SCCS/1575/16 119 NOAEL rows Safety conclusion

codes .................................... 6, Phenoxyethanol

Structured SCCS opinion summary generated from source-matched D1 rows for SCCS/1575/16.

Opinion Number

SCCS/1575/16

NOAEL Rows

119

Substances Covered

Substance(s) Covered

codes .................................... 6 Phenoxyethanol

NOAEL Values Extracted from This Opinion

Substance	Endpoint	Value	Study	Source
codes .................................... 6 122-99-6	NOAEL	0.2 %	rat oral	Regulatory source p.22 SCCS Opinion
codes .................................... 6 122-99-6	NOAEL	0.5 %	rat oral 4 weeks	Regulatory source p.21 SCCS Opinion
codes .................................... 6 122-99-6	NOAEL	0.5 %	oral	Regulatory source p.22 SCCS Opinion
codes .................................... 6 122-99-6	NOAEL	0.5 %	Not recorded	Regulatory source p.22 SCCS Opinion
codes .................................... 6 122-99-6	NOAEL	1 %	rat oral	Regulatory source p.60 SCCS Opinion
codes .................................... 6 122-99-6	NOAEL	1	human	Regulatory source p.61 SCCS Opinion
codes .................................... 6 122-99-6	NOAEL	1	human	Regulatory source p.61 SCCS Opinion
codes .................................... 6 122-99-6	NOAEL	1	Not recorded	Regulatory source p.100 SCCS Opinion
codes .................................... 6 122-99-6	NOAEL	1	Not recorded	Regulatory source p.100 SCCS Opinion
codes .................................... 6 122-99-6	NOAEL	2 mg/kg	intravenous	Regulatory source p.57 SCCS Opinion
codes .................................... 6 122-99-6	NOAEL	2	rat oral	Regulatory source p.100 SCCS Opinion
codes .................................... 6 122-99-6	NOAEL	2 mg/kg	Not recorded	Regulatory source p.57 SCCS Opinion
codes .................................... 6 122-99-6	NOAEL	2	human	Regulatory source p.61 SCCS Opinion
codes .................................... 6 122-99-6	NOAEL	2	human	Regulatory source p.61 SCCS Opinion
codes .................................... 6 122-99-6	NOAEL	2	Not recorded	Regulatory source p.100 SCCS Opinion
codes .................................... 6 122-99-6	NOAEL	2	Not recorded	Regulatory source p.100 SCCS Opinion
codes .................................... 6 122-99-6	NOAEL	2.69 mg/kg/d	rat dermal	Regulatory source p.63 SCCS Opinion
codes .................................... 6 122-99-6	NOAEL	2.69 mg/kg bw/day	rabbit dermal 90-day	Regulatory source p.72 SCCS Opinion
codes .................................... 6 122-99-6	NOAEL	4.5	Not recorded	Regulatory source p.57 SCCS Opinion
codes .................................... 6 122-99-6	NOAEL	5	Not recorded	Regulatory source p.57 SCCS Opinion
codes .................................... 6 122-99-6	NOAEL	7 %	Not recorded	Regulatory source p.57 SCCS Opinion
codes .................................... 6 122-99-6	NOAEL	9	rat oral	Regulatory source p.100 SCCS Opinion
codes .................................... 6 122-99-6	NOAEL	10	Not recorded	Regulatory source p.57 SCCS Opinion
codes .................................... 6 122-99-6	NOAEL	13	Not recorded	Regulatory source p.74 SCCS Opinion
codes .................................... 6 122-99-6	NOAEL	13	Not recorded	Regulatory source p.74 SCCS Opinion
codes .................................... 6 122-99-6	NOAEL	13	Not recorded	Regulatory source p.74 SCCS Opinion
codes .................................... 6 122-99-6	NOAEL	13	Not recorded	Regulatory source p.74 SCCS Opinion
codes .................................... 6 122-99-6	NOAEL	13	rabbit dermal	Regulatory source p.74 SCCS Opinion
codes .................................... 6 122-99-6	NOAEL	61	rat oral	Regulatory source p.61 SCCS Opinion
codes .................................... 6 122-99-6	NOAEL	75	rat oral 90 days	Regulatory source p.75 SCCS Opinion
codes .................................... 6 122-99-6	NOAEL	75	rat oral 90 days	Regulatory source p.75 SCCS Opinion
codes .................................... 6 122-99-6	NOAEL	75	rat oral 90 days	Regulatory source p.75 SCCS Opinion
