SCCS/1652/23 76 NOAEL rows Safety conclusion

codes ............................................... 10, Methylparaben

Structured SCCS opinion summary generated from source-matched D1 rows for SCCS/1652/23.

Opinion Number

SCCS/1652/23

NOAEL Rows

Substances Covered

Substance(s) Covered

codes ............................................... 10 Methylparaben

NOAEL Values Extracted from This Opinion

Substance	Endpoint	Value	Study	Source
codes ............................................... 10 99-76-3	NOAEL	0.1 %	rat oral 27-day	Regulatory source p.45 SCCS Opinion
codes ............................................... 10 99-76-3	NOAEL	0.1 %	rat oral 27-day	Regulatory source p.45 SCCS Opinion
codes ............................................... 10 99-76-3	NOAEL	0.105 mg/kg bw/day	rat	Regulatory source p.64 SCCS Opinion
codes ............................................... 10 99-76-3	NOAEL	0.105 mg/kg bw/day	rat	Regulatory source p.64 SCCS Opinion
codes ............................................... 10 99-76-3	NOAEL	24	Chronic	Regulatory source p.43 SCCS Opinion
codes ............................................... 10 99-76-3	NOAEL	24	Chronic	Regulatory source p.43 SCCS Opinion
codes ............................................... 10 99-76-3	NOAEL	250 mg/kg bw/day	rat	Regulatory source p.46 SCCS Opinion
codes ............................................... 10 99-76-3	NOAEL	250 mg/kg bw/day	rat	Regulatory source p.46 SCCS Opinion
codes ............................................... 10 99-76-3	NOAEL	250 mg/kg bw/day	rat	Regulatory source p.46 SCCS Opinion
codes ............................................... 10 99-76-3	NOAEL	250 mg/kg bw/day	rat	Regulatory source p.46 SCCS Opinion
codes ............................................... 10 99-76-3	NOAEL	1000 mg/kg bw/day	Not recorded	Regulatory source p.40 SCCS Opinion
codes ............................................... 10 99-76-3	NOAEL	1000 mg/kg bw/d	rat oral Chronic	Regulatory source p.43 SCCS Opinion
codes ............................................... 10 99-76-3	NOAEL	1000 mg/kg/day	rat oral 27-day	Regulatory source p.45 SCCS Opinion
codes ............................................... 10 99-76-3	NOAEL	1000 mg/kg bw/day	rat	Regulatory source p.46 SCCS Opinion
codes ............................................... 10 99-76-3	NOAEL	1000 mg/kg bw/day	rat	Regulatory source p.46 SCCS Opinion
codes ............................................... 10 99-76-3	NOAEL	1000 mg/kg bw/day	Not recorded	Regulatory source p.65 SCCS Opinion
codes ............................................... 10 99-76-3	NOAEL	1000 mg/kg bw	Chronic	Regulatory source p.43 SCCS Opinion
codes ............................................... 10 99-76-3	NOAEL	1000 mg/kg bw/day	Not recorded	Regulatory source p.40 SCCS Opinion
codes ............................................... 10 99-76-3	NOAEL	1000 mg/kg bw/d	rat oral Chronic	Regulatory source p.43 SCCS Opinion
codes ............................................... 10 99-76-3	NOAEL	1000 mg/kg/day	rat oral 27-day	Regulatory source p.45 SCCS Opinion
codes ............................................... 10 99-76-3	NOAEL	1000 mg/kg bw/day	rat	Regulatory source p.46 SCCS Opinion
codes ............................................... 10 99-76-3	NOAEL	1000 mg/kg bw/day	rat	Regulatory source p.46 SCCS Opinion
codes ............................................... 10 99-76-3	NOAEL	1000 mg/kg bw/day	Not recorded	Regulatory source p.65 SCCS Opinion
codes ............................................... 10 99-76-3	NOAEL	1000 mg/kg bw	Chronic	Regulatory source p.43 SCCS Opinion
codes ............................................... 10 99-76-3	repeated dose toxicity	42	repeated dose toxicity oral developmental	Regulatory source p.42 SCCS Opinion
codes ............................................... 10 99-76-3	repeated dose toxicity	42	repeated dose toxicity oral developmental	Regulatory source p.42 SCCS Opinion
codes ............................................... 10 99-76-3	repeated dose toxicity	99	repeated dose toxicity oral developmental	Regulatory source p.42 SCCS Opinion
codes ............................................... 10 99-76-3	repeated dose toxicity	99	repeated dose toxicity oral developmental	Regulatory source p.42 SCCS Opinion
codes ............................................... 10 99-76-3	repeated dose toxicity	300 mg/kg bw/day	repeated dose toxicity oral 90-day	Regulatory source p.51 SCCS Opinion
