Evaluating Chemical and Other Agent Exposures for Reproductive and Developmental Toxicity (2001) / Chapter Skim
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Pages 86-91
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From page 86... ...
The risk of adverse reproductive or developmental effects from exposure to a given substance should be considered only in the context of the exposure situation. In this way, both the agent itself and the conditions of exposure, including the dose, route, timing, and duration of exposure are considered, rather than "labeling" an agent either as "toxic" or as "safe." The subcommittee acknowledges that the Navy might need to use a screening process in which decisions are made in a dichotomous 86
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From page 87... ...
In cases in which the data set is incomplete or insufficient, evaluators should assume that susceptibility to reproductive or developmental toxicity may be greater than susceptibility to any known toxicity of the agent, and apply adlditionaZ uncertainty factors to refect the degree of uncertainty attributable to missing data. When the reproductive and developmental risks of a particular exposure cannot be fully characterized, a conservative approach is to assume that such risks exist with exposure conditions below those that produce toxicity for the most sensitive system known for the agent.
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From page 88... ...
DART is a bibliographic database that covers the literature on teratology and other aspects of reproductive and developmental toxicology. DART is an essential resource to the Navy for gathering information on the potential reproductive and developmental effects of agents because it greatly simplifies the process for searching for literature in this area.
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From page 89... ...
To account for such incomplete or inadequate data sets, an uncertainty factor is applied to the no-observed-adverse-effect level, lowestobserved-adverse-effect level, or benchmark dose. It is possible that such uncertainty could lead to the calculation of an exposure limit that is more conservative than necessary and, based on those limits, the Navy could decide to curtail use of specific substances or institute costly exposure control measures.
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From page 90... ...
This would provide important baseline information and permit study of maternally and paternally mediated effects. The reproductive history should address sexual activity and inactivity, sexual libido, sexual dysfunction, semen analysis, menstruation history, pregnancy intentions, time-to-pregnancy (conception delays, fecundability, infertility)
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From page 91... ...
Research also should be conducted to illuminate exposure scenarios associated with chemical mixtures.
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