SCCS/0963/05 10 NOAEL rows Safety conclusion

p-Methylaminophenol sulphate (INCI name), p-Methylaminophenol sulphate, COLIPA A22

Structured SCCS opinion summary generated from source-matched D1 rows for SCCS/0963/05.

Opinion Number

SCCS/0963/05

NOAEL Rows

Substances Covered

Substance(s) Covered

p-Methylaminophenol sulphate (INCI name) p-Methylaminophenol sulphate, COLIPA A22

NOAEL Values Extracted from This Opinion

Substance	Endpoint	Value	Study	Source
p-Methylaminophenol sulphate (INCI name) 150-75-4	NOAEL	5 mg/kg/day	Not recorded	Regulatory source p.21 SCCS Opinion
p-Methylaminophenol sulphate (INCI name) 150-75-4	NOAEL	5 mg/kg/day	Not recorded	Regulatory source p.21 SCCS Opinion
p-Methylaminophenol sulphate (INCI name) 150-75-4	NOAEL	125 mg/kg/day	Not recorded	Regulatory source p.21 SCCS Opinion
p-Methylaminophenol sulphate (INCI name) 150-75-4	carcinogenicity	10 mg/kg/day	carcinogenicity Chronic	Regulatory source p.14 SCCS Opinion
p-Methylaminophenol sulphate (INCI name) 150-75-4	carcinogenicity	10 mg/kg/day	carcinogenicity Chronic	Regulatory source p.14 SCCS Opinion
p-Methylaminophenol sulphate (INCI name) 150-75-4	developmental toxicity	0.047 mg/kg	developmental toxicity rat oral prenatal	Regulatory source p.22 SCCS Opinion
p-Methylaminophenol sulphate (INCI name) 150-75-4	developmental toxicity	5 mg/kg	developmental toxicity rat oral prenatal	Regulatory source p.22 SCCS Opinion
p-Methylaminophenol sulphate (INCI name) 150-75-4	developmental toxicity	5 mg/kg	developmental toxicity rat oral prenatal	Regulatory source p.22 SCCS Opinion
p-Methylaminophenol sulphate (INCI name) 150-75-4	developmental toxicity	10 mg/kg bw/day	developmental toxicity rat oral prenatal	Regulatory source p.22 SCCS Opinion
p-Methylaminophenol sulphate (INCI name) 150-75-4	developmental toxicity	10 mg/kg bw/day	developmental toxicity rat oral prenatal	Regulatory source p.22 SCCS Opinion

Safety Conclusion

sccs_opinions Max 0.68%

Based on the information provided, the SCCP is of the opinion that the use of p-methylaminophenol sulphate itself as an oxidative hair dye at a maximum concentration of 0.68% in the finished cosmetic product (after mixing with hydrogen peroxide) does not pose a risk to the health of the consumer, apart from its sensitising potential.

Key concerns: Does not pose a risk apart from its sensitising potential. As a secondary amine it is prone to nitrosation; should not be used with nitrosating substances; nitrosamine content should be < 50 ppb. Genotoxicity/mutagenicity studies on finished hair dye formulations should be undertaken.

Opinion date: 2006-03-28

Source Citation

Primary source https://health.ec.europa.eu/scientific-committees/scientific-committee-consumer-safety-sccs/sccs-opinions_en