Reproductive toxicology Japan

Reproductive toxicology, usually embryo/ foetal development studies in two species, is required in Europe and Japan if women of childbearing potential are included. Not required in the United States for some early trials... 

Based on this characterization of the reproductive cycle, testing strategies were developed to detect effects on reproduction. The first fundamental introduction in reproductive toxicology was given by Wilson and Warkany in 1965b. The first test guideline was published by the FDA in 1966, followed by the CSM (1974), MHW of Japan (1975) and many other... 

In Japan, there has been harmonization with the other regions in the area of toxicology (animal studies) the Japanese Ministry of Health, Labor and Welfare (MHLW) accepts appropriate foreign animal data and animal safety studies performed according to ICH guidelines. Indeed, Japan has played a major role, and its then current fertility and reproductive animal studies requirements have been adopted by the other two regions. 

C) m.p. 295 C subl. 145-148 C Toxicology LD50 (IP, rat) 5379 mg/kg LDLo (subcut., rabbit) 2620 mg/kg mod. toxic by subcut. route experimental teratogen, reproductive effects TSCA listed Hazardous Decomp. Prods. Heated to decomp., emits toxic fumes of NOx Uses Antistat in cosmetics nutrient, dietary supplement, flavor modifier in foods biochemical research infusion sol ns. diagnostic aids raw material in peptide drugs flavor in pharmaceuticals food flavoring (Japan)... 

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