SCCS/1316/10 75 NOAEL rows Safety conclusion

could be considered safe for the, Diethylene glycol monoethyl ether (DEGEE)

Structured SCCS opinion summary generated from source-matched D1 rows for SCCS/1316/10.

Opinion Number

SCCS/1316/10

NOAEL Rows

Substances Covered

Substance(s) Covered

could be considered safe for the Diethylene glycol monoethyl ether (DEGEE)

NOAEL Values Extracted from This Opinion

Substance	Endpoint	Value	Study	Source
could be considered safe for the 111-90-0	NOAEL	1 %	rat oral 90 days	Regulatory source p.25 SCCS Opinion
could be considered safe for the 111-90-0	NOAEL	5 %	rat oral 90 day	Regulatory source p.29 SCCS Opinion
could be considered safe for the 111-90-0	NOAEL	5 %	rat oral 90 day	Regulatory source p.29 SCCS Opinion
could be considered safe for the 111-90-0	NOAEL	5.4 %	mouse oral 90 day	Regulatory source p.29 SCCS Opinion
could be considered safe for the 111-90-0	NOAEL	10 %	human	Regulatory source p.43 SCCS Opinion
could be considered safe for the 111-90-0	NOAEL	29.5 %	rat 2 year	Regulatory source p.29 SCCS Opinion
could be considered safe for the 111-90-0	NOAEL	167 mg/kg bw/day	rabbit dermal 13- week	Regulatory source p.27 SCCS Opinion
could be considered safe for the 111-90-0	NOAEL	167 mg/kg bw/day	rat oral 90 day	Regulatory source p.29 SCCS Opinion
could be considered safe for the 111-90-0	NOAEL	167 mg/kg bw/day	pig 90 day	Regulatory source p.29 SCCS Opinion
could be considered safe for the 111-90-0	NOAEL	180 mg/kg bw/d	rat oral	Regulatory source p.26 SCCS Opinion
could be considered safe for the 111-90-0	NOAEL	180 mg/kg bw/d	rat oral 90 days	Regulatory source p.26 SCCS Opinion
could be considered safe for the 111-90-0	NOAEL	180 mg/kg bw/day	rat oral 90 day	Regulatory source p.29 SCCS Opinion
could be considered safe for the 111-90-0	NOAEL	180 mg/kg	rat 90 day	Regulatory source p.29 SCCS Opinion
could be considered safe for the 111-90-0	NOAEL	180 mg/kg bw/day	rat 90 day	Regulatory source p.29 SCCS Opinion
could be considered safe for the 111-90-0	NOAEL	200 mg/kg bw/day	rat oral 90 day	Regulatory source p.29 SCCS Opinion
could be considered safe for the 111-90-0	NOAEL	200 mg/kg bw/day	dog oral 13 week	Regulatory source p.45 SCCS Opinion
could be considered safe for the 111-90-0	NOAEL	200 mg/kg bw/day	rat 2 year	Regulatory source p.29 SCCS Opinion
could be considered safe for the 111-90-0	NOAEL	250 mg/kg bw/day	rat oral 90 day	Regulatory source p.29 SCCS Opinion
could be considered safe for the 111-90-0	NOAEL	250 mg/kg bw/day	rat oral 90 day	Regulatory source p.29 SCCS Opinion
could be considered safe for the 111-90-0	NOAEL	400 mg/kg bw/day	dog 90 day	Regulatory source p.29 SCCS Opinion
could be considered safe for the 111-90-0	NOAEL	500 mg/kg bw/day	rat oral 90 day	Regulatory source p.29 SCCS Opinion
could be considered safe for the 111-90-0	NOAEL	800 mg/kg bw/day	rat oral 6-week	Regulatory source p.29 SCCS Opinion
could be considered safe for the 111-90-0	NOAEL	800 mg/kg bw/day	rat oral 90 day	Regulatory source p.29 SCCS Opinion
could be considered safe for the 111-90-0	NOAEL	850 mg/kg bw/day	mouse oral 90 days	Regulatory source p.26 SCCS Opinion
could be considered safe for the 111-90-0	NOAEL	1000 mg/kg bw	oral 13 weeks	Regulatory source p.24 SCCS Opinion
could be considered safe for the 111-90-0	NOAEL	1000 mg/kg bw/day	rat oral 90 day	Regulatory source p.29 SCCS Opinion
could be considered safe for the 111-90-0	NOAEL	1000 mg/kg	pig 90 day	Regulatory source p.29 SCCS Opinion
could be considered safe for the 111-90-0	NOAEL	1000 mg/kg bw/day	mouse oral 90 day	Regulatory source p.29 SCCS Opinion
could be considered safe for the 111-90-0	NOAEL	1340 mg/kg bw	rat oral 90 days	Regulatory source p.25 SCCS Opinion
could be considered safe for the 111-90-0	NOAEL	1340 mg/kg bw/day	rat oral 90 day	Regulatory source p.29 SCCS Opinion
