Aminolevulinic Acid HCl

INCI: AMINOLEVULINIC ACID HCL

CAS Number
5451-09-2
Function
Antimicrobial, Hair Conditioning, Skin Conditioning
Safety Rating
POOR

Regulatory Status

๐Ÿ‡ช๐Ÿ‡บ EU Status prohibited
๐Ÿ‡บ๐Ÿ‡ธ US Status restricted
US Notes FDA-approved as a prescription drug (Levulan Kerastick) for photodynamic therapy; cosmetic use would likely trigger drug classification

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

Severe phototoxicity risk: 5-ALA is a porphyrin precursor that accumulates protoporphyrin IX in skin, causing intense photosensitivity upon light exposure. Use in leave-on cosmetics is dangerous and FDA likely classifies it as a drug rather than cosmetic.

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Concern Level: High

Frequently Asked Questions

Is Aminolevulinic Acid HCl safe in cosmetics?

Severe phototoxicity risk: 5-ALA is a porphyrin precursor that accumulates protoporphyrin IX in skin, causing intense photosensitivity upon light exposure. Use in leave-on cosmetics is dangerous and FDA likely classifies it as a drug rather than cosmetic. The EU classifies Aminolevulinic Acid HCl as "prohibited". Safety rating: POOR.

Is Aminolevulinic Acid HCl allowed in the EU?

Aminolevulinic Acid HCl EU regulatory status: prohibited. This is based on EU Regulation 1223/2009 and its amendments.

What does Aminolevulinic Acid HCl do in cosmetics?

Aminolevulinic Acid HCl functions as: Antimicrobial, Hair Conditioning, Skin Conditioning. It is classified as a cosmetic ingredient in our database. CAS number: 5451-09-2.

What is the Margin of Safety for Aminolevulinic Acid 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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