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set of toxicological and environmental data on 2000 chemical substances with high production and use throughout the world. The Screening Information Data Set (SIDS) represents the core data that are assessed to determine whether a substance can be set aside with low priority for additional evaluation or needs further study because of possible environmental or human health effects. The data address physical and chemical properties and acute and repeated dose (28-day) mammalian toxicity. SIDS dossiers are reviewed by a committee of technical and scientific experts from OECD-member countries. More than 100 dossiers have been completed. Information on SIDS can be found on the Internet at <http://www.oecd.org/ehs/hpv.htm>.

Reproductive and Developmental Toxicity

The core data requirements include assessment of fertility and reproduction. This requirement is commonly met through a 28-day repeated-dose protocol in rats, which requires treated members of both sexes to be mated and females observed for pregnancy, parturition, and survival of pups through postnatal day 4. Histological evaluations of testis and ovary also are required. Positive test results are not considered definitive, in part because of the limited numbers of animals used, but they signal the need to confirm and expand the characterization of possible effects using more traditional protocols.

Quality Control

The studies are done according to a standardized OECD protocol and in compliance with good laboratory practices. Test results are reviewed by the responsible government entity within the country with lead responsibility. Dossiers are subsequently reviewed by an international committee of experts.

Usefulness in Identifying Exposures That Pose a Substantial Risk of Reproductive or Developmental Toxicity in Humans

The SIDS profiles rank chemical substances based on their potential environmental and human health effects. Some information on reproductive and developmental toxicity is included in each profile.



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