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EC number: 232-373-2
CAS number: 8009-03-8
A complex combination of hydrocarbons obtained as a semi-solid from dewaxing paraffinic residual oil. It consists predominantly of saturated crystalline and liquid hydrocarbons having carbon numbers predominantly greater than C25.
Refined Petrolatum (Carcinogenic or Unknown Feed-stock)
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.
Refined Petrolatum (Non-carcinogenic Feed-stock)
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.
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
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.
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.
refined and insufficiently refined petrolatums do not meet the EU CLP
Regulation (EC No. 1272/2008) criteria for classification as dermal
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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