SCCS/1080/07 11 NOAEL rows Safety conclusion

HC Yellow No. 10, HC Yellow n° 10 (COLIPA n° B81)

Structured SCCS opinion summary generated from source-matched D1 rows for SCCS/1080/07.

Opinion Number

SCCS/1080/07

NOAEL Rows

Substances Covered

Substance(s) Covered

HC Yellow No. 10 HC Yellow n° 10 (COLIPA n° B81)

NOAEL Values Extracted from This Opinion

Substance	Endpoint	Value	Study	Source
HC Yellow No. 10 109023-83-8	NOAEL	100 mg/kg/day	Not recorded	Regulatory source p.13 SCCS Opinion
HC Yellow No. 10 109023-83-8	NOAEL	125 mg/kg/day	oral 93 days	Regulatory source p.13 SCCS Opinion
HC Yellow No. 10 109023-83-8	dermal absorption	0.0016 mg/kg	dermal absorption rat oral 90-day	Regulatory source p.19 SCCS Opinion
HC Yellow No. 10 109023-83-8	dermal absorption	100 mg/kg	dermal absorption rat oral 90-day	Regulatory source p.19 SCCS Opinion
HC Yellow No. 10 109023-83-8	dermal absorption	100 mg/kg	dermal absorption rat oral 90-day	Regulatory source p.19 SCCS Opinion
HC Yellow No. 10 109023-83-8	dermal absorption	500 mg/kg bw	dermal absorption rat oral 28-day	Regulatory source p.5 SCCS Opinion
HC Yellow No. 10 109023-83-8	developmental toxicity	100 mg/kg/day	developmental toxicity rat	Regulatory source p.18 SCCS Opinion
HC Yellow No. 10 109023-83-8	developmental toxicity	100 mg/kg/day	developmental toxicity rat	Regulatory source p.18 SCCS Opinion
HC Yellow No. 10 109023-83-8	developmental toxicity	100 mg/kg/day	developmental toxicity rat oral 90-day	Regulatory source p.19 SCCS Opinion
HC Yellow No. 10 109023-83-8	developmental toxicity	100 mg/kg/day	developmental toxicity rat oral 90-day	Regulatory source p.19 SCCS Opinion
HC Yellow No. 10 109023-83-8	developmental toxicity	2000 mg/kg	developmental toxicity rat oral 90-day	Regulatory source p.19 SCCS Opinion

Safety Conclusion

sccs_opinions Max 0.1% (on-head)

The SCCP is of the opinion that the use of HC Yellow n°10 itself as a semi-permanent hair dye at an on-head concentration of maximum 0.1% does not pose a risk to the health of the consumer.

Key concerns: HC Yellow n°10 is a secondary amine; should not be used in combination with nitrosating substances; nitrosamine content should be < 50 ppb.

Opinion date: 2007-06-19

Source Citation

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