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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.
Oral and dermal carcinogenicity studies have been conducted on petroleum waxes, and were judged to be negative, i.e., the petroleum waxes were not considered to be carcinogenic.
Paraffin and hydrocarbon waxes are
classified as non-carcinogenic and are not classified according to EU
guidelines. The classification is based on 8
studies with 5, unspecified, paraffin waxes in rats, mice and rabbits.
Oral and dermal
carcinogenicity studies have been conducted on waxes, and were judged to
be negative, i. e., the waxes were not considered to be carcinogenic. Based
on a report that the application dose in the dermal carcinogenesis
studies was approximately 7.5 mg, applied three times per week, and
assuming an average body weight for the mice of 25 g, the average daily
dose in the dermal studies was approximately 128 mg/kg/day.
In a key
carcinogenicity study (Klimisch score = 2), five petroleum waxes (3 of
the waxes were microcrystalline and the other two were unidentified)
were given to male and female Sprague-Dawley rats at a dietary
concentration of 10% for 2 years (Shubik et al., 1962). Survival
rates and growth rates were unaffected by oral exposure to any of the
waxes tested. A
number of tumours were found in all groups at necropsy. The
most common tumours were those of the mammary regions (fibrocarcinomas,
adenocarcinomas, fibromas, and sarcomas), of the adrenal glands
(cortical adenomas with a few carcinomas and pheochromocytomas) and of
the pituitary. The
number of tumour-bearing animals and the incidence of tumours of each
type were similar across groups. No
other toxic effects were found at histological examination. The
authors concluded that the five petroleum waxes were devoid of
carcinogenic or other toxic action when fed at a level of 10% in the
diet. Based on the
body weights, this equates to a daily dose of approximately 5700
A lifetime skin
painting carcinogenicity study of petroleum waxes (Klimisch score = 2)
was conducted in mice and rabbits (Shubik et al., 1962). Five
petroleum waxes were selected from 36 samples on the basis of their
ultraviolet absorptivity, representing the range of aromatic contents. Each
of the 5 waxes was dissolved in warm benzene to achieve 15% solutions. Survival
rates of the mice were similar for treated and control animals with a
better survival among females than males. No
degenerative or necrotic changes were observed. A
few epidermal tumours appeared in most groups, including controls. A
few sebaceous gland adenomas were also found in some of the wax-painted
groups. Two tumours
originating from the skin appendages, a squamous cell carcinoma and a
benign trichoepithelioma, were observed in the wax-painted groups. The
authors judged that these studies were negative. According
to the report, the wax sample was applied three times weekly at a dose
of approximately 7.5 milligrams. Assuming
the mice weigh approximately 25 grams, this equates to an average daily
dose of approximately 128 mg/kg/day.
carcinogenicity data are available on paraffin or microcrystalline waxes.
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