SCCS/1122/07 6 NOAEL rows Safety conclusion

2,5,6-Triamino-4-pyrimidinol sulfate

Structured SCCS opinion summary generated from source-matched D1 rows for SCCS/1122/07.

Opinion Number

SCCS/1122/07

NOAEL Rows

Substances Covered

Substance(s) Covered

2,5,6-Triamino-4-pyrimidinol sulfate

NOAEL Values Extracted from This Opinion

Substance	Endpoint	Value	Study	Source
2,5,6-Triamino-4-pyrimidinol sulfate 1603-02-7	NOAEL	1000 mg/kg bw/day	human	Regulatory source p.18 SCCS Opinion
2,5,6-Triamino-4-pyrimidinol sulfate 1603-02-7	genotoxicity	200 mg/kg bw/day	genotoxicity Chronic	Regulatory source p.14 SCCS Opinion
2,5,6-Triamino-4-pyrimidinol sulfate 1603-02-7	genotoxicity	200 mg/kg bw/day	genotoxicity Chronic	Regulatory source p.14 SCCS Opinion
2,5,6-Triamino-4-pyrimidinol sulfate 1603-02-7	repeated dose toxicity	200 mg/kg bw/day	repeated dose toxicity rat oral Sub-chronic	Regulatory source p.13 SCCS Opinion
2,5,6-Triamino-4-pyrimidinol sulfate 1603-02-7	repeated dose toxicity	200 mg/kg bw/day	repeated dose toxicity rat oral subchronic	Regulatory source p.19 SCCS Opinion
2,5,6-Triamino-4-pyrimidinol sulfate 1603-02-7	repeated dose toxicity	200 mg/kg bw/day	repeated dose toxicity rat oral subchronic	Regulatory source p.19 SCCS Opinion

Safety Conclusion

sccs_opinions Max 0.5%

The SCCP is of the opinion that the safe use of 2,5,6-triamino-4-pyrimidinol sulfate as an ingredient in oxidative hair dye formulations at a maximum concentration of 0.5% on the head cannot be assessed.

Key concerns: Safe use cannot be assessed at 0.5% on the head. The potential for induction of gene mutations has to be clarified. Genotoxicity/mutagenicity studies in finished hair dye formulations should be undertaken. A skin sensitising potential cannot be excluded.

Opinion date: 30 September 2008

Source Citation

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