9.8 9.5 9.0 10 10 10 10 10 11 9.3 10
10 10 10 10
Mlran (tR)* Individual (ppm)
10 10 10/9.1 9.6/9.2
10 10 10 10 9.8 8.5 9.3 9.4 10 10 10 9.3 10 10 10 10 10 10 9.4 9.4 11 11 10 10 10 10 10 10 10 11 10 9.9
10 11/8.5
10 10 9.2 9.7 10 10 10 10 10 It 10 10 10 10 11 10
10 10/8.8
10 10 9.5 9.4 10 10 10 9.6 10 10 9.3 10 10 10 10 10
Particle Size
Chamber Environment
Determinations
MMAD GSD TMC
(pm)
(mg/m5)
0.870 1.71 2.27E-03
1.918 2.10 6.70E-04
Mean
Temperature Humidity
re)
(V.)
21 62 22 63
22 64 23 67
22 72
22 51 20 43
20 57
19 43
18 47
20 59
19 49
20 57
22 65
1.622 1.98 5.36E-04
21 19 19 23
58 54 45 51
BFG 003233
Mean: SD:
9.08 0.58
10.5 1 0.85
10.9 i 2.2
2.0 1.9 4.0E-03 3.0 - 5.8E-03
22 1.8
52 12
Huntingdon Life Sciences Reproduction Study
96-4080
Page 40 Draft Final Report
Group III - 100 ppm
Cumulative Exposure Record Chamber Monitoring Results
Appendix X
Week I 2 3 4
Date
7-Jan-97 8-Jan-97 9-Jan-97 l0-Jan-97 13*Jan-97 14-Jan-97 15-Jan-97 16-Jan-97 l7-Jan-97 20-Jan-97 21-Jan-97 22-Jan-97 23-Jan-97 24-Jan-97 27-Jan-97 28-Jan-97 29-Jan-97 30-Jan-97 3l-Jan-97 3-Feb-97
Exposure
Number Nominal (ppm) 94
2 94 3 94 4 94 5 94 6 94 7 94 8 94 9 95 10 94 11 94 12 94 13 94 14 94 15 94 16 94 17 94 18 94 19 94 20 94
Mean (ppm)
97 100 99/110 98 110 110 98 96 100/63 100 110 110 110/100 99 100
99 100 110/130 100 too
Chamber Concentration
Miran (IR' a
Individual
(ppm)
95 95 100 96
99 110 100 no 99 96/110 100/110 100/110
97 97 99 95
110 110 no 97
no 100 100 no
93 94 93 no
94 93 96 96
110/50* 90/90* 110/93* 93/0.0*
100 100 no no
100 110 no 100
110 no no
d
110/120 100/75* 100/65* 110/120
100 98 100 99
100 100 100 100
100 100 100 97
100 100 100 100
110/140 100/120 110/130 110/130
110 100 100 100
100 100 no 100
Particle Size
Chamber Environment
94 100 100/110 too 100
no 100 98 100/37* 100 no 100 110/120 100 100 100 99 110/130 100 100
100 100 100/120 100 no no 100 96 100/110 100 no 100 110/120 98 100 98 110 100/130 100 100
Determinations
MMAD GSD TMC
(Mm)
(mg/m3)
7.015 2.056 1.06E-03
3.727 2.495 1.94E-03
1.356 1.487 1.48E-03
3.273 1.856 4.27E-04
Mean
Temoerature Humiditv <C) <%) 21 40 20 40 20 41 21 42 22 48 23 40 22 39 23 57 22 40 22 40 20 39 21 43 20 46 20 44 20 42 20 47 21 44 20 45 20 44 21 44
BFG 003234
Huntingdon Life Sciences Reproduction Study_____
96-4080
Page 41 Draft Final Report
Group III - 100 ppm
Cumulative Exposure Record Chamber Monitoring Results
Appendix X
Week 5 6 7 8
Date
4-Feb-97 S-Feb-97 6-Feb-97 7-Feb-97 IO-Fcb-97 11 -Feb-97 l2-Feb-97 13-Feb-97 I4-Feb-97 17-Feb-97 I8-Feb-97 19-Feb-97 20-Feb-97 21-Feb-97 24-Feb-97 25-Feb-97 26-Feb-97 27-Feb-97 28-Feb-97 3-Mar-97
Exposure
Number Nominal (ppm)
21 91 22 94 23 94 24 94 25 94
26 94 27 94 28 94 29 94 30 94
31 94 32 97 33 100 34 100 35 100 36 100 37 100 38 100 39 100 40 100
Mean
(ppm)
98 100
110
MO
100
100 100
100/120 100 100
no no no ioo
100
100
100
110/130 100
no
Chamber Concentration
Minin (IR)
individual
(ppm)
100 97 100 100
93 100 100 no 110 no 100 too 98 no 120 120
98 100 99 100
100 100 100 100
95 100 100 100
99/(20 95
100/120 100/120 100/120
96 97 no
96 99 100 100
no no no no
100 110 100 110
no no 100 100
no 100 100 100 no 100 100 100
100 100 100 100
100 100 no no
110/130 110/130 110/130 100/130
98 100 100 100
110 no no no
83
110
MO
110
no too
110
110/120
no
100
120
no no
100
100
no
100
110/130
no
110
Particle Size
Chamber Environment
no no
100
no no no no
100/120
no no no no no
100
no
Determinations
MMAD OSD TMC
(pm) 5.493 1.849 5.93E-04
1.349 2.187 2.55E-03
7.082 2.603 1.29E-03
Mean Temperature Humidity
CO {%)
21 44 22 45 20 46 20 46 20 46 20 48 20 41 19 41 20 42 19 41 20 42 21 50 20 44 20 44 20 41
100
100 100/130
100
no
0.9237 1.493 3.84E-03
20 20 23 21 20
40 45 53 45 40
BFG 003235
Huntingdon Life Sciences Reproduction Study
96-4080
Page 42 Draft Final Report
Group III - 100 ppm
Cumulative Exposure Record Chamber Monitoring Results
Appendix X
Week 9 10
n
12
Date
4-Mar-97 5-Mar-97 6-Mar-97 7-Mar-97 10-Mar-97 11-Mar-97 12-Mar-97 13-Mar-97 14-Mar-97 17-Mar-97 !8-Mar-97 19-Mar-97 20-Mar-97 21-Mar-97 22-Mar-97 23-Mar-97 24-Mar-97 25-Mar-97 26-Mar-97 27-Mar-97 28-Mar-97 29-Mar-97 30-Mar-97 31-Mar-97
Exposure
Number Nominal (ppm)
41 100 42 100 43 100 44 100 45 100
46 100 47 100 48 100 49 100 50 100 51 100 52 100 53 100 54 100 55 100 56 100 57 100
58 too
59 100
60 too 61 100
62 100 63 100 64 100
Mean (ppm)
100 100 99 100 100 100 100 98/95 100 100 100 99 97
no
100 100 99 100
no
110/100 100 100 98 99
Chamber Concentration
Miran (IR)ft
Individual
(ppm)
97 98 no no no 99 100 100
99 98 100 99
100 100 100 98
100 100 100 100
110 no 100 100 no 100 100 99
100/91
92/92
98/93 100/100
100 100 100 100
no 100 no 100
no 100 no 100
100 99
98 100
93 100 100 96
110 92 100 no
100 100 100 98
92 100 95 100
100 96 100 100
100
100
no/ito 100
100
98
99
100 100 110/110 100
no
95 99
100
no n o/ioo
100
100
100 100
100
no
100/100 99 100 100 100
100 100 99 100 100
100 100 100/96 100 100 100 98 97
no
100 100 99
100
no
100/100 100 100 95 95
Particle Size
Chamber Environment
100 100 97 100 98
99 100 100/99 98 100
100 100 98
no
100
no
100
no
100 110/100
100 100 100 100
Determinations
MMAD OSD TMC
(pm)
(mg/m3)
0.9302 1.549 1.07E-02
1.396 1.560 1.72E-03
1 240 1.582 3.41E-03
0.9995 1.639 1.11E-03
Mean Temperature Humiditv
co (%)
21 44 20 46 21 45 21 44 21 57
22 57 21 56 21 58 21 56 20 53 21 53 20 53 20 53 21 53 22 53 20 54 22 44
22 46 22 45 23 46 24 46 23 46 24 45 21 56
BFG 003236
Huntingdon Life Sciences Reproduction Study
96-4080
Page 43 Draft Final Report
Group Id - 100 ppm
Cumulative Exposure Record Chamber Monitoring Results
Appendix X
Week
n
14
15
Date
