SCCS/1668/24 29 NOAEL rows Safety conclusion

s through damaged skin. Also, Hexyl Salicylate is classified as a, Hexyl Salicylate - children 0-3 years, Hexyl Salicylate SCCS/1658/23

Structured SCCS opinion summary generated from source-matched D1 rows for SCCS/1668/24.

Opinion Number

SCCS/1668/24

NOAEL Rows

Substances Covered

Substance(s) Covered

s through damaged skin. Also, Hexyl Salicylate is classified as a Hexyl Salicylate - children 0-3 years Hexyl Salicylate SCCS/1658/23

NOAEL Values Extracted from This Opinion

Substance	Endpoint	Value	Study	Source
s through damaged skin. Also, Hexyl Salicylate is classified as a 6259-76-3	NOAEL	3	Not recorded	Regulatory source p.17 SCCS Opinion
s through damaged skin. Also, Hexyl Salicylate is classified as a 6259-76-3	NOAEL	13	3 years	Regulatory source p.46 SCCS Opinion
s through damaged skin. Also, Hexyl Salicylate is classified as a 6259-76-3	NOAEL	13.4 %	dermal 3 years	Regulatory source p.17 SCCS Opinion
s through damaged skin. Also, Hexyl Salicylate is classified as a 6259-76-3	NOAEL	75	Not recorded	Regulatory source p.17 SCCS Opinion
s through damaged skin. Also, Hexyl Salicylate is classified as a 6259-76-3	NOAEL	180 mg/kg bw/day	rat	Regulatory source p.35 SCCS Opinion
s through damaged skin. Also, Hexyl Salicylate is classified as a 6259-76-3	NOAEL	370 mg/kg bw/day	rat oral 13-week	Regulatory source p.33 SCCS Opinion
s through damaged skin. Also, Hexyl Salicylate is classified as a 6259-76-3	NOAEL	540 mg/kg bw/day	rat	Regulatory source p.35 SCCS Opinion
s through damaged skin. Also, Hexyl Salicylate is classified as a 6259-76-3	NOAEL	736	3 years	Regulatory source p.46 SCCS Opinion
s through damaged skin. Also, Hexyl Salicylate is classified as a 6259-76-3	NOAEL	801	3 years	Regulatory source p.46 SCCS Opinion
s through damaged skin. Also, Hexyl Salicylate is classified as a 6259-76-3	NOAEL	822	3 years	Regulatory source p.46 SCCS Opinion
s through damaged skin. Also, Hexyl Salicylate is classified as a 6259-76-3	NOAEL	1668	3 years	Regulatory source p.46 SCCS Opinion
s through damaged skin. Also, Hexyl Salicylate is classified as a 6259-76-3	NOAEL	75000	3 years	Regulatory source p.46 SCCS Opinion
s through damaged skin. Also, Hexyl Salicylate is classified as a 6259-76-3	NOAEL	1668	NOAEL study 3 years	SCCS Opinion p.46 SCCS Opinion
s through damaged skin. Also, Hexyl Salicylate is classified as a 6259-76-3	NOAEL	1668	NOAEL study 3 years	SCCS Opinion p.46 SCCS Opinion
s through damaged skin. Also, Hexyl Salicylate is classified as a 6259-76-3	NOAEL	1668	NOAEL study 3 years	SCCS Opinion p.46 SCCS Opinion
s through damaged skin. Also, Hexyl Salicylate is classified as a 6259-76-3	NOAEL	1668	NOAEL study 3 years	SCCS Opinion p.46 SCCS Opinion
s through damaged skin. Also, Hexyl Salicylate is classified as a 6259-76-3	developmental toxicity	75 mg/kg bw/day	developmental toxicity human oral developmental	Regulatory source p.35 SCCS Opinion
s through damaged skin. Also, Hexyl Salicylate is classified as a 6259-76-3	developmental toxicity	75 mg/kg bw/day	developmental toxicity human oral developmental	Regulatory source p.35 SCCS Opinion
s through damaged skin. Also, Hexyl Salicylate is classified as a 6259-76-3	developmental toxicity	75 mg/kg bw/day	developmental toxicity human oral developmental	Regulatory source p.49 SCCS Opinion
s through damaged skin. Also, Hexyl Salicylate is classified as a 6259-76-3	developmental toxicity	75 mg/kg bw/day	developmental toxicity human oral developmental	Regulatory source p.49 SCCS Opinion
s through damaged skin. Also, Hexyl Salicylate is classified as a 6259-76-3	developmental toxicity	180 mg/kg bw/day	developmental toxicity rat	Regulatory source p.35 SCCS Opinion
s through damaged skin. Also, Hexyl Salicylate is classified as a 6259-76-3	repeated dose toxicity	1000 mg/kg bw/day	repeated dose toxicity rat oral sub-chronic	Regulatory source p.33 SCCS Opinion
s through damaged skin. Also, Hexyl Salicylate is classified as a 6259-76-3	repeated dose toxicity	1127 mg/kg	repeated dose toxicity rat oral sub-acute	Regulatory source p.33 SCCS Opinion
s through damaged skin. Also, Hexyl Salicylate is classified as a 6259-76-3	repeated dose toxicity	1127 mg/kg	repeated dose toxicity rat oral sub-acute	Regulatory source p.33 SCCS Opinion
s through damaged skin. Also, Hexyl Salicylate is classified as a 6259-76-3	reproductive toxicity	0.1 %	reproductive toxicity human oral developmental	Regulatory source p.35 SCCS Opinion
s through damaged skin. Also, Hexyl Salicylate is classified as a 6259-76-3	reproductive toxicity	0.1 %	reproductive toxicity human oral developmental	Regulatory source p.49 SCCS Opinion
s through damaged skin. Also, Hexyl Salicylate is classified as a 6259-76-3	reproductive toxicity	75 mg/kg/day	reproductive toxicity rat developmental	Regulatory source p.45 SCCS Opinion
s through damaged skin. Also, Hexyl Salicylate is classified as a 6259-76-3	reproductive toxicity	75 mg/kg/day	reproductive toxicity rat developmental	Regulatory source p.45 SCCS Opinion
s through damaged skin. Also, Hexyl Salicylate is classified as a 6259-76-3	sensitisation	35433 μg/cm2	sensitisation human 2 weeks	Regulatory source p.30 SCCS Opinion

Safety Conclusion

sccs_opinions Max 0.1% shower gels/hand soaps/shampoos/conditioners/body lotions/face creams/hand creams/lip products/fine fragrance; 0.001% toothpaste

Safe with restrictions for children ≤3 years old

Key concerns: CMR Cat.2 (reprotoxic); skin sensitiser Cat.1; salicylic acid metabolite not permitted in <3yr cosmetics; enhanced uptake through damaged skin

Opinion date: 25 October 2024

safety_opinions oral care Max 0.5

safe

ncluding potential endocrine disrupting effects, the SCCS considers Hexyl Salicylate safe for children up to 3 years old when used up to the maximum concentrations as below: o 0.1 % (w/w) for shower gel, hand soap, shampoo, hair conditioner, body lotion, face cream, hand cream, lips

Opinion date: 25 October 2024

Source Citation

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