Also known as: 2,6-bis(1,1-Dimethylethyl)-4-methyl-phenol, 2,6-Di-tert-butyl-4-methylphenol, 2,6-Di-tert-butyl-p-cresol, p-Cresol, 2,6-di-tert-butyl-, Phenol, 2,6-bis(1,1-dimethylethyl)-4-methyl- (+13 more)
INCI: BHT
Butylated Hydroxytoluene (CAS 128-37-0) is a cosmetic antioxidant functioning as Antioxidant; synthetic chain-breaking free radical scavenger (SET/HAT. Reported NOAEL 3.2 mg/kg bw/day in rabbit (COSMOS_DB); EU Regulation 1223/2009 status: restricted, max 0.001% in mouthwash; 0.1% in toothpaste; 0.8% in all other leave-on and rinse-off products; 1 safety opinion reviewed (cir). Industrial safety data is also available in the chemical safety database. Same-CAS public records also appear in industrial chemical safety and pharmaceutical data.
EU Max Conc.0.001% in mouthwash; 0.1% in toothpaste; 0.8% in all other leave-on and rinse-off products
US US Statuspermitted
US NotesFDA GRAS since 1958 (21 CFR 172.110 et al.). No specific cosmetic concentration limit — manufacturer safety assessment responsibility. CIR Expert Panel (Burnett et al. 2023, Int J Toxicol 42(3_suppl):17S): safe as used. Max 0.02% in food fat/oil content. Approved indirect food additive under 21 CFR Parts 175–178.
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Safety Data
Margin of Safety, dermal absorption, and sensitization profile summaries for Butylated Hydroxytoluene.
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Toxicological Studies
10 study endpoints found for Butylated Hydroxytoluene. 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
3.2 mg/kg bw/day
oral
rabbit
Developmental
COSMOS_DB
NOAEL
4 mg/kg bw/day
oral
dog
Subchronic
COSMOS_DB
NOAEL
6 mg/kg bw/day
oral
rat
Chronic
COSMOS_DB
NOAEL
12.5 mg/kg bw/day
oral
rat
Chronic
COSMOS_DB
NOAEL
34 mg/kg bw/day
oral
chinese hamster
Special Toxicology Study
COSMOS_DB
NOAEL
50 mg/kg bw/day
oral
rat
Chronic
COSMOS_DB
NOAEL
58 mg/kg bw/day
oral
mouse
Special Toxicology Study
COSMOS_DB
NOAEL
75 mg/kg bw/day
oral
mouse
Carcinogenicity
COSMOS_DB
NOAEL
85 mg/kg bw/day
oral
guinea pig
Short Term Toxicity
COSMOS_DB
NOAEL
=15 mg/kg bw/day
-
-
NOAEL study
SCCS_vision_codex
GHS Hazard Classification
Globally Harmonized System classification per ECHA C&L inventory and ILO/WHO International Chemical Safety Cards.
Short-term Exposure Effects
The substance is irritating to the eyes and skin.
Long-term Exposure Effects
Repeated or prolonged contact with skin may cause dermatitis. The substance may have effects on the liver.
Routes of Exposure
The substance can be absorbed into the body by inhalation of its aerosol and by ingestion.
Safety Opinions
Official safety assessments from the Scientific Committee on Consumer Safety (SCCS) and Cosmetic Ingredient Review (CIR).
cir6 June 2002
Verdict: unknown
NOAEL: 1000 ppm (oral)
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
LOAEL
=250 mg/kg-day
Rat
oral
-
ECHA IUCLID
LOAEL
=750 mg/kg-day
Rat
oral
-
ECHA IUCLID
NOAEL
=25 mg/kg-day
Rat
oral
-
EFSA
LOEL
=100 mg/kg-day
Mouse
oral
acute
ECOTOX
NOEL
=10 mg/kg-day
Mouse
oral
acute
ECOTOX
ADI
<=0.3 mg/kg
Human
oral
-
WHO JECFA ADI
NOEL
=1000 mg/kg-day
Mouse
oral
short-term
ECOTOX
NOEL
=900 mg/kg-day
Rat
oral
short-term
ECOTOX
NOEL
=900 mg/kg-day
Rat
oral
acute
ECOTOX
NOEL
=900 mg/kg-day
Rat
oral
short-term
ECOTOX
IARC Carcinogenicity
International Agency for Research on Cancer (WHO) monograph evaluation.
