Good Emollient NOAEL Data GHS Classified

Paraffin

INCI: PARAFFIN

CAS Number
8002-74-2
Function
wax structurant, thickener, emollient, occlusive
Safety Rating
GOOD

Regulatory Status

๐Ÿ‡ช๐Ÿ‡บ EU Status permitted
๐Ÿ‡บ๐Ÿ‡ธ US Status permitted
US Notes CIR-assessed safe. FDA-permitted. GRAS. No restriction.

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 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.

Short-term Exposure Effects
The fume is irritating to the eyes, nose and throat.
Routes of Exposure
The substance can be absorbed into the body by inhalation of fume.

Expert Verdict

Petroleum-derived macrocrystalline paraffin wax for bulk structuring of balms and sticks with melting range 47โ€“65 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.

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Concern Level: Low

Regulatory Flags

petroleum-derived macrocrystalline wax-structurant occlusive emollient balms sticks cir-approved gras not-cosmos-eligible mosh-moah-contamination-watch refining-standards-required ifra_fragrance fda_food_additive jecfa_concern

Frequently Asked Questions

Is Paraffin safe in cosmetics?

Petroleum-derived macrocrystalline paraffin wax for bulk structuring of balms and sticks with melting range 47โ€“65 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.

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