Registration Dossier
Registration Dossier
Diss Factsheets
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EC number: 270-348-8 | CAS number: 68425-34-3
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data

Endpoint summary
Administrative data
Description of key information
Key value for chemical safety assessment
Skin sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
In a key dermal sensitization study (STILLMEADOW, Inc., 1995) using white petrolatum USP (CAS No. 8009-03-8), young adult Hartley (albino) guinea pigs (5/sex) were tested using a modified Buehler method in a guinea pig dermal sensitization assay.
The test material produced no irritation in animals of the naive control group after the single treatment at challenge. The test material likewise produced no irritation in animals of the test group after the challenge treatment and therefore did not elicit a sensitizing reaction in guinea pigs.
No supporting data is available for sufficiently refined petrolatum, and hence studies reported for paraffin and hydrocarbon waxes, (materials similar to sufficiently refined petrolatum) have been utilized for read across.
In a dermal sensitisation study (Shell International Gas Ltd., 2007) using paraffin wax, 11 Dunkin Hartley albino guinea pigs were tested using the Magnusson & Kligman Guinea Pig Maximisation Test with 5 animals serving as controls. At challenge phase, no skin reactions were observed at 24 or 48 hours in both the controls and groups treated with 100% or 50% paraffin wax in liquid paraffin. There was a 0% sensitisation rate. Therefore, paraffin and hydrocarbon waxes are not considered to be dermal sensitizers.
Supporting data from studies conducted in humans with 5% paraffin wax in eye shadow (CTFA, 1975; Elder, 1983) and 15% microcrystalline wax in lipstick formulations (CTFA, 1980b; Elder, 1983) indicate that paraffin and hydrocarbon waxes are not dermal sensitizers.
Respiratory sensitisation
Endpoint conclusion
- Additional information:
Migrated from Short description of key information:
This endpoint is not a REACH requirement and no data are available for this endpoint but these substances are not expected to cause respiratory sensitisation.
Justification for classification or non-classification
Sufficiently refined petrolatums do not meet the EU CLP Regulation (EC No. 1272/2008) criteria for classification as dermal sensitizers.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.

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