Good Cosmetic Ingredient NOAEL Data

Dihydroxyindoline

INCI: DIHYDROXYINDOLINE

CAS Number
29539-03-5
Function
Hair dyeing — non-oxidative direct dye (melanin precursor)
Safety Rating
GOOD

Regulatory Status

🇪🇺 EU Status restricted
🇺🇸 US Status permitted
US Notes Permitted under coal-tar hair dye exemption (FD&C Act §601(a)); must carry statutory caution labeling

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

Safety Data

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

Calculate MoS for your specific formulation with the MoS Calculator.

Toxicological Studies

2 study endpoints found for Dihydroxyindoline. 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 10 mg/kg bw/day oral rat Subchronic COSMOS_DB
LOAEL 20 mg/kg bw/day oral rat Subchronic COSMOS_DB

Expert Verdict

Annex III restrictions on max concentration; mandatory patch test warning; non-oxidative use only at entry 204

⚠️
Concern Level: Moderate

Frequently Asked Questions

Is Dihydroxyindoline safe in cosmetics?

Annex III restrictions on max concentration; mandatory patch test warning; non-oxidative use only at entry 204 The EU classifies Dihydroxyindoline as "restricted". Safety rating: GOOD. 2 toxicological study endpoint(s) are available in our database.

Is Dihydroxyindoline allowed in the EU?

Dihydroxyindoline EU regulatory status: restricted. This is based on EU Regulation 1223/2009 and its amendments.

What does Dihydroxyindoline do in cosmetics?

Dihydroxyindoline functions as: Hair dyeing — non-oxidative direct dye (melanin precursor). It is classified as a cosmetic ingredient in our database. CAS number: 29539-03-5.

What is the Margin of Safety for Dihydroxyindoline?

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 Dihydroxyindoline?

The NOAEL (No Observed Adverse Effect Level) for Dihydroxyindoline is 10 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.

📱

Is Dihydroxyindoline in Your Products?

Scan any product label with Piro — our free ingredient scanner. Point your camera at the ingredients list and get instant safety scores for every ingredient.

Try Piro Free →

Analyze Your Full Ingredient List

Paste any INCI list into the Decoder for instant safety analysis, or calculate the Margin of Safety for Dihydroxyindoline in your formulation.