Registration Dossier

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:

Insufficiently Refined Petrolatum (Carcinogenic or Unknown Feed-stock)

No dermal sensitization studies have been reported for insufficiently refined petrolatum, but data have been reported for unrefined/acid treated oils, materials similar to insufficiently refined petrolatum.

In a key read-across dermal sensitisation study (API, 1986a), API 84 -01 (in paraffin oil) was tested in 10 young Hartley guinea pigs using the method of Buehler. Slight erythema reaction was exhibited by six animals but did not exceed the highest reaction of the naive control animals. The other four animals tested did not exhibit a reaction. Based on the results of this study, unrefined/acid treated oils are not considered to be dermal sensitizers.

 Sufficiently Refined Petrolatum (Non-carcinogenic Feed-stock)

 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.

In a key read-across dermal sensitisation study using paraffin wax (Huntingdon Life Sciences Ltd. 1997a), Dunkin Hartley albino guinea pigs (10/sex) were tested using the Magnusson & Kligman Guinea Pig Maximisation Test along with appropriate positive and negative controls. At the topical challenge phase, no skin reactions were observed at 24 or 48 hours in both the controls and groups treated with 10% or 50% paraffin wax in propylene glycol. There was a 0% sensitisation rate. Therefore, under conditions of this study, paraffin wax is not a dermal sensitiser.

Supporting data from studies conducted in humans with 5% paraffin wax in eye shadow (CTFA, 1975a; 1975b; 1975c; Elder, 1984) and 15% microcrystalline wax in lipstick formulations (CTFA, 1980b; Elder, 1984) indicate that paraffin and hydrocarbon waxes are not dermal sensitizers.

Migrated from Short description of key information:

No dermal sensitisation studies have been reported for insufficiently refined petrolatum while one key study has been reported for sufficiently refined petrolatum. Key data was read-across from unrefined/acid treated oils and supporting data from paraffin and hydrocarbon waxes for insufficiently refined and sufficiently refined petrolatum, respectively. Based on observations conducted during the studies in guinea pigs and human volunteers, sufficiently and insufficiently refined petrolatums are not considered to be dermal sensitizers.

Justification for selection of skin sensitisation endpoint:

One of 7 available skin sensitisation studies.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available
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 and insufficiently refined petrolatums do not meet the EU CLP Regulation (EC No. 1272/2008) criteria for classification as dermal sensitizers.