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__Manufacturing Chemists As'sociation
Minutes of Meeting
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SHELL CHEMICAL COMPANY. Environment and Safety RCliVr.D
APR 151974
TECHNICAL TASK GROUP ON VINYL CHLORIDE RESE$AR
Sheraton O'Hare Hotel
Ro senior
J* MEMBERS PRESENT:
February 20, 1974
MFG. & 01STRIB. Plans & Analysis
T. R. Torkelson, CHAIRMAN T. R. Aalto Z Ga Bell/ Jr. R. S. Brookman E. M. Dixon, M.D. for
W. A. Knapp R. J. Dowling for
W. D. Harris Ba W. Duck
M. R. Gasque, M.D. N. V. Hendricks C. A. Johnson, M.D. Flynt Kennedy H. L. Kusnetz for
R. L. Maycock . A. B. Lindquist R. W. McBurney, M.D, W. E. Rinehart George Roush, Jr., M.D. H. L. Schmidt, Jr.
W. M. Smith R. N. Wheeler, K. D. Johnson
Jr.
The Dow Chemical Company Tenneco Chemicals, Inc. PPG Industries, Inc. Firestone Plastics Company. Allied Chemical Corporation
UNIROYAL Chemical Division/ UNIROYAL, Inc.
The British Petroleum Company Limited, England
Olin Corporation Exxon Corporation The Goodyear Tire &. Rubber Company Continental Oil Company Shell Oil Company
Stauffer Chemical Company Diamond Shamrock Corporation Ethyl Corporation Monsanto Company Borden Chemical/Division of
Borden, Inc. Air Products & Chemicals, Inc. Union Carbide Corporation MCA Staff
GUESTS PRESENT:
L. .H..--.Ballou,:' jyi;D. A. W. Barnes ' Emilio Bartalini, M.D.
K. n. c. Bessant
R. L. Bourget W. j. Boyne
W. C. Cooper, M.D.
(
Firestone Plastics Company . ICI, Ltd., Plastics Division, England MONTEDISON, Italy BP Chemicals Int., Ltd., England Monsanto Company Borden Chemical/Division of
Borden, Inc. Tabershaw-Cooper Associates, Inc.
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Minutes of Technic^ ) Task Group on VinyJL Chloride Research Meeting
February 20, 1974 Page Two
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GUESTS (contj
C. U. Dernehl, M.D. D. P. Duffield, M.D. B. W. Eley J. D. Forbes, M.D. W. R. Gaffey J. W. Goode D. E. Gordon, D.V.M. R. B. Howard E. Q. Hull, M.D. M. L. Keplinger C. H. Kim
J. R. Livingston, Jr. W. F. Madden Richard Maier Cesare Maltoni, M.D.
X. S. Pasternak Oddi Pietro D. P. Reid, M.D.
D. E. Rhoads Ken Schadeberg X. R. Tabershaw, M.D. C. H. Whetstone, M.D. B. M. G. Zwicker
Union Carbide Corporation ICI, Mond Division/ England Monsanto Company UNIROYAL, Inc. Tabershaw-Cooper Associates, Inc. Industrial BIO-TEST Laboratories, Inc. Industrial BIO-TEST Laboratories, Inc. Shell Chemical Company Union Carbide Corporation Industrial BIO-TEST Laboratories, Inc. UNIROYAL Chemical Division/
UNIROYAL, Inc. Exxon Chemical Company ICI, Plastics Division, England Stauffer Chemical Company Institute of Oncology of Bologna,
Italy Esso Chemical Canada Montecatini Edison # Italy London School of Hygiene and
Tropical Medicine/ England Tenneco Chemicals, Inc. Industrial BIO-TEST Laboratories, Inc. Tabershaw-Cooper Associates, Inc. Continental Oil Company B. F. Goodrich Chemical Company,
A Division of The B. F. Goodrich Company
1. Minutes of the Meeting of January 25, 1974
The.subject minutes were .approved as distributed.
2. Industrial BIO-TEST Oral Progress Report
As copies of the detailed quarterly progress report had been earlier distributed to members of the Technical Task Group on Vinyl Chloride Research, the oral presentation was primarily a summary report, augmented by slides illustrating the physical
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Minutes of Technical Task Group on Vinyl Chloride Research Meeting
February 20, 1974 Page Three
facilities set up for this project. The tabular data presented by Mr. Schadeberg on his slides is reproduced in Appendix A to these minutes.
