SCCS/1016/06 63 NOAEL rows Safety conclusion

s.” Names in brackets, Phthalates in cosmetic products

Structured SCCS opinion summary generated from source-matched D1 rows for SCCS/1016/06.

Opinion Number

SCCS/1016/06

NOAEL Rows

Substances Covered

Substance(s) Covered

s.” Names in brackets Phthalates in cosmetic products

NOAEL Values Extracted from This Opinion

Substance	Endpoint	Value	Study	Source
s.” Names in brackets 131-11-3	NOAEL	3 mg/kg	90-day	Regulatory source p.10 SCCS Opinion
s.” Names in brackets 131-11-3	NOAEL	5 %	rat	Regulatory source p.10 SCCS Opinion
s.” Names in brackets 131-11-3	NOAEL	9	Not recorded	Regulatory source p.9 SCCS Opinion
s.” Names in brackets 131-11-3	NOAEL	10	Not recorded	Regulatory source p.10 SCCS Opinion
s.” Names in brackets 131-11-3	NOAEL	12	Not recorded	Regulatory source p.12 SCCS Opinion
s.” Names in brackets 131-11-3	NOAEL	13	Not recorded	Regulatory source p.13 SCCS Opinion
s.” Names in brackets 131-11-3	NOAEL	15 mg/kg bw/day	rat oral 13-week	Regulatory source p.11 SCCS Opinion
s.” Names in brackets 131-11-3	NOAEL	15 mg/kg bw/day	rat 2-year	Regulatory source p.11 SCCS Opinion
s.” Names in brackets 131-11-3	NOAEL	15	dog oral 13-week	Regulatory source p.10 SCCS Opinion
s.” Names in brackets 131-11-3	NOAEL	25 mg/kg/d	rat oral 13-week	Regulatory source p.11 SCCS Opinion
s.” Names in brackets 131-11-3	NOAEL	33 mg/kg bw/day	rat oral 13-week	Regulatory source p.11 SCCS Opinion
s.” Names in brackets 131-11-3	NOAEL	50	Not recorded	Regulatory source p.9 SCCS Opinion
s.” Names in brackets 131-11-3	NOAEL	600	Not recorded	Regulatory source p.9 SCCS Opinion
s.” Names in brackets 131-11-3	NOAEL	2982 mg/kg	Not recorded	Regulatory source p.9 SCCS Opinion
s.” Names in brackets 131-11-3	NOAEL	0.0167 %	dermal absorption rat dermal	SCCS Opinion p.14 SCCS Opinion
s.” Names in brackets 131-11-3	NOAEL	0.0167 %	dermal absorption rat dermal	SCCS Opinion p.14 SCCS Opinion
s.” Names in brackets 131-11-3	NOAEL	0.0167 %	dermal absorption rat dermal	SCCS Opinion p.14 SCCS Opinion
s.” Names in brackets 131-11-3	NOAEL	0.0167 %	dermal absorption rat dermal	SCCS Opinion p.14 SCCS Opinion
s.” Names in brackets 131-11-3	NOAEL	3 mg/kg	NOAEL study 90-day	SCCS Opinion p.10 SCCS Opinion
s.” Names in brackets 131-11-3	NOAEL	3 mg/kg	NOAEL study 90-day	SCCS Opinion p.10 SCCS Opinion
s.” Names in brackets 131-11-3	NOAEL	3 mg/kg	NOAEL study 90-day	SCCS Opinion p.10 SCCS Opinion
s.” Names in brackets 131-11-3	NOAEL	3 mg/kg	NOAEL study 90-day	SCCS Opinion p.10 SCCS Opinion
s.” Names in brackets 131-11-3	NOAEL	1016	reproductive toxicity	SCCS Opinion p.13 SCCS Opinion
s.” Names in brackets 131-11-3	NOAEL	1016	reproductive toxicity	SCCS Opinion p.13 SCCS Opinion
s.” Names in brackets 131-11-3	NOAEL	1016	reproductive toxicity	SCCS Opinion p.13 SCCS Opinion
s.” Names in brackets 131-11-3	NOAEL	1016	reproductive toxicity	SCCS Opinion p.13 SCCS Opinion
s.” Names in brackets 131-11-3	NOAEL	2982 mg/kg	NOAEL study	SCCS Opinion p.9 SCCS Opinion
s.” Names in brackets 131-11-3	NOAEL	2982 mg/kg	NOAEL study	SCCS Opinion p.9 SCCS Opinion
s.” Names in brackets 131-11-3	NOAEL	2982 mg/kg	NOAEL study	SCCS Opinion p.9 SCCS Opinion
s.” Names in brackets 131-11-3	NOAEL	2982 mg/kg	NOAEL study	SCCS Opinion p.9 SCCS Opinion
s.” Names in brackets 131-11-3	carcinogenicity	15 mg/kg bw/day	carcinogenicity rat chronic	Regulatory source p.11 SCCS Opinion
s.” Names in brackets 131-11-3	carcinogenicity	15 mg/kg bw/day	carcinogenicity rat dermal chronic	Regulatory source p.11 SCCS Opinion
s.” Names in brackets 131-11-3	dermal absorption	0.000009 mg/kg/d	dermal absorption dog oral	Regulatory source p.12 SCCS Opinion
s.” Names in brackets 131-11-3	dermal absorption	0.00036 mg/kg/d	dermal absorption rat oral	Regulatory source p.11 SCCS Opinion
s.” Names in brackets 131-11-3	dermal absorption	0.00247 mg/kg/d	dermal absorption human dermal 2005d	Regulatory source p.14 SCCS Opinion
s.” Names in brackets 131-11-3	dermal absorption	0.006 %	dermal absorption dog oral	Regulatory source p.12 SCCS Opinion
