Is Methylene Di-t-Butylcresol safe in cosmetics?
Methylene Di-t-Butylcresol has a safety rating of "MODERATE" in our database. EU status: restricted. US status: permitted. 10 toxicological study endpoint(s) are available in our database.
Methylene Di-t-Butylcresol
Also known as: 2,2'-Methanediylbis(6-tert-butyl-4-methylphenol), 4-06-00-06801, Alterungsschutzmittel BKF, Antioxidant NG-2246, AO 1 (+15 more)
INCI: METHYLENE DI-T-BUTYLCRESOL
Methylene Di-t-Butylcresol (CAS 119-47-1) is a cosmetic cosmetic ingredient functioning as Antioxidant (stabilizer for oils, fats, and formulations). NOAEL 4 mg/kg bw/day (PDF-verified against ToxValDB ECHA IUCLID); EU Regulation 1223/2009 status: restricted, max 0.5%. 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 119-47-1 →
Auto-generated CPSR Part A draft with source citations
Cross-Vertical Regulatory Divergence
Methylene Di-t-Butylcresol is classified GHS Danger (H360F, H361, H413, H360, H373) in the chemicals database but is restricted in EU cosmetics at max 0.5%.
Source: Cosmetics: ingredients.eu_status/eu_max; Chemicals: ghs_classifications.signal_word/hazard_statement_code
Function
Antioxidant (stabilizer for oils, fats, and formulations)
Safety Rating
MODERATE
Chemistry & Identifiers
IUPAC Name
2-tert-butyl-6-[(3-tert-butyl-2-hydroxy-5-methylphenyl)methyl]-4-methylphenol
InChIKey
KGRVJHAUYBGFFP-UHFFFAOYSA-N
Regulatory Status
EU EU Status
restricted
EU Max Conc.
0.5%
US 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 multiple jurisdictions, use the Substance Compliance tool.
Safety Data
Margin of Safety, dermal absorption, and sensitization profile summaries for Methylene Di-t-Butylcresol.
Calculate MoS for your specific formulation with the MoS Calculator.
Toxicological Studies
10 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 | =4 mg/kg bw/day | oral | Dog | chronic | ToxValDB_ECHA_IUCLID |
| NOAEL | =12.5 mg/kg bw/day | oral | Rat | subchronic | ToxValDB_ECHA_IUCLID |
| NOAEL | =12.7 mg/kg bw/day | oral | Rat | chronic | ToxValDB_ECHA_IUCLID |
| NOAEL | =15.1 mg/kg bw/day | oral | Rat | chronic | ToxValDB_ECHA_IUCLID |
| NOAEL | =24.91 mg/kg bw/day | oral | Rat | subchronic | ToxValDB_ECHA_IUCLID |
| NOAEL | =31.3 mg/kg bw/day | oral | Rat | subchronic | ToxValDB_ECHA_IUCLID |
| NOAEL | =50 mg/kg bw/day | oral | Rat | developmental | ToxValDB_ECHA_IUCLID |
| NOAEL | =54.2 mg/kg bw/day | oral | Rat | reproduction developmental | ToxValDB_ECHA_IUCLID |
| NOAEL | =113.16 mg/kg bw/day | oral | Rat | reproduction developmental | ToxValDB_ECHA_IUCLID |
| NOAEL | =800 mg/kg bw/day | oral | Rat | reproduction developmental | ToxValDB_ECHA_IUCLID |
Pre-Calculated Safety Assessment
Pre-calculated NOAEL → SED → MoS audit trail for Methylene Di-t-Butylcresol across SCCS product categories, with measured dermal absorption where available.
EU CLP Annex VI Harmonized Classification
Legally binding harmonized classification per Regulation (EC) No 1272/2008 (CLP) Annex VI.
Signal Word
Danger
Pictograms
Health Hazard
Hazard Class and Category
Repr. 1B
Hazard Statements
- H360F
Inserted via ATP: ATP17
ECHA REACH Registration
European Chemicals Agency REACH dossier and Substances of Very High Concern listing.
