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Toxicological information

Carcinogenicity

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Description of key information

An oral  carcinogenicity conducted in the rat was negative at doses up to 30 mg/kg/day.

Key value for chemical safety assessment

Carcinogenicity: via oral route

Endpoint conclusion
Dose descriptor:
NOAEL
30 mg/kg bw/day

Additional information

4 -aminophenol was administered by daily gavage for at least 101 weeks to Sprague-Dawley rats at 2, 5, 12 and 30 mg/kg/day. Principal effects in this study were observed at 30 mg/kg/day and included a slightly lower survival rate in females and orange-coloured urine which may be due to urinary elimination of the test substance or its metabolites. The test substance showed neither a carcinogenic potential, nor an effect on the incidence of spontaneously occurring tumours at any dose-level. Moreover, the test substance did not induce a decrease in the onset of tumour appearance. Consequently, 4 -aminophenol was not considered carcinogenic under the test conditions. This study provides weight of evidence that the mutagenicity / clastogenicity effects observed in the micronucleus area did not "translate" to the in vivo carcinogenicity of 4 -aminophenol.

Justification for classification or non-classification

4 -aminophenol is not classified as carcinogenic based on a repeated oral oncogenicity study in rats.