Excellent Active Ingredient SCCS/CIR Reviewed Dermal Penetration

Allantoin

INCI: ALLANTOIN

CAS Number
97-59-6
Function
Skin conditioner, keratolytic, anti-irritant, wound-healing agent; promotes orderly cell turnover; stimulates fibroblast proliferation; typical use 0.5โ€“2%
Safety Rating
EXCELLENT

Regulatory Status

๐Ÿ‡ช๐Ÿ‡บ EU Status permitted
๐Ÿ‡บ๐Ÿ‡ธ US Status permitted
US Notes OTC skin protectant active at 0.5-2.0% (21 CFR 347). Dual cosmetic/drug status. Wound healing claims = drug classification.

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

Safety Data

Margin of Safety (MoS)
adequate
Dermal Absorption
high
Sensitization
none

Calculate MoS for your specific formulation with the MoS Calculator.

Safety Opinions

Official safety assessments from the Scientific Committee on Consumer Safety (SCCS) and Cosmetic Ingredient Review (CIR).

cir
Verdict: unknown

Dermal Penetration Profile

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

Absorption %
2-5%
Penetration Level
surface
Penetration Depth
stratum corneum
Molecular Weight
158.1 Da
Log P
-1.5
Systemic Absorption
minimal
Topical Bioavailability
1-3%
Safety Margin Factor
low
Vehicle Dependent
Yes โ€” absorption varies by formulation

Source: CIR

Expert Verdict

CIR safe as used (2010). MoS approximately 21,846 (200x SCCS minimum). Non-sensitizing with HRIPT n=600+. Comedogenicity 0. US OTC dual status: 0.5-2% as skin protectant drug (21 CFR 347). DNEL 284 mg/kg/day (REACH). Ames negative. COSMOS approved nature-identical. Not listed in EU or global Annexes. Readily biodegradable.

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Concern Level: None

Regulatory Flags

cir-safe-as-used-2010 us-otc-skin-protectant-21cfr347 mos-21846 dermal-absorption-5-20-pct non-sensitizing-hript-n600 comedogenicity-0 cosmos-approved readily-biodegradable no-annex-listing canada-symphytum-hotlist-risk eu_children_restricted ifra_fragrance

Frequently Asked Questions

Is Allantoin safe in cosmetics?

CIR safe as used (2010). MoS approximately 21,846 (200x SCCS minimum). Non-sensitizing with HRIPT n=600+. Comedogenicity 0. US OTC dual status: 0.5-2% as skin protectant drug (21 CFR 347). DNEL 284 mg/kg/day (REACH). Ames negative. COSMOS approved nature-identical. Not listed in EU or global Annexes. Readily biodegradable. The EU classifies Allantoin as "permitted". Safety rating: EXCELLENT. This ingredient has been reviewed by cir.

Is Allantoin allowed in the EU?

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

What does Allantoin do in cosmetics?

Allantoin functions as: Skin conditioner, keratolytic, anti-irritant, wound-healing agent; promotes orderly cell turnover; stimulates fibroblast proliferation; typical use 0.5โ€“2%. It is classified as a Active Ingredient in our database. CAS number: 97-59-6.

What is the Margin of Safety for Allantoin?

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.

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