Single-Dose Toxicity Mice1) : Maximum 5000 mg/kg in a single oral administration • No cases of animal death were reported. Repeated-Dose Toxicity Rats1): Maximum 1200 mg/kg  13-week oral administration Rats2): Maximum 1000 mg/kg  5-week oral administration Rats2): Maximum 600 mg/kg  26-week oral administration Rabbits3): Maximum 600 mg/kg  23-day oral administration • No abnormalities were reported with regard to body weight, general condition, blood and biochemical findings, necropsy, or histopathology. Mutagenicity Test 1) Chromosome Aberration Test:  Chinese hamster lung fibroblast (CHL/IU) cells • Neither structural chromosomal aberrations nor numerical chromosomal aberrations were induced. Ames Test: One strain of E. coli and four strains of Salmonella typhimurium • No reverse mutagenic activity was observed in any of the strains. Teratogenicity Test 4) Primigravid rats and mice:  600 mg/kg/day, orally administered for 7 consecutive days during fetal organogenesis • No fatalities, growth suppression, or teratogenicity to embryos, nor influence on form or functional differentiation of newborns was observed. Irritation Test (Skin and Eyes) 1) Primary Skin Irritation Test (rabbits):  Ten mg/mL or 1 mg/mL was applied to normal skin and broken skin of male rabbits for 24 hrs. • No skin irritation reaction was observed on any of the treated areas. Accumulated Skin Irritation Test (rabbits):  A 0.1% solution was applied repeatedly eleven times to normal skin and broken skin of five rabbits. • No skin irritation reaction was observed on any of the treated areas. Primary Ocular Irritation Test (rabbits):   Ten mg/mL or 1 mg/mL was applied to the conjunctival sacs of rabbit eyes. • No primary ocular irritation was observed. Photo-irritation Test (guinea pigs): 　Five w/v% solution was applied to the skin, which was subsequently exposed to ultraviolet radiation. • No skin reaction was observed on any of the treated areas 24, 48 or 72 hours after exposure to ultraviolet radiation. Sensitization Test 1) Skin Sensitization Test (guinea pigs):  Up to a maximum 2.5 w/v% solution was applied to the skin after an endermic injection of a 10 w/v% suspension, and then a 10 w/v% solution was applied to the skin. • No skin reaction was observed on any of the treated areas 24, 48 or 72 hours after application. Photo Sensitization Test (guinea pigs):  Ten w/v% solution was applied to the skin, and then up to a maximum 2.5 w/v% solution was applied to the skin, which was exposed to ultraviolet radiation. • No skin reaction was observed on any of the treated areas. 1) In-house data, Asahi Kasei Pharma Corporation 2) Chiba T, et al., Oyo Yakuri, 6 (4), 769-779 (1972) 3) Chiba T, et al., Oyo Yakuri, 6 (4), 781-786 (1972) 4) Notake Y, et al., Iyakuhin Kenkyu, 3 (3), 306-315 (1972)