SCCS/0873/05 25 NOAEL rows Safety conclusion

Parabens (P82), Parabens

Structured SCCS opinion summary generated from source-matched D1 rows for SCCS/0873/05.

Opinion Number

SCCS/0873/05

NOAEL Rows

Substances Covered

Substance(s) Covered

Parabens (P82) Parabens

NOAEL Values Extracted from This Opinion

Substance	Endpoint	Value	Study	Source
Unnamed substance	NOAEL	0.4 %	reproductive toxicity rat developmental	SCCS Opinion p.9 SCCS Opinion
Unnamed substance	NOAEL	0.4 %	reproductive toxicity rat developmental	SCCS Opinion p.9 SCCS Opinion
Unnamed substance	NOAEL	0.4 %	reproductive toxicity rat developmental	SCCS Opinion p.9 SCCS Opinion
Unnamed substance	NOAEL	2 mg/kg bw/day	reproductive toxicity rat developmental	SCCS Opinion p.9 SCCS Opinion
Unnamed substance	NOAEL	2 mg/kg bw/day	reproductive toxicity rat developmental	SCCS Opinion p.9 SCCS Opinion
Unnamed substance	NOAEL	2 mg/kg bw/day	reproductive toxicity rat developmental	SCCS Opinion p.9 SCCS Opinion
Unnamed substance	developmental toxicity	10 mg/kg bw/day	developmental toxicity human oral developmental	Regulatory source p.6 SCCS Opinion
Unnamed substance	developmental toxicity	100 mg/kg bw/day	developmental toxicity rat oral developmental	Regulatory source p.8 SCCS Opinion
Unnamed substance	repeated dose toxicity	1000 mg/kg bw/day	repeated dose toxicity rat subchronic	Regulatory source p.4 SCCS Opinion
Unnamed substance	repeated dose toxicity	1000 mg/kg bw/day	repeated dose toxicity rat subacute	Regulatory source p.6 SCCS Opinion
Unnamed substance	reproductive toxicity	0.4 %	reproductive toxicity rat developmental	Regulatory source p.9 SCCS Opinion
Unnamed substance	reproductive toxicity	2 mg/kg bw/day	reproductive toxicity rat developmental	Regulatory source p.9 SCCS Opinion
Unnamed substance	reproductive toxicity	2 mg/kg bw/day	reproductive toxicity rat oral developmental	Regulatory source p.9 SCCS Opinion
Unnamed substance	reproductive toxicity	3.3	reproductive toxicity	Regulatory source p.8 SCCS Opinion
Unnamed substance	reproductive toxicity	100 mg/kg bw/day	reproductive toxicity rat oral developmental	Regulatory source p.9 SCCS Opinion
Unnamed substance	reproductive toxicity	1000 mg/kg bw/day	reproductive toxicity rat oral	Regulatory source p.5 SCCS Opinion
Unnamed substance	reproductive toxicity	1000 mg/kg	reproductive toxicity rat	Regulatory source p.5 SCCS Opinion
Unnamed substance	reproductive toxicity	1000 mg/kg	reproductive toxicity	Regulatory source p.5 SCCS Opinion
Unnamed substance	reproductive toxicity	1000 mg/kg bw/day	reproductive toxicity rat oral developmental	Regulatory source p.8 SCCS Opinion
Unnamed substance	DERMAL_ABSORPTION	0.4 %	in vitro dermal 4-Hydroxybenzoic acid, its salts and esters ("parabens") are currently authorised in Annex VI, entry 12 of the Cosmetics Directive (76/768/EEC) at a maximum use concentration of 0.4% (acid) for one ester and 0.8% for a mixture of esters.	SCCS Opinion p.5 SCCS Opinion
Unnamed substance	DERMAL_ABSORPTION	0.4 %	in vitro dermal 4-Hydroxybenzoic acid, its salts and esters ("parabens") are currently authorised in Annex VI, entry 12 of the Cosmetics Directive (76/768/EEC) at a maximum use concentration of 0.4% (acid) for one ester and 0.8% for a mixture of esters.	SCCS Opinion p.5 SCCS Opinion
Unnamed substance	DERMAL_ABSORPTION	0.4 %	in vitro dermal 4-Hydroxybenzoic acid, its salts and esters ("parabens") are currently authorised in Annex VI, entry 12 of the Cosmetics Directive (76/768/EEC) at a maximum use concentration of 0.4% (acid) for one ester and 0.8% for a mixture of esters.	SCCS Opinion p.5 SCCS Opinion
Unnamed substance	DERMAL_ABSORPTION	3.5 %	in vitro human skin dermal	SCCS Opinion p.13 SCCS Opinion
Unnamed substance	DERMAL_ABSORPTION	3.5 %	in vitro human skin dermal	SCCS Opinion p.13 SCCS Opinion
Unnamed substance	DERMAL_ABSORPTION	3.5 %	in vitro human skin dermal	SCCS Opinion p.13 SCCS Opinion

Safety Conclusion

sccs_opinions Max 0.5%

safe

Key concerns: sensitisation not excluded; secondary amine; nitrosamine <50ppb

Opinion date: 21 June 2005

sccs_opinions Max Methyl/ethyl: 0.4% (individual)/0.8% (mixtures); propyl/butyl/isopropyl/isobutyl: under review

Insufficient data — conclusion of SCCP/0873/05 remains unchanged: insufficient data for propyl/isopropyl/butyl/isobutylparaben

Key concerns: Endocrine disruption; male reproductive toxicity of propyl/butylparaben; estrogenic activity of isopropyl/isobutylparaben

Opinion date: 10 October 2006

sccs_opinions

As explained in detail under section 3 of the present opinion, the tests provided in Submission I of February 2006 contain too many shortcomings in order to be considered as scientifically valid. Therefore, the conclusion of opinion SCCP/0873/05 remains unchanged.

Key concerns: Submission I (February 2006) tests contain too many shortcomings to be scientifically valid; the conclusion of the earlier opinion SCCP/0873/05 remains unchanged.

Opinion date: 10 October 2006

Source Citation

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