SCCS/1552/15 60 NOAEL rows Safety conclusion

Alpha-Arbutin, Alpha-Arbutin (CAS 84380-01-8; EC 283-934-3) with the chemical, α-arbutin

Structured SCCS opinion summary generated from source-matched D1 rows for SCCS/1552/15.

Opinion Number

SCCS/1552/15

NOAEL Rows

Substances Covered

Substance(s) Covered

Alpha-Arbutin Alpha-Arbutin (CAS 84380-01-8; EC 283-934-3) with the chemical α-arbutin

NOAEL Values Extracted from This Opinion

Substance	Endpoint	Value	Study	Source
Alpha-Arbutin 84380-01-8	NOAEL	1000 mg/kg bw/day	repeated dose toxicity rat oral 28-day	SCCS Opinion p.37 SCCS Opinion
Alpha-Arbutin 84380-01-8	NOAEL	1000 mg/kg bw/day	repeated dose toxicity rat oral 28-day	SCCS Opinion p.37 SCCS Opinion
Alpha-Arbutin 84380-01-8	NOAEL	1000 mg/kg bw/day	repeated dose toxicity rat oral 28-day	SCCS Opinion p.37 SCCS Opinion
Alpha-Arbutin 84380-01-8	NOAEL	1000 mg/kg bw/day	repeated dose toxicity rat oral 28-day	SCCS Opinion p.37 SCCS Opinion
Alpha-Arbutin 84380-01-8	NOAEL	1550	repeated dose toxicity rat oral 28-day	SCCS Opinion p.37 SCCS Opinion
Alpha-Arbutin 84380-01-8	NOAEL	1550	repeated dose toxicity rat oral 28-day	SCCS Opinion p.37 SCCS Opinion
Alpha-Arbutin 84380-01-8	NOAEL	1550	repeated dose toxicity rat oral 28-day	SCCS Opinion p.37 SCCS Opinion
Alpha-Arbutin 84380-01-8	NOAEL	1550	repeated dose toxicity rat oral 28-day	SCCS Opinion p.37 SCCS Opinion
Alpha-Arbutin 84380-01-8	repeated dose toxicity	1000 mg/kg bw/day	repeated dose toxicity rat oral 28-day	Regulatory source p.37 SCCS Opinion
Alpha-Arbutin 84380-01-8	repeated dose toxicity	1550	repeated dose toxicity rat oral 28-day	Regulatory source p.37 SCCS Opinion
Alpha-Arbutin (CAS 84380-01-8; EC 283-934-3) with the chemical 84380-01-8	NOAEL	2 %	Not recorded	Regulatory source p.38 SCCS Opinion
Alpha-Arbutin (CAS 84380-01-8; EC 283-934-3) with the chemical 84380-01-8	NOAEL	9	Not recorded	Regulatory source p.38 SCCS Opinion
Alpha-Arbutin (CAS 84380-01-8; EC 283-934-3) with the chemical 84380-01-8	NOAEL	15 mg/kg/day	rat	Regulatory source p.38 SCCS Opinion
Alpha-Arbutin (CAS 84380-01-8; EC 283-934-3) with the chemical 84380-01-8	NOAEL	20 mg/kg/day	rat oral 28d	Regulatory source p.37 SCCS Opinion
Alpha-Arbutin (CAS 84380-01-8; EC 283-934-3) with the chemical 84380-01-8	NOAEL	20 mg/kg bw/day	dermal	Regulatory source p.40 SCCS Opinion
Alpha-Arbutin (CAS 84380-01-8; EC 283-934-3) with the chemical 84380-01-8	NOAEL	20 mg/kg/day	rat oral 28d	Regulatory source p.37 SCCS Opinion
Alpha-Arbutin (CAS 84380-01-8; EC 283-934-3) with the chemical 84380-01-8	NOAEL	74 mg/kg/day	rat dermal 28d	Regulatory source p.38 SCCS Opinion
Alpha-Arbutin (CAS 84380-01-8; EC 283-934-3) with the chemical 84380-01-8	NOAEL	344	rat	Regulatory source p.38 SCCS Opinion
Alpha-Arbutin (CAS 84380-01-8; EC 283-934-3) with the chemical 84380-01-8	NOAEL	15 mg/kg/day	reproductive toxicity rat oral 28d	SCCS Opinion p.38 SCCS Opinion
Alpha-Arbutin (CAS 84380-01-8; EC 283-934-3) with the chemical 84380-01-8	NOAEL	15 mg/kg/day	reproductive toxicity rat oral 28d	SCCS Opinion p.38 SCCS Opinion
Alpha-Arbutin (CAS 84380-01-8; EC 283-934-3) with the chemical 84380-01-8	NOAEL	15 mg/kg/day	reproductive toxicity rat oral 28d	SCCS Opinion p.38 SCCS Opinion
Alpha-Arbutin (CAS 84380-01-8; EC 283-934-3) with the chemical 84380-01-8	NOAEL	15 mg/kg/day	reproductive toxicity rat oral 28d	SCCS Opinion p.38 SCCS Opinion
