Excellent Cosmetic Ingredient NOAEL Data Dermal Penetration

Arginine

INCI: ARGININE

CAS Number
74-79-3
Function
Amino acid / pH Adjuster
Safety Rating
EXCELLENT

Regulatory Status

๐Ÿ‡ช๐Ÿ‡บ EU Status permitted
๐Ÿ‡บ๐Ÿ‡ธ US Status permitted
US Notes GRAS as direct food additive under 21 CFR 172.320. No specific FDA restrictions on cosmetic use. 505 reported formulations in VCRP โ€” highest among all alpha-amino acids at time of CIR review.

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

Safety Data

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

Calculate MoS for your specific formulation with the MoS Calculator.

Toxicological Studies

8 study endpoints found for Arginine. 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 1000 mg/kg bw/day oral rat Subchronic COSMOS_DB
NOAEL 50 mg/kg bw/day oral mouse Carcinogenicity COSMOS_DB
NOAEL 174 mg/kg bw/day oral rat Special Toxicology Study COSMOS_DB
dose_tested 1000 mg/kg bw/day oral rat Subchronic COSMOS_DB
dose_tested 50 mg/kg bw/day oral mouse Carcinogenicity COSMOS_DB
dose_tested 174 mg/kg bw/day oral rat Special Toxicology Study COSMOS_DB
NOAEL 3130.9 mg/kg bw/day oral rat oral REACH
NOAEL 3318 mg/kg bw/day oral rat oral REACH

Dermal Penetration Profile

Skin absorption and penetration characteristics of Arginine, relevant to systemic exposure and MoS calculations.

Absorption %
2-5%
Penetration Level
surface
Penetration Depth
stratum corneum
Molecular Weight
174.2 Da
Log P
-4.2
Systemic Absorption
minimal
Topical Bioavailability
1-3%
Safety Margin Factor
low
Vehicle Dependent
Yes โ€” absorption varies by formulation

Source: J Cosmet Sci 2017

Expert Verdict

Arginine (CAS 74-79-3) is one of the safest, most well-documented cosmetic amino acids. CIR-approved as safe across all product types including eye area and leave-on. FDA GRAS under 21 CFR 172.320, no EU concentration cap, no SCCS restrictions. Typical use range of 0.5-5% is well within the established safety envelope. Monitor pH when used as neutralizer โ€” alkaline at higher concentrations.

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Concern Level: None

Regulatory Flags

eu-unrestricted cir-approved gras-fda non-sensitizing humectant eu_children_restricted fda_food_additive

Frequently Asked Questions

Is Arginine safe in cosmetics?

Arginine (CAS 74-79-3) is one of the safest, most well-documented cosmetic amino acids. CIR-approved as safe across all product types including eye area and leave-on. FDA GRAS under 21 CFR 172.320, no EU concentration cap, no SCCS restrictions. Typical use range of 0.5-5% is well within the established safety envelope. Monitor pH when used as neutralizer โ€” alkaline at higher concentrations. The EU classifies Arginine as "permitted". Safety rating: EXCELLENT. 8 toxicological study endpoint(s) are available in our database.

Is Arginine allowed in the EU?

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

What does Arginine do in cosmetics?

Arginine functions as: Amino acid / pH Adjuster. It is classified as a Cosmetic Ingredient in our database. CAS number: 74-79-3.

What is the Margin of Safety for Arginine?

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 Arginine?

The NOAEL (No Observed Adverse Effect Level) for Arginine is 1000 mg/kg bw/day based on a Subchronic study via oral route in rat. A total of 8 study endpoints are available. Source: COSMOS_DB.

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