1 -Apr*97 2-Apr-97 3~Apr-97 4-Apr-97 5-Apr*97 6-Apr-97 7-Apr-97 8-Apr-97 9-Apr-97 10-Apt-97 11-Apr-97 12-Apr-97 13-Apr-97 14-Apr-97 15-Apr-97 16-Apr-97 17-Apr-97 18-Apr-97 19-Apr-97 20-Apr-97 21-Apr-97
Exposure Number Nominal
(ppm) 65 100 66 100 67 100 68 100 69 100 70 100 71 96 72 97 73 100 74 100 75 100 76 100 77 100 78 100 79 100 80 100 81 100 82 100 83 100 84 100 85 100
Mean (ppm)
100 98 99 100 100 97 110
120 98
no/iio
100 110
no
100
99 100 100 98 100 100
no
Chamber Concentration Mlran (IR]
Individual
(ppm)
100 100 100 100
97 100 98 100
100 98
97 100
100 100 too 100
98 110 no 99
96 100 94 100
85 100 130 130
150 84
87 92
68 70 120 no
110/120
100
no
120
110/120
no no no
110/110
no no no
110/110
97
no
100
100 100 100 100
99 97 too 96 100 no 98 no 99 no no 100
92 99 100 100
99 98 no 110 96 95 100 no
110 no no 120
99 97 100 98 95 94 100
140
no
110/110
100
no
100 110
100
no no
99 110 100 96
Particle Size
Chamber Environment
Determinations
Mean
99 98 100 100 91 99 95
140
no
100/110 100 100
no
100
100 100
100 100 100
no
97
MMAD OSD TMC
(pm)
(mg/m1)
3.122 1.875 8.66E-03
1.314 1.394 6.10E-04
1.453 2.059 1.67E-03
Temoerature
ec) 20 19 19 20 20 22 23 21 20 20 20 20 22 20
20 20 21 21 21 22 22
Humidity (%) 56 60 56 56 57 57 65 61 52 52 52 57 62 32
33 36 37 36 34 34 34
BFG 003237
Huntingdon Life Sciences Reproduction Study_____
96-4080
Page 44 Draft Final Report
Group III - 100 ppm
Cumulative Exposure Record Chamber Monitoring Results
Appendix X
Week 16
17
18
Date
22-Apr-97 23-Apr-97 24-Apr-97 25-Apr-97 26-Apr-97 27-Apr-97 28-Apr-97 29-Apr-97 30-Apr-97 1-May-97 2-May-97 3-May-97 4-May-97 5-May-97 6-May-97 7-May-97 8-May-97 9-May-97 I0-May-97 11-May-97 12-May-97
Exposure
Number Nominal (ppm)
86 100 87 100 88 100 89 100 90 100 91 100 92 100 93 100 94 100 95 100 96 100 97 100 98 100 99 100 100 100 101 97 102 94 103 98 104 100 105 100 106 95
Mean (ppm)
100 110 100/94 110 no 100 no no no 100 100 100 100 no no 120 no/no 100 100 99 no
Chamber Concentration Miran (IR] a
Individual
(ppm) 100 no 110 98 110 no no 100 100/91 100/94 110/94 100/91 no 100 no no no no no no no 100 100 100 no no no 110 no no 100 no no 120 no 120 no no 100 110 100 100 99 100 too 100 97 100 no 100 100 100 100 100 HO 100 no 120 120 no 120 120 120 120 no/no 110/110 120/110 no/no no no 91 no 100 100 100 100 97 99 100 100 120 no 100 100
100 100 110/96 no 100 100 97
100 no 100 100 100 100 no
no no 100/100
too
100 98 no
Particle Size
Chamber Environment
Determinations
MMAD GSD TMC
(pm)
(mg/m3)
3 8I
Mean Humidity (%)
no 100 100/95 no no 100 no no no 96 100 100 97 no no no 100/100 100 100 98 no
0.805 1.840 8.70E-03 1.485 3.38 2.09E-03 1.698 2.71 6.93E-04
22 20 20 20 20 20 22 22 23 23 22 23 23 22
22 21 22 22 22 22 21
36 37 37 36 35 34 51 46 46 49 44 48 46 37
46 37 39 45 44
41 46
BFG 003238
Huntingdon Life Sciences Reproduction Study
96-4080
Page 45 Draft Final Report
Group III - 100 ppm
Cumulative Exposure Record Chamber Monitoring Results
Appendix X
Week Date
19 13-May-97 l4-May-97 15-May-97 16-May~97 17-May-97 18-May-97 19-May-97
20 20-May-97 21-May-97 22-May-97 23-Mey-97 26-May-97
21 27-May-97 28-May-97 29-May-97 30-May-97 2-Jun-97
22 3-Jun-97 4-Jun-97 5-Jun-97 6-Jun-97 9-Jun-97
Exposure
Number Nominal (ppm)
107 94 108 92 109 100 no 100 111 96 112 96 m 100 114 100 ns 100 116 100 117 94 118 100 119 94 120 94 121 94 122 94 123 94 124 94 125 94 126 94 127 94 128 94
Mean (ppm)
100 110 120 110 98 92 100 100
no
110/110 no 100 100 100 110 99 too
100/95 no 99 99 100
Chamber Concentration Mlran (IR)
Individual
(ppm)
no 100 100 100
no no 110 120
no 120 no no
no 110 no no
99 98 96 97 91 93 94 90
100 100 100 100
92 100 99 96
no 100 no 110
110/110 no/no 110/110 100/110 no 110 100 no
100 100 100 100
100 98
100 100
100 99 100 no
no no no 110
100 96
100 100
no 99
100 100
100/90 100
95/97 no
100/97 no
100/97 no
94 no 100 100
100 97
100 98
no 100 100 100
100 100 120 MO 98 93 100 no 100 110/110 no 98
100 HO no 100 100 110/97 no 91 100 100
100 MO 120 100 98 90 100 100 100 MO/UO 100 100 100 110 100 100 100 100/92 100 98 100 100
Particle Size
Chamber Environment
Determinations
Mean
MMAD OSD TMC Temnerature Humiditv
(pm)
(mg/m3)
(C)
(%)
20 47
0.873 1.96 1.78E-03
20 20 21 21 21 24
45 48 42 45 43 54
22 56
2.245 2.73 9.53E-04
22 22 22 f
50 48 49 56
1.818 2.48 9.23E-04
21 21 21 20 22
47 46 47 52 56
4.414 3.27 I.72E-03
21 21 21 21 22
53 50 52 52 49
BFG 003239
Huntingdon Life Sciences Reproduction Study_____
96-4060
Page 46 Draft Final Report
Group III - 100 ppm
Cumulative Exposure Record Chamber Monitoring Results
Appendix X
Week 23 24 25 26
Date
10-Jun-97 1 l-Jun-97 12-Jun-97 !3*Jun-97 16-Jun*97 17-Jun-97 18-Jun-97 19-Jun-97 20-Jun-97 23-Jun-97 24-Jun-97 25-Jun-97 26-Jun-97 27-Jun-97 30-Jun-97 l-Jul-97 2-Jul-97 3-Jul-97 4-Jul-97 7-JuI-97
Exposure Number Nominal
(ppm) 129 94 130 94 131 94 132 94 133 94 134 94 135 94 136 94 137 94 138 94 139 94 140 94 141 94 142 94 143 94 144 94 145 94 146 94 147 96 148 94
Mean (ppm)
100 98 100 100 100
100/99 97 100 100 100 100 110 97 99 100
98 110/110
100 96 110
Chamber Concentration
Mi ran (IR)II
Individual
(ppm)
100 100 110 100
100 100 96
98
100 1 10 100 97
100 100 100 110
100 97
100 100
98/98
96/97 100/100 100/100
96 96 97 95
100 99
100 100
110 100 100 100
110 no 100 99 97 100 97 no 110 100 110 no
91 100 100 95
91 96 110 100
100 110 100 100
94 93 89 110
110/110 95/100 100/100 100/110
110 110 no 100
90 95 90 98
110 100 no 110
98 100 110 100 100
98/99 100 100 100 100 110 110 98 100 100
100 110/110
89 100 100
Particle Size
Chamber Environment
no
94 100 100 100
110/100 100 99 100
no
Determinations
MMAD GSD TMC
(pm)
(mg/m3)
1.204 2.33 1.49E-03
0.988 1.58 9.86E-03
Mean Temnerature Humiditv
CC) <%) 23 50 25 49 22 52
22 52
21 49
21 52 21 52 22 53 22 51 25 58
110 100 0.666 1.35 5.99E-03 100 99 100
