Also known as: (1,1-Dimethylethyl)-4-methoxyphenol, 1,1-(Dimethylethyl)-4-methoxyphenol, Phenol, tert-butyl-4-methoxy-, terc-butil-4-metoxifenol, tert-Butyl-4-hydroxyanisole (+14 more)
INCI: BHA
Butylated Hydroxyanisole (CAS 25013-16-5) is a cosmetic antioxidant functioning as Antioxidant; synthetic chain-breaking free radical scavenger (SET/HAT. NOAEL 50 mg/kg bw/day (PDF-verified against ToxValDB ECHA IUCLID); EU Regulation 1223/2009 status: restricted, max 0.07%; 5 safety opinions reviewed (sccs). Industrial safety data is also available in the chemical safety database. Same-CAS public records also appear in industrial chemical safety data.
Auto-generated CPSR Part A draft with source citations
Cross-Vertical Regulatory Divergence
Butylated Hydroxyanisole is classified GHS CMR hazard (H302, H315, H319, H335, H351, H361, H361f, H411) in the chemicals database but is restricted in EU cosmetics at max 0.07%.
US NotesFDA: GRAS for food use (21 CFR 172.110). No specific cosmetic concentration limit under 21 CFR; manufacturer safety assessment responsibility. CIR Final Amended Report (Sep 2024): under review. California Prop 65 listed carcinogen (NSRL 4000 µg/day) — warning required for intentional exposure products in CA if threshold exceeded.
For full compliance data across multiple jurisdictions, use the
Substance Compliance tool.
Safety Data
Margin of Safety, dermal absorption, and sensitization profile summaries for Butylated Hydroxyanisole.
Calculate MoS for your specific formulation with the
MoS Calculator.
Toxicological Studies
10 study endpoints found for Butylated Hydroxyanisole. 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
=220 mg/kg/d
oral
rat
reproductive toxicity
CIR_vision_codex
NOAEL
=220 mg/kg/d
oral
rat
reproductive toxicity
CIR_vision_codex
NOAEL
=220 mg/kg/d
oral
rat
reproductive toxicity
CIR_vision_codex
NOAEL
=220 mg/kg/d
oral
rat
reproductive toxicity
CIR_vision_codex
NOAEL
=420 mg/kg/d
oral
rat
reproductive toxicity
CIR_vision_codex
NOAEL
=420 mg/kg/d
oral
rat
reproductive toxicity
CIR_vision_codex
NOAEL
=420 mg/kg/d
oral
rat
reproductive toxicity
CIR_vision_codex
NOAEL
=420 mg/kg/d
oral
rat
reproductive toxicity
CIR_vision_codex
NOAEL
50 mg/kg bw/day
oral
swine
Subchronic
COSMOS_DB
NOAEL
60 mg/kg bw/day
oral
dog
Subchronic
COSMOS_DB
Safety Opinions
Official safety assessments from the Scientific Committee on Consumer Safety (SCCS) and Cosmetic Ingredient Review (CIR).
sccsSCCS/1682/25unknown
Verdict: unknown
NOAEL: 50 mg/kg bw/d (oral)
sccsSCCS/1682/25unknown
Verdict: unknown
NOAEL: 50 mg/kg bw/d (dermal)
sccsSCCS/1682/25unknown
Verdict: unknown
NOAEL: 100 mg/kg bw/d (oral)
sccsSCCS/1682/25unknown
Verdict: unknown
NOAEL: 50 mg/kg bw/d (not specified)
sccsSCCS/1682/25unknown
Verdict: unknown
NOAEL: 55 mg/kg bw/d (not specified)
Pre-Calculated Safety Assessment
Pre-calculated NOAEL → SED → MoS audit trail for Butylated Hydroxyanisole across SCCS product categories, with measured dermal absorption where available.
EPA ToxValDB — Toxicity Values
10 toxicity values from EPA ToxValDB (aggregated from CCTE, HPV, ToxRefDB, IRIS, and other regulatory dossiers).
