Document ak3gaL0DVj9mpjx3YYXeEzvN
MANUFACTURING CHEMISTS ASSOCIATION
1825 CONNECTICUT AVENUE, N.W. WASHINGTON. D.C. 20009 (202) 483-6126 ^ ^ ^
APR 2 219/4
April 17, 1974
To: TECHNICAL TASK GROUP ON VINYL CHLORIDE RESEARCH
Subject: Report on Conference with Industrial BIOTEST Laboratories. April 15, 1974
Gentlemen:
As a result of the telephoned information received by MCA from Industrial BIO-TEST personnel last week, a conference at the Northbrook, Illinois offices of IBT was set up at which an oral status report on the chronic in halation studies with vinyl chloride was presented to MCA, industry and federal agency representatives.
Those in attendance, and their affiliations, are shown below:
Z. G Bell, Jr. A. S. Cummin E. J. Fairchild J. W. Goode D. E. Gordon W. D. Harris M. N. Johnson, M.D. Flynt Kennedy M. L. Keplinger R. J. Kociba H. L. Kusnetz D. V. Lassiter W. E. Rinehart W. M. Smith J. F. Stara
T. R. Torkelson R. N. Wheeler B. M. G. Zwicker R. F. Blewitt A. C. Clark K. D. Johnson
PPG Industries, Inc. Borden, Inc. NIOSH Industrial BIO-TEST Laboratories Industrial BIO-TEST Laboratories UNIROYAL, Inc. The B. F. Goodrich Company Continental Oil Company Industrial BIO-TEST Laboratories The Dow Chemical Company Shell Oil Company OSHA Ethyl Corporation Air Products & Chemicals, Inc. U. S- Environmental Protection
Agency The Dow Chemical Company Union Carbide Corporation B. F. Goodrich Chemical Company MCA MCA MCA
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Dr. Goode first presented the mortality data and gross observations, and then Dr. Gordon described the pathology observed in the mice. The data, as presented, are shown in the attached tables. There are apparent discrepancies between the total mortality data and the detailed listing of recent deaths. These will be re solved. No test-related pathology has yet been noted in any animals other than mice.
Dr. Fairchild, of NIQSH, reported that Dr. David Rail, of HEW, had appointed a committee to coordinate departmental toxicology and related programs, and that junder this committee there has been named a subcommittee |to develop a "white paper" on guidelines for research to determine "socially acceptable" levels of risk. A report
(from this subcommittee, which will cover both philosophical
and statistical considerations, is expected in the next few weeks.
Dr. Stara expressed the view that the vinyl chloride problem presented industry with a unique opportunity to seek to demonstrate a "no effect level" of a human carcinogen with a sensitive animal model of well-documented validity.
Dr. Lassiter expressed a guarded judgment that the mouse data reported by IBT would not lead -OSHA to modify the emergency temporary standard, but that it might well cause OSHA to accelerate the rule-making process for the development of a permanent standard.
Dr. Lassiter also reported briefly on the retrospective morbidity and mortality studies being conducted by NIOSH/CDC at nine or ten locations (six companies) around the country. No epidemiological data were presented.
In an afternoon session of the Research Coordinators, it was agreed that the exposure of the mice in the present project should be terminated at nine months, but that exposures of both rats and hamsters should proceed for the initially-planned twelve months.
It was further moved, seconded and carried that the chairman appoint a group to begin investigating the cost and availability of facilities of new experiments to be con ducted at lower levels of exposure, with larger groups of animals. He was asked specifically to seek to encourage the National Center for Toxicological Research, at Pine
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Bluff, Arkansas, to offer to undertake such a program. Details of the test protocol are to be left open until after the Rail committee makes its report available.
The Research Coordinators asked MCA to call a meet ing of the Technical Task Group on Vinyl Chloride Research as soon as the report of Tabershaw-Cooper Associates on their epidemiological study reaches them.
A copy of the MCA news release reporting the Industrial BIO-TEST mouse data has been sent to you in this morning's mail.
