SCCS/1158/08 75 NOAEL rows Safety conclusion

Alpha-Arbutin (CAS 84380-01-8; EC 283-934-3) with the chemical, Beta-Arbutin, Tetrahydropyranyloxy Phenol is a skin lightening agent synthesised through removal

Structured SCCS opinion summary generated from source-matched D1 rows for SCCS/1158/08.

Opinion Number

SCCS/1158/08

NOAEL Rows

Substances Covered

Substance(s) Covered

Alpha-Arbutin (CAS 84380-01-8; EC 283-934-3) with the chemical Beta-Arbutin Tetrahydropyranyloxy Phenol is a skin lightening agent synthesised through removal alpha-Arbutin

NOAEL Values Extracted from This Opinion

Substance	Endpoint	Value	Study	Source
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/day	NOAEL study rat oral 28d	SCCS Opinion p.37 SCCS Opinion
Alpha-Arbutin (CAS 84380-01-8; EC 283-934-3) with the chemical 84380-01-8	NOAEL	20 mg/kg/day	NOAEL study rat oral 28d	SCCS Opinion p.37 SCCS Opinion
Alpha-Arbutin (CAS 84380-01-8; EC 283-934-3) with the chemical 84380-01-8	NOAEL	20 mg/kg/day	NOAEL study rat oral 28d	SCCS Opinion p.37 SCCS Opinion
Alpha-Arbutin (CAS 84380-01-8; EC 283-934-3) with the chemical 84380-01-8	NOAEL	20 mg/kg/day	NOAEL study rat oral 28d	SCCS Opinion p.37 SCCS Opinion
Beta-Arbutin 497-76-7	NOAEL	15 mg/kg/day	rat	Regulatory source p.30 SCCS Opinion
Beta-Arbutin 497-76-7	NOAEL	20 mg/kg/day	rat oral 28d	Regulatory source p.30 SCCS Opinion
Beta-Arbutin 497-76-7	NOAEL	74 mg/kg/day	rat dermal 28d	Regulatory source p.30 SCCS Opinion
Beta-Arbutin 497-76-7	NOAEL	618 mg/kg bw/day	oral 28 day	Regulatory source p.18 SCCS Opinion
Beta-Arbutin 497-76-7	NOAEL	0.522 µg/cm	reproductive toxicity rat oral 28d	SCCS Opinion p.30 SCCS Opinion
Beta-Arbutin 497-76-7	NOAEL	0.522 µg/cm	reproductive toxicity rat oral 28d	SCCS Opinion p.30 SCCS Opinion
Beta-Arbutin 497-76-7	NOAEL	0.522 µg/cm	reproductive toxicity rat oral 28d	SCCS Opinion p.30 SCCS Opinion
Beta-Arbutin 497-76-7	NOAEL	0.522 µg/cm	reproductive toxicity rat oral 28d	SCCS Opinion p.30 SCCS Opinion
Beta-Arbutin 497-76-7	NOAEL	20 mg/kg/day	reproductive toxicity rat oral 28d	SCCS Opinion p.30 SCCS Opinion
Beta-Arbutin 497-76-7	NOAEL	20 mg/kg/day	reproductive toxicity rat oral 28d	SCCS Opinion p.30 SCCS Opinion
Beta-Arbutin 497-76-7	NOAEL	20 mg/kg/day	reproductive toxicity rat oral 28d	SCCS Opinion p.30 SCCS Opinion
Beta-Arbutin 497-76-7	NOAEL	20 mg/kg/day	reproductive toxicity rat oral 28d	SCCS Opinion p.30 SCCS Opinion
Beta-Arbutin 497-76-7	NOAEL	25 mg/kg/day	reproductive toxicity rat oral 28d	SCCS Opinion p.30 SCCS Opinion
Beta-Arbutin 497-76-7	NOAEL	25 mg/kg/day	reproductive toxicity rat oral 28d	SCCS Opinion p.30 SCCS Opinion
Beta-Arbutin 497-76-7	NOAEL	25 mg/kg/day	reproductive toxicity rat oral 28d	SCCS Opinion p.30 SCCS Opinion
Beta-Arbutin 497-76-7	NOAEL	25 mg/kg/day	reproductive toxicity rat oral 28d	SCCS Opinion p.30 SCCS Opinion
