Petrolatum
INCI: PETROLATUM
Regulatory Status
For full compliance data across 55 jurisdictions, use the Substance Compliance tool.
Safety Data
Calculate MoS for your specific formulation with the MoS Calculator.
Toxicological Studies
10 study endpoints found for 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.
Dermal Penetration Profile
Skin absorption and penetration characteristics of Petrolatum, relevant to systemic exposure and MoS calculations.
Source: CIR
Expert Verdict
Refined petrolatum is permitted; unrefined petrolatum may contain polycyclic aromatic hydrocarbons (PAHs) classified as Carc. Cat. 1B. Supplier must provide Certificate of Analysis with IP 346 and EP compliance.
Regulatory Flags
Frequently Asked Questions
Is Petrolatum safe in cosmetics?
Refined petrolatum is permitted; unrefined petrolatum may contain polycyclic aromatic hydrocarbons (PAHs) classified as Carc. Cat. 1B. Supplier must provide Certificate of Analysis with IP 346 and EP compliance. The EU classifies Petrolatum as "permitted". Safety rating: EXCELLENT. 10 toxicological study endpoint(s) are available in our database.
Is Petrolatum allowed in the EU?
Petrolatum EU regulatory status: permitted. This is based on EU Regulation 1223/2009 and its amendments.
What does Petrolatum do in cosmetics?
Petrolatum functions as: Emollient, occlusive, skin protectant, hair conditioning. It is classified as a cosmetic ingredient in our database. CAS number: 8009-03-8.
What is the Margin of Safety for 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 Petrolatum?
The NOAEL (No Observed Adverse Effect Level) for 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
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Related Ingredients
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