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 Paraffin. 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 | Short Term Toxicity | COSMOS_DB |
| NOAEL | 1000 mg/kg bw/day | oral | rat | Short Term Toxicity | COSMOS_DB |
| NOAEL | 2 mg/kg bw/day | oral | rat | Subchronic | COSMOS_DB |
| NOAEL | 17 mg/kg bw/day | oral | rat | Subchronic | COSMOS_DB |
| NOAEL | 17 mg/kg bw/day | oral | rat | Subchronic | COSMOS_DB |
| NOAEL | 1815 mg/kg bw/day | oral | rat | Subchronic | COSMOS_DB |
| NOAEL | 1815 mg/kg bw/day | oral | rat | Subchronic | COSMOS_DB |
| NOAEL | 160 mg/kg bw/day | oral | rat | Subchronic | COSMOS_DB |
| NOAEL | 157 mg/kg bw/day | oral | rat | Subchronic | COSMOS_DB |
| dose_tested | 1000 mg/kg bw/day | oral | rat | Short Term Toxicity | COSMOS_DB |
GHS Hazard Classification
Globally Harmonized System classification per ECHA C&L inventory and ILO/WHO International Chemical Safety Cards.
Expert Verdict
Petroleum-derived macrocrystalline paraffin wax for bulk structuring of balms and sticks with melting range 47โ65 ยฐC. Macrocrystalline morphology produces coarser, less flexible networks than microcrystalline wax, giving firmer, more brittle textures. CIR-confirmed safe at cosmetic use levels. Key concern: MOSH/MOAH mineral oil hydrocarbon contamination must be controlled via refining standard compliance.
Regulatory Flags
Frequently Asked Questions
Is Paraffin safe in cosmetics?
Petroleum-derived macrocrystalline paraffin wax for bulk structuring of balms and sticks with melting range 47โ65 ยฐC. Macrocrystalline morphology produces coarser, less flexible networks than microcrystalline wax, giving firmer, more brittle textures. CIR-confirmed safe at cosmetic use levels. Key concern: MOSH/MOAH mineral oil hydrocarbon contamination must be controlled via refining standard compliance. The EU classifies Paraffin as "permitted". Safety rating: GOOD. 10 toxicological study endpoint(s) are available in our database.
Is Paraffin allowed in the EU?
Paraffin EU regulatory status: permitted. This is based on EU Regulation 1223/2009 and its amendments.
What does Paraffin do in cosmetics?
Paraffin functions as: wax structurant, thickener, emollient, occlusive. It is classified as a Emollient in our database. CAS number: 8002-74-2.
What is the Margin of Safety for Paraffin?
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 Paraffin?
The NOAEL (No Observed Adverse Effect Level) for Paraffin is 1000 mg/kg bw/day based on a Short Term Toxicity 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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