Registration Dossier
Registration Dossier
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EC number: 270-348-8 | CAS number: 68425-34-3
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.
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