Moderate Cosmetic Ingredient NOAEL Data

Methylene Di-t-Butylcresol

INCI: METHYLENE DI-T-BUTYLCRESOL

CAS Number
119-47-1
Function
Antioxidant (stabilizer for oils, fats, and formulations)
Safety Rating
MODERATE

Regulatory Status

๐Ÿ‡ช๐Ÿ‡บ EU Status restricted
EU Max Conc. 0.5%
๐Ÿ‡บ๐Ÿ‡ธ US Status permitted
US Notes Allowed - no specific cosmetic prohibition; also used as a food additive antioxidant (FDA 21 CFR)

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

Safety Data

Margin of Safety (MoS)
not established
Dermal Absorption
low
Sensitization
low

Calculate MoS for your specific formulation with the MoS Calculator.

Toxicological Studies

6 study endpoints found for Methylene Di-t-Butylcresol. 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 12.7 mg/kg bw/day oral rat oral REACH
NOAEL 24.91 mg/kg bw/day oral rat oral REACH
LOAEL 88 mg/kg bw/day oral rat oral REACH
NOAEL 12.5 mg/kg bw/day oral rat oral REACH
LOAEL 50 mg/kg bw/day oral rat oral REACH
NOAEL 200 ppm oral dog oral REACH

Expert Verdict

Classified as a potential endocrine disruptor; reproductive toxicity concerns flagged in some assessments. EU restricts concentration due to these concerns. Also known as BHT dimer / 2,2'-methylenebis(6-tert-butyl-4-methylphenol). A bisphenolic antioxidant that prevents oxidative degradation of oils, fats, and active ingredients. More effective than BHT alone in some applications due to its dimeric structure. Must comply with the 0.5% limit in the EU.

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Concern Level: High

Regulatory Flags

ifra_fragrance

Frequently Asked Questions

Is Methylene Di-t-Butylcresol safe in cosmetics?

Classified as a potential endocrine disruptor; reproductive toxicity concerns flagged in some assessments. EU restricts concentration due to these concerns. Also known as BHT dimer / 2,2'-methylenebis(6-tert-butyl-4-methylphenol). A bisphenolic antioxidant that prevents oxidative degradation of oils, fats, and active ingredients. More effective than BHT alone in some applications due to its dimeric structure. Must comply with the 0.5% limit in the EU. The EU classifies Methylene Di-t-Butylcresol as "restricted". Safety rating: MODERATE. 6 toxicological study endpoint(s) are available in our database.

Is Methylene Di-t-Butylcresol allowed in the EU?

Methylene Di-t-Butylcresol EU regulatory status: restricted. Maximum allowed concentration: 0.5%. This is based on EU Regulation 1223/2009 and its amendments.

What does Methylene Di-t-Butylcresol do in cosmetics?

Methylene Di-t-Butylcresol functions as: Antioxidant (stabilizer for oils, fats, and formulations). It is classified as a cosmetic ingredient in our database. CAS number: 119-47-1.

What is the Margin of Safety for Methylene Di-t-Butylcresol?

not established 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 Methylene Di-t-Butylcresol?

The NOAEL (No Observed Adverse Effect Level) for Methylene Di-t-Butylcresol is 12.7 mg/kg bw/day based on a oral study via oral route in rat. A total of 6 study endpoints are available. Source: REACH.

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