Moderate Cosmetic Ingredient NOAEL Data

CI 10316 (Ext. D&C Yellow No. 7)

Also known as: 2-Naphthalenesulfonic acid, 8-hydroxy-5,7-dinitro-, sodium salt (1:2), 2-Naphthalenesulfonic acid, 5,7-dinitro-8-hydroxy-, disodium salt, C.I. Acid Yellow 1, disodium 5,7-dinitro-8-oxidonaphthalene-2-sulphonate, 1307 Yellow (+15 more)

INCI: CI 10316

CI 10316 (Ext. D&C Yellow No. 7) (CAS 846-70-8) is a cosmetic cosmetic ingredient functioning as Colorant. Synthetic nitro dye (Disodium 5,7-dinitro-8-oxidonaphthalene-2-sulphon. EU Regulation 1223/2009 status: restricted, max Permitted in all cosmetics except those applied in the vicinity of the eyes and lip products; no maximum concentration specified. Industrial safety data is also available in the chemical safety database. Same-CAS public records also appear in industrial chemical safety data.

View industrial chemical safety profile for CAS 846-70-8 →

Auto-generated CPSR Part A draft with source citations
Function
Colorant. Synthetic nitro dye (Disodium 5,7-dinitro-8-oxidonaphthalene-2-sulphonate), also known as Naphthol Yellow S and Acid Yellow 1. Imparts yellow coloration to cosmetic products. Water-soluble anionic dye. Historically used as a food colorant but delisted from food use in the US in 1959. Now restricted to external-use cosmetics and drugs only.
Safety Rating
MODERATE

Chemistry & Identifiers

Formula
C10H4N2Na2O8S
MW
358.19 g/mol
PubChem CID
2724063
IUPAC Name
disodium;5,7-dinitro-8-oxidonaphthalene-2-sulfonate
InChIKey
CTIQLGJVGNGFEW-UHFFFAOYSA-L

Regulatory Status

EU EU Status restricted
EU Max Conc. Permitted in all cosmetics except those applied in the vicinity of the eyes and lip products; no maximum concentration specified
US US Status restricted
US Notes FDA-certified color additive listed as Ext. D&C Yellow No. 7. Permitted only in externally applied drugs and cosmetics. Prohibited in eye area products (eye makeup, eye makeup removers) and lip products. Subject to mandatory FDA batch certification. Regulated under 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 CI 10316 (Ext. D&C Yellow No. 7).

Calculate MoS for your specific formulation with the MoS Calculator.

Toxicological Studies

10 study endpoints found for CI 10316 (Ext. D&C Yellow No. 7). 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 = mg/kg bw/day - guinea pig developmental toxicity SCCNFP_vision_codex
NOAEL = mg/kg bw/day - guinea pig developmental toxicity SCCNFP_vision_codex
NOAEL = mg/kg bw/day - guinea pig developmental toxicity SCCNFP_vision_codex
NOAEL = mg/kg bw/day - guinea pig developmental toxicity SCCNFP_vision_codex
NOAEL =30 mg/kg bw/day dermal - repeated dose toxicity SCCNFP_vision_codex
NOAEL =30 mg/kg bw/day dermal - repeated dose toxicity SCCNFP_vision_codex
NOAEL =30 mg/kg bw/day dermal - repeated dose toxicity SCCNFP_vision_codex
NOAEL =30 mg/kg bw/day dermal - repeated dose toxicity SCCNFP_vision_codex
NOAEL =50 mg/kg bw/day - pig developmental toxicity SCCNFP_vision_codex
NOAEL =50 mg/kg bw/day - pig developmental toxicity SCCNFP_vision_codex

EU CosIng Annex Listing

European Commission CosIng database Annex references per Regulation (EC) No 1223/2009.

Annex IV — Permitted Colorants
Product type: Yellow

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 (III - Restricted)
Product type: (a) Hair dye substance in oxidative hair dye products (b) Hair dye substance in non-oxidative hair dye products. Max: (b) 0,2%.
BRIN Brazil/India Cosmetics
India: Restricted · max (b) 0,2%
India: Permitted Colorant

Expanded Dermal Absorption Data

Cross-database dermal penetration: EPA Dryad physics-based, Roberts Mendeley permeation, and SCCS-aggregated measured values.