codes .................................... 6 122-99-6	NOAEL	75	mouse oral 90 days	Regulatory source p.75 SCCS Opinion
codes .................................... 6 122-99-6	NOAEL	75	rat oral 2 years	Regulatory source p.75 SCCS Opinion
codes .................................... 6 122-99-6	NOAEL	75	mouse oral 2 years	Regulatory source p.75 SCCS Opinion
codes .................................... 6 122-99-6	NOAEL	79 %	rat oral 13-week	Regulatory source p.78 SCCS Opinion
codes .................................... 6 122-99-6	NOAEL	80 mg/kg bw/day	rat	Regulatory source p.23 SCCS Opinion
codes .................................... 6 122-99-6	NOAEL	80	rat oral 90 days	Regulatory source p.75 SCCS Opinion
codes .................................... 6 122-99-6	NOAEL	164 mg/kg bw/day	rat oral 90 days	Regulatory source p.75 SCCS Opinion
codes .................................... 6 122-99-6	NOAEL	164 mg/kg bw/day	rat oral 90 days	Regulatory source p.75 SCCS Opinion
codes .................................... 6 122-99-6	NOAEL	164 mg/kg bw/day	rat oral 90 days	Regulatory source p.75 SCCS Opinion
codes .................................... 6 122-99-6	NOAEL	164 mg/kg bw/day	rabbit dermal 3 years	Regulatory source p.81 SCCS Opinion
codes .................................... 6 122-99-6	NOAEL	164 mg/kg bw/day	rat oral 90 days	Regulatory source p.75 SCCS Opinion
codes .................................... 6 122-99-6	NOAEL	249	rat oral 2 years	Regulatory source p.75 SCCS Opinion
codes .................................... 6 122-99-6	NOAEL	357 mg/kg bw/d	rabbit dermal 90-day	Regulatory source p.72 SCCS Opinion
codes .................................... 6 122-99-6	NOAEL	357 mg/kg bw/d	rabbit dermal 90-day	Regulatory source p.72 SCCS Opinion
codes .................................... 6 122-99-6	NOAEL	357 mg/kg bw/day	rabbit dermal 90-day	Regulatory source p.73 SCCS Opinion
codes .................................... 6 122-99-6	NOAEL	357 mg/kg bw/day	rat oral 77 day	Regulatory source p.77 SCCS Opinion
codes .................................... 6 122-99-6	NOAEL	357 mg/kg bw/day	rabbit dermal 3 years	Regulatory source p.81 SCCS Opinion
codes .................................... 6 122-99-6	NOAEL	357 mg/kg bw/day	rat oral 3 years	Regulatory source p.82 SCCS Opinion
codes .................................... 6 122-99-6	NOAEL	357 mg/kg bw/day	rabbit oral 90-day	Regulatory source p.82 SCCS Opinion
codes .................................... 6 122-99-6	NOAEL	369	rat oral	Regulatory source p.100 SCCS Opinion
codes .................................... 6 122-99-6	NOAEL	369	rat oral	Regulatory source p.100 SCCS Opinion
codes .................................... 6 122-99-6	NOAEL	369	rat oral 90 days	Regulatory source p.75 SCCS Opinion
codes .................................... 6 122-99-6	NOAEL	390	mouse oral 90 days	Regulatory source p.75 SCCS Opinion
codes .................................... 6 122-99-6	NOAEL	468	mouse oral 2 years	Regulatory source p.75 SCCS Opinion
codes .................................... 6 122-99-6	NOAEL	500 mg/kg bw/day	rabbit dermal	Regulatory source p.28 SCCS Opinion
codes .................................... 6 122-99-6	NOAEL	500 mg/kg bw/day	rabbit dermal	Regulatory source p.28 SCCS Opinion
codes .................................... 6 122-99-6	NOAEL	500 mg/kg bw/day	rabbit dermal 90 days	Regulatory source p.74 SCCS Opinion
codes .................................... 6 122-99-6	NOAEL	500 mg/kg bw/day	rat oral 77 day	Regulatory source p.77 SCCS Opinion
codes .................................... 6 122-99-6	NOAEL	697	rat oral 90 days	Regulatory source p.75 SCCS Opinion
codes .................................... 6 122-99-6	NOAEL	1000 mg/kg bw/day	rabbit dermal 90 days	Regulatory source p.74 SCCS Opinion
codes .................................... 6 122-99-6	NOAEL	1000 mg/kg bw/day	rabbit dermal 90 days	Regulatory source p.74 SCCS Opinion
codes .................................... 6 122-99-6	NOAEL	1000 mg/kg bw/day	rat oral 10 days	Regulatory source p.75 SCCS Opinion