Alpha-Arbutin (CAS 84380-01-8; EC 283-934-3) with the chemical 84380-01-8	NOAEL	25 mg/kg/day	reproductive toxicity rat oral 28d	SCCS Opinion p.38 SCCS Opinion
Alpha-Arbutin (CAS 84380-01-8; EC 283-934-3) with the chemical 84380-01-8	NOAEL	25 mg/kg/day	reproductive toxicity rat oral 28d	SCCS Opinion p.38 SCCS Opinion
Alpha-Arbutin (CAS 84380-01-8; EC 283-934-3) with the chemical 84380-01-8	NOAEL	25 mg/kg/day	reproductive toxicity rat oral 28d	SCCS Opinion p.38 SCCS Opinion
Alpha-Arbutin (CAS 84380-01-8; EC 283-934-3) with the chemical 84380-01-8	NOAEL	25 mg/kg/day	reproductive toxicity rat oral 28d	SCCS Opinion p.38 SCCS Opinion
Alpha-Arbutin (CAS 84380-01-8; EC 283-934-3) with the chemical 84380-01-8	NOAEL	74 mg/kg/day	reproductive toxicity rat oral 28d	SCCS Opinion p.38 SCCS Opinion
Alpha-Arbutin (CAS 84380-01-8; EC 283-934-3) with the chemical 84380-01-8	NOAEL	74 mg/kg/day	reproductive toxicity rat oral 28d	SCCS Opinion p.38 SCCS Opinion
Alpha-Arbutin (CAS 84380-01-8; EC 283-934-3) with the chemical 84380-01-8	NOAEL	74 mg/kg/day	reproductive toxicity rat oral 28d	SCCS Opinion p.38 SCCS Opinion
Alpha-Arbutin (CAS 84380-01-8; EC 283-934-3) with the chemical 84380-01-8	NOAEL	74 mg/kg/day	reproductive toxicity rat oral 28d	SCCS Opinion p.38 SCCS Opinion
Alpha-Arbutin (CAS 84380-01-8; EC 283-934-3) with the chemical 84380-01-8	NOAEL	75 mg/kg/day	reproductive toxicity rat oral 28d	SCCS Opinion p.38 SCCS Opinion
Alpha-Arbutin (CAS 84380-01-8; EC 283-934-3) with the chemical 84380-01-8	NOAEL	75 mg/kg/day	reproductive toxicity rat oral 28d	SCCS Opinion p.38 SCCS Opinion
Alpha-Arbutin (CAS 84380-01-8; EC 283-934-3) with the chemical 84380-01-8	NOAEL	75 mg/kg/day	reproductive toxicity rat oral 28d	SCCS Opinion p.38 SCCS Opinion
Alpha-Arbutin (CAS 84380-01-8; EC 283-934-3) with the chemical 84380-01-8	NOAEL	75 mg/kg/day	reproductive toxicity rat oral 28d	SCCS Opinion p.38 SCCS Opinion
Alpha-Arbutin (CAS 84380-01-8; EC 283-934-3) with the chemical 84380-01-8	carcinogenicity	15 mg/kg bw	carcinogenicity oral	Regulatory source p.41 SCCS Opinion
Alpha-Arbutin (CAS 84380-01-8; EC 283-934-3) with the chemical 84380-01-8	carcinogenicity	20 mg/kg bw	carcinogenicity oral	Regulatory source p.41 SCCS Opinion
Alpha-Arbutin (CAS 84380-01-8; EC 283-934-3) with the chemical 84380-01-8	carcinogenicity	20 mg/kg bw	carcinogenicity oral	Regulatory source p.41 SCCS Opinion
Alpha-Arbutin (CAS 84380-01-8; EC 283-934-3) with the chemical 84380-01-8	carcinogenicity	25 mg/kg/day	carcinogenicity	Regulatory source p.38 SCCS Opinion
Alpha-Arbutin (CAS 84380-01-8; EC 283-934-3) with the chemical 84380-01-8	developmental toxicity	25 mg/kg/day	developmental toxicity rabbit developmental	Regulatory source p.38 SCCS Opinion
Alpha-Arbutin (CAS 84380-01-8; EC 283-934-3) with the chemical 84380-01-8	developmental toxicity	75 mg/kg/day	developmental toxicity rabbit developmental	Regulatory source p.38 SCCS Opinion
Alpha-Arbutin (CAS 84380-01-8; EC 283-934-3) with the chemical 84380-01-8	irritation	20 %	irritation guinea pig dermal 14-day	Regulatory source p.43 SCCS Opinion
Alpha-Arbutin (CAS 84380-01-8; EC 283-934-3) with the chemical 84380-01-8	repeated dose toxicity	3.3	repeated dose toxicity guinea pig oral Sub-chronic	Regulatory source p.29 SCCS Opinion
Alpha-Arbutin (CAS 84380-01-8; EC 283-934-3) with the chemical 84380-01-8	repeated dose toxicity	29	repeated dose toxicity oral 14 days	Regulatory source p.29 SCCS Opinion