25 24 25 23 23
60 61 61 59 61
100 100/100
93 100 100
1.263 1.88 1.I9E-03
23 23 23 22 23
61 63 64 63 63
BFG 003240
Huntingdon Life Sciences Reproduction Study_____
96-4080
Page 47 Draft Final Report
Group III - 100 ppm
Cumulative Exposure Record Chamber Monitoring Results
Appendix X
Week Date
27 8-Jul-97 9-Ju!-97 10-Jul-97 II-Jul-97 l4-Jul-97
28 lS-Jul-97 16-Jul-97 I7-Jul-97 18-Jul-97 21-Jul-97
29 22-Jul-97 23-Jul-97 24-Jul-97 25-Jul-97 28-Jul-97
30 29-Jul-97 30-Jul-97 31-Jul-97 1-Aug-97 2-Aug-97 3-Aug-97 4-Aug-97
Exposure
Number Nominal (ppm)
149 94 150 96 151 96 152 96 153 96
154 96 155 96 156 96 157 96 158 96 159 96 160 96 161 96 162 96 163 96 164 94 165 94 166 94 167 94 168 96 169 96 170 96
Mean (ppm)
100 95 97 100 96 90 97/100 95 96 95 98 97 99 99 96
98 110 HO 100/100 94 94 93
Chamber Concentration Miran (IR)A
Individual
(ppm)
100 99
100 100
90 94 99 95
98 99 95 100
100 100 100 100
100 91
100 97
84 89 85 87
98/100 95/100 95/100 97/99
no 98 81 90
96 100 100 100
100 96
100 90
92 100 100 100
100 100 96
92
95 96 100 100
100 94
100 100
95 99 100 94
96 100 100 98
110 110 no 120
no no no no
98/110 99/100 100/100 110/100
91 90 93 93
95 80 97 95
85 86 94 100
99 94 91 100 93
97 100/99
95 91 90 100 95 100 100 96
95 120 no 110/110 98 100 97
Partlcte Size
Chamber Environment
100 100 97 100 93 98 98/100 94 91 93 98 97 too 97 94 100 no 98 100/100 98 99 96
Determinations
MMAD GSD TMC
(pm)
(mg/m3)
0.705 1.17 1.50E-02
0.675 2.97 2.47E-02
1.127 1.57 5.82E-04
1.411 1.74 4.76E-04
Mean Temperature Humidity
(C) (%) 24 65 25 64 23 63 24 62 26 64 23 65 23 68 22 65 20 63 22 66 20 68 21 66 20 65 21 67 22 64 21 63 24 58 25 60 22 63 22 66 22 67 21 62
BTG 003241
Huntingdon Life Sciences Reproduction Study __
96-4080
Page 48 Draft Final Report
Group III - 100 ppm
Cumulative Exposure Record Chamber Monitoring Results
Appendix X
Week 31
32
33
Date Exposure
Number Nominal (ppm)
5-Aug-97
I7J
94
6-Aug-97
172
94
7-Aug'97
173
94
8-Aug-97
174
94
9-Aug-97 l0-Aug-97 11-Aug-97
175 176 177
96 96 94
12-Aug-97 13-Aug-97 M-Aug-97 15-Aug-97 16-Aug-97
178 179 180 181 182
94 94 94 94 96
17-Aug-97 18-Aug-97
183 184
96 94
19-Aug-97 19-Aug-97B
185 185
94 96
20-Aug-97 21-Aug-97
186 187
94 94
22-Aug-97 188
94
23-Aug-97 24-Aug-97
189 190
99 99
25-Aug-97
191
94
Mean (ppm)
100 100 no 100 97 97 100 100 100 100 100/100 88 88 100 no 99
99 no 100 95 92 100
Chamber Concentration Mlran (IR]
Individual
(ppm)
100 100 too 100
100 100 100 100 no no 100 100 100 100 100 100
91 95 95 98 96 96 98 94 83 100 100 100
100 100 100 100 no 100 100 100 110 110 100 100
100/110 90 83
100/100 91 87
99/100 86 89
98/100 86 90
130 93 98 95
120 120 no 110 100 100 100 94
95 100 100 100 no 110 no 110 no 100 100 too
91 87 99 95
89 94 89 97 100 100 100 110
100 100 110 100 100 99 no 100 100 100 100/100 90 88 100 100
100 100 100 100 90 no
Particle Size
Chamber Environment
100 100 no 100 100 99 110 100 no 100 110/100 87 91 110 too -
Determinations
MMAD GSD TMC
(pm)
(mg/m3)
1.528 1.99 8.36E-04
0.754 1.25 2.20E-02
Mean
Temperature Humiditv (C) (%)
22 60 22 63 22 63 21 61 22 64 22 66 22 64 22 62 22 66 22 63 22 62 23 67 22 65 21 63 21 67 23 62
100 h h h 100 100 98 92 100
23 67 22 68 21 68 23 65 23 64 23 69
BFG 003242
Huntingdon Life Sciences Reproduction Study
96-4080
Page 49 Draft Final Report
Group III - 100 ppm
Cumulative Exposure Record Chamber Monitoring Results
Appendix X
Week 34
35
36
Date
26-Aug-97 27-Aug-97 28-Aug-97 29-Aug-97 30-Aug-97 31-Aug-97 1-Sep-97 2-Sep-97 3-Sep-97 4-Sep-97 5-Sep-97 6-Sep-97 7-Sep-97 8-Scp-97 9-Sep-97 IO-Sep-97 11 -Scp-97 !2-Sep-97 13-Sep-97 !4-Sep-97 !5-Sep-97
Exposure Number Nominal
(ppm) 192 94 193 94 194 94 195 94 196 96 197 96 198 96 199 94 200 94 201 94 202 94 203 96 204 96 205 94
206 94 207 94 208 94 209 94 210 96 211 96 212 94
Mean (ppm)
100 100 110 100 93 100 96 100 100/110
no
100 97 100 97
100 100 110 100 99 96 100
Chamber Concentration Miran (tR)
Individual
(ppm)
100 no no 91
110 100 100 98
110 no no 100 100 100 too no
91 91 89 90
100 100 100 98
98 95 100 93
100
100/110
too
97
100/110
no
no 100/110
no
98 100/110
110
100 100 120 100
92 98 99 100
92 96 100 no
100 95 92 96
110 100 100 97
100 100 100 100
110 no no 100 100 100 100 100
98 99 97 100
100 100 100 90
100 100 100 100
97 97
no no
100 100 90 100 100/110 120 100 96
no
97
100 100 100 100 97 96 100
100 100
no
100 99 100 97 100 98/100 120 100 95 95 100
100 100 100 100
too
90 100
Particle Size
Chamber Environment
Determinations
MMAD GSD TMC
(pm)
(mg/m3)
0.759 2.01 3.32E-03
1.959 2.41 7.96E-04
0.802 1.27 7.1 IE-03
Mean
Temoerature Humiditv
CC) (%)
23 69 23 69 24 74 23 69 22 69 22 72 22 73 21 72 20 65 20 61 20 64 20 67 22 69 22 69
22 68
22 69 23 72 22 72
22 68
21 67 22 60
BFG 003243
Huntingdon Life Sciences Reproduction Study_____
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Page 50 Draft Final Report
Group III - 100 ppm
Cumulative Exposure Record Chamber Monitoring Results
Appendix X
Week 37
38
39
Date
16-Scp-97 l7-Sep-97 18-Sep-97 (9-Sep-97 20-Sep-97 21-Sep-97 22-Sep-97 23-Sep-97 24-Sep-97 25-Sep-97 26-Sep-97 27-Sep-97 28-Sep-97 29-Sep-97 30-Sep-97 1-Oct-97 2-Oct-97 3-Ocl-97
Exposure Number Nominal
(ppm) 218 94 219 94 220 94 ,221 94 222 96 223 96 224 94 225 94 226 94 227 94 228 96 229 96 230 96 231 94 232 94 233 96 234 96 235 100
Mean (ppm)
100 110/110
110 100 89 91 100 100 100 100 99 94 95 100
100 98 97 110
Chamber Concentration
Mlran (IR] m Individual
(PPm) 100 100 100 100 100/110 100/100 100/110 110/110
110 no 110 110
100 100 100 97 94 87 90 86 91 87 92 87 HO 100 100 100 100 100 100 99 100 100 100 100 100 100 99 100 87 94 94 100 93 92 93 95 98 93 97 95 98 99 100 100 100 100 100 100 87 95 97 100 92 93 100 100 HO 100 100 100
100 110/110
no
