SCCS/0981/06 13 NOAEL rows Safety conclusion

HC Red n° 1 (INCI name), HC Red n° 1

Structured SCCS opinion summary generated from source-matched D1 rows for SCCS/0981/06.

Opinion Number

SCCS/0981/06

NOAEL Rows

Substances Covered

Substance(s) Covered

HC Red n° 1 (INCI name) HC Red n° 1

NOAEL Values Extracted from This Opinion

Substance	Endpoint	Value	Study	Source
HC Red n° 1 (INCI name) 2784-89-6	NOAEL	5 mg/kg bw/d	rabbit oral 13 weeks	Regulatory source p.16 SCCS Opinion
HC Red n° 1 (INCI name) 2784-89-6	NOAEL	20 mg/kg bw/d	rabbit oral	Regulatory source p.16 SCCS Opinion
HC Red n° 1 (INCI name) 2784-89-6	NOAEL	20 mg/kg bw/d	rabbit oral	Regulatory source p.16 SCCS Opinion
HC Red n° 1 (INCI name) 2784-89-6	developmental toxicity	25 mg/kg/day	developmental toxicity oral developmental	Regulatory source p.31 SCCS Opinion
HC Red n° 1 (INCI name) 2784-89-6	developmental toxicity	125 mg/kg bw/d	developmental toxicity developmental	Regulatory source p.31 SCCS Opinion
HC Red n° 1 (INCI name) 2784-89-6	repeated dose toxicity	0.0294 mg/kg	repeated dose toxicity rat oral subchronic	Regulatory source p.33 SCCS Opinion
HC Red n° 1 (INCI name) 2784-89-6	repeated dose toxicity	5 mg/kg	repeated dose toxicity rat oral subchronic	Regulatory source p.33 SCCS Opinion
HC Red n° 1 (INCI name) 2784-89-6	repeated dose toxicity	5 mg/kg	repeated dose toxicity rat oral subchronic	Regulatory source p.33 SCCS Opinion
HC Red n° 1 (INCI name) 2784-89-6	repeated dose toxicity	5 mg/kg bw/d	repeated dose toxicity rat oral subchronic	Regulatory source p.33 SCCS Opinion
HC Red n° 1 (INCI name) 2784-89-6	repeated dose toxicity	25 mg/kg/day	repeated dose toxicity rat oral subchronic	Regulatory source p.33 SCCS Opinion
HC Red n° 1 (INCI name) 2784-89-6	repeated dose toxicity	50 mg/kg bw/d	repeated dose toxicity rat oral 91-day	Regulatory source p.14 SCCS Opinion
HC Red n° 1 (INCI name) 2784-89-6	repeated dose toxicity	50 mg/kg bw/d	repeated dose toxicity rat oral 91-day	Regulatory source p.14 SCCS Opinion
HC Red n° 1 (INCI name) 2784-89-6	repeated dose toxicity	125 mg/kg bw/d	repeated dose toxicity mouse dermal subchronic	Regulatory source p.33 SCCS Opinion

Safety Conclusion

sccs_opinions Max 1.0%

The SCCP is of the opinion that the use of HC Red n° 1 in semi-permanent hair dye formulation at a maximum final concentration of 1.0% does not pose a risk to the health of the consumer, apart from its sensitising property.

Key concerns: Sensitising property; genotoxicity/mutagenicity studies of finished hair dye formulations should be undertaken per SCCNFP/SCCP opinions and Notes of Guidance.

Opinion date: 10 October 2006

Source Citation

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