Beta-Arbutin 497-76-7	NOAEL	74 mg/kg/day	reproductive toxicity rat oral 28d	SCCS Opinion p.30 SCCS Opinion
Beta-Arbutin 497-76-7	NOAEL	74 mg/kg/day	reproductive toxicity rat oral 28d	SCCS Opinion p.30 SCCS Opinion
Beta-Arbutin 497-76-7	NOAEL	74 mg/kg/day	reproductive toxicity rat oral 28d	SCCS Opinion p.30 SCCS Opinion
Beta-Arbutin 497-76-7	NOAEL	74 mg/kg/day	reproductive toxicity rat oral 28d	SCCS Opinion p.30 SCCS Opinion
Beta-Arbutin 497-76-7	NOAEL	75 mg/kg/day	reproductive toxicity rat oral 28d	SCCS Opinion p.30 SCCS Opinion
Beta-Arbutin 497-76-7	NOAEL	75 mg/kg/day	reproductive toxicity rat oral 28d	SCCS Opinion p.30 SCCS Opinion
Beta-Arbutin 497-76-7	NOAEL	75 mg/kg/day	reproductive toxicity rat oral 28d	SCCS Opinion p.30 SCCS Opinion
Beta-Arbutin 497-76-7	NOAEL	75 mg/kg/day	reproductive toxicity rat oral 28d	SCCS Opinion p.30 SCCS Opinion
Beta-Arbutin 497-76-7	developmental toxicity	25 mg/kg/day	developmental toxicity rabbit developmental	Regulatory source p.30 SCCS Opinion
Beta-Arbutin 497-76-7	developmental toxicity	75 mg/kg/day	developmental toxicity rabbit developmental	Regulatory source p.30 SCCS Opinion
Beta-Arbutin 497-76-7	repeated dose toxicity	400 mg/kg bw/day	repeated dose toxicity rat 28 day	Regulatory source p.21 SCCS Opinion
Beta-Arbutin 497-76-7	repeated dose toxicity	1000 mg/kg bw/day	repeated dose toxicity rat oral Sub-chronic	Regulatory source p.17 SCCS Opinion
Beta-Arbutin 497-76-7	repeated dose toxicity	1000 mg/kg bw/day	repeated dose toxicity rat oral 28 day	Regulatory source p.32 SCCS Opinion
Beta-Arbutin 497-76-7	repeated dose toxicity	1000 mg/kg bw/day	repeated dose toxicity rat oral 28-day	Regulatory source p.24 SCCS Opinion
Beta-Arbutin 497-76-7	reproductive toxicity	0.522 µg/cm	reproductive toxicity rat oral 28d	Regulatory source p.30 SCCS Opinion
Beta-Arbutin 497-76-7	reproductive toxicity	15 mg/kg/day	reproductive toxicity rat oral 28d	Regulatory source p.30 SCCS Opinion
Beta-Arbutin 497-76-7	reproductive toxicity	15 mg/kg/day	reproductive toxicity rat oral 28d	Regulatory source p.35 SCCS Opinion
Beta-Arbutin 497-76-7	reproductive toxicity	20 mg/kg/day	reproductive toxicity rat oral 28d	Regulatory source p.30 SCCS Opinion
Beta-Arbutin 497-76-7	reproductive toxicity	20 mg/kg/day	reproductive toxicity rat oral 28d	Regulatory source p.35 SCCS Opinion
Beta-Arbutin 497-76-7	reproductive toxicity	20 mg/kg/day	reproductive toxicity rat oral 28d	Regulatory source p.35 SCCS Opinion
Beta-Arbutin 497-76-7	reproductive toxicity	25 mg/kg/day	reproductive toxicity rat oral 28d	Regulatory source p.30 SCCS Opinion
Beta-Arbutin 497-76-7	reproductive toxicity	25 mg/kg/day	reproductive toxicity rat oral 28d	Regulatory source p.35 SCCS Opinion
Beta-Arbutin 497-76-7	reproductive toxicity	74 mg/kg/day	reproductive toxicity rat oral 28d	Regulatory source p.30 SCCS Opinion
