Good Cosmetic Ingredient NOAEL Data

TBHQ (tert-Butylhydroquinone)

INCI: TBHQ

CAS Number
1948-33-0
Function
Antioxidant, Masking, Perfuming
Safety Rating
GOOD

Regulatory Status

๐Ÿ‡ช๐Ÿ‡บ EU Status permitted
๐Ÿ‡บ๐Ÿ‡ธ US Status permitted
US Notes FDA-approved as direct food additive; CIR concluded safe โ‰ค0.1% in cosmetics

For full compliance data across 55 jurisdictions, use the Substance Compliance tool.

Safety Data

Margin of Safety (MoS)
adequate
Dermal Absorption
moderate
Sensitization
low

Calculate MoS for your specific formulation with the MoS Calculator.

Toxicological Studies

10 study endpoints found for TBHQ (tert-Butylhydroquinone). 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 125 mg/kg bw/day oral dog Chronic COSMOS_DB
NOAEL 250 mg/kg bw/day oral rat Chronic COSMOS_DB
NOAEL 250 mg/kg bw/day oral rat Carcinogenicity COSMOS_DB
NOAEL 250 mg/kg bw/day oral rat Multigeneration Reproductive COSMOS_DB
NOAEL 250 mg/kg bw/day oral rat Reproductive-developmental COSMOS_DB
NOAEL 250 mg/kg bw/day oral rat Subchronic COSMOS_DB
NOAEL 277 mg/kg bw/day oral rat Reproductive COSMOS_DB
NOAEL 326 mg/kg bw/day oral rat Developmental COSMOS_DB
NOAEL 1000 mg/kg bw/day oral rat Chronic COSMOS_DB
NOAEL 600 mg/kg bw/day oral hamster Subchronic COSMOS_DB

Expert Verdict

Must not exceed 0.1% in cosmetics (CIR limit); potential skin depigmentation at higher levels; not approved in Japan for food use; Health Canada also caps at 0.1%

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Concern Level: Low

Regulatory Flags

fragrance-component ifra_fragrance fda_food_additive

Frequently Asked Questions

Is TBHQ (tert-Butylhydroquinone) safe in cosmetics?

Must not exceed 0.1% in cosmetics (CIR limit); potential skin depigmentation at higher levels; not approved in Japan for food use; Health Canada also caps at 0.1% The EU classifies TBHQ (tert-Butylhydroquinone) as "permitted". Safety rating: GOOD. 10 toxicological study endpoint(s) are available in our database.

Is TBHQ (tert-Butylhydroquinone) allowed in the EU?

TBHQ (tert-Butylhydroquinone) EU regulatory status: permitted. This is based on EU Regulation 1223/2009 and its amendments.

What does TBHQ (tert-Butylhydroquinone) do in cosmetics?

TBHQ (tert-Butylhydroquinone) functions as: Antioxidant, Masking, Perfuming. It is classified as a cosmetic ingredient in our database. CAS number: 1948-33-0.

What is the Margin of Safety for TBHQ (tert-Butylhydroquinone)?

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 TBHQ (tert-Butylhydroquinone)?

The NOAEL (No Observed Adverse Effect Level) for TBHQ (tert-Butylhydroquinone) is 125 mg/kg bw/day based on a Chronic study via oral route in dog. A total of 10 study endpoints are available. Source: COSMOS_DB.

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