Moderate Cosmetic Ingredient NOAEL Data

Basic Orange 31

INCI: BASIC ORANGE 31

CAS Number
97404-02-9
Function
Hair Dyeing (semi-permanent / direct dye)
Safety Rating
MODERATE

Regulatory Status

๐Ÿ‡ช๐Ÿ‡บ EU Status prohibited
๐Ÿ‡บ๐Ÿ‡ธ US Status restricted
US Notes Not an approved color additive; usable under coal-tar hair dye exemption with caution statement

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

Safety Data

Margin of Safety (MoS)
not established
Dermal Absorption
moderate
Sensitization
moderate

Calculate MoS for your specific formulation with the MoS Calculator.

Toxicological Studies

2 study endpoints found for Basic Orange 31. 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 66 mg/kg bw/day oral rat Subchronic COSMOS_DB
LOAEL 229 mg/kg bw/day oral rat Subchronic COSMOS_DB

Expert Verdict

Contains primary aromatic amine (aminophenyl group) requiring monitoring for free amine levels; restricted to non-oxidative systems only; must comply with purity specifications

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Concern Level: Moderate

Regulatory Flags

eu_children_restricted eu_cosing_listed

Frequently Asked Questions

Is Basic Orange 31 safe in cosmetics?

Contains primary aromatic amine (aminophenyl group) requiring monitoring for free amine levels; restricted to non-oxidative systems only; must comply with purity specifications The EU classifies Basic Orange 31 as "prohibited". Safety rating: MODERATE. 2 toxicological study endpoint(s) are available in our database.

Is Basic Orange 31 allowed in the EU?

Basic Orange 31 EU regulatory status: prohibited. This is based on EU Regulation 1223/2009 and its amendments.

What does Basic Orange 31 do in cosmetics?

Basic Orange 31 functions as: Hair Dyeing (semi-permanent / direct dye). It is classified as a cosmetic ingredient in our database. CAS number: 97404-02-9.

What is the Margin of Safety for Basic Orange 31?

not established 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 Orange 31?

The NOAEL (No Observed Adverse Effect Level) for Basic Orange 31 is 66 mg/kg bw/day based on a Subchronic study via oral route in rat. A total of 2 study endpoints are available. Source: COSMOS_DB.

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