Beta-Arbutin 497-76-7	reproductive toxicity	74 mg/kg/day	reproductive toxicity rat oral 28d	Regulatory source p.35 SCCS Opinion
Beta-Arbutin 497-76-7	reproductive toxicity	75 mg/kg/day	reproductive toxicity rat oral 28d	Regulatory source p.30 SCCS Opinion
Beta-Arbutin 497-76-7	reproductive toxicity	75 mg/kg/day	reproductive toxicity rat oral 28d	Regulatory source p.35 SCCS Opinion
Beta-Arbutin 497-76-7	reproductive toxicity	100 mg/kg bw/day	reproductive toxicity rat dermal	Regulatory source p.33 SCCS Opinion
Beta-Arbutin 497-76-7	reproductive toxicity	150 mg/kg/day	reproductive toxicity rat	Regulatory source p.30 SCCS Opinion
Tetrahydropyranyloxy Phenol is a skin lightening agent synthesised through removal 53936-56-4	NOAEL	15 mg/kg/day	reproductive toxicity rat oral 28d	SCCS Opinion p.38 SCCS Opinion
Tetrahydropyranyloxy Phenol is a skin lightening agent synthesised through removal 53936-56-4	NOAEL	15 mg/kg/day	reproductive toxicity rat oral 28d	SCCS Opinion p.38 SCCS Opinion
Tetrahydropyranyloxy Phenol is a skin lightening agent synthesised through removal 53936-56-4	NOAEL	15 mg/kg/day	reproductive toxicity rat oral 28d	SCCS Opinion p.38 SCCS Opinion
Tetrahydropyranyloxy Phenol is a skin lightening agent synthesised through removal 53936-56-4	NOAEL	15 mg/kg/day	reproductive toxicity rat oral 28d	SCCS Opinion p.38 SCCS Opinion
Tetrahydropyranyloxy Phenol is a skin lightening agent synthesised through removal 53936-56-4	NOAEL	20 mg/kg/day	reproductive toxicity rat oral 8 weeks	SCCS Opinion p.38 SCCS Opinion
Tetrahydropyranyloxy Phenol is a skin lightening agent synthesised through removal 53936-56-4	NOAEL	20 mg/kg/day	reproductive toxicity rat oral 8 weeks	SCCS Opinion p.38 SCCS Opinion
Tetrahydropyranyloxy Phenol is a skin lightening agent synthesised through removal 53936-56-4	NOAEL	20 mg/kg/day	reproductive toxicity rat oral 8 weeks	SCCS Opinion p.38 SCCS Opinion
Tetrahydropyranyloxy Phenol is a skin lightening agent synthesised through removal 53936-56-4	NOAEL	20 mg/kg/day	reproductive toxicity rat oral 8 weeks	SCCS Opinion p.38 SCCS Opinion
Tetrahydropyranyloxy Phenol is a skin lightening agent synthesised through removal 53936-56-4	NOAEL	25 mg/kg/day	reproductive toxicity rat oral 8 weeks	SCCS Opinion p.38 SCCS Opinion
Tetrahydropyranyloxy Phenol is a skin lightening agent synthesised through removal 53936-56-4	NOAEL	25 mg/kg/day	reproductive toxicity rat oral 8 weeks	SCCS Opinion p.38 SCCS Opinion
Tetrahydropyranyloxy Phenol is a skin lightening agent synthesised through removal 53936-56-4	NOAEL	25 mg/kg/day	reproductive toxicity rat oral 8 weeks	SCCS Opinion p.38 SCCS Opinion
Tetrahydropyranyloxy Phenol is a skin lightening agent synthesised through removal 53936-56-4	NOAEL	25 mg/kg/day	reproductive toxicity rat oral 8 weeks	SCCS Opinion p.38 SCCS Opinion
