Poor Cosmetic Ingredient

Prasterone (DHEA)

INCI: PRASTERONE

CAS Number
53-43-0
Function
Skin conditioning agent (hormonal — dehydroepiandrosterone/DHEA)
Safety Rating
POOR

Regulatory Status

🇪🇺 EU Status prohibited
🇺🇸 US Status restricted
US Notes Available as a dietary supplement (DSHEA); as a topical, classified as a drug (Intrarosa vaginal); cosmetic use is a regulatory gray area — FDA considers hormonal claims drug claims

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

Safety Data

Margin of Safety (MoS)
not established
Dermal Absorption
high
Sensitization
low

Calculate MoS for your specific formulation with the MoS Calculator.

Expert Verdict

Prohibited in EU cosmetics as an endocrine disruptor with reproductive toxicity concerns; prescription drug in EU (Intrarosa). In US, inclusion in cosmetics would trigger drug classification due to hormonal activity. Not suitable for cosmetic formulation under any major regulatory framework.

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Concern Level: High

Frequently Asked Questions

Is Prasterone (DHEA) safe in cosmetics?

Prohibited in EU cosmetics as an endocrine disruptor with reproductive toxicity concerns; prescription drug in EU (Intrarosa). In US, inclusion in cosmetics would trigger drug classification due to hormonal activity. Not suitable for cosmetic formulation under any major regulatory framework. The EU classifies Prasterone (DHEA) as "prohibited". Safety rating: POOR.

Is Prasterone (DHEA) allowed in the EU?

Prasterone (DHEA) EU regulatory status: prohibited. This is based on EU Regulation 1223/2009 and its amendments.

What does Prasterone (DHEA) do in cosmetics?

Prasterone (DHEA) functions as: Skin conditioning agent (hormonal — dehydroepiandrosterone/DHEA). It is classified as a cosmetic ingredient in our database. CAS number: 53-43-0.

What is the Margin of Safety for Prasterone (DHEA)?

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.

Compliance Tools

Check Prasterone (DHEA) compliance across multiple jurisdictions:

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Ingredient Decoder
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82 Allergen Checker
Check for EU declarable fragrance allergens
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Substance Compliance
Check compliance across 55 jurisdictions
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MoS Calculator
Calculate Margin of Safety using SCCS methodology
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Heavy Metal Limits
Compare limits across jurisdictions

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