Registration Type
Full
Tonnage Band
1,000 - 10,000 tonnes
Substance Type
SUBSTANCE
SVHC Candidate
Yes (since 17-Jan-2022)
Hazard classification: Restricted (Annex XVII)
SVHC reason: Toxic for reproduction (Article 57c)
EU CosIng Annex Listing
European Commission CosIng database Annex references per Regulation (EC) No 1223/2009.
Annex II — Prohibited
Ref: 1682
(EU) 2022/1531
CMR: Reprotoxic Cat. 1B()
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.
SA Saudi SFDA (II - Prohibited)
PubChem Annotations
Safety and regulatory annotations from PubChem (NCBI) aggregated sources.
Safety (1)
Endocrine Disruptors
Potential endocrine disrupting compound
Source: NORMAN Suspect List Exchange
Function Categories & List Membership
Cosmetic/Chemical Function Categories
Antioxidant
Fragrance
Heat stabilizer
Regulatory List Membership (2)
IFRA Fragrance Transparency List
FDA Indirect Food Contact Additives
Expert Verdict
Expert safety assessment and concern-level summary for Methylene Di-t-Butylcresol.
Regulatory Flags
ifra_fragrance
NOAEL Studies Summary
View details ->Public NOAEL study rows linked to Methylene Di-t-Butylcresol by CAS number or substance name.
Studies
10
Lowest NOAEL
4 mg/kg bw/day
Highest NOAEL
800 mg/kg bw/day
ToxValDB_ECHA_IUCLID
Known Synonyms
2,2'-Methanediylbis(6-tert-butyl-4-methylphenol)
4-06-00-06801
Alterungsschutzmittel BKF
Antioxidant NG-2246
AO 1
Bisaklofen BP
BRN 2062676
p-Cresol, 2,2'-methylenebis(6-tert-butyl-
Di(2-hydroxy-5-methyl-3-tert-butylphenyl)methane
EINECS 204-327-1
Methane, 2,2'-bis(6-tert-butyl-p-cresyl)-
Methylene bis methyl butyl phenol
2,2'-Methylenebis(6-tert-butyl-p-cresol)
2,2'-Methylene-bis(6-tert-butyl-4-methylphenol)
2,2'-Methylenebis(6-(1,1-dimethylethyl)-p-cresol)
2,2-Methylenebis(4-methyl-6-t-butylphenol)
Oxy Chek 114
Plastanox 2246 Antioxidant
2,2'-Bis-6-terc.butyl-p-kresylmethan
UNII-KVM0X4X57B
Chemical Function
Antioxidant
Fragrance
Heat stabilizer
Regulatory Lists
Indirect additives food contact (10/2018)
inert_ingredient; non_food_use; Pesticides
drinking_water; Europe; manufacturing; plastic_additive
Europe; plastic_additive
Europe
IFRA Transparency
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.
ChEMBL ID
CHEMBL460648
Frequently Asked Questions
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 NOAEL for Methylene Di-t-Butylcresol?
The NOAEL (No Observed Adverse Effect Level) for Methylene Di-t-Butylcresol is =4 mg/kg bw/day based on a chronic study via oral route in Dog. A total of 10 study endpoints are available. Source: ToxValDB_ECHA_IUCLID.
Is Methylene Di-t-Butylcresol used outside cosmetics?
Methylene Di-t-Butylcresol 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.
Does Methylene Di-t-Butylcresol have different safety status in cosmetics vs industrial chemicals?
Methylene Di-t-Butylcresol is classified GHS Danger (H360F, H361, H413, H360, H373) in the chemicals database but is restricted in EU cosmetics at max 0.5%.
Compliance Tools
Check Methylene Di-t-Butylcresol compliance across multiple jurisdictions:
Ingredient Decoder
Paste a full ingredient list for instant analysis
82 Allergen Checker
Check for EU declarable fragrance allergens
Substance Compliance
Check compliance across multiple jurisdictions
MoS Calculator
Calculate Margin of Safety using SCCS methodology
Heavy Metal Limits
Compare limits across jurisdictions
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