Good Cosmetic Ingredient NOAEL Data GHS Classified Dermal Penetration

Vaseline (Petrolatum)

INCI: PETROLATUM

CAS Number
8009-03-8
Function
Skin conditioning, skin protecting, emollient, occlusive agent
Safety Rating
GOOD

Regulatory Status

🇪🇺 EU Status permitted
🇺🇸 US Status permitted
US Notes Permitted; FDA-approved OTC skin protectant (21 CFR 347); CIR-assessed as safe; GRAS for food contact

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

Safety Data

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

Calculate MoS for your specific formulation with the MoS Calculator.

Toxicological Studies

10 study endpoints found for Vaseline (Petrolatum). 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 2500 mg/kg bw/day oral rat Carcinogenicity COSMOS_DB
dose_tested 2500 mg/kg bw/day oral rat Carcinogenicity COSMOS_DB
LOEL 0.2 other oral rat oral REACH
NOAEL 30 mg/kg bw/day dermal rat dermal REACH
LOAEL ca.2 other oral rat oral REACH
LOAEL 100 mg/kg bw/day dermal code:3543 dermal REACH
NOAEL 125 mg/kg bw/day oral rat oral REACH
NOAEL ca.1000 mg/kg bw/day dermal code:3484 dermal REACH
NOAEL >=2000 mg/kg bw/day dermal rat dermal REACH
NOAEL 5000 other oral rat oral REACH

GHS Hazard Classification

Globally Harmonized System classification per ECHA C&L inventory and ILO/WHO International Chemical Safety Cards.

Routes of Exposure
The substance can be absorbed into the body by ingestion.

Dermal Penetration Profile

Skin absorption and penetration characteristics of Vaseline (Petrolatum), relevant to systemic exposure and MoS calculations.

Absorption %
0%
Penetration Level
surface
Penetration Depth
surface only
Molecular Weight
Variable Da
Log P
n/a
Systemic Absorption
no
Topical Bioavailability
0%
Safety Margin Factor
none

Source: CIR

Expert Verdict

Unrefined or poorly refined petrolatum may contain polycyclic aromatic hydrocarbons (PAHs); EU requires documented refining history proving non-carcinogenicity; always verify supplier CoA for PAH content

⚠️
Concern Level: Moderate

Regulatory Flags

eu_banned_cosmetics fda_food_additive eu_cosing_listed jecfa_concern

Frequently Asked Questions

Is Vaseline (Petrolatum) safe in cosmetics?

Unrefined or poorly refined petrolatum may contain polycyclic aromatic hydrocarbons (PAHs); EU requires documented refining history proving non-carcinogenicity; always verify supplier CoA for PAH content The EU classifies Vaseline (Petrolatum) as "permitted". Safety rating: GOOD. 10 toxicological study endpoint(s) are available in our database.

Is Vaseline (Petrolatum) allowed in the EU?

Vaseline (Petrolatum) EU regulatory status: permitted. This is based on EU Regulation 1223/2009 and its amendments.

What does Vaseline (Petrolatum) do in cosmetics?

Vaseline (Petrolatum) functions as: Skin conditioning, skin protecting, emollient, occlusive agent. It is classified as a cosmetic ingredient in our database. CAS number: 8009-03-8.

What is the Margin of Safety for Vaseline (Petrolatum)?

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 Vaseline (Petrolatum)?

The NOAEL (No Observed Adverse Effect Level) for Vaseline (Petrolatum) is 2500 mg/kg bw/day based on a Carcinogenicity study via oral route in rat. A total of 10 study endpoints are available. Source: COSMOS_DB.

Compliance Tools

Check Vaseline (Petrolatum) 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
Compare limits across jurisdictions

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