Good Cosmetic Ingredient NOAEL Data Sensitization Data

Basic Red 76

CAS Number
68391-30-0
Function
Dye
Safety Rating
GOOD

Regulatory Status

๐Ÿ‡ช๐Ÿ‡บ EU Status prohibited
EU Max Conc. 2.0%
๐Ÿ‡บ๐Ÿ‡ธ US Status permitted
US Notes Not an FDA-approved color additive; coal tar hair dye exemption applies for hair dye use

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

Safety Data

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

Calculate MoS for your specific formulation with the MoS Calculator.

Toxicological Studies

1 study endpoint found for Basic Red 76. 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 60 mg/kg bw/day oral rat Subchronic COSMOS_DB

Sensitization Profile

Contact sensitization data for Basic Red 76 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

Contains monomethyl sulfate (11.4-18%) as counter-ion with no specific toxicity data; o-anisidine impurity (<19 ppm) from azo cleavage; haematological effects (reduced RBC, reduced Hb, hemolysis, elevated methaemoglobin) at 60 mg/kg bw/day or higher in 90-day rat study; positive bacterial gene mutation at high concentrations; negative in mammalian cell MLA and micronucleus tests.

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Concern Level: High

Regulatory Flags

eu_cosing_listed

Frequently Asked Questions

Is Basic Red 76 safe in cosmetics?

Contains monomethyl sulfate (11.4-18%) as counter-ion with no specific toxicity data; o-anisidine impurity (<19 ppm) from azo cleavage; haematological effects (reduced RBC, reduced Hb, hemolysis, elevated methaemoglobin) at 60 mg/kg bw/day or higher in 90-day rat study; positive bacterial gene mutation at high concentrations; negative in mammalian cell MLA and micronucleus tests. The EU classifies Basic Red 76 as "prohibited". Safety rating: GOOD. 1 toxicological study endpoint(s) are available in our database.

Is Basic Red 76 allowed in the EU?

Basic Red 76 EU regulatory status: prohibited. Maximum allowed concentration: 2.0%. This is based on EU Regulation 1223/2009 and its amendments.

What does Basic Red 76 do in cosmetics?

Basic Red 76 functions as: Dye. It is classified as a cosmetic ingredient in our database. CAS number: 68391-30-0.

What is the Margin of Safety for Basic Red 76?

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 Basic Red 76?

The NOAEL (No Observed Adverse Effect Level) for Basic Red 76 is 60 mg/kg bw/day based on a Subchronic study via oral route in rat. Source: COSMOS_DB.

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