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.
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.
Ema
Makoto
M
Division of Risk Assessment, Biological Safety Research Center, National Institute of Health Sciences, Tokyo, Japan. ema@nihs.go.jp
Fukui
Yoshihiro
Y
Aoyama
Hiroaki
H
Fujiwara
Michio
M
Fuji
Junichiro
J
Inouye
Minoru
M
Iwase
Takayuki
T
Kihara
Takahide
T
Oi
Akihide
A
Otani
Hiroki
H
Shinomiya
Mitsuhiro
M
Sugioka
Kozo
K
Yamano
Tsunekazu
T
Yamashita
Keisuke H
KH
Tanimura
Takashi
T
D000014:Abnormalities, Drug-Induced / Q000175:diagnosis; D015509:Developmental Biology; D005260:Female; D005333:Fetus / Q000187:drug effects; D017408:Guidelines as Topic; D015386:Hazardous Substances / Q000633:toxicity*; D006801:Humans; D007564:Japan; D011247:Pregnancy; D012098:Reproduction / Q000187:drug effects*; D012107:Research Design / Q000592:standards*; D013723:Teratogens / Q000494:pharmacology*; D018600:Teratology; D018675:Toxicity Tests / Q000379:methods* / Q000592:standards*
D015386:Hazardous Substances; D013723:Teratogens