SCCS/1622/20 31 NOAEL rows Safety conclusion

codes .............................................. 8, Homosalate

Structured SCCS opinion summary generated from source-matched D1 rows for SCCS/1622/20.

Opinion Number

SCCS/1622/20

NOAEL Rows

Substances Covered

Substance(s) Covered

codes .............................................. 8 Homosalate

NOAEL Values Extracted from This Opinion

Substance	Endpoint	Value	Study	Source
codes .............................................. 8 118-56-9	NOAEL	0.5 %	oral	Regulatory source p.48 SCCS Opinion
codes .............................................. 8 118-56-9	NOAEL	9	Not recorded	Regulatory source p.48 SCCS Opinion
codes .............................................. 8 118-56-9	NOAEL	75 mg/kg bw/d	human	Regulatory source p.47 SCCS Opinion
codes .............................................. 8 118-56-9	NOAEL	75 mg/kg bw/d	human	Regulatory source p.51 SCCS Opinion
codes .............................................. 8 118-56-9	NOAEL	100 mg/kg bw	rat 14 days	Regulatory source p.27 SCCS Opinion
codes .............................................. 8 118-56-9	NOAEL	120 mg/kg bw/d	rat oral	Regulatory source p.20 SCCS Opinion
codes .............................................. 8 118-56-9	NOAEL	300 mg/kg bw/day	Not recorded	Regulatory source p.30 SCCS Opinion
codes .............................................. 8 118-56-9	NOAEL	300 mg/kg bw/day	NOAEL study	SCCS Opinion p.30 SCCS Opinion
codes .............................................. 8 118-56-9	NOAEL	300 mg/kg bw/day	NOAEL study	SCCS Opinion p.30 SCCS Opinion
codes .............................................. 8 118-56-9	NOAEL	300 mg/kg bw/day	NOAEL study	SCCS Opinion p.30 SCCS Opinion
codes .............................................. 8 118-56-9	NOAEL	300 mg/kg bw/day	NOAEL study	SCCS Opinion p.30 SCCS Opinion
codes .............................................. 8 118-56-9	dermal absorption	10 mg/kg bw/d	dermal absorption rat oral	Regulatory source p.48 SCCS Opinion
codes .............................................. 8 118-56-9	dermal absorption	20 mg/kg bw/d	dermal absorption rat oral	Regulatory source p.48 SCCS Opinion
codes .............................................. 8 118-56-9	developmental toxicity	300 mg/kg bw/day	developmental toxicity oral Developmental	Regulatory source p.31 SCCS Opinion
codes .............................................. 8 118-56-9	repeated dose toxicity	10 mg/kg bw/day	repeated dose toxicity oral Developmental	Regulatory source p.47 SCCS Opinion
codes .............................................. 8 118-56-9	repeated dose toxicity	50 %	repeated dose toxicity oral Developmental	Regulatory source p.47 SCCS Opinion
codes .............................................. 8 118-56-9	repeated dose toxicity	300 mg/kg bw/day	repeated dose toxicity oral	Regulatory source p.50 SCCS Opinion
codes .............................................. 8 118-56-9	reproductive toxicity	300 mg/kg/day	reproductive toxicity	Regulatory source p.31 SCCS Opinion
Unnamed substance	DERMAL_ABSORPTION	5.3 %	in vitro human skin dermal	SCCS Opinion Ref.: ECHA 2020a, 2020b, p.7 SCCS Opinion
Unnamed substance	DERMAL_ABSORPTION	5.3 %	in vitro human skin dermal	SCCS Opinion Ref.: ECHA 2020a, 2020b, p.7 SCCS Opinion
Unnamed substance	DERMAL_ABSORPTION	5.3 %	in vitro human skin dermal	SCCS Opinion Ref.: ECHA 2020a, 2020b, p.7 SCCS Opinion
118-56-9 118-56-9	NOAEL	10 mg/kg bw/day	repeated dose toxicity oral developmental	SCCS Opinion p.10 SCCS Opinion
118-56-9 118-56-9	NOAEL	10 mg/kg bw/day	repeated dose toxicity oral developmental	SCCS Opinion p.10 SCCS Opinion
118-56-9 118-56-9	NOAEL	10 mg/kg bw/day	repeated dose toxicity oral developmental	SCCS Opinion p.10 SCCS Opinion
118-56-9 118-56-9	NOAEL	10 mg/kg bw/day	repeated dose toxicity oral developmental	SCCS Opinion p.10 SCCS Opinion
118-56-9 118-56-9	NOAEL	50 %	repeated dose toxicity human oral developmental	SCCS Opinion Ref.: SCCS/1622/20 3, p.10 SCCS Opinion
118-56-9 118-56-9	NOAEL	50 %	repeated dose toxicity human oral developmental	SCCS Opinion Ref.: SCCS/1622/20 3, p.10 SCCS Opinion
118-56-9 118-56-9	NOAEL	50 %	repeated dose toxicity human oral developmental	SCCS Opinion Ref.: SCCS/1622/20 3, p.10 SCCS Opinion
118-56-9 118-56-9	NOAEL	50 %	repeated dose toxicity human oral developmental	SCCS Opinion Ref.: SCCS/1622/20 3, p.10 SCCS Opinion
118-56-9 118-56-9	repeated dose toxicity	10 mg/kg bw/day	repeated dose toxicity oral developmental	Regulatory source p.10 SCCS Opinion
118-56-9 118-56-9	repeated dose toxicity	50 %	repeated dose toxicity human oral developmental	Regulatory source p.10 SCCS Opinion

Safety Conclusion

sccs_opinions Max up to 0.5% (full body products); 7.34% established in subsequent SCCS/1638/21

safe with restrictions

Key concerns: Potential endocrine disrupting properties (equivocal evidence); reproductive/developmental toxicity based on LOAEL 60 mg/kg bw/d; MoS insufficient at 10%

Opinion date: 24-25 June 2021

Source Citation

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