Excellent Active Ingredient NOAEL Data

L-Lysine

INCI: LYSINE

CAS Number
56-87-1
Function
Essential amino acid with a positively charged side chain (pKa ~10.5) at physiological pH. In cosmetic context: facilitates peptide-membrane adhesion by binding to the negatively charged lipid bilayer; enhances peptide penetration when positioned at sequence extremities; structural component of collagen-stimulating sequences (KTTKS in Palmitoyl Pentapeptide-4/Matrixyl). Serves as counter-ion for pH adjustment and as a skin conditioning humectant.
Safety Rating
EXCELLENT

Regulatory Status

๐Ÿ‡ช๐Ÿ‡บ EU Status permitted
๐Ÿ‡บ๐Ÿ‡ธ US Status permitted
US Notes FDA GRAS as direct food additive. CIR Expert Panel assessed safe for cosmetic use. No concentration restrictions.

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

Safety Data

Margin of Safety (MoS)
not established
Dermal Absorption
high
Sensitization
none

Calculate MoS for your specific formulation with the MoS Calculator.

Toxicological Studies

2 study endpoints found for L-Lysine. 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 2100 mg/kg bw/day oral rat Short Term Toxicity COSMOS_DB
dose_tested 2100 mg/kg bw/day oral rat Short Term Toxicity COSMOS_DB

Expert Verdict

L-Lysine's positive charge at physiological pH is functionally critical for peptide formulation, improving membrane binding and percutaneous penetration. As the K in the KTTKS Matrixyl sequence, it has GRAS status and CIR approval confirming excellent safety with no restrictions.

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Concern Level: None

Regulatory Flags

gras-fda cir-approved essential-amino-acid penetration-enhancer positive-charge fda_food_additive jecfa_safe

Frequently Asked Questions

Is L-Lysine safe in cosmetics?

L-Lysine's positive charge at physiological pH is functionally critical for peptide formulation, improving membrane binding and percutaneous penetration. As the K in the KTTKS Matrixyl sequence, it has GRAS status and CIR approval confirming excellent safety with no restrictions. The EU classifies L-Lysine as "permitted". Safety rating: EXCELLENT. 2 toxicological study endpoint(s) are available in our database.

Is L-Lysine allowed in the EU?

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

What does L-Lysine do in cosmetics?

L-Lysine functions as: Essential amino acid with a positively charged side chain (pKa ~10.5) at physiological pH. In cosmetic context: facilitates peptide-membrane adhesion by binding to the negatively charged lipid bilayer; enhances peptide penetration when positioned at sequence extremities; structural component of collagen-stimulating sequences (KTTKS in Palmitoyl Pentapeptide-4/Matrixyl). Serves as counter-ion for pH adjustment and as a skin conditioning humectant.. It is classified as a Active Ingredient in our database. CAS number: 56-87-1.

What is the Margin of Safety for L-Lysine?

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.

What is the NOAEL for L-Lysine?

The NOAEL (No Observed Adverse Effect Level) for L-Lysine is 2100 mg/kg bw/day based on a Short Term Toxicity study via oral route in rat. A total of 2 study endpoints are available. Source: COSMOS_DB.

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