Good Cosmetic Ingredient NOAEL Data

Dihydroxyacetone

INCI: DIHYDROXYACETONE

CAS Number
96-26-4
Function
Skin Tanning, Skin Conditioning, Hair Colouring
Safety Rating
GOOD

Regulatory Status

๐Ÿ‡ช๐Ÿ‡บ EU Status restricted
EU Max Conc. 10% self-tanning; 6.25% non-oxidative hair dye (leave-on)
๐Ÿ‡บ๐Ÿ‡ธ US Status permitted
US Notes FDA classifies DHA as a color additive approved for external application in sunless tanning products under 21 CFR 73.2150. Not a GRASE sunscreen active. FDA advises against ingestion, inhalation, or mucosal contact.

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

Safety Data

Margin of Safety (MoS)
adequate
Dermal Absorption
moderate
Sensitization
none

Calculate MoS for your specific formulation with the MoS Calculator.

Toxicological Studies

3 study endpoints found for Dihydroxyacetone. 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 1000 mg/kg bw/day oral rat Subchronic COSMOS_DB
NOEL 1000 mg/kg bw/day oral rat oral REACH
NOEL >1000 mg/kg bw/day oral rat oral REACH

Expert Verdict

DHA is EU-restricted (Annex III, Entry 322) with a well-established SCCS safety profile confirming safety up to 10% in self-tanning and 6.25% in leave-on hair dye within its aggregate MoS >100. Non-sensitizing per LLNA with very low systemic absorption confirmed in vivo.

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Concern Level: Low

Regulatory Flags

sccs-assessed eu-annex-iii-restricted fda-color-additive non-sensitizing spray-inhalation-concern formaldehyde-impurity-monitor no-cir-opinion fda_food_additive

Frequently Asked Questions

Is Dihydroxyacetone safe in cosmetics?

DHA is EU-restricted (Annex III, Entry 322) with a well-established SCCS safety profile confirming safety up to 10% in self-tanning and 6.25% in leave-on hair dye within its aggregate MoS >100. Non-sensitizing per LLNA with very low systemic absorption confirmed in vivo. The EU classifies Dihydroxyacetone as "restricted". Safety rating: GOOD. 3 toxicological study endpoint(s) are available in our database.

Is Dihydroxyacetone allowed in the EU?

Dihydroxyacetone EU regulatory status: restricted. Maximum allowed concentration: 10% self-tanning; 6.25% non-oxidative hair dye (leave-on). This is based on EU Regulation 1223/2009 and its amendments.

What does Dihydroxyacetone do in cosmetics?

Dihydroxyacetone functions as: Skin Tanning, Skin Conditioning, Hair Colouring. It is classified as a cosmetic ingredient in our database. CAS number: 96-26-4.

What is the Margin of Safety for Dihydroxyacetone?

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 Dihydroxyacetone?

The NOAEL (No Observed Adverse Effect Level) for Dihydroxyacetone is 1000 mg/kg bw/day based on a Subchronic study via oral route in rat. A total of 3 study endpoints are available. Source: COSMOS_DB.

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