codes ............................................... 10 99-76-3	repeated dose toxicity	300 mg/kg bw/day	repeated dose toxicity oral 90-day	Regulatory source p.70 SCCS Opinion
codes ............................................... 10 99-76-3	repeated dose toxicity	300 mg/kg bw/day	repeated dose toxicity oral 90-day	Regulatory source p.51 SCCS Opinion
codes ............................................... 10 99-76-3	repeated dose toxicity	300 mg/kg bw/day	repeated dose toxicity oral 90-day	Regulatory source p.70 SCCS Opinion
codes ............................................... 10 99-76-3	repeated dose toxicity	1000 mg/kg/day	repeated dose toxicity oral 14 days	Regulatory source p.38 SCCS Opinion
codes ............................................... 10 99-76-3	repeated dose toxicity	1000 mg/kg/day	repeated dose toxicity oral subchronic	Regulatory source p.38 SCCS Opinion
codes ............................................... 10 99-76-3	repeated dose toxicity	1000 mg/kg/day	repeated dose toxicity oral developmental	Regulatory source p.44 SCCS Opinion
codes ............................................... 10 99-76-3	repeated dose toxicity	1000 mg/kg bw/d	repeated dose toxicity oral 90-day	Regulatory source p.44 SCCS Opinion
codes ............................................... 10 99-76-3	repeated dose toxicity	1000 mg/kg bw/d	repeated dose toxicity oral 90-day	Regulatory source p.44 SCCS Opinion
codes ............................................... 10 99-76-3	repeated dose toxicity	1000 mg/kg bw/d	repeated dose toxicity oral 90-day	Regulatory source p.44 SCCS Opinion
codes ............................................... 10 99-76-3	repeated dose toxicity	1000 mg/kg/day	repeated dose toxicity human oral subchronic	Regulatory source p.70 SCCS Opinion
codes ............................................... 10 99-76-3	repeated dose toxicity	1000 mg/kg bw/d	repeated dose toxicity oral subchronic	Regulatory source p.70 SCCS Opinion
codes ............................................... 10 99-76-3	repeated dose toxicity	1000 mg/kg bw/d	repeated dose toxicity oral 90-day	Regulatory source p.70 SCCS Opinion
codes ............................................... 10 99-76-3	repeated dose toxicity	1000 mg/kg/day	repeated dose toxicity oral 14 days	Regulatory source p.38 SCCS Opinion
codes ............................................... 10 99-76-3	repeated dose toxicity	1000 mg/kg/day	repeated dose toxicity oral subchronic	Regulatory source p.38 SCCS Opinion
codes ............................................... 10 99-76-3	repeated dose toxicity	1000 mg/kg/day	repeated dose toxicity oral developmental	Regulatory source p.44 SCCS Opinion
codes ............................................... 10 99-76-3	repeated dose toxicity	1000 mg/kg bw/d	repeated dose toxicity oral 90-day	Regulatory source p.44 SCCS Opinion
codes ............................................... 10 99-76-3	repeated dose toxicity	1000 mg/kg bw/d	repeated dose toxicity oral 90-day	Regulatory source p.44 SCCS Opinion
codes ............................................... 10 99-76-3	repeated dose toxicity	1000 mg/kg bw/d	repeated dose toxicity oral 90-day	Regulatory source p.44 SCCS Opinion
codes ............................................... 10 99-76-3	repeated dose toxicity	1000 mg/kg/day	repeated dose toxicity human oral subchronic	Regulatory source p.70 SCCS Opinion
codes ............................................... 10 99-76-3	repeated dose toxicity	1000 mg/kg bw/d	repeated dose toxicity oral subchronic	Regulatory source p.70 SCCS Opinion
codes ............................................... 10 99-76-3	repeated dose toxicity	1000 mg/kg bw/d	repeated dose toxicity oral 90-day	Regulatory source p.70 SCCS Opinion
codes ............................................... 10 99-76-3	reproductive toxicity	25	reproductive toxicity oral developmental	Regulatory source p.44 SCCS Opinion
codes ............................................... 10 99-76-3	reproductive toxicity	25	reproductive toxicity oral developmental	Regulatory source p.44 SCCS Opinion
codes ............................................... 10 99-76-3	reproductive toxicity	25	reproductive toxicity oral developmental	Regulatory source p.44 SCCS Opinion
