# BUTYLATED HYDROXYTOLUENE

URL: https://app.greenveil.ai/ingredients/ingredient_cas_128_37_0
Categories: beauty, cleaning, food, industrial, pharma
Functions: Antioxidant, Cosmetics, Defoamer, Degradant/impurity, Deodorizer, Flavouring and nutrient, Fragrance, Pharmaceutical, Preservative, Stabilizing agent, UV stabilizer, rubber
Identifier: 128-37-0

> BUTYLATED HYDROXYTOLUENE is used as antioxidant / cosmetics. Greenveil chemical-concern score: 70/100 — High concern driven by antioxidant.. Assessed from 41 sources.

## Safety assessment

- Chemical concern score: 70/100 — High concern driven by antioxidant.
- Confidence: 4
- Rationale: 2,6-Di-Tert-Butyl-4-Methylphenol is restricted in cosmetic products under Annex III of the EU Cosmetics Regulation (EC) 1223/2009.

## Regulatory status

- EU: restricted — Annex III of EU Cosmetics Regulation (EC) 1223/2009: substances which cosmetic products must not contain except subject to the restrictions laid down. Product types: a) Mouthwash b) Toothpaste c) Other leave-on and rinse-off products Maximum concentration: a) 0,001 % b) 0,1 % c) 0,8 % Other conditions: From 1 July 2023 cosmetic products containing that substance and not complying with the restrictions shall not be placed on the Union market. From 1 January 2024 cosmetic products containing that substance and not complying with the restrictions shall not be made available on the Union market.
- US: commercial use observed — EPA CPDat observed this chemical in 7055 composition records across product categories including Cleaning products and household care, Home maintenance, Specialty occupational products. EPA CPDat classifies this chemical for functional uses including Stabilizing agent, Fragrance, Preservative.
- US: inactive ingredient database — Route: BUCCAL; Dosage form: GUM, CHEWING; Maximum daily exposure: 5 mg
- US: inactive ingredient database — Route: INTRAVENOUS; Dosage form: INJECTION; Potency: NA
- US: inactive ingredient database — Route: INTRAVENOUS; Dosage form: INJECTION, POWDER, FOR SOLUTION; Potency: NA
- US: inactive ingredient database — Route: INTRAVENOUS; Dosage form: INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION; Potency: 0.02 mg
- US: inactive ingredient database — Route: INTRAVENOUS; Dosage form: INJECTION, SOLUTION; Potency: NA
- US: inactive ingredient database — Route: NASAL; Dosage form: SPRAY, METERED; Potency: 0.1 mg/1ml
- US: inactive ingredient database — Route: ORAL; Dosage form: CAPSULE; Maximum daily exposure: 1 mg
- US: inactive ingredient database — Route: ORAL; Dosage form: CAPSULE, EXTENDED RELEASE; Potency: 0.03 mg
- US: inactive ingredient database — Route: ORAL; Dosage form: CAPSULE, LIQUID FILLED; Potency: 0.1 mg
- US: inactive ingredient database — Route: ORAL; Dosage form: FILM, SOLUBLE; Potency: 0.06 mg
- US: inactive ingredient database — Route: ORAL; Dosage form: SOLUTION; Maximum daily exposure: 14 mg
- US: inactive ingredient database — Route: ORAL; Dosage form: SOLUTION, CONCENTRATE; Potency: 0.1 mg/1ml
- US: inactive ingredient database — Route: ORAL; Dosage form: TABLET; Maximum daily exposure: 3 mg
- US: inactive ingredient database — Route: ORAL; Dosage form: TABLET, EXTENDED RELEASE; Maximum daily exposure: 1 mg
- US: inactive ingredient database — Route: ORAL; Dosage form: TABLET, FOR SUSPENSION; Potency: 0.1 mg
- US: inactive ingredient database — Route: ORAL; Dosage form: TABLET, ORALLY DISINTEGRATING; Maximum daily exposure: 1 mg
- US: inactive ingredient database — Route: RECTAL; Dosage form: SUPPOSITORY; Maximum daily exposure: 1 mg
- US: inactive ingredient database — Route: SUBLINGUAL; Dosage form: TABLET; Potency: 0.13 mg
- US: inactive ingredient database — Route: TOPICAL; Dosage form: AEROSOL, FOAM; Maximum daily exposure: 4 mg
- US: inactive ingredient database — Route: TOPICAL; Dosage form: CREAM; Maximum daily exposure: 1 mg
- US: inactive ingredient database — Route: TOPICAL; Dosage form: CREAM, AUGMENTED; Potency: 0.2 %w/w
- US: inactive ingredient database — Route: TOPICAL; Dosage form: GEL; Maximum daily exposure: 8 mg
- US: inactive ingredient database — Route: TOPICAL; Dosage form: GEL, METERED; Maximum daily exposure: 4 mg
- US: inactive ingredient database — Route: TOPICAL; Dosage form: LOTION; Maximum daily exposure: 1000 mg
- US: inactive ingredient database — Route: TOPICAL; Dosage form: OINTMENT; Maximum daily exposure: 57 mg
- US: inactive ingredient database — Route: TOPICAL; Dosage form: SHAMPOO; Potency: 0.1 %w/w
- US: inactive ingredient database — Route: TOPICAL; Dosage form: SOAP; Potency: 0.02 %w/w
- US: inactive ingredient database — Route: TOPICAL; Dosage form: SOLUTION; Maximum daily exposure: 3 mg
- US: inactive ingredient database — Route: TOPICAL; Dosage form: SPRAY; Maximum daily exposure: 3 mg
- US: inactive ingredient database — Route: TOPICAL; Dosage form: SUSPENSION; Potency: 0.02 %w/w
- US: inactive ingredient database — Route: TOPICAL; Dosage form: SWAB; Potency: 0.5 %w/w
- US: inactive ingredient database — Route: VAGINAL; Dosage form: CREAM; Potency: 0.05 %w/w
- US: inactive ingredient database — Route: VAGINAL; Dosage form: SUPPOSITORY; Potency: NA
- US: marketed drug occurrence — FDA NDC lists this ingredient in 1 active drug products and 7 total products.
- US: listed in openFDA substance — openFDA substance registry classifies this ingredient as chemical.

_Assessed by Greenveil._