SCCS/1225/09 7 NOAEL rows Safety conclusion

. Before any further consideration, the following, 5-Amino-6-chloro-o-cresol (COLIPA A94)

Structured SCCS opinion summary generated from source-matched D1 rows for SCCS/1225/09.

Opinion Number

SCCS/1225/09

NOAEL Rows

Substances Covered

Substance(s) Covered

. Before any further consideration, the following 5-Amino-6-chloro-o-cresol (COLIPA A94)

NOAEL Values Extracted from This Opinion

Substance	Endpoint	Value	Study	Source
. Before any further consideration, the following 84540-50-1	NOAEL	100 mg/kg/day	Not recorded	Regulatory source p.16 SCCS Opinion
. Before any further consideration, the following 84540-50-1	dermal absorption	33 mg/kg bw/day	dermal absorption rabbit dermal 90-day	Regulatory source p.24 SCCS Opinion
. Before any further consideration, the following 84540-50-1	developmental toxicity	24 mg/kg bw/d	developmental toxicity rat developmental	Regulatory source p.21 SCCS Opinion
. Before any further consideration, the following 84540-50-1	developmental toxicity	90 mg/kg/d	developmental toxicity rat developmental	Regulatory source p.21 SCCS Opinion
. Before any further consideration, the following 84540-50-1	developmental toxicity	90 mg/kg/d	developmental toxicity rat developmental	Regulatory source p.21 SCCS Opinion
. Before any further consideration, the following 84540-50-1	developmental toxicity	270 mg/kg bw/d	developmental toxicity rat developmental	Regulatory source p.21 SCCS Opinion
. Before any further consideration, the following 84540-50-1	irritation	30 mg/kg bw/d	irritation rat 90-day	Regulatory source p.24 SCCS Opinion

Safety Conclusion

sccs_opinions Max 2.0% (on-head; deemed unsafe at this level)

Because of the low margin of safety for the use in both oxidative and non-oxidative hair dye formulations, the SCCS is of the opinion that the use of 5-amino-6-chloro-o-cresol as a hair dye ingredient up to a final on-head concentration of 2.0% under oxidative and nonoxidative conditions poses a risk to the health of the consumer.

Key concerns: Low margin of safety at 2.0% on-head concentration under both oxidative and non-oxidative conditions.

Opinion date: 8 December 2009 (Revision of 07 January 2011)

Source Citation

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