SCCS/1103/07 21 NOAEL rows Safety conclusion

HC Orange No. 2, HC Orange n° 2

Structured SCCS opinion summary generated from source-matched D1 rows for SCCS/1103/07.

Opinion Number

SCCS/1103/07

NOAEL Rows

Substances Covered

Substance(s) Covered

HC Orange No. 2 HC Orange n° 2

NOAEL Values Extracted from This Opinion

Substance	Endpoint	Value	Study	Source
HC Orange No. 2 85765-48-6	NOAEL	20 mg/kg/day	Not recorded	Regulatory source p.21 SCCS Opinion
HC Orange No. 2 85765-48-6	NOAEL	100 mg/kg bw/day	90-day	Regulatory source p.22 SCCS Opinion
HC Orange No. 2 85765-48-6	NOAEL	150 mg/kg bw	90-day	Regulatory source p.22 SCCS Opinion
HC Orange No. 2 85765-48-6	NOAEL	500 mg/kg/day	Not recorded	Regulatory source p.21 SCCS Opinion
HC Orange No. 2 85765-48-6	NOAEL	100 mg/kg/day	developmental toxicity rat oral developmental	SCCS Opinion p.21 SCCS Opinion
HC Orange No. 2 85765-48-6	NOAEL	100 mg/kg/day	developmental toxicity rat oral developmental	SCCS Opinion p.21 SCCS Opinion
HC Orange No. 2 85765-48-6	NOAEL	100 mg/kg/day	developmental toxicity rat oral developmental	SCCS Opinion p.21 SCCS Opinion
HC Orange No. 2 85765-48-6	NOAEL	100 mg/kg/day	developmental toxicity rat oral developmental	SCCS Opinion p.21 SCCS Opinion
HC Orange No. 2 85765-48-6	NOAEL	500 mg/kg bw/day	developmental toxicity rabbit developmental	SCCS Opinion p.23 SCCS Opinion
HC Orange No. 2 85765-48-6	NOAEL	500 mg/kg bw/day	developmental toxicity rabbit developmental	SCCS Opinion p.23 SCCS Opinion
HC Orange No. 2 85765-48-6	NOAEL	500 mg/kg bw/day	developmental toxicity rabbit developmental	SCCS Opinion p.23 SCCS Opinion
HC Orange No. 2 85765-48-6	NOAEL	500 mg/kg bw/day	developmental toxicity rabbit developmental	SCCS Opinion p.23 SCCS Opinion
HC Orange No. 2 85765-48-6	dermal absorption	0.016 mg/kg	dermal absorption rat oral	Regulatory source p.22 SCCS Opinion
HC Orange No. 2 85765-48-6	dermal absorption	20 mg/kg bw	dermal absorption rat oral	Regulatory source p.22 SCCS Opinion
HC Orange No. 2 85765-48-6	dermal absorption	20 mg/kg bw	dermal absorption rat oral	Regulatory source p.22 SCCS Opinion
HC Orange No. 2 85765-48-6	dermal absorption	150 mg/kg/day	dermal absorption rat oral 90 day	Regulatory source p.5 SCCS Opinion
HC Orange No. 2 85765-48-6	developmental toxicity	20 mg/kg/day	developmental toxicity rabbit developmental	Regulatory source p.23 SCCS Opinion
HC Orange No. 2 85765-48-6	developmental toxicity	100 mg/kg/day	developmental toxicity rat oral developmental	Regulatory source p.21 SCCS Opinion
HC Orange No. 2 85765-48-6	developmental toxicity	100 mg/kg bw/day	developmental toxicity rabbit developmental	Regulatory source p.23 SCCS Opinion
HC Orange No. 2 85765-48-6	developmental toxicity	500 mg/kg bw/day	developmental toxicity rabbit developmental	Regulatory source p.23 SCCS Opinion
HC Orange No. 2 85765-48-6	genotoxicity	500 mg/kg/day	genotoxicity Chronic	Regulatory source p.16 SCCS Opinion

Safety Conclusion

sccs_opinions Max 1.0% on the head

The SCCP is of the opinion that, apart from the risks associated with the use of a strong sensitiser, the use of HC Orange n° 2, at a maximum concentration of 1.0% on the head, does not pose any other risk to the health of the consumer.

Key concerns: Strong skin sensitiser (per EC3-value); secondary amine prone to nitrosation, should not be used with nitrosating substances, nitrosamine content should be < 50 ppb.

Opinion date: 18 December 2007

Source Citation

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