100 88 96 100 100 100 100 100 97 93 100 100 97 99 110
100 110/110
110
no
89 91 100 110 100 110 120 95 95 100 100 110 98 110
Particle Size
Chamber Environment
Determinations
MMAD GSD TMC
(pm)
(mg/m3)
0.896 2.04 2.58E-03
1.573 1.98 4.67E-04
Mean
TemDerature Humiditv
(C)
(%)
21 6) 22 61
22 62
24 60
22 65
22 52
20 42
20 49
19 44 19 47
20 49
19 46
20 52
23 69
1.308 1.72 2.77E-04
22 21 20 24
66 66 60 61
B FG 003244
Mean: SD:
96.41 2.69
102 1 7.0
105 J 17.5
1.9 2.0 4.1E-03 1.6 - 5.8E-03
22 1.4
54 10
Huntingdon Life Sciences Reproduction Study____
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Page 51 Draft_FinaLReoort
Group IV - 1100 ppm
Cumulative Exposure Record Chamber Monitoring Results
Appendix X
Week 1 2 3 4
Date
7-Jan-97 8-Jan-97 9-Jan-97 IO-Jnn-97 13-Jan-97 14-Jan-97 15-Jan-97 16-Jan-97 17-Jan-97 20-Jan-97 21-Jan-97 22-Jan-97 23-Jan-97 24-Jan-97 27-Jan-97 28-Jan-97 29-Jan-97 30-Jan-97 31-Jan-97 3-Feb-97
Chamber Concentration
Particle Size
Chamber Environment
Exposure
MJran (IR)B
Determinations
Mean
Number Nominal Mean
Individual
MMAD GSD TMC Temnerature Humidity
(ppm) (ppm)
(ppm)
(Mm)
(mg/m3)
(*C)
<%)
1
noo MOO
1200
MOO
MOO
1100
1100
MOO
20 45
2
1100
MOO
1100
MOO
1200
1200
1100
1100
1.544 1.357 2.27E-04
20
3 1100 1200/1100 U00b 1200/1200 1100/760 1200/1200 1200/1100 1100/1200
20
45 45
4
1100
MOO
MOO
MOO
1100
1100
MOO
MOO
20 45
5
1100
MOO
1200
1200
i 100
MOO
MOO
MOO
20 46
6
1100
MOO
MOO
MOO
MOO
MOO
1200
MOO
20 45
7
1100
MOO
MOO
1100
noo
MOO
1100
MOO 1.227 1.345 7.05E-04
20
39
8
MOO
MOO
MOO
MOO
noo
MOO
MOO
1100
20 42
9 1100 1200/1300 1100/890' 1100/1300 1300/1400 1200/1300 1200/1400 1200/1300
20 42
10
MOO
1200
1200
1200
1200
1200
MOO
1200
21 43
11
1100
1100
noo
noo
MOO
1200
1200
noo
20 42
12
1100
MOO
MOO
MOO
MOO
1100
1200
1100 1.404 1.837 I.79E-03
21
48
13 1100 1100/1300 1200/1400 1100/1300 1100/1300 1100/1300 1100/1300 1100/1300
14
1100
1100
1100
MOO
MOO
1100
MOO
MOO
21 52 20 47
15
1100
1100
1100
1100
MOO
MOO
MOO
MOO
20 47
16
MOO
MOO
1100
MOO
MOO
1100
MOO
noo
21 53
17
MOO
1100
MOO
MOO
1100
MOO
MOO
1100 1.325 1.336 2.37E-04
21
47
18 MOO 1100/1400 1100/1500 1100/1400 1200/1500 1100/1400 1100/1400 1100/1400
19
MOO
MOO
1100
MOO
MOO
1100
MOO
noo
20 53 21 49
20
MOO
MOO
noo
1100
MOO
1100
1200
1200
21 49
BFG 003245
Huntingdon Life Sciences Reproduction Study
96-4080
Page 52 Draft Final Report
Group IV - 1100 ppm
Cumulative Exposure Record Chamber Monitoring Results
Appendix X
Week 5 6 7 8
Chamber Concentration
Particle Size
Chamber Environment
Date Exposure
Miran (IR) i
Determinations
Mean
Number Nominal Mean
Individual
MMAD GSD TMC Temperature Humidity
(ppm) (ppm)
(ppm)
(pm)
(mg/m5)
to
<%)
4-Feb-97
21
1100
1100
1100 1100 noo
noo
noo noo
21 51
5-Feb-97
22
1100
1100
1100
1100
noo
noo
1200
noo 1.197 1.296 1.50E-04
21
49
6-Feb-97
23
1100
1100
1100
1200
noo
1200
noo
noo
20 49
7-Feb-97
24
1100
1100
1100
1100
1100
noo
noo
noo
21 48
IO-Feb-97 25
1100
1100
1100
1100
noo
noo
noo
1100
20 45
11-Feb-97
26
1100
1100
1100
1100
noo
noo
noo
noo
20 47
12-Feb-97
27
1100
1100
1100
1100
noo
noo
noo
noo 1.372 2.280 2.94E-03
20
44
13-Feb-97 28
1100 1100/1400 1100/1400 1100/1400 1100/1400 1100/1400 1100/1500 1100/1500
20 39
l4-Fcb-97 17-Feb-97
29 30
1100 1100
1100 1100
1100 1100
1100 1100
noo noo
noo
1200
noo
1100
1200
noo
20 48 20 46
18-Feb-97
31
1100
1200
1100
1200
1200
1100
1200
1200
21 48
I9-Feb-97
32
1100
1200
1200
1100
noo
1200
1200
1200 2.322 1.910 9.55E-04
22
58
20-Feb-97
33
1100
1200
1200
1200
noo
1200
1200
1200
20 57
21-Feb-97
34
1100
1200
1200
noo
noo
1200
noo
1200
21 57
24-Feb-97
35
1100
1100
1100
noo
noo
noo
noo
1100
21 48
25-Feb-97
36
1100
1100
1100
1100
noo
noo
noo
1100
20 49
26-Feb-97
37
1100
1200
1100
noo
1200
1200
1200
1200 0,9406 1.844 5.15E-03
20
54
27-Feb-97
38
1100 1200/1500 1200/1500 1200/1500 1200/1500 n oo/i 400 1100/1500 1200/1500
22 62
28-Feb-97
39
1)00
1100
noo
1100
1100
1200
noo
noo
20 53
3-Mar-97
40
1100 noo
noo
noo
noo
noo
noo
1000
20 45
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iExposure Number Nominal
(ppm)
Mean (ppm)
Individual (ppm)
S--'
22
GSD TMC j (mg/mJ)
0011 i 0011 0011 O tOl
oori !
-V ('ST W^ ^'I- W'T
1100 1100
1200 1100
1200 1100
1200 1100
1100 1100
1100 1100
1200 1100
0.9226 1.307 1.02E-02
1100
1100
1200
1100
1100
1100
1100
1100
1100
1100
1(00
1100
1100
1100
1100
1200
1100
1200
1200
1200
1100
0011
0011
0011/0011 0011/0011
0011
0011
00(1 0001 0011 0011 0011
oou
0011
0011
oooi !
oou oou j
0001 I
oou oou
;
oou oou oou oou oou
0011
oou
0011 0011 0011 0011
001!
46
1100 1 1100
1100
1100
47
1100 1 1100
1100
1100
0011
0011
1100 1100
7.226 2.695 3.32E-03
48 1100/1100 1100/1100 1100/1000 1100/1100
49
1100 j 1100
1100
1100
0011
0011
1200/1200
noo
50
1200
1100
1200
1200
1200
uoo
1100
1200
noo
noo 1 1200
ci
oou oou oou oou
O lOl/OOU
oou oou
m-rsi/ifmn^v)um'i'oviri-^i g*'o1 9> O> -O N'M nsD 'tO
uoo noo
noo noo noo 1100
1.234 1.573
1100
noo
noo uoo
noo noo
1200
noo
1200 1100
1100 1200
uoo
1100
1100 1100
noo noo
noo noo
1100
noo
1100 1100
uoo uoo uoo uoo
uoo noo
1000
1(00
uoo noo
1100
noo noo
1100
noo uoo
noo uoo
1.114 1.678 1.28E-03
1100/1200 1100/1200
uoo uoo
1100/1100 1100/1200 1100/1100 1100/1200
noo noo noo uoo
1100
1100
uoo
uoo uoo uoo
uoo noo uoo
uoo noo
1200
uoo uoo
1100
1100
uoo noo
g a I
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20 20 20 20
21
21 21 21 21 21 21
20 20 21 21 21 21 22 22 22 23 23 24 20
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*2 ? kO oTnT o'T r*%r 'VC< so >n w**>i t*' <vs* *i r* rw* *o d
aV ECz
Huntingdon Life Sciences Reproduction Study
96-4080
Page 54 Draft Final. Recoct
Group IV - 1100 ppm
Cumulative Exposure Record Chamber Monitoring Results
Appendix X
Week 13
14
15
Date