Endpoint
Value
Species
Route
Duration
Source
cancer slope factor
=0.0002 (mg/kg-day)-1
Human
inhalation
chronic
Cal OEHHA
cancer slope factor
=0.0002 (mg/kg-day)-1
Human
oral
chronic
Cal OEHHA
NOAEL
=100 mg/kg-day
Rat
oral
-
EFSA
NOAEL
=100 mg/kg-day
Rat
oral
-
EFSA
NOAEL
=100 mg/kg-day
Rat
oral
-
EFSA
LOEL
=500 mg/kg-day
Mouse
oral
acute
ECOTOX
NOEL
=100 mg/kg-day
Mouse
oral
acute
ECOTOX
LOEL
=2 %
Rat
oral
subchronic
ECOTOX
NOEL
=2 %
Rat
oral
subchronic
ECOTOX
LOEL
=2 %
Rat
oral
subchronic
ECOTOX
IARC Carcinogenicity
International Agency for Research on Cancer (WHO) monograph evaluation.
IARC Group
2B
Volume
40, Sup 7
Evaluation Year
1987
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, ERβ, AR
LOEC:10 µM
EU status:under_review (EU priority list 2019 Group B; SCCS requested)
SIN List ED: Endocrine DisruptorCosmetic relevance: direct
ECHA REACH Registration
European Chemicals Agency REACH dossier and Substances of Very High Concern listing.
Registration Type
Full
Tonnage Band
Ceased manufacture
Substance Type
SUBSTANCE; GROUP
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.
Additional Jurisdictional Restrictions (2)
Jurisdiction
Status
Max %
Product Type
CN
restricted
0.5
All cosmetics (antioxidant use)
AU
restricted
-
antioxidants
Expanded Dermal Absorption Data
Cross-database dermal penetration: EPA Dryad physics-based, Roberts Mendeley permeation, and SCCS-aggregated measured values.
Aggregated DA Values (3 records across 5 sources)
Type
DA %
Method
Skin Model
SCCS Ref
measured_in_vitro
2.68
In vitro; human skin; 16h continuous
Human skin in vitro
SCCS/0306 BHA opinion; CIR 2024 (2024)
default
50.0
method=default
-
-
measured
0.07
method=measured
-
-
Typical Use Concentrations
Reported concentration ranges per product category from SCCS/CIR/industry sources.
Product Category
Typical Range
Max Reported
Source
Body Lotion
0.01–0.1
0.5
CIR (max 0.5%)
Additional Ingredient Properties
1 property record from structured ingredient metadata.
AntioxidantDeodorizerFragranceBiocideFlavouring and nutrientFillerFood preservative
Regulatory Lists
drinking_water; Europe; manufacturing; plastic_additiveactive_ingredient; Europe; PesticidesEuropeconsumer_product; EuropeEurope; Raw materialsinert_ingredient; non_food_use; PesticidesOEHHA Proposition 65 (3/2019)IFRA Transparencydetected; drinking_water; MN Chemical Screeningdetected; drinking_water; MN Chemical Screeningdetected; drinking_water; MN Chemical Screeningfood_additive; Substances Added to Food (formerly EAFUS) (2/2019)childrenOEHHA Proposition 65 (1/2023)children; WA Children's Safe Product Act (4/2020)childrenchildrenEurope; pharmaceutical
Australian Status
AICIS status:listed
Frequently Asked Questions
Is Butylated Hydroxyanisole safe in cosmetics?
Butylated Hydroxyanisole 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. This ingredient has been reviewed by sccs.
Is Butylated Hydroxyanisole allowed in the EU?
Butylated Hydroxyanisole EU regulatory status: restricted. Maximum allowed concentration: 0.07%. This is based on EU Regulation 1223/2009 and its amendments.
What does Butylated Hydroxyanisole do in cosmetics?
Butylated Hydroxyanisole functions as: Antioxidant; synthetic chain-breaking free radical scavenger (SET/HAT mechanism); product preservative against oxidative degradation in oils and waxes. It is classified as a Antioxidant in our database. CAS number: 25013-16-5.
What is the NOAEL for Butylated Hydroxyanisole?
The NOAEL (No Observed Adverse Effect Level) for Butylated Hydroxyanisole is =220 mg/kg/d based on a reproductive toxicity study via oral route in rat. A total of 10 study endpoints are available. Source: CIR_vision_codex.
Is Butylated Hydroxyanisole used outside cosmetics?
Butylated Hydroxyanisole also appears in industrial chemical safety data. The cross-vertical cards on this page render same-CAS public rows from the matched databases.
Does Butylated Hydroxyanisole have different safety status in cosmetics vs industrial chemicals?
Butylated Hydroxyanisole is classified GHS CMR hazard (H302, H315, H319, H335, H351, H361, H361f, H411) in the chemicals database but is restricted in EU cosmetics at max 0.07%.
Compliance Tools
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