Sincerely
Kenneth D. Johnson, Ph.D. Secretary Technical Task Group on
Vinyl Chloride Research
KDJ:mb
Tables Attached
cc :
Mr. A. W. Barnes D. P. Duffield, M.D. Dr. Tiziano Garlanda Vinyl Chloride Management Contacts
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TABLE 2
Mouse Mortality Data
DATE
Controls FM
February 10, 1974
28
GROUP 2Lf
FM
TII . o'
FM
6 26
24
mi. 4-'*
FM
78
April 12, 1974
5 11
9 31
13 7
13 18
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1610 FRONTAGE ROAD
NORTHBROOK. M 1 INOI5 60062
Summary of Tumors in Vinyl Chloride Exposed Mice IBT Number 663-03222-MCA
TABLE II
Group. Animal No. . Sex
Histopathologic Finding s
Date of Death
T-I 023 Male :\IQ Female
1 5 19 Female 1200 Female
Lung
Liver
AA (s)*
HS (s)**
AA (s), Metastatic
Skin Tumor
HS (a)
Metastatic Skin
Tumor
-
Skin
EC (para-aural) 3-20-74
3-24-74
EC & MC+ (Fern ral
region)
3-30-74
7 -II 1347 Female
1309 Female 1889 Male 1382 Female 1350 Female 1299 Female
T-HI 1538 Female 1532 Female 1562 Female 1598 Female 1405 Male 1494 Male 1574 Female 1531 Female
1588 Female 1593 Female 1505 Female 1565 Female 1409 Male 1543 Female :544 Female ) 646 Female
:535 Female i432 Male 477 Female
UV'lw- K;.,^ T-"kJ
Metastatic Skin
Tumor
IIS (s)
AA (s)
HS
HS (s)
AA (s)
HS (s)
AA (s)
AA (s) AA (s) AA (s) AA (s) AA (s) AA (s) AA (s)
HS (s)
HS (s) HS (s) HS (s) HS (s) IIS (s) HS (s)
AA (s) AA (s) AA (s) AA (s) AA (s) AA (S) AA (s)
HS (s) HS (s) HS (s) HS (s) HS (s) HS (s) HS HS (s)
AA (s) AA (s)
HS (s)
AA (s)
HS (s)
Metastatic Skin
Tumor ?
EC( Abdomen) 3-5-74
3-18-74
3-25-74
4-2-74
4-5-74
EC & MC (Inguinal
Region)
4-9-74
LS<>
3-6-74 3-7-74 3-8-74
2-25-74
3-22-74
3-22-74
EC St MC (Femoral
region)
3-23-74
3-25-74
3-30-74
4-3-74
4-3-74
4-5-74
4-5-74
4-5-74
MC (Axillary
region)
4-5-74
4-7-74
4-8-74
EC (Para-Aural)
MC (Abdomen)
EC( Pelvic region) 4-9-74
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Group
T-I T-II T-IU
TABLE III
9w&u6t/u&l BIO - T E S T J!&{>&uitouie6'l JMc.
1810 FRONTAGE ROAD NORTHBROOK, ILLINOIS 60062
Summary of Mortality & Tumor Data Among Vinyl Chloride Mice IBT Number 663-03222 (MCA)
No. Mortalities with Neoplasms
Location ot Tumors
......."
Lung
Liver
Skin Metastasis- Lunj
4 (1 Male, 3 Females)
2(50%)
2(50%)
2(50%) 2
6 (1 Male, 5 Females)
3(50%)
4(66. 7%) 2(33%)
1
19 (4 Males, 15 Females)
17(89.5%] 17(89.5 %) 3(15.8%)
Key to Symbols
* Alveologenic Adenoma of J ung (AA) Hemangiosarcoma of Liver (US)
** Epidermoid Carcinoma of Skin (EC) + Mammary Carcinoma of Skin (MC) (3 Lymphosarcoma of Thymus (s) Multiple tumors of indicated type
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W. A. K.
MANUFACTURING CHEMISTS ASSOCIATIQ^
1825 CONNECTICUT AVENUE. N. W.
WASHINGTON. D. C. 20009
19fa
FOR RELEASE-----------------------------------------------------------------------------------
CONTACT:
For Immediate Release
Richard F. Blevitt
(202) 483-6126, eat. 282
WASHINGTON, D. C., April 16 -- The Manufacturing Chemists Association (MCA) announced today preliminary indications that vinyl chloride exposure has produced angiosarcoma -- a liver cancer -- in mice at several exposure levels.
Industrial Bio-Test Laboratories, Inc., who are conducting the MCA-administered vinyl chloride animal exposure study, informed MCA that their work -- although very preliminary at this point -- tends to confirm the findings of Professor Cesare Maltoni, an Italian scientist who found that vinyl chloride exposure in rats caused cancer.
MCA immediately notified the Occupational Safety and Health Administration, the National Institute for Occupational Safety and Health and the Environmental Protection Agency of the preliminary test results.
In the MCA-administered study, rats, hamsters and mice are being exposed seven hours a day, five days a week, to 2500 parts per million (ppm), 200 ppm and 50 ppm. After seven months of exposure, angiosarcoma has been observed in mice at all levels, but not in rats or hamsters.
(more)
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Professor Maltoni reported at the OSHA hearings on vinyl chloride February 15 that he had observed the liver cancer in rats exposed four hours a day, five days a week, to 250 ppm for up to 12 months. However, he did not find the cancer in testing at the 50 ppm level.
The animal exposure study is continuing. Another MCAadministered study on the chemical, documenting the health experience of present and former employees who have worked with the material, the results of which also will be released, is expected to be completed in the near future. Further vinyl chloride testing is under consideration.
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MCA-3839
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