Is Alpha-Arbutin safe in cosmetics?
Alpha-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.
Alpha-Arbutin
INCI: ALPHA-ARBUTIN
Alpha-Arbutin (CAS 84380-01-8) is a cosmetic active ingredient functioning as Tyrosinase inhibitor; synthetic alpha-enantiomer of arbutin; approximately 10x. Reported NOAEL =15 mg/kg/day in rat (SCCS_vision_codex); EU Regulation 1223/2009 status: restricted, max 2% face / 0.5% body. 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 84380-01-8 →
Auto-generated CPSR Part A draft with source citations
Function
Tyrosinase inhibitor; synthetic alpha-enantiomer of arbutin; approximately 10x stronger tyrosinase inhibition than beta-arbutin at equivalent concentrations; reversible competitive inhibition at L-DOPA binding site
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. HQ not GRASE per 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 Alpha-Arbutin.
Calculate MoS for your specific formulation with the MoS Calculator.
Toxicological Studies
10 study endpoints found for Alpha-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 | =15 mg/kg/day | oral | rat | reproductive toxicity | SCCS_vision_codex |
| NOAEL | =15 mg/kg bw | oral | - | carcinogenicity | SCCS_vision_codex |
| NOAEL | =15 mg/kg bw/d | - | - | repeated dose toxicity | SCCS_vision_codex |
| NOAEL | =15 mg/kg/day | oral | rat | reproductive toxicity | SCCS_vision_codex |
| NOAEL | =15 mg/kg bw | oral | - | carcinogenicity | SCCS_vision_codex |
| NOAEL | =15 mg/kg/day | oral | rat | reproductive toxicity | SCCS_vision_codex |
| NOAEL | =15 mg/kg bw | oral | - | carcinogenicity | SCCS_vision_codex |
| NOAEL | =15 mg/kg bw/d | - | - | repeated dose toxicity | SCCS_vision_codex |
| NOAEL | =15 mg/kg bw/d | - | - | repeated dose toxicity | SCCS_vision_codex |
| NOAEL | =15 mg/kg/day | oral | rat | reproductive toxicity | SCCS_vision_codex |
SCCS NOAEL Values
NOAEL/LOAEL values cited in official SCCS opinions for Alpha-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) |
Dermal Penetration Profile
Skin absorption and penetration characteristics of Alpha-Arbutin, relevant to systemic exposure and MoS calculations.
Absorption %
8-15%
Penetration Level
epidermis
Penetration Depth
epidermis
Molecular Weight
272.3 Da
Log P
-1.42
Systemic Absorption
minimal
Topical Bioavailability
5-12%
Safety Margin Factor
moderate
Vehicle Dependent
Yes — absorption varies by formulation
Source: J Dermatol Sci 2005
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 2% face; 0.5% body; EU 2024/996)
agonist (ER, indirect via HQ metabolism)
ECHA REACH Registration
European Chemicals Agency REACH dossier and Substances of Very High Concern listing.
Registration Type
Full
Tonnage Band
1 - 10 tonnes
Substance Type
SUBSTANCE
SVHC Candidate
No
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.
JPKR Japan/Korea Cosmetics
Korea (Restricted): max 2.0
Additional Jurisdictional Restrictions (3)
| Jurisdiction | Status | Max % | Product Type |
|---|---|---|---|
| AU | therapeutic_good | 5.0 | skin lightening |
| GCC | banned | - | Skin lightening products |
| 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 (2 records across 5 sources)
| Type | DA % | Method | Skin Model | SCCS Ref |
|---|---|---|---|---|
| measured_in_vitro | 0.27 | In vitro; dermatomed human skin | Dermatomed human skin | SCCS/1552/15; SCCS/1642/22 (2022) |
| measured_sccs_opinion | 0.53% | - | - | SCCS/1552/15 |
Typical Use Concentrations
Reported concentration ranges per product category from SCCS/CIR/industry sources.
| Product Category | Typical Range | Max Reported | Source |
|---|---|---|---|
| Serum | 0.5–2 | 4 | CIR/SCCS |
| Face Cream | 0.5–2 | 4 | CIR/SCCS |
Additional Ingredient Properties
10 property records from structured ingredient metadata.
