Registration Dossier

Administrative data

Key value for chemical safety assessment

Effects on fertility

Effect on fertility: via oral route
Dose descriptor:
NOAEL
20 mg/kg bw/day
Additional information

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 considered teratogenic.


Short description of key information:
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.

Effects on developmental toxicity

Description of key information
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.
Effect on developmental toxicity: via oral route
Dose descriptor:
NOAEL
100 mg/kg bw/day
Additional information

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 considered teratogenic.

Justification for classification or non-classification