Good Antioxidant NOAEL Data GHS Classified SCCS/CIR Reviewed

Butylated Hydroxytoluene

INCI: BHT

CAS Number
128-37-0
Function
Antioxidant; synthetic chain-breaking free radical scavenger (SET/HAT mechanism); product stabiliser against oxidative rancidity in lipid-containing formulations
Safety Rating
GOOD

Regulatory Status

🇪🇺 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 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 55 jurisdictions, use the Substance Compliance tool.

Safety Data

Margin of Safety (MoS)
adequate
Dermal Absorption
low
Sensitization
none

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 300 mg/kg bw/day oral rat Subchronic COSMOS_DB
NOAEL 500 mg/kg bw/day oral rat Chronic COSMOS_DB
NOAEL 200 mg/kg bw/day oral rat Chronic COSMOS_DB
NOAEL 50 mg/kg bw/day oral rat Chronic COSMOS_DB
NOAEL 6 mg/kg bw/day oral rat Chronic COSMOS_DB
NOAEL 750 mg/kg bw/day oral mouse Chronic COSMOS_DB
NOAEL 1125 mg/kg bw/day oral mouse Carcinogenicity COSMOS_DB
NOAEL 150 mg/kg bw/day oral mouse Carcinogenicity COSMOS_DB
NOAEL 1125 mg/kg bw/day oral mouse Chronic COSMOS_DB
NOAEL 250 mg/kg bw/day oral rat Chronic COSMOS_DB

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)

Expert Verdict

EU Annex III restricted (Reg 2022/2195, entry 325): mouthwash 0.001%, toothpaste 0.1%, other products 0.8%. Prohibition effective Jul 2023 (placement), Jan 2024 (availability). SCCS/1636/21 confirms safety at limits. Not genotoxic. Not carcinogenic (IARC Group 3). No direct endocrine disruption — thyroid effects secondary to hepatic enzyme induction only. FDA GRAS since 1958; CIR 2023: safe as used.

⚠️
Concern Level: Low

Regulatory Flags

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

Frequently Asked Questions

Is Butylated Hydroxytoluene safe in cosmetics?

EU Annex III restricted (Reg 2022/2195, entry 325): mouthwash 0.001%, toothpaste 0.1%, other products 0.8%. Prohibition effective Jul 2023 (placement), Jan 2024 (availability). SCCS/1636/21 confirms safety at limits. Not genotoxic. Not carcinogenic (IARC Group 3). No direct endocrine disruption — thyroid effects secondary to hepatic enzyme induction only. FDA GRAS since 1958; CIR 2023: safe as used. The EU classifies Butylated Hydroxytoluene as "restricted". Safety rating: GOOD. 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 Margin of Safety for Butylated Hydroxytoluene?

adequate The Margin of Safety (MoS) is calculated using SCCS methodology. A MoS above 100 is generally considered safe. Use the MoS Calculator tool to calculate MoS for your specific formulation and product category.

What is the NOAEL for Butylated Hydroxytoluene?

The NOAEL (No Observed Adverse Effect Level) for Butylated Hydroxytoluene is 300 mg/kg bw/day based on a Subchronic study via oral route in rat. A total of 10 study endpoints are available. Source: COSMOS_DB.

Compliance Tools

Check Butylated Hydroxytoluene compliance across multiple jurisdictions:

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82 Allergen Checker
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Substance Compliance
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MoS Calculator
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Heavy Metal Limits
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