could be considered safe for the 111-90-0	NOAEL	1340 mg/kg bw/day	rat 6-week	Regulatory source p.29 SCCS Opinion
could be considered safe for the 111-90-0	NOAEL	1500 mg/kg bw	oral 13 weeks	Regulatory source p.24 SCCS Opinion
could be considered safe for the 111-90-0	NOAEL	1500 mg/kg	dog 90 day	Regulatory source p.29 SCCS Opinion
could be considered safe for the 111-90-0	NOAEL	5360 mg/kg	rat 6-week	Regulatory source p.29 SCCS Opinion
could be considered safe for the 111-90-0	NOAEL	250 mg/kg bw/day	repeated dose toxicity rat oral 90 day	SCCS Opinion p.26 SCCS Opinion
could be considered safe for the 111-90-0	NOAEL	250 mg/kg bw/day	repeated dose toxicity rat oral 90 day	SCCS Opinion p.26 SCCS Opinion
could be considered safe for the 111-90-0	NOAEL	250 mg/kg bw/day	repeated dose toxicity rat oral 90 day	SCCS Opinion p.26 SCCS Opinion
could be considered safe for the 111-90-0	NOAEL	250 mg/kg bw/day	repeated dose toxicity rat oral 90 day	SCCS Opinion p.26 SCCS Opinion
could be considered safe for the 111-90-0	NOAEL	1000 mg/kg bw/day	NOAEL study rat oral 90 day	SCCS Opinion p.29 SCCS Opinion
could be considered safe for the 111-90-0	NOAEL	1000 mg/kg bw/day	NOAEL study rat oral 90 day	SCCS Opinion p.29 SCCS Opinion
could be considered safe for the 111-90-0	NOAEL	1000 mg/kg bw/day	NOAEL study rat oral 90 day	SCCS Opinion p.29 SCCS Opinion
could be considered safe for the 111-90-0	NOAEL	1000 mg/kg bw/day	NOAEL study rat oral 90 day	SCCS Opinion p.29 SCCS Opinion
could be considered safe for the 111-90-0	dermal absorption	0.08 mg/kg bw	dermal absorption human dermal	Regulatory source p.43 SCCS Opinion
could be considered safe for the 111-90-0	dermal absorption	0.17 mg/kg bw	dermal absorption human dermal	Regulatory source p.44 SCCS Opinion
could be considered safe for the 111-90-0	dermal absorption	0.62 mg/kg bw	dermal absorption human dermal	Regulatory source p.44 SCCS Opinion
could be considered safe for the 111-90-0	dermal absorption	1.5 %	dermal absorption human dermal	Regulatory source p.43 SCCS Opinion
could be considered safe for the 111-90-0	dermal absorption	8.2 mg/kg bw	dermal absorption dog dermal 13 week	Regulatory source p.43 SCCS Opinion
could be considered safe for the 111-90-0	dermal absorption	400 mg/kg bw/day	dermal absorption dog dermal 13 week	Regulatory source p.43 SCCS Opinion
could be considered safe for the 111-90-0	dermal absorption	400 mg/kg bw	dermal absorption human dermal	Regulatory source p.44 SCCS Opinion
could be considered safe for the 111-90-0	dermal absorption	400 mg/kg bw	dermal absorption human dermal	Regulatory source p.44 SCCS Opinion
could be considered safe for the 111-90-0	dermal absorption	400 mg/kg bw	dermal absorption human dermal	Regulatory source p.44 SCCS Opinion
could be considered safe for the 111-90-0	dermal absorption	400 mg/kg bw	dermal absorption human dermal	Regulatory source p.44 SCCS Opinion
could be considered safe for the 111-90-0	developmental toxicity	300 mg/kg bw/day	developmental toxicity prenatal	Regulatory source p.34 SCCS Opinion
could be considered safe for the 111-90-0	developmental toxicity	300 mg/kg bw/day	developmental toxicity rat	Regulatory source p.46 SCCS Opinion
could be considered safe for the 111-90-0	developmental toxicity	1000 mg/kg bw	developmental toxicity Prenatal	Regulatory source p.34 SCCS Opinion
could be considered safe for the 111-90-0	developmental toxicity	1000 mg/kg bw/day	developmental toxicity rat	Regulatory source p.37 SCCS Opinion
could be considered safe for the 111-90-0	developmental toxicity	1000 mg/kg bw/day	developmental toxicity rat	Regulatory source p.46 SCCS Opinion
could be considered safe for the 111-90-0	developmental toxicity	1000 mg/kg bw/day	developmental toxicity rat	Regulatory source p.46 SCCS Opinion
