Moderate Active Ingredient NOAEL Data Dermal Penetration

Pro-Retinol

INCI: RETINYL PALMITATE

CAS Number
79-81-2
Function
Skin conditioning; vitamin A ester
Safety Rating
MODERATE

Regulatory Status

🇪🇺 EU Status permitted
🇺🇸 US Status permitted
US Notes No FDA restriction on retinyl propionate or HPR in cosmetics. Neither has OTC drug status. CIR assessed within retinyl ester class review. Brands marketing Pro-Retinol may use retinyl propionate, HPR, or retinyl beta-glucoside -- verify INCI on label. PM use recommended; not recommended during pregnancy.

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.

Toxicological Studies

10 study endpoints found for Pro-Retinol. 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 138 mg/kg bw/day oral rat Special Toxicology Study COSMOS_DB
NOAEL 28 mg/kg bw/day oral rat Chronic COSMOS_DB
NOAEL 14 mg/kg bw/day oral dog Chronic COSMOS_DB
NOAEL 220 mg/kg bw/day oral rat Short Term Toxicity COSMOS_DB
NOAEL 1100 mg/kg bw/day oral rat Short Term Toxicity COSMOS_DB
NOAEL 138 mg/kg bw/day oral rat Short Term Toxicity COSMOS_DB
NOAEL 30 mg/kg bw/day oral cat Chronic COSMOS_DB
NOAEL 1.2 mg/kg bw/day oral rat Chronic COSMOS_DB
NOAEL 138 mg/kg bw/day oral rat Developmental COSMOS_DB
NOAEL 138 mg/kg bw/day oral rat Developmental COSMOS_DB

Dermal Penetration Profile

Skin absorption and penetration characteristics of Pro-Retinol, relevant to systemic exposure and MoS calculations.

Absorption %
1-3%
Penetration Level
stratum-corneum
Penetration Depth
stratum corneum
Molecular Weight
524.9 Da
Log P
13.5
Systemic Absorption
minimal
Topical Bioavailability
0.5-2%
Safety Margin Factor
variable
Vehicle Dependent
Yes — absorption varies by formulation

Source: SCCS/1378/10

Expert Verdict

Retinyl propionate (CAS 7069-42-3) and hydroxypinacolone retinoate (CAS 893412-73-2) are not restricted in EU or US at specified concentrations. Primary concern is dose-dependent irritation rather than sensitization; use at recommended levels (≤0.3% RE leave-on, ≤0.05% RE body lotion) ensures adequate margin of safety.

⚠️
Concern Level: Moderate

Regulatory Flags

enhanced-skin-absorption developmental-reproductive-toxicity pregnancy-warning use-restrictions photodegradation-free-radicals vitamin-a-derivative ewg-restricted fda_food_additive

Frequently Asked Questions

Is Pro-Retinol safe in cosmetics?

Retinyl propionate (CAS 7069-42-3) and hydroxypinacolone retinoate (CAS 893412-73-2) are not restricted in EU or US at specified concentrations. Primary concern is dose-dependent irritation rather than sensitization; use at recommended levels (≤0.3% RE leave-on, ≤0.05% RE body lotion) ensures adequate margin of safety. The EU classifies Pro-Retinol as "permitted". Safety rating: MODERATE. 10 toxicological study endpoint(s) are available in our database.

Is Pro-Retinol allowed in the EU?

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

What does Pro-Retinol do in cosmetics?

Pro-Retinol functions as: Skin conditioning; vitamin A ester. It is classified as a Active Ingredient in our database. CAS number: 79-81-2.

What is the Margin of Safety for Pro-Retinol?

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 Pro-Retinol?

The NOAEL (No Observed Adverse Effect Level) for Pro-Retinol is 138 mg/kg bw/day based on a Special Toxicology Study study via oral route in rat. A total of 10 study endpoints are available. Source: COSMOS_DB.

Compliance Tools

Check Pro-Retinol compliance across multiple jurisdictions:

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Ingredient Decoder
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82 Allergen Checker
Check for EU declarable fragrance allergens
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Substance Compliance
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MoS Calculator
Calculate Margin of Safety using SCCS methodology
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Heavy Metal Limits
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