s.” Names in brackets 131-11-3	dermal absorption	0.0167 %	dermal absorption rat dermal	Regulatory source p.14 SCCS Opinion
s.” Names in brackets 131-11-3	dermal absorption	0.0445 mg/kg	dermal absorption rat dermal	Regulatory source p.9 SCCS Opinion
s.” Names in brackets 131-11-3	dermal absorption	0.24 %	dermal absorption rat oral	Regulatory source p.11 SCCS Opinion
s.” Names in brackets 131-11-3	dermal absorption	4.8 mg/kg/d	dermal absorption rat dermal 2005d	Regulatory source p.14 SCCS Opinion
s.” Names in brackets 131-11-3	dermal absorption	5 %	dermal absorption rat dermal	Regulatory source p.9 SCCS Opinion
s.” Names in brackets 131-11-3	dermal absorption	5 %	dermal absorption rat dermal 2005d	Regulatory source p.14 SCCS Opinion
s.” Names in brackets 131-11-3	dermal absorption	15 mg/kg bw/d	dermal absorption rat oral	Regulatory source p.11 SCCS Opinion
s.” Names in brackets 131-11-3	dermal absorption	15 mg/kg bw/d	dermal absorption dog oral	Regulatory source p.12 SCCS Opinion
s.” Names in brackets 131-11-3	dermal absorption	600 mg/kg bw/day	dermal absorption rat dermal	Regulatory source p.9 SCCS Opinion
s.” Names in brackets 131-11-3	dermal absorption	600 mg/kg bw/day	dermal absorption rat dermal	Regulatory source p.9 SCCS Opinion
s.” Names in brackets 131-11-3	dermal absorption	600 mg/kg bw/day	dermal absorption rat dermal	Regulatory source p.9 SCCS Opinion
s.” Names in brackets 131-11-3	developmental toxicity	0.00163 mg/kg/d	developmental toxicity rat dermal developmental	Regulatory source p.15 SCCS Opinion
s.” Names in brackets 131-11-3	developmental toxicity	0.5 mg/kg/d	developmental toxicity rat developmental	Regulatory source p.15 SCCS Opinion
s.” Names in brackets 131-11-3	developmental toxicity	5 %	developmental toxicity rat oral developmental	Regulatory source p.14 SCCS Opinion
s.” Names in brackets 131-11-3	developmental toxicity	50 mg/kg/d	developmental toxicity rat dermal developmental	Regulatory source p.15 SCCS Opinion
s.” Names in brackets 131-11-3	reproductive toxicity	2 mg/kg bw/d	reproductive toxicity rat oral developmental	Regulatory source p.14 SCCS Opinion
s.” Names in brackets 131-11-3	reproductive toxicity	4.8	reproductive toxicity developmental	Regulatory source p.12 SCCS Opinion
s.” Names in brackets 131-11-3	reproductive toxicity	5 %	reproductive toxicity rat oral 13-week	Regulatory source p.10 SCCS Opinion
s.” Names in brackets 131-11-3	reproductive toxicity	13	reproductive toxicity	Regulatory source p.13 SCCS Opinion
s.” Names in brackets 131-11-3	reproductive toxicity	13	reproductive toxicity	Regulatory source p.13 SCCS Opinion
s.” Names in brackets 131-11-3	reproductive toxicity	13	reproductive toxicity	Regulatory source p.13 SCCS Opinion
s.” Names in brackets 131-11-3	reproductive toxicity	50 mg/kg	reproductive toxicity rat oral developmental	Regulatory source p.10 SCCS Opinion
s.” Names in brackets 131-11-3	reproductive toxicity	50	reproductive toxicity	Regulatory source p.13 SCCS Opinion
s.” Names in brackets 131-11-3	reproductive toxicity	50	reproductive toxicity	Regulatory source p.13 SCCS Opinion
s.” Names in brackets 131-11-3	reproductive toxicity	100 ppm	reproductive toxicity developmental	Regulatory source p.12 SCCS Opinion
s.” Names in brackets 131-11-3	reproductive toxicity	201	reproductive toxicity	Regulatory source p.13 SCCS Opinion
s.” Names in brackets 131-11-3	reproductive toxicity	1016	reproductive toxicity	Regulatory source p.13 SCCS Opinion

Safety Conclusion

sccs_opinions Max DEP: safe as intentional ingredient; DEHP/DBP/BBP: banned as ingredients; traces from contamination acceptable (<100 ppm)

safe with restrictions (trace impurities) / prohibited (intentional use)

Key concerns: DEHP/DBP/BBP banned as CMR; DEP safe as denaturant/solvent; traces from contamination not of concern; phthalates may leach from plastic containers

Opinion date: 21 March 2007

Source Citation

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