could be considered safe for the 111-90-0	developmental toxicity	>2000 mg/kg bw	developmental toxicity prenatal	Regulatory source p.34 SCCS Opinion
could be considered safe for the 111-90-0	genotoxicity	400 mg/kg bw/day	genotoxicity dog 13 week	Regulatory source p.46 SCCS Opinion
could be considered safe for the 111-90-0	repeated dose toxicity	167 mg/kg bw/day	repeated dose toxicity rat oral 13 week	Regulatory source p.45 SCCS Opinion
could be considered safe for the 111-90-0	repeated dose toxicity	200 mg/kg bw/day	repeated dose toxicity rat oral 2 year	Regulatory source p.29 SCCS Opinion
could be considered safe for the 111-90-0	repeated dose toxicity	250 mg/kg bw/day	repeated dose toxicity rat oral 90 day	Regulatory source p.26 SCCS Opinion
could be considered safe for the 111-90-0	repeated dose toxicity	400 mg/kg bw/day	repeated dose toxicity	Regulatory source p.24 SCCS Opinion
could be considered safe for the 111-90-0	repeated dose toxicity	400 mg/kg bw/day	repeated dose toxicity rat oral 90 day	Regulatory source p.29 SCCS Opinion
could be considered safe for the 111-90-0	repeated dose toxicity	400 mg/kg bw/day	repeated dose toxicity dog 13 week	Regulatory source p.30 SCCS Opinion
could be considered safe for the 111-90-0	repeated dose toxicity	400 mg/kg bw/day	repeated dose toxicity rat oral 13 week	Regulatory source p.45 SCCS Opinion
could be considered safe for the 111-90-0	repeated dose toxicity	1000 mg/kg bw/day	repeated dose toxicity rat oral 2 year	Regulatory source p.29 SCCS Opinion
could be considered safe for the 111-90-0	repeated dose toxicity	1000 mg/kg bw/day	repeated dose toxicity rat oral	Regulatory source p.45 SCCS Opinion
could be considered safe for the 111-90-0	reproductive toxicity	1000 mg/kg bw/day	reproductive toxicity rat	Regulatory source p.35 SCCS Opinion
could be considered safe for the 111-90-0	reproductive toxicity	2000 mg/kg bw	reproductive toxicity rat oral 10 days	Regulatory source p.36 SCCS Opinion
could be considered safe for the 111-90-0	reproductive toxicity	2000 mg/kg bw	reproductive toxicity rat dermal 10 days	Regulatory source p.36 SCCS Opinion
could be considered safe for the 111-90-0	reproductive toxicity	2000 mg/kg bw	reproductive toxicity rat oral prenatal	Regulatory source p.46 SCCS Opinion
could be considered safe for the 111-90-0	reproductive toxicity	2000 mg/kg bw	reproductive toxicity rat oral prenatal	Regulatory source p.46 SCCS Opinion
could be considered safe for the 111-90-0	reproductive toxicity	29190	reproductive toxicity rat oral	Regulatory source p.52 SCCS Opinion

Safety Conclusion

sccs_opinions Max Up to 10% in rinse-off (safe); up to 1.5% in all cosmetic products (safe); up to 7.0% on-head in oxidative and up to 5.0% on-head in non-oxidative hair dyes (safe); 5.5% in leave-on products NOT safe

Based on the new information submitted, SCCS is of the opinion that: 1. the use of DEGEE as a solvent in cosmetic products in a concentration up to 10% in rinse-off products does not pose a risk to the health of the consumer. 2. the use of DEGEE as a solvent in cosmetic products in a concentration up to 5.5% in leave-on products does pose a risk to the health of the consumer. 3. an additional use of DEGEE as solvent in an on-head concentration up to 7.0% in oxidative hair dye formulations and up to 5.0% in non-oxidative hair dye formulations does not pose a risk to the health of the consumer. 4. the additional use of DEGEE at concentrations up to 1.5% in all cosmetic products does not pose a risk to the health of the consumer.

Key concerns: Ethylene glycol level in DEGEE must be < 0.2%. Opinion relates to dermal application only; does not cover aerosol/spray exposure or aggregate non-cosmetic exposure. Use at 5.5% in leave-on products specifically does pose a risk.

Opinion date: 2010-09-21

Source Citation

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