Excellent Active Ingredient NOAEL Data Dermal Penetration

L-Proline

INCI: PROLINE

CAS Number
147-85-3
Function
Dominant residue in collagen Gly-X-Y repeat. Major structural component of collagen; among the most common amino acids in cosmetic formulations.
Safety Rating
EXCELLENT

Regulatory Status

๐Ÿ‡ช๐Ÿ‡บ EU Status permitted
๐Ÿ‡บ๐Ÿ‡ธ US Status permitted
US Notes Amino acid with GRAS status as direct food additive; CIR-assessed safe class.

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

Safety Data

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

Calculate MoS for your specific formulation with the MoS Calculator.

Toxicological Studies

4 study endpoints found for L-Proline. 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 50 mg/kg bw/day oral rat Short Term Toxicity COSMOS_DB
NOAEL 2772.9 mg/kg bw/day oral rat oral REACH
NOAEL 1693 mg/kg bw/day oral rat oral REACH
NOAEL 50 mg/kg bw/day oral rat oral REACH

Dermal Penetration Profile

Skin absorption and penetration characteristics of L-Proline, relevant to systemic exposure and MoS calculations.

Absorption %
3-6%
Penetration Level
surface
Penetration Depth
stratum corneum
Molecular Weight
115.1 Da
Log P
-2.5
Systemic Absorption
minimal
Topical Bioavailability
2-4%
Safety Margin Factor
low
Vehicle Dependent
Yes โ€” absorption varies by formulation

Source: Cosmetic Science

Expert Verdict

Structural collagen amino acid with excellent safety profile and no regulatory restrictions in EU or US at cosmetic use levels.

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Concern Level: None

Regulatory Flags

fda_food_additive jecfa_safe

Frequently Asked Questions

Is L-Proline safe in cosmetics?

Structural collagen amino acid with excellent safety profile and no regulatory restrictions in EU or US at cosmetic use levels. The EU classifies L-Proline as "permitted". Safety rating: EXCELLENT. 4 toxicological study endpoint(s) are available in our database.

Is L-Proline allowed in the EU?

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

What does L-Proline do in cosmetics?

L-Proline functions as: Dominant residue in collagen Gly-X-Y repeat. Major structural component of collagen; among the most common amino acids in cosmetic formulations.. It is classified as a Active Ingredient in our database. CAS number: 147-85-3.

What is the Margin of Safety for L-Proline?

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-Proline?

The NOAEL (No Observed Adverse Effect Level) for L-Proline is 50 mg/kg bw/day based on a Short Term Toxicity study via oral route in rat. A total of 4 study endpoints are available. Source: COSMOS_DB.

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