IARC Group
3
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.
SuspectedEvidence: Moderate(2016)
Health effects:Yes
Affected pathways:Estrogenic (weak), Thyroid
Regulatory framework:REACH
Source list: II
Cosmetic-Specific Mechanism
Category:other
Receptor targets:TR, AR (weak); synergistic with parabens
LOEC:100 µM
EU status:under_review (EU priority list 2019 Group A; SCCS 2021 no concern but substance evaluation ongoing)
antagonist (TR); synergistic anti-AR in mixtures
Dose-Response Data Points
Endpoint
Target
Value
Direction
dermal_absorption
skin
<4% %
-
ECHA REACH Registration
European Chemicals Agency REACH dossier and Substances of Very High Concern listing.
Registration Type
Full
Tonnage Band
10,000 - 100,000 tonnes
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.
JPKR Japan/Korea Cosmetics
Korea (Restricted): Restricted in leave-on lip products; Category: Other
Additional Jurisdictional Restrictions (3)
Jurisdiction
Status
Max %
Product Type
AU
restricted
-
antioxidants
UK
restricted
-
-
ID
restricted
Updated limits (Indonesia PerBPOM 25/2025)
All products
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
0.4
In vitro; OECD TG 428-compliant; flow-through; GLP (Eurofins 2020)
Dermatomed human abdominal skin (350-450 µm), 5 donors
SCCS/1636/21 (2021)
measured_sccs_opinion
0.4%
-
-
SCCS/1636/21
Typical Use Concentrations
Reported concentration ranges per product category from SCCS/CIR/industry sources.
Product Category
Typical Range
Max Reported
Source
Body Lotion
0.01–0.2
0.5
CIR (max 0.5%)
Lipstick
0.01–0.2
0.5
CIR
Additional Ingredient Properties
1 property record from structured ingredient metadata.
Arts and crafts/Office supplies - children's art and toys - modeling clay; detecteddetected; MN Chemical Screening; surface_waterdetected; MN Chemical Screening; surface_waterdetected; MN Chemical Screening; surface_waterair; detected; emissions; Europe; Toys and children's productsair; detected; emissions; Europe; Toys and children's productsEurope; plastic_additiveEuropedrinking_water; Europe; manufacturing; plastic_additiveactive_ingredient; Europe; Pesticidesartificial_sweat; detected; emissions; Europe; Toys and children's productsair; artificial_sweat; detected; emissions; Europe; Toys and children's productsArts and crafts/Office supplies - home office - pens and markers; detected; Europechildren; Europe; Personal carechildren; Europe; Personal care - specialized bath products - bath saltschildren; Europe; Personal care - general moisturizing - hand/body lotionchildren; Europe; Personal careartificial_saliva; detected; emissions; Europe; Other direct contact consumer goods
Australian Status
AICIS status:listed
Cross-Vertical Safety Context
Same-CAS public records found in pharmaceutical data.
SOURCEChEMBL / DrugCentral / FAERSDB_PHARMA CAS match
Pharmaceutical Data
Same-CAS rows from the pharmaceutical spoke database.
Butylated Hydroxytoluene 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 cir.
Is Butylated Hydroxytoluene allowed in the EU?
Butylated Hydroxytoluene EU regulatory status: restricted. Maximum allowed concentration: 0.001% in mouthwash; 0.1% in toothpaste; 0.8% in all other leave-on and rinse-off products. This is based on EU Regulation 1223/2009 and its amendments.
What does Butylated Hydroxytoluene do in cosmetics?
Butylated Hydroxytoluene functions as: Antioxidant; synthetic chain-breaking free radical scavenger (SET/HAT mechanism); product stabiliser against oxidative rancidity in lipid-containing formulations. It is classified as a Antioxidant in our database. CAS number: 128-37-0.
What is the NOAEL for Butylated Hydroxytoluene?
The NOAEL (No Observed Adverse Effect Level) for Butylated Hydroxytoluene is 3.2 mg/kg bw/day based on a Developmental study via oral route in rabbit. A total of 10 study endpoints are available. Source: COSMOS_DB.
Is Butylated Hydroxytoluene used outside cosmetics?
Butylated Hydroxytoluene also appears in industrial chemical safety and pharmaceutical data. The cross-vertical cards on this page render same-CAS public rows from the matched databases.
Compliance Tools
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