Good Cosmetic Ingredient NOAEL Data

Arbutin (Alpha-Arbutin and Beta-Arbutin)

Also known as: 5-17-07-00110, beta-Arbutin, BRN 0089673, EINECS 207-850-3, Hydroquinone beta-D-glucopyranoside (+10 more)

INCI: ARBUTIN

Arbutin (Alpha-Arbutin and Beta-Arbutin) (CAS 497-76-7) is a cosmetic cosmetic ingredient functioning as Skin Brightening. NOAEL 20 mg/kg bw/day (PDF-verified against ToxValDB ECHA IUCLID); EU Regulation 1223/2009 status: restricted, max 2% face / 0.5% body. Industrial safety data is also available in the chemical safety database.

View industrial chemical safety profile for CAS 497-76-7 →

Auto-generated CPSR Part A draft with source citations
Function
Skin Brightening
Safety Rating
GOOD

Regulatory Status

EU EU Status restricted
EU Max Conc. 2% face / 0.5% body
US US Status permitted
US Notes No specific US limit. FDA HQ connection via 21 CFR 310.545.

For full compliance data across multiple jurisdictions, use the Substance Compliance tool.

Safety Data

Margin of Safety, dermal absorption, and sensitization profile summaries for Arbutin (Alpha-Arbutin and Beta-Arbutin).

Calculate MoS for your specific formulation with the MoS Calculator.

Toxicological Studies

10 study endpoints found for Arbutin (Alpha-Arbutin and Beta-Arbutin). NOAEL (No Observed Adverse Effect Level) values are used to calculate the Margin of Safety per SCCS methodology.

Endpoint Value Route Species Study Type Source
NOAEL =0.0005 mg/kg bw/d dermal - dermal absorption SCCS Opinion
NOAEL =0.0005 mg/kg bw/d dermal - dermal absorption SCCS Opinion
NOAEL =0.0005 mg/kg bw/d dermal - dermal absorption SCCS Opinion
NOAEL =0.0005 mg/kg bw/d dermal - dermal absorption SCCS Opinion
NOAEL =0.00076 mg/kg bw/d dermal - dermal absorption SCCS Opinion
NOAEL =0.00076 mg/kg bw/d dermal - dermal absorption SCCS Opinion
NOAEL =0.00076 mg/kg bw/d dermal - dermal absorption SCCS Opinion
NOAEL =0.00076 mg/kg bw/d dermal - dermal absorption SCCS Opinion
NOAEL =15 mg/kg/day oral rat reproductive toxicity SCCS Opinion
NOAEL =15 mg/kg/day oral rat reproductive toxicity SCCS Opinion

Pre-Calculated Safety Assessment

Pre-calculated NOAEL → SED → MoS audit trail for Arbutin (Alpha-Arbutin and Beta-Arbutin) across SCCS product categories, with measured dermal absorption where available.

Endocrine Disruptor Evidence (Expanded)

Cross-referenced EDC classifications, mechanism data, and dose-response evidence from EDLists, SIN List, and cosmetic-specific detail sources.

Cosmetic-Specific Mechanism
Category: other
Receptor targets: ERα (via hydroquinone metabolite)
LOEC: 10 µM
EU status: restricted (max 7% face; EU 2024/996)

agonist (ER, indirect via HQ metabolism)

Expanded Jurisdictional Detail

Additional regulatory detail beyond the 7-jurisdiction summary: Saudi SFDA, Korea MFDS, ASEAN ACD, Japan/Korea, Brazil/India, and cross-jurisdictional restriction entries.

Additional Jurisdictional Restrictions (1)
Jurisdiction Status Max % Product Type
UK restricted - -

Expanded Dermal Absorption Data

Cross-database dermal penetration: EPA Dryad physics-based, Roberts Mendeley permeation, and SCCS-aggregated measured values.

Aggregated DA Values (5 records across 5 sources)
Type DA % Method Skin Model SCCS Ref
measured 57.0% - - SCCP/0134
measured 0.214% - - SCCP/0134
measured 0.214% - - SCCS/0169
measured 11.8% in_vitro - SCCS/0169
measured 50.0% - - SCCS/0169

Additional Ingredient Properties

5 property records from structured ingredient metadata.

