SCCS/1442/11 9 NOAEL rows Safety conclusion

2-Amino-5-ethylphenol HCl

Structured SCCS opinion summary generated from source-matched D1 rows for SCCS/1442/11.

Opinion Number

SCCS/1442/11

NOAEL Rows

Substances Covered

Substance(s) Covered

2-Amino-5-ethylphenol HCl

NOAEL Values Extracted from This Opinion

Substance	Endpoint	Value	Study	Source
2-Amino-5-ethylphenol HCl 149861-22-3	NOAEL	7	oral 90 days	Regulatory source p.25 SCCS Opinion
2-Amino-5-ethylphenol HCl 149861-22-3	dermal absorption	0.026 mg/kg bw/d	dermal absorption rat oral 90 day	Regulatory source p.26 SCCS Opinion
2-Amino-5-ethylphenol HCl 149861-22-3	dermal absorption	16 mg/kg bw/d	dermal absorption rat oral 90 day	Regulatory source p.26 SCCS Opinion
2-Amino-5-ethylphenol HCl 149861-22-3	developmental toxicity	74 mg/kg bw/day	developmental toxicity oral developmental	Regulatory source p.23 SCCS Opinion
2-Amino-5-ethylphenol HCl 149861-22-3	developmental toxicity	369 mg/kg bw/day	developmental toxicity oral developmental	Regulatory source p.23 SCCS Opinion
2-Amino-5-ethylphenol HCl 149861-22-3	genotoxicity	16 mg/kg bw/day	genotoxicity rat Chronic	Regulatory source p.17 SCCS Opinion
2-Amino-5-ethylphenol HCl 149861-22-3	repeated dose toxicity	16 mg/kg bw/day	repeated dose toxicity rat oral subchronic	Regulatory source p.27 SCCS Opinion
2-Amino-5-ethylphenol HCl 149861-22-3	repeated dose toxicity	369 mg/kg bw/day	repeated dose toxicity rat oral subchronic	Regulatory source p.27 SCCS Opinion
2-Amino-5-ethylphenol HCl 149861-22-3	reproductive toxicity	74 mg/kg bw/day	reproductive toxicity mouse oral developmental	Regulatory source p.27 SCCS Opinion

Safety Conclusion

sccs_opinions Max As per existing Annex V limits (0.4% individual; 0.8% mixtures)

Safe — no scientific basis to specifically ban parabens from products intended for children under 3 years

Key concerns: Endocrine disruption concern (Danish ban context); aggregate exposure; note: superseded by later SCCS/1674/25 for butylparaben in children 0.5-10 yrs

Opinion date: 10 October 2011

Source Citation

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