Alpha-Arbutin (CAS 84380-01-8; EC 283-934-3) with the chemical 84380-01-8	repeated dose toxicity	56	repeated dose toxicity dermal 14-day	Regulatory source p.40 SCCS Opinion
Alpha-Arbutin (CAS 84380-01-8; EC 283-934-3) with the chemical 84380-01-8	repeated dose toxicity	>250 mg/kg bw	repeated dose toxicity rat oral 14-day	Regulatory source p.42 SCCS Opinion
Alpha-Arbutin (CAS 84380-01-8; EC 283-934-3) with the chemical 84380-01-8	repeated dose toxicity	>250 mg/kg bw	repeated dose toxicity guinea pig oral 14-day	Regulatory source p.42 SCCS Opinion
Alpha-Arbutin (CAS 84380-01-8; EC 283-934-3) with the chemical 84380-01-8	reproductive toxicity	15 mg/kg/day	reproductive toxicity rat oral 28d	Regulatory source p.38 SCCS Opinion
Alpha-Arbutin (CAS 84380-01-8; EC 283-934-3) with the chemical 84380-01-8	reproductive toxicity	25 mg/kg/day	reproductive toxicity rat oral 28d	Regulatory source p.38 SCCS Opinion
Alpha-Arbutin (CAS 84380-01-8; EC 283-934-3) with the chemical 84380-01-8	reproductive toxicity	74 mg/kg/day	reproductive toxicity rat oral 28d	Regulatory source p.38 SCCS Opinion
Alpha-Arbutin (CAS 84380-01-8; EC 283-934-3) with the chemical 84380-01-8	reproductive toxicity	75 mg/kg/day	reproductive toxicity rat oral 28d	Regulatory source p.38 SCCS Opinion
Alpha-Arbutin (CAS 84380-01-8; EC 283-934-3) with the chemical 84380-01-8	reproductive toxicity	150 mg/kg/day	reproductive toxicity rat	Regulatory source p.38 SCCS Opinion
Unnamed substance	DERMAL_ABSORPTION	0.53 %	Dermal absorption dermal	SCCS Opinion p.35 SCCS Opinion
Unnamed substance	DERMAL_ABSORPTION	0.53 %	Dermal absorption dermal	SCCS Opinion p.35 SCCS Opinion
Unnamed substance	DERMAL_ABSORPTION	0.53 %	Dermal absorption dermal	SCCS Opinion p.35 SCCS Opinion
Unnamed substance	DERMAL_ABSORPTION	3 %	in vivo dermal Percutaneous absorption in vivo from SCCS/1552/15 In a study with human volunteers who applied a gel with either 3% alpha-arbutin or 3% beta- arbutin or 1.9% hydroquinone, the (relative) amounts present in tape strips were assessed (Mamabolo et al., unpubli...	SCCS Opinion p.34 SCCS Opinion
Unnamed substance	DERMAL_ABSORPTION	3 %	in vivo dermal Percutaneous absorption in vivo from SCCS/1552/15 In a study with human volunteers who applied a gel with either 3% alpha-arbutin or 3% beta- arbutin or 1.9% hydroquinone, the (relative) amounts present in tape strips were assessed (Mamabolo et al., unpubli...	SCCS Opinion p.34 SCCS Opinion
Unnamed substance	DERMAL_ABSORPTION	3 %	in vivo dermal Percutaneous absorption in vivo from SCCS/1552/15 In a study with human volunteers who applied a gel with either 3% alpha-arbutin or 3% beta- arbutin or 1.9% hydroquinone, the (relative) amounts present in tape strips were assessed (Mamabolo et al., unpubli...	SCCS Opinion p.34 SCCS Opinion
Unnamed substance	DERMAL_ABSORPTION	80 %	in vitro human skin dermal	SCCS Opinion p.33 SCCS Opinion
Unnamed substance	DERMAL_ABSORPTION	80 %	in vitro human skin dermal	SCCS Opinion p.33 SCCS Opinion
Unnamed substance	DERMAL_ABSORPTION	80 %	in vitro human skin dermal	SCCS Opinion p.33 SCCS Opinion

Safety Conclusion

sccs_opinions Max 2% face cream; 0.5% body lotion

safe with restrictions

Key concerns: Hydroquinone release potential; limited data on other product types; precursor to updated SCCS/1642/22

Opinion date: 27 May 2015

Source Citation

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