codes ............................................... 10 99-76-3	reproductive toxicity	25	reproductive toxicity oral developmental	Regulatory source p.44 SCCS Opinion
codes ............................................... 10 99-76-3	reproductive toxicity	300 mg/kg bw/day	reproductive toxicity developmental	Regulatory source p.50 SCCS Opinion
codes ............................................... 10 99-76-3	reproductive toxicity	300 mg/kg bw/day	reproductive toxicity developmental	Regulatory source p.50 SCCS Opinion
codes ............................................... 10 99-76-3	reproductive toxicity	1000 mg/kg bw/d	reproductive toxicity	Regulatory source p.43 SCCS Opinion
codes ............................................... 10 99-76-3	reproductive toxicity	1000 mg/kg/day	reproductive toxicity dog oral 422 days	Regulatory source p.44 SCCS Opinion
codes ............................................... 10 99-76-3	reproductive toxicity	1000 mg/kg bw/day	reproductive toxicity oral developmental	Regulatory source p.45 SCCS Opinion
codes ............................................... 10 99-76-3	reproductive toxicity	1000 mg/kg/day	reproductive toxicity developmental	Regulatory source p.45 SCCS Opinion
codes ............................................... 10 99-76-3	reproductive toxicity	1000 mg/kg bw/day	reproductive toxicity rat developmental	Regulatory source p.45 SCCS Opinion
codes ............................................... 10 99-76-3	reproductive toxicity	1000 mg/kg bw/day	reproductive toxicity rat	Regulatory source p.45 SCCS Opinion
codes ............................................... 10 99-76-3	reproductive toxicity	1000 mg/kg	reproductive toxicity developmental	Regulatory source p.50 SCCS Opinion
codes ............................................... 10 99-76-3	reproductive toxicity	1000 mg/kg	reproductive toxicity developmental	Regulatory source p.50 SCCS Opinion
codes ............................................... 10 99-76-3	reproductive toxicity	1000 mg/kg bw/d	reproductive toxicity 90-day	Regulatory source p.70 SCCS Opinion
codes ............................................... 10 99-76-3	reproductive toxicity	1000 mg/kg bw/d	reproductive toxicity	Regulatory source p.43 SCCS Opinion
codes ............................................... 10 99-76-3	reproductive toxicity	1000 mg/kg/day	reproductive toxicity dog oral 422 days	Regulatory source p.44 SCCS Opinion
codes ............................................... 10 99-76-3	reproductive toxicity	1000 mg/kg bw/day	reproductive toxicity oral developmental	Regulatory source p.45 SCCS Opinion
codes ............................................... 10 99-76-3	reproductive toxicity	1000 mg/kg/day	reproductive toxicity developmental	Regulatory source p.45 SCCS Opinion
codes ............................................... 10 99-76-3	reproductive toxicity	1000 mg/kg bw/day	reproductive toxicity rat developmental	Regulatory source p.45 SCCS Opinion
codes ............................................... 10 99-76-3	reproductive toxicity	1000 mg/kg bw/day	reproductive toxicity rat	Regulatory source p.45 SCCS Opinion
codes ............................................... 10 99-76-3	reproductive toxicity	1000 mg/kg	reproductive toxicity developmental	Regulatory source p.50 SCCS Opinion
codes ............................................... 10 99-76-3	reproductive toxicity	1000 mg/kg	reproductive toxicity developmental	Regulatory source p.50 SCCS Opinion
codes ............................................... 10 99-76-3	reproductive toxicity	1000 mg/kg bw/d	reproductive toxicity 90-day	Regulatory source p.70 SCCS Opinion
codes ............................................... 10 99-76-3	reproductive toxicity	10000 ppm	reproductive toxicity rat oral	Regulatory source p.45 SCCS Opinion
codes ............................................... 10 99-76-3	reproductive toxicity	10000 ppm	reproductive toxicity rat oral	Regulatory source p.45 SCCS Opinion

Safety Conclusion

sccs_opinions Max 0.4% as individual ester; 0.8% in mixtures of esters

Safe — safe as preservative at current EU-authorised concentrations

Key concerns: Endocrine disruption potential evaluated; estrogenic potency very low; no additional restrictions required beyond existing Annex V limits

Opinion date: 14 December 2023

safety_opinions general Max 0.4

unknown

Opinion date: 14 December 2023

Source Citation

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