codes .................................... 6 122-99-6	NOAEL	1000 mg/kg bw/day	rat oral 10 days	Regulatory source p.75 SCCS Opinion
codes .................................... 6 122-99-6	NOAEL	1000 mg/kg bw/day	rat oral	Regulatory source p.75 SCCS Opinion
codes .................................... 6 122-99-6	NOAEL	1000 mg/kg bw/day	rabbit oral 10 days	Regulatory source p.75 SCCS Opinion
codes .................................... 6 122-99-6	NOAEL	1575	rat oral	Regulatory source p.61 SCCS Opinion
codes .................................... 6 122-99-6	NOAEL	1575	rat oral	Regulatory source p.100 SCCS Opinion
codes .................................... 6 122-99-6	NOAEL	1977	rat oral 90 days	Regulatory source p.75 SCCS Opinion
codes .................................... 6 122-99-6	NOAEL	2002	rat oral 90 days	Regulatory source p.75 SCCS Opinion
codes .................................... 6 122-99-6	NOAEL	2002	rat oral 90 days	Regulatory source p.75 SCCS Opinion
codes .................................... 6 122-99-6	NOAEL	2015	rat oral	Regulatory source p.80 SCCS Opinion
codes .................................... 6 122-99-6	NOAEL	5000 ppm	Not recorded	Regulatory source p.25 SCCS Opinion
codes .................................... 6 122-99-6	NOAEL	5000 ppm	Not recorded	Regulatory source p.25 SCCS Opinion
codes .................................... 6 122-99-6	NOAEL	5000 ppm	oral chronic	Regulatory source p.40 SCCS Opinion
codes .................................... 6 122-99-6	NOAEL	5000 ppm	oral chronic	Regulatory source p.40 SCCS Opinion
codes .................................... 6 122-99-6	NOAEL	10000 ppm	oral	Regulatory source p.20 SCCS Opinion
codes .................................... 6 122-99-6	NOAEL	10000 ppm	Not recorded	Regulatory source p.25 SCCS Opinion
codes .................................... 6 122-99-6	NOAEL	10000 ppm	mouse oral 13-week	Regulatory source p.40 SCCS Opinion
codes .................................... 6 122-99-6	NOAEL	10000 ppm	rat oral 10 days	Regulatory source p.77 SCCS Opinion
codes .................................... 6 122-99-6	NOAEL	2 mg/kg	NOAEL study intravenous	SCCS Opinion p.57 SCCS Opinion
codes .................................... 6 122-99-6	NOAEL	2 mg/kg	NOAEL study intravenous	SCCS Opinion p.57 SCCS Opinion
codes .................................... 6 122-99-6	NOAEL	2 mg/kg	NOAEL study intravenous	SCCS Opinion p.57 SCCS Opinion
codes .................................... 6 122-99-6	NOAEL	2 mg/kg	NOAEL study intravenous	SCCS Opinion p.57 SCCS Opinion
codes .................................... 6 122-99-6	NOAEL	357 mg/kg bw/day	genotoxicity Chronic	SCCS Opinion p.29 SCCS Opinion
codes .................................... 6 122-99-6	NOAEL	357 mg/kg bw/day	genotoxicity Chronic	SCCS Opinion p.29 SCCS Opinion
codes .................................... 6 122-99-6	NOAEL	357 mg/kg bw/day	genotoxicity Chronic	SCCS Opinion p.29 SCCS Opinion
codes .................................... 6 122-99-6	NOAEL	357 mg/kg bw/day	genotoxicity Chronic	SCCS Opinion p.29 SCCS Opinion
codes .................................... 6 122-99-6	NOAEL	1575	NOAEL study rat oral	SCCS Opinion p.61 SCCS Opinion
codes .................................... 6 122-99-6	NOAEL	1575	NOAEL study rat oral	SCCS Opinion p.61 SCCS Opinion
codes .................................... 6 122-99-6	NOAEL	1575	NOAEL study rat oral	SCCS Opinion p.61 SCCS Opinion
codes .................................... 6 122-99-6	NOAEL	1575	NOAEL study rat oral	SCCS Opinion p.61 SCCS Opinion
codes .................................... 6 122-99-6	carcinogenicity	2500 ppm	carcinogenicity mouse oral 13-week	Regulatory source p.78 SCCS Opinion
codes .................................... 6 122-99-6	carcinogenicity	5000 ppm	carcinogenicity mouse oral	Regulatory source p.38 SCCS Opinion
codes .................................... 6 122-99-6	carcinogenicity	5000 ppm	carcinogenicity rat oral 90-day	Regulatory source p.78 SCCS Opinion
codes .................................... 6 122-99-6	carcinogenicity	10000 ppm	carcinogenicity rat oral 90-day	Regulatory source p.77 SCCS Opinion
