Is Beta-Arbutin safe in cosmetics?
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.
Beta-Arbutin
Also known as: 5-17-07-00110, BRN 0089673, EINECS 207-850-3, Hydroquinone beta-D-glucopyranoside, Hydroquinone-beta-D-glucopyranoside (+9 more)
INCI: BETA-ARBUTIN
Beta-Arbutin (CAS 497-76-7) is a cosmetic active ingredient functioning as Skin lightening agent; tyrosinase inhibitor. NOAEL 20 mg/kg bw/day (PDF-verified against ToxValDB ECHA IUCLID); EU Regulation 1223/2009 status: restricted, max 7%. Industrial safety data is also available in the chemical safety database. Same-CAS public records also appear in pharmaceutical data.
View industrial chemical safety profile for CAS 497-76-7 →
Auto-generated CPSR Part A draft with source citations
Function
Skin lightening agent; tyrosinase inhibitor
Safety Rating
GOOD
Regulatory Status
EU EU Status
restricted
EU Max Conc.
7%
US US Status
permitted
US Notes
Beta-Arbutin is not restricted by the FDA and may be used freely in cosmetic products without concentration limit. Not classified as an OTC drug active ingredient. No completed CIR monograph exists specifically for beta-arbutin. Widely sold OTC in skin brightening products. No federal hydroquinone impurity limits imposed on arbutin-containing cosmetics in the US.
For full compliance data across multiple jurisdictions, use the Substance Compliance tool.
Safety Data
Margin of Safety, dermal absorption, and sensitization profile summaries for Beta-Arbutin.
Calculate MoS for your specific formulation with the MoS Calculator.
Toxicological Studies
10 study endpoints found for 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_vision_codex |
| NOAEL | =0.0005 mg/kg bw/d | dermal | - | dermal absorption | SCCS_vision_codex |
| NOAEL | =0.0005 mg/kg bw/d | dermal | - | dermal absorption | SCCS_vision_codex |
| NOAEL | =0.0005 mg/kg bw/d | dermal | - | dermal absorption | SCCS_vision_codex |
| NOAEL | =0.00076 mg/kg bw/d | dermal | - | dermal absorption | SCCS_vision_codex |
| NOAEL | =0.00076 mg/kg bw/d | dermal | - | dermal absorption | SCCS_vision_codex |
| NOAEL | =0.00076 mg/kg bw/d | dermal | - | dermal absorption | SCCS_vision_codex |
| NOAEL | =0.00076 mg/kg bw/d | dermal | - | dermal absorption | SCCS_vision_codex |
| NOAEL | =15 mg/kg/day | oral | rat | reproductive toxicity | SCCS_vision_codex |
| NOAEL | =15 mg/kg/day | oral | rat | reproductive toxicity | SCCS_vision_codex |
Pre-Calculated Safety Assessment
Pre-calculated NOAEL → SED → MoS audit trail for Beta-Arbutin across SCCS product categories, with measured dermal absorption where available.
SCCS NOAEL Values
NOAEL/LOAEL values cited in official SCCS opinions for Beta-Arbutin.
| NOAEL | LOAEL | Route | Species | Study | DA% (SCCS) | Opinion |
|---|---|---|---|---|---|---|
| 200 mg/kg/day | - | Oral | Rat | Subchronic (90-day) (90 days) | 10 | SCCS/1642/22 (2023) |
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
4 property records from structured ingredient metadata.
pregnancy_detail
{"pregnancy_safe": "yes", "breastfeeding_safe": "yes", "risk_category": "not-rated", "reason": "Plant-derived lightening agent; low systemic absorption", "source": "dermatology literature"}
regulatory
{"eu_status": "allowed", "us_status": "allowed"}
sensory
{"silky": "powdery", "smooth, glides easily": "smooth, dissolves", "dry-touch, non-greasy": "brightened, even", "instant": "fast", "low": "low", "w/o": "o/w", "very-high": "excellent", "no": "no", "yes": "no", "1.40": "1.54", "transparent": "opaque", "colorless": "white", "excellent": "excellent", "light": "light", "synthetic": "botanical"}
skin_brightening
{"cas_number": "497-76-7", "mechanism_of_action": "Tyrosinase inhibition", "melanogenesis_pathway_target": "Tyrosinase", "tyrosinase_inhibition_ic50_um": "1687 (monophenolase)", "tyrosinase_inhibition_vs_kojic_acid": "~25x weaker", "melanosome_transfer_inhibitor": "No", "melanin_oxidation_reducer": "Yes", "endothelin_pathway_blocker": "No", "alpha_msh_antagonist": "No", "clinical_efficacy_score": …
Function Categories & List Membership
Cosmetic/Chemical Function Categories
Antioxidant
Bleaching agent
Softener and conditioner
Expert Verdict
Expert safety assessment and concern-level summary for Beta-Arbutin.
Regulatory Flags
eu-annex-iii-restricted
hydroquinone-precursor
hydroquinone-impurity-limit
face-cream-only-eu
skin-lightening
sccs-reviewed-2023
microbiome-conversion-risk
NOAEL Studies Summary
View details ->Public NOAEL study rows linked to 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/day, mg/kg/day, mg/kg bw/d
SCCS_vision_codex
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
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
Cross-Vertical Safety Context
Same-CAS public records found in pharmaceutical data.
SOURCE
ChEMBL / DrugCentral / FAERS
DB_PHARMA CAS match
Pharmaceutical Data
Same-CAS rows from the pharmaceutical spoke database.
Compound
ARBUTIN
ChEMBL ID
CHEMBL232202
Max Phase
2
Frequently Asked Questions
Is Beta-Arbutin allowed in the EU?
Beta-Arbutin EU regulatory status: restricted. Maximum allowed concentration: 7%. This is based on EU Regulation 1223/2009 and its amendments.
What does Beta-Arbutin do in cosmetics?
Beta-Arbutin functions as: Skin lightening agent; tyrosinase inhibitor. It is classified as a Active Ingredient in our database. CAS number: 497-76-7.
What is the NOAEL for Beta-Arbutin?
The NOAEL (No Observed Adverse Effect Level) for 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_vision_codex.
Is Beta-Arbutin used outside cosmetics?
Beta-Arbutin also appears in pharmaceutical data. The cross-vertical cards on this page render same-CAS public rows from the matched databases.
Compliance Tools
Check Beta-Arbutin compliance across multiple jurisdictions:
Ingredient Decoder
Paste a full ingredient list for instant analysis
82 Allergen Checker
Check for EU declarable fragrance allergens
Substance Compliance
Check compliance across multiple jurisdictions
MoS Calculator
Calculate Margin of Safety using SCCS methodology
Heavy Metal Limits
Compare limits across jurisdictions
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Insufficient Data
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