It was .suggested that, in future progress reports, the summary tables, as exemplified by this appendix, be furnished in the copies provided for general distribution to the group, and that the detailed data be filed with MCA for the record, but not included in the general reports. Mr. Schadeberg agreed to follow this format in the future.
The mortality revealed in Table I was discussed at some length. Members were somewhat relieved to note the improving picture, particularly with respect to losses from hamster cannabilism. It was agreed not to try to replace any animals lost to date, on the grounds that the stresses introduced by such disturbances to established orders of social dominance in the populations in any given cage would tend to perpetuate the earlier situation.
The reduced weight gain of the TE-IV Group rats (those with bedding and food in the cages during exposures) was noted, but the significance of this observation, if any, could not be determined. This group will be observed carefully for evidence of systemic toxicity.
3. Report of European Research
Dr. Maltoni repeated his presentation of the results of the European research programs, and the description of on going experiments, that he had earlier presented to the OSHA hearing on February 15 in Washington. An updated version of his report, with the inclusion of the tabular data that appeared on his slides, will, upon receipt, be distributed as a separate mailing.
The' only experiment that is now essentially complete- is the initial`series of exposures of Sprague-Dawley rats to levels of.10,000 ppm VCM down to 50 ppm. With the exception of the highest exposure group for which early mortality limited the incidence of such cancers, the rats showed a dose-related incidence of angiosarcomas of the liver, as shown in the fol lowing table:
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Minutes of Technic^ ^Task Group on
Vinyl Choride Research Meeting February 20, 1974 Page Four
Exposure levelsa (p_- P m - )
Rats with liver angio
sarcomas
Number of rats exposed
10,000 6,000 2,500 500 250 50
6 11
9 7 2 0
69 72 74 67 67 64
a Atmospheric exposure of Sprague-Dawley rats to vinyl chloride, four hours daily, five days a week, for 12 months. Note; No liver angiosarcomas were observed in controls or rats exposed similarly to 2500 p.p.m. vinyl acetate.
4. Support of Dow Proposals
The TTGVCR voted to request their managements to provide $80,000 for the support of the Dow research as described in their proposal distributed to the group in the MCA mailing of January 29, 1974.
5. Support for Other Research
The TTGVCR endorsed the position of the Research Coor dinators with respect to current support of research in the areas of mutagenicity, three-generation feeding studies, and 90-day feeding studies, recommending that these be deferred for the present.
6. Revision of SD-56 - Vinyl Chloride
This matter will be attended to after completion of the sub-task groups of their tasks of the development of work practices standards, medical surveillance, and industrial hygiene monitoring and analysis.
7 ,, Progress Report from Tabershaw-^Cooper Association on, the Epidemiology Study
The staff of TCA distributed copies of an updated progress report (copy attached to these minutes as Appendix B). They pointed out that, in its present format and state, their tabulation merely reflects a distribution of death and is not
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Minutes of Technl-ihl Task Group on Vinyl Chloride Research Meeting
February 20, 1974 Page Five
intended to indicate the existence or non-existence of any specific risk or excess mortality in any category.
8. Tabershaw-Cooper Associates Proposals for Expanded Epidemiological Research
Dr. Tabershaw summarized his pending proposals for new studies involving (1) intensifying their efforts to trace missing cases, (2) clinical study of suspect deaths in the mortality study, and (3) undertaking a prospective epidemiology study among high-risk segments of the worker population. He indicated that he would soon be submitting formal proposals for these projects. (Prior to the publication of the present minutes, these proposals were received and distributed to the Technical Task Group by MCA under date of March 12, 1974.)
9. Establishment of a Vinyl Chloride Pathology Register
The full task group endorsed the recommendations of the Research Coordinators that the University of Michigan be requested to reactivate and expand their acro-osteolysis registry program to include all categories of occupational illnesses specifically related to vinyl chloride exposure. They requested that MCA pursue this matter with the University, and if necessary, to seek other agencies willing to perform such a service.
10. Report of the Working Group on Analysis and Monitoring
The report of the group, in the absence of its chairman, was read, and is attached to these minutes as Appendix C. The tenor or the resulting discussion was that member companies should submit their candidate analytical and monitoring methods for consideration by the working group as soon as possible. The latter should attempt to draft its recommendations in format that provided the maximum flexibility of implementation, as long as the methods employed met appropriate standards of sensitivity, selectivity, and precision.
