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1. Comments from the Developmental Neurotoxicology Committee of the Japanese Teratology Society on the OECD Guideline for the Testing of Chemicals, Proposal for a New Guideline 426, Developmental Neurotoxicity Study, Draft Document (October 2006 version), and on the Draft Document of the Retrospective Performance Assessment of the Draft Test Guideline 426 on Developmental Neurotoxicity.

Author

Ema M, Fukui Y, Aoyama H, Fujiwara M, Fuji J, Inouye M, Iwase T, Kihara T, Oi A, Otani H, Shinomiya M, Sugioka K, Yamano T, Yamashita KH, and Tanimura T

Subjects
Abnormalities, Drug-Induced diagnosis, Female, Fetus drug effects, Guidelines as Topic, Humans, Japan, Pregnancy, Developmental Biology, Hazardous Substances toxicity, Reproduction drug effects, Research Design standards, Teratogens pharmacology, Teratology, Toxicity Tests methods, Toxicity Tests standards
Abstract

In October 2006, a new revision of the draft guideline (OECD Guideline for the Testing of Chemicals, Proposal for a New Guideline 426. Developmental Neurotoxicity Study) and Draft Document of the Retrospective Performance Assessment (RPA) of the Draft Test Guideline 426 on Developmental Neurotoxicity were distributed following incorporation of the results of the Expert Consultation Meeting in Tokyo on May 24-26, 2005. The draft guideline consists of 50 paragraphs and an appendix with 102 references; and the draft RPA consists of 37 paragraphs with 109 references. National coordinators were requested to arrange for national expert reviews of these draft documents in their member countries. Members of the Developmental Neurotoxicology (DNT) Committee of the Japanese Teratology Society (JTS) reviewed, discussed, and commented on the draft Test Guideline Proposal. The DNT Committee of the JTS also commented on the draft document of the RPA. These comments were sent to the OECD Secretariat. The DNT Committee of the JTS expects the comments to be useful for the finalization of these draft documents.

Published
2007
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2. Comments from the Behavioral Teratology Committee of the Japanese Teratology Society on OECD guideline for the testing of chemicals, proposal for a new guideline 426, developmental neurotoxicity study, draft document (September 2003).

Author

Fukui Y, Ema M, Fujiwara M, Higuchi H, Inouye M, Iwase T, Kihara T, Nishimura T, Oi A, Ooshima Y, Otani H, Shinomiya M, Sugioka K, Yamano T, Yamashita KH, and Tanimura T

Subjects
Behavior drug effects, Developmental Biology, Research Design standards, Teratogens pharmacology, Teratology
Abstract

In September 2003, a new revision of the draft guideline (Organization for Economic Co-operation and Development [OECD] Guideline for the Testing of Chemicals, Proposal for a New Guideline 426, Developmental Neurotoxicity Study) was distributed. The draft guideline consists of 51 paragraphs and an appendix. The National Coordinators were requested to arrange national expert reviews of the guideline proposal in their member countries. The member of the Behavioral Teratology (BT) Committee of the Japanese Teratology Society (JTS) reviewed, discussed and commented on the draft Test Guideline proposal. The BT Committee of the JTS also commented that the International Collaborative Study to validate this protocol should be definitely performed. These comments were sent to the OECD Secretariat. The BT Committee of the JTS expects that the comments are useful for further discussion.

Published
2004
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