I-Apr-97 2-Apr-97 3-Apr-97 4-Apr-97 5-Apr-97 6-Apr-97 7-Apr-97 8-Apr-97 9-Apr-97 10-Apr-97 11-Apr-97 12-Apr-97 13-Apr-97 14-Apr-97 15-Apr-97 16-Apr-97 17-Apr-97 l8-Apr-97 19-Apr-97 20-Apr-97 21 -Apr-97
Exposure
Number Nominal
(ppm)
65 1100 66 1100 67 1100 68 1100 69 1100 70 1100 71 1100 72 1100 73 1100 74 1100
75 uoo
76 1100 77 1100 78 1100 79 1100 80 1100 81 1100 82 1100 83 1100 84 1100 85 1)00
Chamber Concentration
Mlran (1R) 1
Particle Size Determinations
Mean
Individual
MMAD GSD TMC
(ppm)
(ppm)
(pm)
(mg/m3)
1100 1100 UOO uoo uoo uoo uoo
1100 1100 UOO uoo uoo uoo uoo 6.444 2.699 8.67E-03
1100 UOO 1100 uoo uoo uoo uoo
1100 UOO 1200 uoo uoo 1100 uoo 1100 1100 1200 uoo uoo uoo 1200
1100 UOO UOO uoo 1100 1100 1200
1100 1100 1200 uoo uoo 1000 uoo
1200 uoo uoo 1200 1200 1200 1200 1200 UOO 1200 uoo 1200 1200 1200 1.218 1.350 4.70E-04
1200/1300 1200/1300 1200/1300 1200/1300 1200/1200 1100/1200 1200/1300 UOO UOO UOO uoo 1200 1200 UOO
UOO UOO 1200 uoo uoo uoo uoo UOO UOO UOO 1200 1000 1000 uoo
1100 uoo UOO uoo 1200 1200 uoo
1100 1000 UOO uoo uoo uoo uoo
1100 uoo uoo uoo uoo uoo uoo 1.144 1.528 1.20E-03 uoo 1000 1100 uoo uoo 1200 1200 1100 uoo uoo 1100 1100 uoo 1100
1100 1000 1100 uoo uoo uoo 1100
1100 uoo uoo uoo uoo uoo uoo 1200 1200 1200 uoo uoo uoo 1200
Chamber Environment
Mean
Temperature Humidity
CC) (%) 19 46 18 49
19 50 19 49 19 50
20 55 21 64 20 50 20 50
19 57
20 56
19 59
21 67 20 40 20 43 20 44 21 48 21 47 22 43
23 48
23 46
BFG 003248
Huntingdon Life Sciences Reproduction Study_____
96-4080
Rage 55 Draft Final Report
Group IV - 1100 ppm
Cumulative Exposure Record Chamber Monitoring Results
Appendix X
Chamber Concentration
Particle Size
Chamber Environment
Week Date Exposure
Miran (1R)a
Determinations
Mean
Number Nominal Mean
Individual
MMAD GSD TMC Temoerature Humiditv
(ppm) (ppm)
(ppm)
(Mm)
(mg/m3)
CC)
(%)
16 22-Apr-97
86
1100 1100
1100
MOO
MOO
MOO
MOO
1200
22 48
23-Apr-97
87
1100 1200
1200
1200
1200
MOO
MOO
1200 0.925 7.860 1.08E-02
20
50
24-Apr-97
88
1100 1100/1200 1100/1200 1100/1200 MOO/1100 1100/1200 1100/1200 1100/1200
20 50
25-Apr-97
89
1100 1100
1100
MOO
MOO
MOO
MOO
1200
20 48
26-Apr-97
90
1100 1200
1200
1200
1200
1200
1200
1200
21 48
27-Apr-97
91
1100 1100
1100 MOO 1100
1100
1200
1200
20 44
28-Apr-97
92
1100 1200
1200
MOO
1200
1200
1200
1200
23 62
17 29-Apr-97
93
1100 1100
1100
MOO
MOO
MOO
MOO
1200
23 49
30-Apr-97
94
1100 1200
1200 1200
1200
1100
MOO
MOO 1.302 3.04 2.12E-03
23
47
1-May-97
95
1100 1100
MOO
1200
1100
1100
MOO
1000
24 53
2-May-97
96
1100 1100
1100
1200
MOO
MOO
MOO
MOO
23 43
3-May-97
97
1100 1100
MOO
MOO
MOO
MOO
MOO
MOO
24 57
4-May~97
98
1100 1100
1200
1100
1100
MOO
MOO
MOO
23 44
5-May-97
99
1100 1100
1100
MOO
1200
1100
MOO
1200
21 40
18 6-May-97 100 1100 1100 1000 1100 1000 MOO MOO MOO
21 53
7-May-97 101 1100 1200 1300 1200 MOO 1200 MOO MOO 3.560 2.62 1.1 IE-03 21
41
8-May-97 102
1100 1100/1200 1200/1300 1100/1200 1100/1100 1100/1200 1100/1200 1100/1100
21 43
9-May*97
103
1100 1100
1100
1100
MOO
MOO
MOO
MOO
21 55
10-May-97 104 1100 1100 1100 MOO MOO MOO MOO MOO
21 53
11-May-97 105 1100 MOO MOO MOO MOO MOO 1100 1100 !2-May-97 106 1100 1200 1200 1100 1100 1200 1200 MOO
22 48 22 50 1
BFG 003249
Huntingdon Life Sciences Reproduction Study:___
96-4080
Page 56 Draft Final Report
Group IV - 1100 ppm
Cumulative Exposure Record Chamber Monitoring Results
Appendix X
Week Date Exposure
Chamber Concentration Miran (1R)a
Particle Sire Determinations
Chamber Environment Mean
Number Nominal Mean
Individual
MMAD GSD TMC Temperature Humidity
(ppm) (ppm)
(ppm)
(pm)
19 13-Mav-97 107 1100 1100 1100 tioo 1100 1100 MOO MOO
(mg/mJ)
(*C)
21
(%) 53
14-May-97 108 1100 1100 1100 MOO 1100 MOO 1200 MOO 0.815 1.97 2.33E-03 20
59
15-May-97 109 1100 1100 1000 1100 1000 MOO 1100 MOO
21 58
16-May-97 110 1100 1100 1200 1200 1200 MOO MOO 1000
21 47
17-May-97 111 1100 1100 1100 1100 MOO MOO MOO 1000
18-May-97 112 MOO 1100
MOO
MOO
MOO
MOO
1 100
1000
19-May-97 113 1100 1100 MOO 1100 MOO 1000 MOO MOO
22 51 22 50 22 58
20 20-Mav-97 114 1100 1100 1000 1000 MOO 1000 MOO MOO
20 56
21-May-97 115 1100 1100 1100 1100 1100 MOO MOO 1100 1.361 1.85 4.89E-04 21
45
22-May-97 116 1100 1100/1200 1100/1200 1100/1100 1100/1100 1100/1200 1100/1200 1100/1200
20 41
23-May-97 117
MOO
1100
1100 1100 1100
MOO
MOO
MOO
26-May-97 118 1100 1100 1000 1100 1100 1100 MOO 1100
20 45 f 59
21 27-May-97 119
MOO
1100
MOO
MOO
MOO
MOO
MOO
MOO
19 48
28-May-97 120 1100 1100 1100 1100 MOO 1200 1100 MOO 1.562 1.86 7.48E-04 19
45
29-May-97 121 MOO 1100 1100 1100 1100 1100 MOO 1100
19 46
30-May-97 122 1100 1100 1100 MOO MOO MOO MOO 1100
2-Jun-97
123
1100
1100
1200
MOO
1200
MOO
1100
1100
19 55
20 58
22 3-Jan-97
4-Jun-97 5-Jun-97 6-Jun-97
124 125 126 127
1100 1100/1100 1100/1100 1100/1100 1100/1100 1100/1100 1100/1100 1100/1100
1100 1100 1000 1100 MOO 1100 1200 1200 1.328 1.69 7.66E-04
MOO 1100
MOO
MOO
MOO
MOO
MOO
MOO
MOO 1100 1100 1100 MOO 1100 MOO MOO
20 20 20 20
50 44 47 47
9-Jun-97 128 1100 1100 1100 1100 MOO 1100 1100 MOO
21 52
osieoo
Huntingdon Life Sciences Reproduction Study
96-4080
Page 57 Draft Final Report
Group IV - 1100 ppm
Cumulative Exposure Record Chamber Monitoring Results
Appendix X
Week 23 24
25 26
Date
10-Jun-97 ll-Jun-97 12-Jun-97 13-Jun-97 !6-Jun-97 l7-Jun-97 I8-Jun-97 19-Jun-97 20-Jun-97 23-Jun-97 24-Jun-97 25-Jun-97 26-Jun-97 27-Jun-97 30-Jun-97 l-Jul-97 2-Jul-97 3-Jul-97 4-Jul-97 7-Jul-97
Chamber Concentration
Particle Size
Chamber Environment
Exposure
Miran (IR)
Determinations
Mean
I
6g
1
Number Nominal Mean
Individual
MMAD GSD TMC
Humidify
(ppm) (ppm)
(ppm)
(pm)
(mg/m3)
(%)
129 1100 1100 noo noo noo 1100 noo noo
21 57
130 1100 1100 noo noo noo noo noo noo 1051 2.08 1.46E-03 23
52
131 1100 1100 1000 1100 1100 noo noo 1000 .
