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11. |
Application of the preliminary developmental toxicity screen for chemical hazard identification under the toxic substances control act |
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Teratogenesis, Carcinogenesis, and Mutagenesis,
Volume 7,
Issue 1,
1987,
Page 107-117
Elaine Z. Francis,
William H. Farland,
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摘要:
AbstractThe Office of Toxic Substances (OTS) within the U.S. Environmental Protection Agency (EPA) is authorized to carry forth the mandates of the Toxic Substances Control Act (TSCA). Included among the provisions of TSCA are the development of requirements for testing of “new” and “existing” chemicals thatmaypresent an unreasonable risk of injury to health or the environment. There are over 63,000 “existing” chemicals on the TSCA inventory, and EPA in recent years has been receiving an average of over 1,300 submissions for “new” chemicals a year. Since it is illogical and unrealistic to expect that all of these chemicals should be subjected to detailed testing for all potential adverse health and environmental effects, OTS views screening assays as highly useful tools to assign priorities to chemicals for further testing according to standard methodologies. The Chernoff/Kavlock assay (preliminary developmental toxicity screen) was specifically developed to address the need for a developmental toxicity assay to prioritize for further testing the large number of “new” and “existing” chemicals. OTS has been involved in seeking the development of data through the preliminary developmental toxicity screen for purposes of validating the screen and to obtain critical data necessary for evaluating chemicals. OTS believes that the screen has a role in the risk assessment process and has developed a testing protocol, which is included along with other OTS test guidelines; has provided internal guidance on when the screen may be recommended; and has discussed how the data may be applied in prioritizing chem
ISSN:0270-3211
DOI:10.1002/tcm.1770070113
出版商:Wiley Subscription Services, Inc., A Wiley Company
年代:1987
数据来源: WILEY
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12. |
Overview and summary: Workshop on the Chernoff/Kavlock preliminary developmental toxicity test |
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Teratogenesis, Carcinogenesis, and Mutagenesis,
Volume 7,
Issue 1,
1987,
Page 119-127
Bryan D. Hardin,
Richard A. Becker,
Robert J. Kavlock,
Janice M. Seidenberg,
Neil Chernoff,
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摘要:
AbstractThe Chernoff/Kavlock assay, proposed as a preliminary screen for teratogenic potential, was the subject of a 2‐day workshop sponsored by the National Institute for Occupational Safety and Health. Data from three large testing programs were presented, representing tests of 165 chemicals, of which 33 were tested at least twice. Applications of the test in industrial laboratories and product development, hazard identification, and risk assessment were discussed. Workshop participants recognized the assay as one of several valid ways to preliminarily evaluate chemicals with unknown developmental toxicity. Other preliminary tests were also discussed in terms of their relationship to this test, which was seen as having the advantage of providing information on neonatal viability. Other techniques, particularly an abbreviated conventional teratology study, were also recognized as appropriate screens. The preferred test in a particular laboratory will be dependent upon the particular skills and objectives of that laboratory. Standardized protocols were suggested, but flexibility in experimental design was considered necessary, and many variations on the basic test could be appropriate. This preliminary test has been used most often as a single‐dose test in mice, but might provide more generally useful data if conducted in rats using two dose levels. Workshop participants viewed the test as highly reliable in correctly identifying developmentally toxic chemicals and suggested that a negative finding in a properly conducted Chernoff/Kavlock test could be a sufficient basis for regulatory agencies to determine that conventional teratology tests in the same species are not warran
ISSN:0270-3211
DOI:10.1002/tcm.1770070114
出版商:Wiley Subscription Services, Inc., A Wiley Company
年代:1987
数据来源: WILEY
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13. |
Preface |
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Teratogenesis, Carcinogenesis, and Mutagenesis,
Volume 7,
Issue 1,
1987,
Page -
Marvin S. Legator,
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PDF (28KB)
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ISSN:0270-3211
DOI:10.1002/tcm.1770070102
出版商:Wiley Subscription Services, Inc., A Wiley Company
年代:1987
数据来源: WILEY
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