# D&C YELLOW NO. 10

URL: https://app.greenveil.ai/ingredients/ingredient_cas_8004_92_0
Categories: beauty, cleaning, food, industrial, pharma
Functions: colorant, Dye, Fragrance
Identifier: 38615-46-2

> D&C YELLOW NO. 10 is used as colorant / dye. Greenveil chemical-concern score: 70/100 — High concern based on regulatory listings.. Assessed from 37 sources.

## Safety assessment

- Chemical concern score: 70/100 — High concern based on regulatory listings.
- Confidence: 4
- Rationale: 1H-Indene-1,3(2H)-dione, 2-(2-quinolinyl)-, sulfonated, sodium salts (CI 47005) 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: Non-oxidative hair dye products Maximum concentration: 0,5 % Other conditions: From 1 July 2023 non-oxidative hair dye products containing that substance and not complying with the restrictions shall not be placed on the Union market. From 1 January 2024 non-oxidative hair dye products containing that substance and not complying with the restrictions shall not be made available on the Union market. For use as a colorant, see Annex IV, entry No 82.
- EU: allowed_listed — Annex IV of EU Cosmetics Regulation (EC) 1223/2009: colorants allowed in cosmetic products. Conditions of use and warnings: Purity criteria as set out in Commission Directive 95/45/EC (E 104)
- US: commercial use observed — EPA CPDat observed this chemical in 442 composition records across product categories including Construction and building materials, Food and drug, Cleaning products and household care. EPA CPDat classifies this chemical for functional uses including Dye, Fragrance.
- US: inactive ingredient database — Route: BUCCAL; Dosage form: GUM, CHEWING; Maximum daily exposure: 24 mg
- US: inactive ingredient database — Route: DENTAL; Dosage form: GEL; Potency: NA
- US: inactive ingredient database — Route: DENTAL; Dosage form: PASTE; Potency: NA
- US: inactive ingredient database — Route: ORAL; Dosage form: CAPSULE; Potency: 20 mg
- US: inactive ingredient database — Route: ORAL; Dosage form: CAPSULE, COATED PELLETS; Potency: 0.01 mg
- US: inactive ingredient database — Route: ORAL; Dosage form: CAPSULE, DELAYED RELEASE; Maximum daily exposure: 1 mg
- US: inactive ingredient database — Route: ORAL; Dosage form: CAPSULE, EXTENDED RELEASE; Maximum daily exposure: 3 mg
- US: inactive ingredient database — Route: ORAL; Dosage form: CAPSULE, LIQUID FILLED; Potency: 1.51 mg
- US: inactive ingredient database — Route: ORAL; Dosage form: CONCENTRATE; Potency: 0.03 mg/1ml
- US: inactive ingredient database — Route: ORAL; Dosage form: ELIXIR; Potency: 0.3 mg/15ml
- US: inactive ingredient database — Route: ORAL; Dosage form: GUM, CHEWING; Maximum daily exposure: 2 mg
- US: inactive ingredient database — Route: ORAL; Dosage form: POWDER; Maximum daily exposure: 48 mg
- US: inactive ingredient database — Route: ORAL; Dosage form: POWDER, FOR SOLUTION; Potency: NA
- US: inactive ingredient database — Route: ORAL; Dosage form: POWDER, FOR SUSPENSION; Maximum daily exposure: 76 mg
- US: inactive ingredient database — Route: ORAL; Dosage form: SOLUTION; Maximum daily exposure: 8 mg
- US: inactive ingredient database — Route: ORAL; Dosage form: SUSPENSION; Potency: 20 mg/5ml
- US: inactive ingredient database — Route: ORAL; Dosage form: SUSPENSION, EXTENDED RELEASE; Maximum daily exposure: 1 mg
- US: inactive ingredient database — Route: ORAL; Dosage form: SYRUP; Maximum daily exposure: 4 mg
- US: inactive ingredient database — Route: ORAL; Dosage form: TABLET; Potency: 80 mg
- US: inactive ingredient database — Route: ORAL; Dosage form: TABLET, CHEWABLE; Maximum daily exposure: 4 mg
- US: inactive ingredient database — Route: ORAL; Dosage form: TABLET, COATED; Potency: 2.5 mg
- US: inactive ingredient database — Route: ORAL; Dosage form: TABLET, DELAYED RELEASE; Potency: 1.9 mg
- US: inactive ingredient database — Route: ORAL; Dosage form: TABLET, EXTENDED RELEASE; Maximum daily exposure: 14 mg
- US: inactive ingredient database — Route: ORAL; Dosage form: TABLET, FILM COATED; Potency: 120 mg
- US: inactive ingredient database — Route: RECTAL; Dosage form: SOLUTION; Potency: NA
- US: inactive ingredient database — Route: RECTAL; Dosage form: SUPPOSITORY; Potency: 0.11 mg
- US: inactive ingredient database — Route: SUBLINGUAL; Dosage form: TABLET; Potency: 0.23 mg
- US: inactive ingredient database — Route: TOPICAL; Dosage form: GEL; Potency: NA
- US: inactive ingredient database — Route: TOPICAL; Dosage form: LOTION; Potency: NA
- US: inactive ingredient database — Route: TOPICAL; Dosage form: SHAMPOO; Potency: NA
- US: inactive ingredient database — Route: TOPICAL; Dosage form: SOAP; Potency: 1.4 %w/w
- US: listed in openFDA substance — openFDA substance registry classifies this ingredient as mixture.

_Assessed by Greenveil._