Tetrahydropyranyloxy Phenol is a skin lightening agent synthesised through removal 53936-56-4	NOAEL	74 mg/kg/day	reproductive toxicity rat oral 8 weeks	SCCS Opinion p.38 SCCS Opinion
Tetrahydropyranyloxy Phenol is a skin lightening agent synthesised through removal 53936-56-4	NOAEL	74 mg/kg/day	reproductive toxicity rat oral 8 weeks	SCCS Opinion p.38 SCCS Opinion
Tetrahydropyranyloxy Phenol is a skin lightening agent synthesised through removal 53936-56-4	NOAEL	74 mg/kg/day	reproductive toxicity rat oral 8 weeks	SCCS Opinion p.38 SCCS Opinion
Tetrahydropyranyloxy Phenol is a skin lightening agent synthesised through removal 53936-56-4	NOAEL	74 mg/kg/day	reproductive toxicity rat oral 8 weeks	SCCS Opinion p.38 SCCS Opinion
Tetrahydropyranyloxy Phenol is a skin lightening agent synthesised through removal 53936-56-4	NOAEL	75 mg/kg/day	reproductive toxicity rat oral 28d	SCCS Opinion p.38 SCCS Opinion
Tetrahydropyranyloxy Phenol is a skin lightening agent synthesised through removal 53936-56-4	NOAEL	75 mg/kg/day	reproductive toxicity rat oral 28d	SCCS Opinion p.38 SCCS Opinion
Tetrahydropyranyloxy Phenol is a skin lightening agent synthesised through removal 53936-56-4	NOAEL	75 mg/kg/day	reproductive toxicity rat oral 28d	SCCS Opinion p.38 SCCS Opinion
Tetrahydropyranyloxy Phenol is a skin lightening agent synthesised through removal 53936-56-4	NOAEL	75 mg/kg/day	reproductive toxicity rat oral 28d	SCCS Opinion p.38 SCCS Opinion
Tetrahydropyranyloxy Phenol is a skin lightening agent synthesised through removal 53936-56-4	reproductive toxicity	15 mg/kg/day	reproductive toxicity rat oral 28d	Regulatory source p.38 SCCS Opinion
Tetrahydropyranyloxy Phenol is a skin lightening agent synthesised through removal 53936-56-4	reproductive toxicity	20 mg/kg/day	reproductive toxicity rat oral 8 weeks	Regulatory source p.38 SCCS Opinion
Tetrahydropyranyloxy Phenol is a skin lightening agent synthesised through removal 53936-56-4	reproductive toxicity	20 mg/kg/day	reproductive toxicity rat oral 8 weeks	Regulatory source p.38 SCCS Opinion
Tetrahydropyranyloxy Phenol is a skin lightening agent synthesised through removal 53936-56-4	reproductive toxicity	25 mg/kg/day	reproductive toxicity rat oral 8 weeks	Regulatory source p.38 SCCS Opinion
Tetrahydropyranyloxy Phenol is a skin lightening agent synthesised through removal 53936-56-4	reproductive toxicity	74 mg/kg/day	reproductive toxicity rat oral 8 weeks	Regulatory source p.38 SCCS Opinion
Tetrahydropyranyloxy Phenol is a skin lightening agent synthesised through removal 53936-56-4	reproductive toxicity	75 mg/kg/day	reproductive toxicity rat oral 28d	Regulatory source p.38 SCCS Opinion

Safety Conclusion

sccs_opinions Max 1.0%

safe

Key concerns: sensitisation potential; MoS adequate

Opinion date: 15 April 2008

Source Citation

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