| Cross-species extrapolations and the biologic basis for safety factor determinations in developmental toxicology. | |
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MedLine Citation:
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PMID: 3285379 Owner: NLM Status: MEDLINE |
Abstract/OtherAbstract:
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Designations of agents as teratogenic or nonteratogenic often are inaccurate, as adverse effects are more a reflection of the timing and severity of treatment during pregnancy than agent nature. Careful consideration of both the similarities and the differences between developmental effects in animals and humans and the extent and nature of the data available are essential for protection of the human conceptus. Animal surrogates prove reliable predictors of human developmental effect levels. When the data are evaluated consistent with contemporary concepts of developmental toxicity, for example, where the effect in the embryo is only seen at maternally toxic doses and exposure is below the adult toxic level, relatively modest safety factors are sufficient for safe cross-species extrapolation. Developmental toxicity safety factor magnitude is predicated on data quality and the fact that thresholds of effect exist in mammalian pregnancy. Safety of human concepti is achieved by considering both the developmental hazard index of the chemicals in question and the severity of exposure. |
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Authors:
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E M Johnson |
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Publication Detail:
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Type: Journal Article; Research Support, Non-U.S. Gov't; Review |
Journal Detail:
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Title: Regulatory toxicology and pharmacology : RTP Volume: 8 ISSN: 0273-2300 ISO Abbreviation: Regul. Toxicol. Pharmacol. Publication Date: 1988 Mar |
Date Detail:
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Created Date: 1988-06-16 Completed Date: 1988-06-16 Revised Date: 2006-11-15 |
Medline Journal Info:
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Nlm Unique ID: 8214983 Medline TA: Regul Toxicol Pharmacol Country: UNITED STATES |
Other Details:
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Languages: eng Pagination: 22-36 Citation Subset: IM |
Affiliation:
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Department of Anatomy, Daniel Baugh Institute, Jefferson Medical College, Philadelphia, Pennsylvania 19107. |
Export Citation:
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APA/MLA Format Download EndNote Download BibTex |
| MeSH Terms | |
Descriptor/Qualifier:
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Animals Humans Models, Biological Risk Factors Species Specificity Teratogens / toxicity* |
| Chemical | |
Reg. No./Substance:
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0/Teratogens |
From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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