20 60
132 1100 1100 1100 1100 noo 1100 noo noo
20 60
133 1100 1100 1100 1100 noo 1100 1100 noo
21 52
134 1100 1100/1100 1100/1100 1100/1100 1100/1100 noo/itoo noo/iioo 1100/1100
21 55
135 1100 noo 1100 noo 1100 noo noo noo 1.010 1.57 I.05E-02 21
55
136 1100 1100 noo noo noo 1100 1100 noo
21 60
137 1100 1100 noo noo noo noo noo noo
21 56
138 1100 1100 1100 noo noo 1100 1100 noo
22 51
139 noo 1200 1200 1200 noo 1200 noo noo
22 60
140 1100 1200 1200 1200 1200 1200 1200 noo 0.658 1.22 8.76E-03 22
63
141 1100 1100 1100 1100 noo 1200 noo noo
22 65
142 1100 1100 1100 1100 noo 1100 noo noo
21 60
143 1100 1100 1200 noo noo 1100 noo noo
22 59
144 1100 1100 1100 noo noo 1100 noo noo
22 61
145 1100 1100/1200 1100/1200 noo/1200 1100/1200 noo/1200 1100/1200 1100/1200 1.299 2.08 1.40E-03 22
64
146 1100 noo noo noo 1100 1100 noo noo
21 68
147 1100 1100 noo noo noo 1100 noo noo
21 65
148 noo noo noo noo noo 1100 noo noo
21 62
BFG 003251
Huntingdon Life Sciences Reproduction Study_____
96-4080
Page 58 Draft Final Report
Group IV - 1100 ppm
Cumulative Exposure Record Chamber Monitoring Results
Appendix X
Week 27 28 29 30
Dale
8-Ju!-97 9-Jul-97 10-Jul-97 !I-Jul-97 !4-Jul-97 15-Jul-97 !6-Jul-97 !7-Jul-97 1 S-Jul-97 21-Jul-97 22-Jul-97 23-Jul-97 24-Jul-97 25-Jul-97 28-JuI-97 29-Jul-97 30-Jul-97 31-Jul-97 1-Aug-97 2-Aug-97 3-Aug-97 4-Aug-97
Chamber Concentration
Particle Size
Chamber Environment
Exposure
Mlran (IR)
Determinations
Mean
Number Nominal Mean
Individual
MMAD GSD TMC Temperature Humidity
(ppm) (ppm)
(ppm)
(pm)
149 1100 1100 noo 1100 1100 MOO 1000 noo
(mg/m3)
(C)
24
<%)
66
150 1100 1200 1200 1200 noo 1200 noo 1200 0.736 1.69 2.2 IE-02 25
67
151 1100 1100 1200 1100 1100 1200 MOO noo
23 67
152 100 1100 noo 1200 1100 1100 1200 noo 153 1100 1200 1200 1200 1200 1100 1200 1200
25 64 26 69
154 1100 1100 1100 1100 1200 1200 noo 1100
22
155 1100 1100/1200 1000/1100 1100/1(00 1100/1200 1200/1200 1100/(200 1100/1100 0.711 7.45 2.90E-02 22
156 1100 1100 1200 noo 1200 noo noo 1100
22
157 1100 1200 1100 1200 1200 1200 noo 1100
20
158 1100 1100 1100 1200 1100 noo 1100 1100
21
71
74
66 68
73
159 1100 1100 1200 110Q 1100 1100 noo 1100
20
160 1100 1100 noo noo 1100 noo 1100 noo 1.323 1.76 8.06E-04 20
161 1100 1100 1100 noo noo noo noo noo
20
162 1100 1100 1100 noo noo 1100 1100 noo
20
163 1100 1100 noo 1100 noo noo noo noo
21
75 73
68
67 61
164 1100 1100 1000 noo noo 1100 1100 1100
21
165 1100 1100 noo 1000 noo noo 1100 1000 2.007 1.87 7.03E-04 23
166 1100 1100 970 noo noo noo noo 1100
23
167 noo 1100/1200 1100/1200 1100/1200 1100/1200 noo/noo 1100/1100 1100/1200
21
168 1100 1100 1100 1100 noo 1100 1100 1100
20
169 1100 1200 1200 1200 1100 noo noo 1200
20
170 1100 noo noo noo noo noo noo noo
20
54 50 57 60 62
68
62
BFG 003252
Huntingdon Life Sciences Renroduction Studv
96-4080
Page 59 Draft Final Report
Group IV - 1100 ppm
Cumulative Exposure Record Chamber Monitoring Results
Appendix X
Chamber Concentration
Particle Size
Chamber Environment
Week Date Exposure
Miran (IF) i
Determinations
Mean
Number Nominal Mean
Individual
MMAD GSD TMC Temnerature Humiditv
(ppm) (ppm)
(ppm)
(pm)
(mg/m3)
co
(%)
31 5-Aug-97
171
1100 1100
1000
1000
noo
noo
noo
1000
20 64
6-Aug-97 172 1100 1100 noo noo noo noo noo 1200 1.502 1,98 8.51E-04 22
62
7-Aug-97 173 1100 1100 noo noo 1100 noo noo noo
21 63
8-Aug-97 174 1100 1100 noo 1100 noo 1100 noo noo
20 64
9-Aug-97 175 1100 noo 1200 noo noo noo noo noo
21 72
1O-Aug-97 176 1100 1100 1200 noo 1100 noo noo 1200
21 74
11 -Aug-97 177 1100 1100 noo 1100 noo noo noo noo
22 64
32 12-Aug-97 178 1100 1100 noo noo noo noo MOO NOO
22 63
13-Aug-97 179 1100 1100 noo noo noo noo noo NOO 0.744 1.21 2.21E-02 22
68
M-Aug-97 180 1100 1100 noo 1100 noo noo NOO NOO
22 63
15-Aug-97 181
1100 1100/1200 1100/1200 1100/1200 1100/1200 1100/1200 1100/1200 1100/1200
22 60
16-Aug-97 182 1100 1100 noo 1100 noo 1000 MOO NOO !7-Aug-97 183 1100 1100 noo noo noo noo 1100 1000
23 70
22 68
lS-Aug-97 184 1100 1100 1200 noo noo noo 1100 1000
19 60
33 !9-Aug-97 185 noo 1200 1200 1200 1200 1200 1100 1100
20 59
19-Aug-97* 185 1100 noo 1100 noo noo noo
-
-
20 55
20-Aug-97 186 noo 1100 noo noo noo 1100 1100 1100 h h h
20 65
21-Aug-97 187 1100 1100 noo noo noo noo 1100 noo
19 70
22-Aug-97 188 1100 1100 noo noo noo noo noo noo 23-Aug-97 189 1100 1200 noo 1200 1200 1200 1200 1100 24-Aug-97 190 1100 1200 MOO noo 1200 1200 1200 NOO
25-Aug-97 19! 1100 1100 noo noo noo 1100 noo noo
18 73
20 65 20 63 20 68
BFG 003253
Huntingdon Life Sciences Reproduction Study
96-4080
Page 60 Draft Final Report
Group IV - 1100 ppm
Cumulative Exposure Record Chamber Monitoring Results
Appendix X
Week 34
35
36
Date
26-Aug-97 27-Aug-97 28-Aug-97 29-Aug-97 30-Aug-97 31-Aug-97 1-Sep-97 2-Sep-97 3-Sep-97 4-Sep-97 5-Sep-97 6-Sep-97 7-Sep-97 8-Sep-97 9-Sep-97 10-Sep-97 11-Sep-97 12-Sep-97 13-Sep-97 14-Sep-97 15-Scp-97
Chamber Concentration
Particle Size
Exposure
Miran (DR)B
Determinations
Number Nominal Mean
Individual
MMAD GSD TMC
(ppm) (ppm)
(ppm)
(pm)
(mg/nri*)
192 1100 1100 1100 1100 1200 MOO MOO MOO 193 1100 1100 1100 1100 1200 1100 1100 MOO 0.883 3.13 3.95E-03 194 1100 1200 1200 1200 1200 MOO 1100 1100 195 1100 1100 1200 1100 1100 1100 1100 MOO 196 1100 1100 1100 1100 1100 MOO MOO 1100 197 1100 1100 1100 1100 1100 1100 1100 1100 198 1100 1100 1100 1100 1100 MOO 1000 1000
199 1100 1000 960 1000 1000 MOO MOO 1100 200 1100 1100/1100 1000/1100 1100/1100 1100/1200 1100/1200 1100/1100 iioo/noo 1.380 2.08 5.62E-04 201 1100 1100 1000 1100 1100 MOO MOO 1100
202 1100 1100 1100 1100 1200 MOO MOO MOO 203 1100 1200 1300 1100 1100 1200 MOO 1200 204 1100 1100 1100 1100 1100 MOO 1200 1200 205 1100 1100 1100 1100 1100 1000 MOO 1100
206 1100 1100 1100 1100 1100 1000 MOO MOO
207 1100 1100 1100 1)00 1100 MOO MOO MOO 0.794 1.31 7.21E-03
208 1100 1100 1100 1100 MOO MOO MOO MOO 209 1100 1100 1100 1100 1100 MOO 1100 MOO 210 1100 1100 1100 1100 1100 MOO MOO MOO 211 1100 1100 1100 1100 1100 1100 1000 MOO 212 1100 1100 1100 1100 MOO MOO MOO MOO
Chamber Environment
Mean
Temperature Hiimiditv
CC)
(%)
20 70
21 69
21 77
21 71
20 69
20 71
21 73
21 73
20 59
20 51
20 56
21 65
22 68
22 68
22 66
22 66
23 76
22 71
22 68
21 62
22 62
BFG 003254
Huntingdon Life Sciences Reproduction Study
96-4080
Page 61 Draft Final Report
Group IV - 1100 ppm
Cumulative Exposure Record Chamber Monitoring Results
Appendix X
Week 37
38
39
Date
16-Sep-97 17-Sep-97 I8-Sep-97 19-$ep-97 20-Sep-97 21-Sep-97 22-Sep-97 23-Sep-97 24-Sep-97 25-Sep-97 26-Sep-97 27-Scp-97 28-Sep-97 29-Sep-97 30-Sep-97 1-Oct-97 2-Oct-97 3-Oct-97
Exposure
Number Nominal
(ppm)
218 1100 219 1100 220 1100 221 1100 222 1100 223 1100 224 1100 225 1100 226 1100 227 1100 228 1100 229 1100 230 1100 231 1100
232 1100 233 1100 234 1100 235 noo
Chamber Concentration
Particle Size
Chamber Environment
Mi ran (IR)
Determinations
Mean
Mean
Individual
MMAD GSD TMC Temperature Humidity
(ppm)
(ppm)
(pm)
(mg/m5)
CC)
(%)
1100 noo 1100 noo 1100 noo noo
21 61
II00/II00 1000/1000 1100/1100 1100/1100 MOO/UO0 1100/1100 1100/1100 0.835 I >00 noo noo noo 1100 1100 1100 1200 1100 noo 1200 1200 1200 1100
1.63 2.27E-03
21 21 23
63
64 67
1100 1100 noo noo 1100 1100 1100
22 71
1100 1000 noo noo 1100 noo 1100 1100 1100 noo 1100 MOO noo noo
22 52 19 46
1100 1000^ noo noo MOO 1000 noo
19
1100 noo noo noo 1100 noo 1100 1.498 1.64 4.01E-04 19
58 45
noo noo 1100 1100 1100 noo noo 1100 noo noo noo 1100 noo 1100
18 49 19 57
1000 1000 1000 1000 1100 1000 1000
18 49
1100 1000 noo noo 1100 noo 1000 1100 noo 1100 1100 noo noo 1100
19 58 20 69
1200 1200 noo noo 1200 1200 noo
20 62
MOO noo noo noo 1100 1100 noo 1.270 1.73 2.75E-04 18
58
noo noo 1100 1100 1100 noo 1200
18 49
noo 1200 1100 1100 1100 1100 1200
22 52
BFG 003255
Mean: SD:
1100
0.00
1112 1--------------
45
1212 j
135
1.6 2.1 4.5E-03
1.4 - 6.8E-03
21
1.3
56
9.3
Huntingdon Life Sciences Reproduction Study