Aggregated DA Values (2 records across 5 sources)
Type DA % Method Skin Model SCCS Ref
measured_sccs_opinion 0.096% - - 2008-12-16
measured_sccs_opinion 0.078% - - 2008-12-16

Additional Ingredient Properties

1 property record from structured ingredient metadata.

colorant
{"Common_Name": "D&C Yellow No. 10", "Chemical_Name": "Quinoline Yellow", "CAS_Number": "8004-92-0", "Colorant_Type": "Synthetic Dye", "Approved_Uses": "External use only", "Max_Concentration_%": "No limit", "EU_Status": "Approved", "US_FDA_Status": "Approved 21 CFR 74.710", "Notes": "Not for mucous membranes"}

Function Categories & List Membership

Cosmetic/Chemical Function Categories
Dye
Regulatory List Membership (1)
EU CosIng Cosmetics Ingredient Database

Expert Verdict

Expert safety assessment and concern-level summary for CI 10316 (Ext. D&C Yellow No. 7).

Regulatory Flags

synthetic-colorant nitro-dye eu-annex-iv fda-certified-color eye-area-prohibited lip-prohibited batch-certified restricted-use ewg-flagged eu_cosing_listed

NOAEL Studies Summary

View details ->

Public NOAEL study rows linked to CI 10316 (Ext. D&C Yellow No. 7) by CAS number or substance name.

Studies
32
Lowest NOAEL
0
Highest NOAEL
50

Units vary across source rows: mg/kg bw/day, mg/kg bw

SCCS_vision_codex SCCNFP_vision_codex

Dermal Absorption

View details ->
Absorption % Method Vehicle
0.096% SCCS opinion extraction -
0.078% SCCS opinion extraction -

Known Synonyms

2-Naphthalenesulfonic acid, 8-hydroxy-5,7-dinitro-, sodium salt (1:2) 2-Naphthalenesulfonic acid, 5,7-dinitro-8-hydroxy-, disodium salt C.I. Acid Yellow 1 disodium 5,7-dinitro-8-oxidonaphthalene-2-sulphonate 1307 Yellow 1422 Yellow A.F. Yellow No. 1 Acid Leather Yellow NYS Amacid Yellow S Calcocid Yellow S Dolkwal Naphthol Yellow S Edicol Supra Yellow Y EINECS 212-690-2 Ext D and C Yellow No. 7 Ext D&C Yellow 7 FD and C Yellow No. 1 Flavianic acid disodium salt Hispacid Yellow NSF Japan Yellow 403-1 Japan Yellow No. 403-1

Chemical Function

Dye

Regulatory Lists

inert_ingredient; non_food_use; Pesticides Europe; Personal care - hair coloring Europe; Personal care - hair coloring Europe; Personal care - hair coloring Europe; Personal care - hair coloring Europe; Personal care; restricted

Australian Status

AICIS status: listed

Frequently Asked Questions

Is CI 10316 (Ext. D&C Yellow No. 7) safe in cosmetics?

CI 10316 (Ext. D&C Yellow No. 7) has a safety rating of "MODERATE" in our database. EU status: restricted. US status: restricted. 10 toxicological study endpoint(s) are available in our database.

Is CI 10316 (Ext. D&C Yellow No. 7) allowed in the EU?

CI 10316 (Ext. D&C Yellow No. 7) EU regulatory status: restricted. Maximum allowed concentration: Permitted in all cosmetics except those applied in the vicinity of the eyes and lip products; no maximum concentration specified. This is based on EU Regulation 1223/2009 and its amendments.

What does CI 10316 (Ext. D&C Yellow No. 7) do in cosmetics?

CI 10316 (Ext. D&C Yellow No. 7) functions as: Colorant. Synthetic nitro dye (Disodium 5,7-dinitro-8-oxidonaphthalene-2-sulphonate), also known as Naphthol Yellow S and Acid Yellow 1. Imparts yellow coloration to cosmetic products. Water-soluble anionic dye. Historically used as a food colorant but delisted from food use in the US in 1959. Now restricted to external-use cosmetics and drugs only.. It is classified as a cosmetic ingredient in our database. CAS number: 846-70-8.

What is the NOAEL for CI 10316 (Ext. D&C Yellow No. 7)?

The NOAEL (No Observed Adverse Effect Level) for CI 10316 (Ext. D&C Yellow No. 7) is =0 mg/kg bw/day based on a developmental toxicity study via oral route in guinea pig. A total of 10 study endpoints are available. Source: SCCNFP_vision_codex.

Is CI 10316 (Ext. D&C Yellow No. 7) used outside cosmetics?

CI 10316 (Ext. D&C Yellow No. 7) also appears in industrial chemical safety data. The cross-vertical cards on this page render same-CAS public rows from the matched databases.

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