Moderate Cosmetic Ingredient NOAEL Data SCCS/CIR Reviewed Sensitization Data

HC Red No. 3

INCI: HC RED NO. 3

CAS Number
2871-01-4
Function
Non-oxidative (semi-permanent) and oxidative hair dye
Safety Rating
MODERATE

Regulatory Status

🇪🇺 EU Status prohibited
EU Max Conc. 3.0%
🇺🇸 US Status permitted
US Notes Permitted under coal tar hair dye exemption (FD&C Act §601(a), 21 CFR 70.3(u)). CIR: safe with conditions.

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

Safety Data

Margin of Safety (MoS)
adequate
Dermal Absorption
low
Sensitization
high

Calculate MoS for your specific formulation with the MoS Calculator.

Toxicological Studies

6 study endpoints found for HC Red No. 3. 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
LOAEL 15 mg/kg bw/day oral mouse Subchronic COSMOS_DB
NOAEL 250 mg/kg bw/day oral rat oral REACH
NOAEL >500 mg/kg bw/day oral mouse oral REACH
NOAEL 1000 mg/kg bw/day oral rat oral REACH
NOAEL >250 mg/kg bw/day oral mouse oral REACH
NOAEL 90 mg/kg bw/day oral - - SCCS_Perplexity

Safety Opinions

Official safety assessments from the Scientific Committee on Consumer Safety (SCCS) and Cosmetic Ingredient Review (CIR).

cir
Verdict: unknown

Sensitization Profile

Contact sensitization data for HC Red No. 3 based on clinical patch test studies and IFRA standards.

Sensitization Rate
low
Allergen Class
dye
EU Allergen Listed
no
Patch Test Positive Rate
0.2%
Cross-reactivity Group
para-amino-group
Reaction Type
contact-dermatitis

Source: IVDK; NACDG; ESSCA

Expert Verdict

Secondary amine prone to nitrosation; must not be used with nitrosating agents. Nitrosamine content must be <50 ppb. Unidentified nitrosamines found in some commercial lots (20 ± 5 ppm, 11 ± 8 ppm). Carcinogenicity studies show one negative and one inadequate result.

⚠️
Concern Level: High

Regulatory Flags

eu_children_restricted eu_cosing_listed

Frequently Asked Questions

Is HC Red No. 3 safe in cosmetics?

Secondary amine prone to nitrosation; must not be used with nitrosating agents. Nitrosamine content must be <50 ppb. Unidentified nitrosamines found in some commercial lots (20 ± 5 ppm, 11 ± 8 ppm). Carcinogenicity studies show one negative and one inadequate result. The EU classifies HC Red No. 3 as "prohibited". Safety rating: MODERATE. 6 toxicological study endpoint(s) are available in our database. This ingredient has been reviewed by cir.

Is HC Red No. 3 allowed in the EU?

HC Red No. 3 EU regulatory status: prohibited. Maximum allowed concentration: 3.0%. This is based on EU Regulation 1223/2009 and its amendments.

What does HC Red No. 3 do in cosmetics?

HC Red No. 3 functions as: Non-oxidative (semi-permanent) and oxidative hair dye. It is classified as a cosmetic ingredient in our database. CAS number: 2871-01-4.

What is the Margin of Safety for HC Red No. 3?

adequate 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 HC Red No. 3?

The NOAEL (No Observed Adverse Effect Level) for HC Red No. 3 is 15 mg/kg bw/day based on a Subchronic study via oral route in mouse. A total of 6 study endpoints are available. Source: COSMOS_DB.

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