Good Antioxidant NOAEL Data GHS Classified SCCS/CIR Reviewed

Butylated Hydroxytoluene

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.

View industrial chemical safety profile for CAS 128-37-0 →

Auto-generated CPSR Part A draft with source citations
Function
Antioxidant; synthetic chain-breaking free radical scavenger (SET/HAT mechanism); product stabiliser against oxidative rancidity in lipid-containing formulations
Safety Rating
GOOD

Chemistry & Identifiers

EC Number
204-881-4

Regulatory Status

EU EU Status restricted
EU Max Conc. 0.001% in mouthwash; 0.1% in toothpaste; 0.8% in all other leave-on and rinse-off products
US US Status permitted
US Notes FDA 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.

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 Hydroxytoluene.

Calculate MoS for your specific formulation with the MoS Calculator.

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).

cir 6 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.

Suspected Evidence: 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.

baby_pediatric
{"cas_number": "CAS-FUNC-25", "ingredient_class": "other", "pediatric_safety_rating": "caution", "minimum_age_months": "12", "neonatal_safe": "no", "premature_infant_safe": "insufficient_data", "skin_barrier_maturity_consideration": "Synthetic antioxidant - scrutiny, limit babies", "transepidermal_absorption_risk_pediatric": "low", "systemic_exposure_concern_pediatric": "low", "dose_per_kg_body_we…

Function Categories & List Membership

Cosmetic/Chemical Function Categories
Antioxidant Defoamer Degradant/impurity Deodorizer Emulsifier Flavouring and nutrient Fragrance Lubricating agent Pharmaceutical Preservative
Regulatory List Membership (4)
EU Restricted for Children (Cosmetics) IFRA Fragrance Transparency List FDA Substances Added to Food (EAFUS) Consumer Product Chemical

Expert Verdict

Expert safety assessment and concern-level summary for Butylated Hydroxytoluene.

Regulatory Flags

eu-restricted annex-iii endocrine-concern antioxidant synthetic gras sccs-assessed endocrine_disruptor eu_children_restricted ifra_fragrance fda_food_additive

NOAEL Studies Summary

View details ->

Public NOAEL study rows linked to Butylated Hydroxytoluene by CAS number or substance name.

Studies
40
Lowest NOAEL
3.2
Highest NOAEL
800

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

COSMOS_DB ToxValDB_ECHA_IUCLID SCCS_vision_codex

Dermal Absorption

View details ->
Absorption % Method Vehicle
0.4 In vitro; OECD TG 428-compliant; flow-through; GLP (Eurofins 2020) Cosmetic formulation
0.4% SCCS opinion extraction -

Known Synonyms

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- Antrancine 8 Butylated hydroxytoluol Caswell No. 291A Catalin antioxydant 1 Catalin cao-3 Di-tert-butyl-p-methylphenol EINECS 204-881-4 EPA Pesticide Chemical Code 022105 FEMA No. 2184 1-Hydroxy-4-methyl-2,6-di-tert-butylbenzene "Ionol" CP-antioxidant 4-Methyl-2,6-tert-butylphenol NCI-C03598

Chemical Function

Stabilizing agent Fragrance Preservative Antioxidant

Regulatory Lists

Arts and crafts/Office supplies - children's art and toys - modeling clay; detected detected; MN Chemical Screening; surface_water detected; MN Chemical Screening; surface_water detected; MN Chemical Screening; surface_water air; detected; emissions; Europe; Toys and children's products air; detected; emissions; Europe; Toys and children's products Europe; plastic_additive Europe drinking_water; Europe; manufacturing; plastic_additive active_ingredient; Europe; Pesticides artificial_sweat; detected; emissions; Europe; Toys and children's products air; artificial_sweat; detected; emissions; Europe; Toys and children's products Arts and crafts/Office supplies - home office - pens and markers; detected; Europe children; Europe; Personal care children; Europe; Personal care - specialized bath products - bath salts children; Europe; Personal care - general moisturizing - hand/body lotion children; Europe; Personal care artificial_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.

SOURCE ChEMBL / DrugCentral / FAERS DB_PHARMA CAS match

Pharmaceutical Data

Same-CAS rows from the pharmaceutical spoke database.

Compound
BUTYLATED HYDROXYTOLUENE
ChEMBL ID
CHEMBL146
Max Phase
2
View full pharmaceutical profile →

Frequently Asked Questions

Is Butylated Hydroxytoluene safe in cosmetics?

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.

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