anti_pollution
{"cas_number": "497-76-7", "ingredient_class": "antioxidant_pollution_shield", "primary_mechanism": "free_radical_scavenging", "pollution_types_targeted": "PM2_5", "IR_A_protection": "no", "visible_light_protection": "no", "digital_screen_protection_claim": "no", "PAH_neutralization": "no", "ozone_protection": "no", "mitochondrial_protection": "no", "Nrf2_activation": "no", "AhR_pathway_modulation…
concentration
{"min_concentration_pct": "1.0", "max_concentration_pct": "3.0", "typical_concentration_pct": "2.0", "product_type": "Moisturizer", "function_at_concentration": "Brightening", "source": "Supplier TDS"}
self_tanning
{"cas_number": "497-76-7", "ingredient_class": "color_adjuster", "tanning_mechanism": "other", "color_development_onset_hours": "0.0", "full_color_development_hours": "0", "color_duration_days": "0", "DHA_concentration_if_applicable_pct": "0", "erythrulose_concentration_pct": "0", "pH_dependent_color": "no", "formaldehyde_release_concern": "no", "formaldehyde_release_ppm": "0", "AGE_formation_conc…
skin_suitability
{"oily_skin": "acceptable", "dry_skin": "acceptable", "sensitive_skin": "acceptable", "combination_skin": "acceptable", "normal_skin": "acceptable", "acne_prone": "acceptable", "rosacea": "acceptable", "eczema": "acceptable", "hyperpigmentation": "recommended", "aging_mature": "acceptable", "dehydrated": "acceptable", "skin_benefit_primary": "brightening", "skin_benefit_secondary": "antioxidant", …
solubility_hlb
{"water_soluble": "yes", "oil_soluble": "no", "soluble_in": "water, glycerin, propylene glycol", "insoluble_in": "oils, ethanol, silicones", "log_p": "-1.4", "melting_point_c": "199-201", "appearance": "white powder", "source": "DSM"}

Function Categories & List Membership

Cosmetic/Chemical Function Categories
Antioxidant Bleaching agent Softener and conditioner

Expert Verdict

Expert safety assessment and concern-level summary for Arbutin (Alpha-Arbutin and Beta-Arbutin).

Regulatory Flags

eu-annex-iii-2024-996 alpha-arbutin-2pct-face-0.5pct-body sccs-1550-15 hq-release-concern hq-below-1ppm-required uk-divergence-not-adopted japan-quasi-drug-whitening korea-functional-cosmetic-whitening eu-transition-feb-nov-2025 10x-more-potent-than-beta

NOAEL Studies Summary

View details ->

Public NOAEL study rows linked to Arbutin (Alpha-Arbutin and Beta-Arbutin) by CAS number or substance name.

Studies
60
Lowest NOAEL
0.0005
Highest NOAEL
1000

Units vary across source rows: mg/kg bw/d, mg/kg/day, mg/kg bw/day

SCCS Opinion

Dermal Absorption

View details ->
Absorption % Method Vehicle
57.0% - -
0.214% - -
0.214% - -
11.8% in_vitro -
50.0% - -

Known Synonyms

5-17-07-00110 beta-Arbutin BRN 0089673 EINECS 207-850-3 Hydroquinone beta-D-glucopyranoside Hydroquinone-beta-D-glucopyranoside 4-Hydroxyphenyl-beta-D-glucopyranoside UNII-C5INA23HXF p-Arbutin (2R,3S,4S,5R,6S)-2-(hydroxymethyl)-6-(4-hydroxyphenoxy)oxane-3,4,5-triol (2R,3S,4S,5R,6S)-2-(hydroxymethyl)-6-(4-hydroxyphenoxy)tetrahydropyran-3,4,5-triol (2S,3R,4S,5S,6R)-2-(4-hydroxyphenoxy)-6-methylol-tetrahydropyran-3,4,5-triol hydroquinone O-beta-D-glucopyranoside p-hydroxyphenyl beta-D-glucopyranoside p-hydroxyphenyl beta-D-glucoside

Chemical Function

Antioxidant Softener and conditioner Bleaching agent

Regulatory Lists

Canada; consumer_product; Substances in Products - Canada (4/2014) Canada; Personal care; Substances in PCP - Canada (4/2014) Canada; pharmaceutical

Frequently Asked Questions

Is Arbutin (Alpha-Arbutin and Beta-Arbutin) safe in cosmetics?

Arbutin (Alpha-Arbutin and Beta-Arbutin) has a safety rating of "GOOD" in our database. EU status: restricted. US status: permitted. 10 toxicological study endpoint(s) are available in our database.

Is Arbutin (Alpha-Arbutin and Beta-Arbutin) allowed in the EU?

Arbutin (Alpha-Arbutin and Beta-Arbutin) EU regulatory status: restricted. Maximum allowed concentration: 2% face / 0.5% body. This is based on EU Regulation 1223/2009 and its amendments.

What does Arbutin (Alpha-Arbutin and Beta-Arbutin) do in cosmetics?

Arbutin (Alpha-Arbutin and Beta-Arbutin) functions as: Skin Brightening. It is classified as a cosmetic ingredient in our database. CAS number: 497-76-7.

What is the NOAEL for Arbutin (Alpha-Arbutin and Beta-Arbutin)?

The NOAEL (No Observed Adverse Effect Level) for Arbutin (Alpha-Arbutin and Beta-Arbutin) is =0.0005 mg/kg bw/d based on a dermal absorption study via dermal route in rat. A total of 10 study endpoints are available. Source: SCCS Opinion.

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