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EC number: 204-616-2
CAS number: 123-30-8
In a reproduction and developmental
toxicity screening test in rats [OECD TG 421], 4-Aminophenol was
administered orally by gavage at doses of 0, 20, 100 and 500 mg/kg/day,
and reproductive performance in parental animals and development and
growth of F1 offspring were examined. As a result, systemic toxic
effects including effects on urine color and food consumption were
observed at 100 mg/kg and higher in parental animals. No abnormalities
were found for the indices of development and growth up to 100
mg/kg/day, and no teratogenicity was found up to 500 mg/kg/day. Thus the
NOAELs for reproductive toxicity in parents and developmental toxicity
in F1 offspring were considered to be 20 and 100 mg/kg/day,
respectively. Under the conditions of the study, the substance was not
A developmental and reproductive toxicity screening study performed according to GLP and OECD guidelines and several studies reported in the literature on the potential for developmental toxicity did not indicate that 4-aminophenol has the potential to be a reproductive or developmental toxicant. Although at this tonnage a 2-generation reproductive study may be needed, it is felt that the number of studies performed to date, the NOAEL doses and lack of indication of these effects would preclude the need to conduct such a study.
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