Key to Observations: Few = < 20% Some = 21 - 50% Most = 51 - 99% All 100%
96-4080
In-chamber Observations Preface
Page 62 Draft Final Report
Appendix X
BFG 003256
Huntingdon Life Sciences Reproduction Study
96-4080
Page 63 Draft Final Report
in-chamber Observations
Appendix X
Group
Observation
Test Days 74 75 76 77 78 79 80
1 - 0 ppm
Within Normal Limits Unobservable
Most Most Most Most Most Most Most Some Some Some Some Some Some Some
II-10 ppm
Within Normal Limits Unobservable
Most Most Most Most Most Most Most Some Some Some Some Some Some Some
(II-100 ppm
Within Normal Limits Unobservable
Most Most Most Most Most Most Most Some Some Some Some Some Some Some
IV -1100 ppm
Within Normal Limits Unobservable
Most Most Most Most Most Most Most Some Some Some Some Some Some Some
Group
Observation
Test Days 81 82 83 84 85
86 87
1 - 0 ppm
Within Normal Limits Unobservable
Most Most Most Most Most Most Most Some Some Some Some Some Some Some
II -10 ppm
Within Normal Limits Unobservable
Most Most Most Most Most Most Most Some Some Some Some Some Some Some
111-100 ppm
Within Normal Limits Unobservable
Most Most Most Most Most Most Most Some Some Some Some Some Some Some
IV -1100 ppm
Within Normal Limits Unobservable
Most Most Most Most Most Most Most Some Some Some Some Some Some Some
BFG 003257
Huntingdon Life Sciences Reproduction Study
96-4080
Page 64 Draft Final Report
In-chamber Observations
Appendix X
Group
Observation
Test Days 88 89 90 91 92 93 94
I - 0 ppm
Within Normal Limits Unobservable
Most Most Most Most Most Most Most Some Some Some Some Some Some Some
II -10 ppm
Within Normal Limits Unobservable
Most Most Most Most Most Most Most Some Some Some Some Some Some Some
III -100 ppm
Within Normal Limits Unobservable
Most Most Most Most Most Most Most Some Some Some Some Some Some Some
IV -1100 ppm
Within Normal Limits Unobservable
Most Most Most Most Most Most Most Some Some Some Some Some Some Some
Group
Observation
Test Days 95 96 97 98 99 100 101
I - 0 ppm
Within Normal Limits Unobservable
Most Most Most Most Most Most Most Some Some Some Some Some Few Few
II -10 ppm
Within Normal Limits Unobservable
Most Most Most Most Most Most Most Some Some Some Some Some Few Few
III -100 ppm
Within Normal Limits Unobservable
Most Most Most Most Most Most Most Some Some Some Some Some Few Few
IV- 1100 ppm
Within Normal Limits Unobservable
Most Most Most Most Most Most Most Some Some Some Some Some Few Few
003258
bfg
Huntingdon Life Sciences
96-4080
Page 65
In-chamber Observations
Appendix X
Group
Observation
Test Days 102 103 104 105 106 107 108
1-0 ppm
Within Normal Limits Unobservable Chromodacryorrhea
Most Most Most Few Few Few
* - Few
Most Few
-
Most Few
-
Most Few
-
Most Few
-
II-10 ppm
Within Normal Limits Unobservable
Most Most Most Most Most Most Most Few Few Few Few Few Few Few
III -100 ppm
Within Normal Limits Unobservable
Most Most Most Most Most Most Most Few Few Few Few Few Few Few
IV -1100 ppm
Within Normal Limits Unobservable
Most Most Most Most Most Most Most Few Few Few Few Few Few Few
Group
Observation
Test Days 109 110 111 112 113
114 115
I-0 ppm
Within Normal Limits Unobservable
Most Most Most Most Most Most Most Few Few Few Few Few Few Few
II-10 ppm
Within Normal Limits Unobservable
Most Most Most Most Most Most Most Few Few Few Few Few Few Few
III -100 ppm
Within Norma! Limits Unobservable
Most Most Most Most Most Most Most Few Few Few Few Few Few Few
IV-1100 ppm
Within Normal Limits Unobservable
Most Most Most Most Most Most Most Few Few Few Few Few Few Few
BFG 003259
Huntingdon Life Sciences Reproduction Study
96-4080
Page 66 Draft Final Report
In-chamber Observations
Appendix X
Group
Observation
Test Days 116 117 118 119 120 121 122
I - 0 ppm
Within Normal Limits Unobservable
Most Most Most Most Most Most Most Few Few Few Few Few Few Few
If-10 ppm
Within Normal Limits Unobservable
Most Most Most Most Most Most Most Few Few Few Few Few Few Few
III -100 ppm
Within Normal Limits Unobservable
Most Most Most Most Most Most Most Few Few Few Few Few Few Few
IV-1100 ppm
Within Normal Limits Unobservable
Most Most Most Most Most Most Most Few Few Few Few Few Few Few
Group
Observation
Test Days 123 124 125 126 127
128 129
I - 0 ppm
Within Normal Limits Unobservable
Most Most Most Most Most Most Most Few Few Few Few Few Few Some
II-10 ppm
Within Normal Limits Unobservable
Most Most Most Most Most Most Most Few Few Few Few Few Few Some
III -100 ppm
Within Normal Limits Unobservable
Most Most Most Most Most Most Most Few Few Few Few Few Few Some
IV-1100 ppm
Within Normal Limits Unobservable
Most Most Most Most Most Most Most Few Few Few Few Few Few Some
bfg
003260
Huntingdon Life Sciences
96-4080
Page 67
In-chamber Observations
Appendix X
Group
Observation
Test Days 130 131 132 133 134 135 136
1-0 ppm
Within Normal Limits Unobservable
Most Most Most Most Most Most Most Few Few Few Few Few Few Few
II -10 ppm
Within Normal Limits Unobservable
Most Most Most Most Most Most Most Few Few Few Few Few Few Few
111 -100 ppm
Within Normal Limits Unobservable
Most Most Most Most Most Most Most Few Few Few Few Few Few Few
IV -1100 ppm
Within Normal Limits Unobservable
Most Most Most Most Most Most Most Few Few Few Few Few Few Few
Group
Observation
Test Days 137 138 139 140 141
142 143
1 - 0 ppm
Within Normal Limits Unobservable
Most Most Most Most Most Most Most Few Few Few Some Few Few Few
11-10 ppm
Within Normal Limits
Unobservable
Red Nasal Discharge
Chromodacryorrhea
Dried Red Material Facial Area Labored Breathing
Most Few
-
-
-
Most Few
-
-
-
Most Few
-
-
Most Some Few Few Few
Few
Most Few
-
-
Most Few
-
-
Most Few
-
--
III - 100 ppm
Within Normal Limits Unobservable
Most Most Most Most Most Most Most Few Few Few Some Few Few Few
IV- 1100 ppm
Within Normal Limits Unobservable
Most Most Most Most Most Most Most Few Few Few Some Few Few Few
BFG 003261
Huntingdon Life Sciences
96-4080
Page 68
In-chamber Observations
Appendix X
Group
Observation
Test Days 144 145 146 147 148
149 150
I * 0 ppm
Within Normal Limits Unobservable
Most Most Most Most Most Most Most Few Few Few Few Few Few Few
11-10 ppm
Within Normal Limits Unobservable
Most Most Most Most Most Most Most Few Few Few Few Few Few Few
Hi -100 ppm
Within Normal Limits Unobservable
Most Most Most Most Most Most Most Few Few Few Few Few Few Few
IV -1100 ppm
Within Normal Limits Unobservable
Most Most Most Most Most Most Most Few Few Few Few Few Few Few
Group
Observation
Test Days 151 153 154 155 156
157 158
I - 0 ppm
Within Normal Limits Unobservable
Most Most Most Most Most Most Most Few Few Few Few Few Few Few
II-10 ppm
Within Normal Limits Unobservable
Most Most Most Most Most Most Most Few Few Few Few Few Few Few
111 100 ppm
Within Normal Limits Unobservable
Most Most Most Most Most Most Most Few Few Few Few Few Few Few
IV-1100 ppm
Within Normal Limits Unobservable
Most Most Most Most Most Most Most Few Few Few Few Few Few Few
BFG 003262
Huntingdon Life Sciences Reproduction Study
96-4080
Page 69 Draft Final Report
In-chamber Observations
Appendix X
Group
Observation
Test Days 161 162 163 164 165 168 169
1 - 0 ppm
Within Normal Limits Unobservable
Most Most All All All All All Few Few - - - - -
11 -10 ppm
Within Normal Limits Unobservable
Most Most All Ail All All All Few Few - - - -
III -100 ppm
Within Normal Limits Unobservable
Most Most All All All All All Few Few - - - - -
IV -1100 ppm
Within Normal Limits Unobservable
Most Most All All All All All Few Few
Group
Observation
170 171
Test Days 172 175 176
177 178
1 - 0 ppm 11-10 ppm
Within Normal Limits Unobservable
Within Normal Limits Unobservable
All Ail All All All All All
m
* ""
All All All All All All All
-
III -100 ppm
Within Normal Limits Unobservable
All All All All All All All
w
IV-1100 ppm
Within Normal Limits Unobservable
All All All All All All All
.
