Good Cosmetic Ingredient NOAEL Data

L-Phenylalanine

INCI: PHENYLALANINE

CAS Number
63-91-2
Function
Fragrance, Hair conditioning, Masking
Safety Rating
GOOD

Regulatory Status

๐Ÿ‡ช๐Ÿ‡บ EU Status permitted
๐Ÿ‡บ๐Ÿ‡ธ US Status permitted
US Notes No FDA cosmetic restrictions; essential amino acid; phenylketonuria (PKU) warning relevant only for ingestible products, not topical cosmetics

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

Safety Data

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

Calculate MoS for your specific formulation with the MoS Calculator.

Toxicological Studies

10 study endpoints found for L-Phenylalanine. 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 5000 mg/kg bw/day oral rat Short Term Toxicity COSMOS_DB
NOAEL 7000 mg/kg bw/day oral rat Short Term Toxicity COSMOS_DB
NOAEL 2500 mg/kg bw/day oral rat Reproductive COSMOS_DB
NOAEL 5000 mg/kg bw/day oral rat Subchronic COSMOS_DB
NOAEL 450 mg/kg bw/day oral mouse Carcinogenicity COSMOS_DB
NOAEL 1500 mg/kg bw/day oral rat Reproductive COSMOS_DB
NOAEL 1300 mg/kg bw/day oral rat Reproductive COSMOS_DB
NOAEL 820 mg/kg bw/day oral rabbit Developmental COSMOS_DB
dose_tested 450 mg/kg bw/day oral mouse Carcinogenicity COSMOS_DB
NOEL ca.500 mg/kg bw/day oral rat oral REACH

Expert Verdict

Essential aromatic amino acid functioning as fragrance enhancer, hair conditioner, and masking agent in cosmetics; safe for topical application with minimal dermal absorption and low sensitization potential.

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Concern Level: Low

Regulatory Flags

amino-acid essential-amino-acid fragrance hair-conditioning masking fda_food_additive jecfa_safe

Frequently Asked Questions

Is L-Phenylalanine safe in cosmetics?

Essential aromatic amino acid functioning as fragrance enhancer, hair conditioner, and masking agent in cosmetics; safe for topical application with minimal dermal absorption and low sensitization potential. The EU classifies L-Phenylalanine as "permitted". Safety rating: GOOD. 10 toxicological study endpoint(s) are available in our database.

Is L-Phenylalanine allowed in the EU?

L-Phenylalanine EU regulatory status: permitted. This is based on EU Regulation 1223/2009 and its amendments.

What does L-Phenylalanine do in cosmetics?

L-Phenylalanine functions as: Fragrance, Hair conditioning, Masking. It is classified as a cosmetic ingredient in our database. CAS number: 63-91-2.

What is the Margin of Safety for L-Phenylalanine?

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 L-Phenylalanine?

The NOAEL (No Observed Adverse Effect Level) for L-Phenylalanine is 5000 mg/kg bw/day based on a Short Term Toxicity study via oral route in rat. A total of 10 study endpoints are available. Source: COSMOS_DB.

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