11. Report of the Working Group on Medical Surveillance
The recommendations of this group have been incorporated in the work practices draft submitted by that group (see the following item in these minutes). It was pointed out that the recommended surveillance is required to document the effectiveness
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Appendix A
TABLE I
TEST MATERIAL: Vinyl Chloride (Ethylene Derived)
Chronic Vapor Inhalation Toxicity Study - Albino Rats, Albino Mice, and Golden Hamsters
Summary of Mortality Data
Month No.
1 2 3 4 5
Total Number of Mortalities at End of Month
ALBINO RATS
Control
T-I
T-II
T-III
MF
MF
MF .MF
00 00 01 02 23
00 20 20 41 51
00 10 10 30 61
00 00 14 14 34
T -IV M F
0 0 0 0 0
Month No.
1 2 3 4 5
Control MF
00 00 20 51 82
ALBINO MICE
T -I
T- II
MF
MF
00 03 64 1.9 5 26 6
00 00 30 41 42
T- III MF
00 00 10 47 87
Month No.
Control MF
1 54 2 8 11 3 ' 8 ' 13 4 9 15 5 9 18
GOLDEN HAMSTERS
T -I
T -II
MF
MF
T -III MF
44 10 12 12 14 16 16 16 16
75 9. . 16 12 18 15 19 16 20
2 . 1C
14 15 15
5 11 . 13 13 15
0
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TABLE II
TEST MATERIAL: Vinyl Chloride (Ethylene Derived)
Chronic Vapor Inhalation Toxicity Study - Albino Rats, Albino Mice, Golden Hamsters
Summary of Mean Body Weight Values - Rats
Group and
Test Level
Control
TE-I 50 ppm
TE-II 200 ppm
TE-tll 2500 ppm
Sex
0
M 205 F.' 160
M - ' 209 F 168
M 201 F ' . 171
M 200 F 165
Mean Body Weights at Week Indicated (grams)
12 348
258 294 335 363 456 188 214 223 235 275
246 286 331 346 448 184 207 223 232 274
261 301 335 360 457 200 208 228 242 289
245 302 326 351 453 185 216 228 240 287
12
498 299
491 297
490 302
499 303
Total We Gain
(grams /an
293 139
282 129
289 131
299 138
T E -1V
F- 181 209 223 236 251 282
2 500 ppm
288
107
see
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iai B IO -T E S T A
TABLE III
TEST MATERIAL: Vinyl Chloride (Ethylene Derived)
Chronic Vapor Inhalation Toxicity Study - Albino Rats, Albino Mice, Golden Hamsters
Summary of Mean Body Weight Values - Mice
Group and
Test Level
Control
Sex
0
M ' 35 F .29
Mean Body We ights at Week Indicated (grams)
1 2 3 4 8
36 37 39 40 41 29 29 30 32 33
12
43 35
Total Weight Gain
(g rams /animal)
8 6
TE-I 50 ppm
M 33
34
35
37 39 39
F ' 30
29
31
31 34 34
43 37
10 7
TE-II
M 36
37
37
40 40 38
ZOO ppm
F 28
29
29
31 31 34
TE-I1I
M 36
35
35
38 38 40
Z 500 ppm F 28
28
27
30 31 34
42 35
43 34
6 7
7 6
see
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TABLE IV
TEST MATERIAL: Vinyl Chloride (Ethylene Derived)
Chronic Vapor Inhalation Toxicity Study - Albino Rats Albino Mice, Golden Hamsters
Summary of Mean Body Weight Value s - Hamsters
It
Group and
Test Level
Sex
0
Mean Body W eights at Week Indicated (grams)
12 348
12
Total Weight
Gain (grams / animal)
Control
M 73 F 77
74 86
99 98 no
80 91
102 104
108
120 118
47 41
TE-I 50 ppm
M 71 F 78
72 79 78 85
89 90 101 96 95 102
114 112
43 34
TE-II 200 ppm
TE-III 2500 ppm
M 63 FT 74
M' 60 F' 69
61 82 75 82
66 83 70 87
83 89 95 94
94 99
86 87
91
95 92 100
99 108
93 106
36 34
33 37
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WEEKS
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FEMALE HAMSTER BODY WEIGHT GAINS