codes .................................... 6 122-99-6	developmental toxicity	300 mg/kg bw/day	developmental toxicity dermal developmental	Regulatory source p.46 SCCS Opinion
codes .................................... 6 122-99-6	developmental toxicity	300 mg/kg bw/day	developmental toxicity rabbit dermal developmental	Regulatory source p.76 SCCS Opinion
codes .................................... 6 122-99-6	developmental toxicity	300 mg/kg bw/day	developmental toxicity rabbit dermal developmental	Regulatory source p.76 SCCS Opinion
codes .................................... 6 122-99-6	developmental toxicity	1000 mg/kg bw/day	developmental toxicity rabbit developmental	Regulatory source p.44 SCCS Opinion
codes .................................... 6 122-99-6	developmental toxicity	1000 mg/kg bw/day	developmental toxicity rabbit dermal developmental	Regulatory source p.44 SCCS Opinion
codes .................................... 6 122-99-6	developmental toxicity	1000 mg/kg bw/day	developmental toxicity dermal developmental	Regulatory source p.46 SCCS Opinion
codes .................................... 6 122-99-6	genotoxicity	357 mg/kg bw/day	genotoxicity Chronic	Regulatory source p.29 SCCS Opinion
codes .................................... 6 122-99-6	genotoxicity	357 mg/kg bw/day	genotoxicity	Regulatory source p.79 SCCS Opinion
codes .................................... 6 122-99-6	irritation	2	irritation rat inhalation 5 days	Regulatory source p.18 SCCS Opinion
codes .................................... 6 122-99-6	irritation	1000 mg/kg bw/day	irritation rat dermal 14 days	Regulatory source p.74 SCCS Opinion
codes .................................... 6 122-99-6	irritation	1000 mg/kg bw/day	irritation rat dermal 14 days	Regulatory source p.74 SCCS Opinion
codes .................................... 6 122-99-6	repeated dose toxicity	2500 ppm	repeated dose toxicity rabbit dermal Sub-chronic	Regulatory source p.27 SCCS Opinion
codes .................................... 6 122-99-6	reproductive toxicity	0	reproductive toxicity mouse oral 2 years	Regulatory source p.75 SCCS Opinion
codes .................................... 6 122-99-6	reproductive toxicity	0.25 %	reproductive toxicity mouse oral	Regulatory source p.42 SCCS Opinion
codes .................................... 6 122-99-6	reproductive toxicity	0.25 %	reproductive toxicity rat oral developmental	Regulatory source p.79 SCCS Opinion
codes .................................... 6 122-99-6	reproductive toxicity	2.5 %	reproductive toxicity mouse oral	Regulatory source p.42 SCCS Opinion
codes .................................... 6 122-99-6	reproductive toxicity	75	reproductive toxicity mouse oral 126 days	Regulatory source p.75 SCCS Opinion
codes .................................... 6 122-99-6	reproductive toxicity	400 mg/kg bw/day	reproductive toxicity mouse oral	Regulatory source p.42 SCCS Opinion
codes .................................... 6 122-99-6	reproductive toxicity	400 mg/kg bw/day	reproductive toxicity rat oral developmental	Regulatory source p.79 SCCS Opinion
codes .................................... 6 122-99-6	reproductive toxicity	400	reproductive toxicity mouse oral 126 days	Regulatory source p.75 SCCS Opinion
codes .................................... 6 122-99-6	reproductive toxicity	950 mg/kg bw/day	reproductive toxicity rat oral developmental	Regulatory source p.79 SCCS Opinion
codes .................................... 6 122-99-6	reproductive toxicity	2007	reproductive toxicity mouse oral 2 years	Regulatory source p.75 SCCS Opinion

Safety Conclusion

sccs_opinions Max 1% in all cosmetic products

Safe — safe at 1% in all cosmetic products for all age groups including infants

Key concerns: Haemotoxicity (critical endpoint for safety assessment); neurotoxicity concerns in young children evaluated; MoS acceptable at 1%

Opinion date: 6 October 2016

Source Citation

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