BFG 003263
Huntingdon Life Sciences
96-4080
Page 70
!n-chamber Observations
Appendix X
Group
Observation
Test Days 179 180 183 184 185
186 189
i - 0 ppm
Within Normal Limits Unobservable
All All All All All All All
II -10 ppm
Within Normal Limits Unobservable
All All All All All All All ... . . -
III -100 ppm
Within Normal Limits Unobservable
All All All All Ail All All ... - - -
IV-1100 ppm
Within Normal Limits Unobservable
All All All All All All All ... . . -
Group
Observation
190 191
Test Days 192 193 196
197 198
I - 0 ppm
Within Normal Limits Unobservable
All All All All All All All
11-10 ppm
Within Normal Limits Unobservable
All All All All All All All ... . . -
III -100 ppm
Within Normal Limits Unobservable
All All All AH All All All ... . - -
IV-1100 ppm
Within Normal Limits Unobservable
All All All All All All AH ... - - -
BFG 003264
Huntingdon Life Sciences Reproduction Study
96-4080
Page 71 Draft Final Report
Group I - 0 ppm
Observation
In-chamber Observations
Appendix X
Test Days 199 200 203 204 205
206 207
Within Normal Limits Unobservable
All All All All All All All
II -10 ppm
Within Normal Limits Unobservable
All All All All All All All ... - . -
III -100 ppm
Within Normal Limits Unobservable
All All All All All All All ... . . -
IV-1100 ppm
Within Normal Limits Unobsenrable
All All All All All All All ... . - -
Group
Observation
Test Days 208 209 210 211 212
213 214
l - 0 ppm
Within Normal Limits Unobservable
All All All All All All All
II-10 ppm
Within Normal Limits Unobservable
All All All All All All All ... . - -
111-100 ppm
Within Normal Limits Unobservable
All All All All All All All ... - - -
IV-1100 ppm
Within Normal Limits Unobservable
Alt All All All All All All ... - - -
BFG 003265
Huntingdon Life Sciences
96-4080
Page 72
Group I - 0 ppm
Observation
In-chamber Observations
Appendix X
Test Days 215 216 217 218 219
220 221
Within Normal Limits Unobservable
All All All All All All All
11-10 ppm
Within Normal Limits Unobservable
Ail All All All All All All
III -100 ppm
Within Normal Limits Unobservable
Ail All All All All All Ail
IV -1100 ppm Within Normal Limits Unobservable
All All Alt All All All Ail - ---
Group
Observation
222 223
Test Days 224 225 226
227 228
1 - 0 ppm
Within Normal Limits Unobservable
All All All All All All All
11-10 ppm
Within Normal Limits Unobservable
All All All All All All All ... - - -
III -100 ppm
Within Normal Limits Unobservable
All All All All All All All - ---
IV-1100 ppm
Within Normal Limits Unobservable
All All All All All All All ... . . -
003266
bfg
Huntingdon Life Sciences
96-4080
Page 73
Reproduction StudyDraft Final Report
In-chamber Observations
Appendix X
Group
Observation
Test Days 229 230 231 232 233
234 235
I - 0 ppm
Within Normal Limits Unobservable Chromodacryorrhea
Ail Most All Ail All AH All
--
-
-
-
--
Few -
II- 10 ppm
Within Normal Limits Unobservable
All All All All All All All
-- - -
-
111-100 ppm
Within Normal Limits Unobservable Chromodacryorrhea
Ail Most All All All All All --- - - -- Few - - -
IV-1100 ppm
Within Normal Limits Unobservable
All All All All AH All All -- - - - --
Group
Observation
Test Days 236 237 238 239 240 241 242
I - 0 ppm
Within Normal Limits Unobservable
All All AH AH All AH All -- - - - -
II -10 ppm
Within Normal Limits Unobservable
All All All All All AH AH -- - - - --
III -100 ppm
Within Normal Limits Unobservable
All All All AH All All All
-- -
-
-
-
IV-1100 ppm
Within Normal Limits Unobservable
All All All Ail All Ail All
.-
.
-
-
-.
BFG 003267
Huntingdon Life Sciences Reproduction Study______
96-4080
Page 74 Draft Final Report
Group
Observation
In-chamber Observations
Appendix X
Test Days 243 244 245 246 247 248 249
I - 0 ppm
Within Normal Limits Unobservable
All All All All All All All --
II -10 ppm
Within Normal Limits Unobservable Chromodacryorrhea
Most Most All All All All Ail
--
-
-
-
--
Few Few
"
III -100 ppm
Within Normal Limits Unobservable
Ail All All All All All All - - - *" "
IV-1100 ppm
Within Normal Limits Unobservable
All All All All All All All -- - - - - -
Group
Observation
Test Days 250 251 252 253 254 255 256
I - 0 ppm
Within Normal Limits Unobservable
All All All All All All All --- - - -
II -10 ppm
Within Normal Limits Unobservable
All All All All All All All -- "
111-100 ppm
Within Normal Limits Unobservable
All All All All All All Ail -- - - - -
IV - 1100 ppm
Within Normal Limits Unobservable
All All All All All All All
--
-
-
.
--
BFG 003268
Huntingdon Life Sciences Reproduction Study
96-4080
Page 75 Draft Final Report
In-chamber Observations
Appendix X
Group 1 - 0 ppm
Observation
Within Normal Limits Unobservable
11 -10 ppm
Within Normal Limits Unobservable
III -100 ppm
Within Normal Limits Unobservable
IV- 1100 ppm
Within Normal Limits Unobservable
Group 1 - 0 ppm
Observation
Within Normal Limits Unobservable Chromodacryorrhea Labored Breathing Gasping
11-10 ppm
Within Normal Limits Unobservable Chromodacryorrhea
111 - 100 ppm
Within Normal Limits Unobservable
IV-1100 ppm
Within Normal Limits Unobservable
257 258 259 260 261 262 263
All All All All All All All
--
-
-
-
AH Ail All Ail All All Ail -- - - - - -
All All AH All All All All
--
-
-
-
--
All All All All All All All
Test Days 264 265 266 267 268
269 270
Most -
Few Few Few
Most -
Few Few
-
Most -
Few Few
-
Most -
Few Few
-
Most -
Few Few
-
Most -
Few -
All -
Most Most Most All All Ail All
- - -- -
-
-
Few Few Few
-
-
--
All All All All All Ail All
--
-
-
-
--
All All All AH All All AH
--
-
-
-
--
BFG 003269