SCCS/1035/06 18 NOAEL rows Safety conclusion

HC Blue n° 2, HC Blue No 2

Structured SCCS opinion summary generated from source-matched D1 rows for SCCS/1035/06.

Opinion Number

SCCS/1035/06

NOAEL Rows

Substances Covered

Substance(s) Covered

HC Blue n° 2 HC Blue No 2

NOAEL Values Extracted from This Opinion

Substance	Endpoint	Value	Study	Source
HC Blue n° 2 33229-34-4	NOAEL	100 mg/kg bw/day	human	Regulatory source p.25 SCCS Opinion
HC Blue n° 2 33229-34-4	NOAEL	300 mg/kg/day	Not recorded	Regulatory source p.14 SCCS Opinion
HC Blue n° 2 33229-34-4	NOAEL	300 mg/kg/day	Not recorded	Regulatory source p.14 SCCS Opinion
HC Blue n° 2 33229-34-4	NOAEL	300 mg/kg bw/day	human	Regulatory source p.25 SCCS Opinion
HC Blue n° 2 33229-34-4	NOAEL	1000 mg/kg/day	rat oral 13-week	Regulatory source p.26 SCCS Opinion
HC Blue n° 2 33229-34-4	NOAEL	300 mg/kg bw/day	NOAEL study human	SCCS Opinion p.25 SCCS Opinion
HC Blue n° 2 33229-34-4	NOAEL	300 mg/kg bw/day	NOAEL study human	SCCS Opinion p.25 SCCS Opinion
HC Blue n° 2 33229-34-4	NOAEL	300 mg/kg bw/day	NOAEL study human	SCCS Opinion p.25 SCCS Opinion
HC Blue n° 2 33229-34-4	NOAEL	300 mg/kg bw/day	NOAEL study human	SCCS Opinion p.25 SCCS Opinion
HC Blue n° 2 33229-34-4	dermal absorption	0.0004 mg/kg	dermal absorption rat oral	Regulatory source p.25 SCCS Opinion
HC Blue n° 2 33229-34-4	dermal absorption	100 mg/kg	dermal absorption rat oral	Regulatory source p.25 SCCS Opinion
HC Blue n° 2 33229-34-4	dermal absorption	100 mg/kg	dermal absorption rat oral	Regulatory source p.25 SCCS Opinion
HC Blue n° 2 33229-34-4	developmental toxicity	100 mg/kg/day	developmental toxicity rat oral developmental	Regulatory source p.26 SCCS Opinion
HC Blue n° 2 33229-34-4	developmental toxicity	300 mg/kg/day	developmental toxicity developmental	Regulatory source p.24 SCCS Opinion
HC Blue n° 2 33229-34-4	developmental toxicity	300 mg/kg/day	developmental toxicity developmental	Regulatory source p.24 SCCS Opinion
HC Blue n° 2 33229-34-4	developmental toxicity	300 mg/kg/day	developmental toxicity developmental	Regulatory source p.24 SCCS Opinion
HC Blue n° 2 33229-34-4	developmental toxicity	300 mg/kg/day	developmental toxicity rat oral developmental	Regulatory source p.26 SCCS Opinion
HC Blue n° 2 33229-34-4	genotoxicity	100 mg/kg bw/day	genotoxicity rat Chronic	Regulatory source p.14 SCCS Opinion

Safety Conclusion

sccs_opinions Max 2.8%

Based on the information provided, the SCCP is of the opinion that the use of HC Blue n° 2 itself in semi-permanent hair dye formulations at a maximum concentration of 2.8% in the finished cosmetic product does not pose a risk to the health of the consumer, apart from its sensitising potential.

Key concerns: Sensitising potential; comprised of both secondary and tertiary amino groups, prone to nitrosation; must not be combined with nitrosating substances; nitrosamine content < 50 ppb.

Opinion date: 2006-12-19

Source Citation

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