Ethyl Aminolevulinate HCl

INCI: ETHYL AMINOLEVULINATE HCL

CAS Number
17687-44-8 (verification recommended) [^1_4]
Function
Skin conditioning
Safety Rating
POOR

Regulatory Status

๐Ÿ‡ช๐Ÿ‡บ EU Status permitted
๐Ÿ‡บ๐Ÿ‡ธ US Status restricted
US Notes Caution โ€” aminolevulinate HCl (Levulan) is FDA-approved as a drug (NDA); cosmetic use may trigger drug/cosmetic boundary scrutiny under FD&C Act ยง201

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

Safety Data

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

Calculate MoS for your specific formulation with the MoS Calculator.

Expert Verdict

Prodrug for protoporphyrin IX acts as potent photosensitizer upon light exposure with risk of severe phototoxic reactions; drug/cosmetic classification ambiguity requires formal NOAEL and dermal penetration studies before regulatory approval.

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Concern Level: High

Regulatory Flags

potential-allergen

Frequently Asked Questions

Is Ethyl Aminolevulinate HCl safe in cosmetics?

Prodrug for protoporphyrin IX acts as potent photosensitizer upon light exposure with risk of severe phototoxic reactions; drug/cosmetic classification ambiguity requires formal NOAEL and dermal penetration studies before regulatory approval. The EU classifies Ethyl Aminolevulinate HCl as "permitted". Safety rating: POOR.

Is Ethyl Aminolevulinate HCl allowed in the EU?

Ethyl Aminolevulinate HCl EU regulatory status: permitted. This is based on EU Regulation 1223/2009 and its amendments.

What does Ethyl Aminolevulinate HCl do in cosmetics?

Ethyl Aminolevulinate HCl functions as: Skin conditioning. It is classified as a cosmetic ingredient in our database. CAS number: 17687-44-8 (verification recommended) [^1_4].

What is the Margin of Safety for Ethyl Aminolevulinate HCl?

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.

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