anti_aging
{"anti_aging_claim": "brightening, dark-spot-reduction", "mechanism_of_action": "Tyrosinase inhibitor, blocks melanin synthesis, more stable than beta-arbutin", "target_skin_layer": "epidermis", "collagen_stimulation": "No", "elastin_protection": "No", "wrinkle_reduction_pct": "0-3", "clinical_study_duration_weeks": "12", "sample_size": "80", "double_blind": "Yes", "placebo_controlled": "Yes", "pu…
concentration
{"min_concentration_pct": "0.5", "max_concentration_pct": "1.5", "typical_concentration_pct": "1.0", "product_type": "Moisturizer", "function_at_concentration": "Brightening", "source": "Supplier TDS"}
depigmentation
{"cas_number": "84380-01-8", "ingredient_class": "tyrosinase_inhibitor", "primary_mechanism_of_action": "Superior tyrosinase competitive inhibition; alpha-anomer provides 10x higher activity vs beta", "secondary_mechanisms": "Melanocyte maturation interference", "molecular_target": "tyrosinase", "tyrosinase_inhibition_IC50_uM": "0.08-0.12", "tyrosinase_inhibition_type": "competitive", "melanin_red…
dermal_absorption
{"molecular_weight_da": "272.3", "log_p_value": "-1.42", "skin_penetration_level": "epidermis", "penetration_depth": "epidermis", "absorption_pct": "8-15", "systemic_absorption": "minimal", "penetration_enhancer": "no", "occlusion_effect": "no", "vehicle_dependent": "yes", "skin_barrier_effect": "neutral", "bioavailability_topical_pct": "5-12", "safety_margin_factor": "moderate", "source": "J Derm…
interactions
{"ingredient_2": "Vitamin C", "interaction_type": "synergistic", "severity": "beneficial", "effect": "Dual brightening pathways, enhanced efficacy", "recommendation": "Compatible; low pH benefits arbutin", "data_source": "Formulation science literature, dermatological research, cosmetic chemistry best practices", "last_updated": "2026-03-05"}
pregnancy_detail
{"pregnancy_safe": "yes", "breastfeeding_safe": "yes", "risk_category": "not-rated", "reason": "Hydroquinone derivative with minimal absorption; considered safe", "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": "1.55", "transparent": "opaque", "colorless": "white", "excellent": "excellent", "light": "light", "synthetic": "botanical"}
Function Categories & List Membership
Cosmetic/Chemical Function Categories
Antioxidant
Bleaching agent
Softener and conditioner
Expert Verdict
Expert safety assessment and concern-level summary for Alpha-Arbutin.
Regulatory Flags
eu-annex-iii-2024-996
alpha-arbutin-2pct-face-0.5pct-body
sccs-1550-15
hq-release-concern
uk-divergence-not-adopted
japan-quasi-drug-whitening
korea-functional-cosmetic-whitening
10x-more-potent-than-beta
NOAEL Studies Summary
View details ->Public NOAEL study rows linked to Alpha-Arbutin by CAS number or substance name.
Studies
52
Lowest NOAEL
15
Highest NOAEL
1000
Units vary across source rows: mg/kg/day, mg/kg bw/day, mg/kg bw
SCCS_vision_codex
Dermal Absorption
View details ->| Absorption % | Method | Vehicle |
|---|---|---|
| 0.27 | In vitro; dermatomed human skin | Cream vehicle |
| 0.53% | SCCS opinion extraction | - |
Chemical Function
Antioxidant
Softener and conditioner
Bleaching agent
Regulatory Lists
Canada; pharmaceutical
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.
ChEMBL ID
CHEMBL226495
Frequently Asked Questions
Is Alpha-Arbutin allowed in the EU?
Alpha-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 Alpha-Arbutin do in cosmetics?
Alpha-Arbutin functions as: Tyrosinase inhibitor; synthetic alpha-enantiomer of arbutin; approximately 10x stronger tyrosinase inhibition than beta-arbutin at equivalent concentrations; reversible competitive inhibition at L-DOPA binding site. It is classified as a Active Ingredient in our database. CAS number: 84380-01-8.
What is the NOAEL for Alpha-Arbutin?
The NOAEL (No Observed Adverse Effect Level) for Alpha-Arbutin is =15 mg/kg/day based on a reproductive toxicity study via oral route in rat. A total of 10 study endpoints are available. Source: SCCS_vision_codex.
Is Alpha-Arbutin used outside cosmetics?
Alpha-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 Alpha-Arbutin compliance across multiple jurisdictions:
Ingredient Decoder
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82 Allergen Checker
Check for EU declarable fragrance allergens
Substance Compliance
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MoS Calculator
Calculate Margin of Safety using SCCS methodology
Heavy Metal Limits
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