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EC number: 295-458-3
CAS number: 92045-76-6
A complex combination of hydrocarbons obtained from residual oils by solvent crystallisation and treated with hydrogen in the presence of a catalyst. It consists predominantly of saturated straight and branched chain hydrocarbons having carbon numbers predominantly greater than C25.
Results of dermal irritation studies in rabbits indicate that paraffin wax is not irritating to the skin.
Eye irritation studies (OECD 405) conducted with paraffin wax in rabbits demonstrated either no irritation or mild irritation that resolved within 24 to 72 hours. Microcrystalline wax tested at concentrations up to 100% purity produced no or mild irritation that resolved within 72 hours.
In a primary skin
irritation study (NOTOX, 2003a), the intact skin of three male New
Zealand albino rabbits was exposed to 0.5 milligrams of paraffin wax
under semi-occlusive conditions for 4 hours. Animals were observed for
72 hours, and skin irritation or corrosion was scored by the method of
Draize at 1, 24, 48, and 72 hours. At the end of the 4 -hour test
period, excess paraffin wax was removed with water. Slight erythema was
observed at 1 hour in all three animals which was fully reversible by 24
hours. Therefore, under conditions of the study, paraffin wax is
considered not irritating.
multiple skin irritation studies (NOTOX, 2003b; BIBRA Toxicology
International, 1993c; CFTA, 1980a; Elder, 1984; CTFA, 1972a; CTFA, 1972
b; CFTA, 1980b; CFTA, 1977a; CFTA, 1977b; CFTA, 1977c) indicate that
paraffin and hydrocarbon waxes are not irritating to the skin of
In a primary eye
irritation study (SafePharm Laboratories Limited, 2007b), 0.1
millilitres of paraffin wax was instilled into the conjunctival sac of
three male New Zealand White rabbits whose eyes were unwashed. Animals
then were observed for 72 hours. Irritation
was scored by the method of Draize and a modified Kay and Calandra
interpretation of the eye irritation test. Results are presented in the
Draize method of scoring. Slight conjunctival irritation was observed at
1 and 24 hours after treatment but was fully reversible after the 24
hour timepoint. In this study, paraffin wax is therefore not considered
to be an eye irritant, based on minimal conjunctival irritation (maximum
score of 2 based on redness in each animal) at 24 hours which was fully
reversible after the 24 -hour observation.
Justification for selection of skin irritation / corrosion endpoint:
one of 11 studies showing similar results
Justification for selection of eye irritation endpoint:
one of 8 results showing similar results
and hydrocarbon waxes do not meet the criteria for classification as a
skin irritant under Annex VI of EU
CLP Regulation (EC No. 1272/2008)
because the waxes were not observed to be irritating in rabbits and in
studies conducted with human volunteers.
waxes do not meet the criteria for classification as an eye irritant under
Annex VI of EU
CLP Regulation (EC No. 1272/2008)
because, in general, the waxes were found to be not irritating to eyes
was no data identified on respiratory irritation.
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