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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.
Table 1. Calculated compound intake.
Treatment (% in diet)
Calculated intake (mg/kg/day)
Paraffin wax 64
19.5 ± 0.8
15.4 ± 1.0
193.4 ± 11.7
154.8 ± 9.6
1949.2 ± 78.2
1577.3 ± 83.5
Micro/paraffin wax mixture
19.6 ± 0.9
15.3 ± 0.7
197.6 ± 10.2
154.9 ± 8.9
1986.2 ± 91.9
1599.2 ± 77.6
Low melting point wax
2010.3 ± 77.3
1609.2 ± 84.8
Data tables with specific values for
haematology, body weights, organ weights, and other measurement were not
provided in the study report, and therefore only qualitative comparisons
are reported in this record.
a 90 -day oral feeding study, three waxes designated as low melting
point wax (LMPW), microcrystalline/paraffin wax mixture (MP), and
paraffin 64, intermediate melting point wax (IMPW) were administered via
the diet. The tests included a main study, a reversal study and a tissue
level study. The reversal group was treated for 90 days followed by 85
days with untreated diet. Group size was 20 rats/sex/untreated control
or dose for the main study, 10 rats/sex/the untreated control or high
dose (2.0%) for the reversal study, and 5 rats/sex at the high dose only
for the tissue level study. Fewer dietary concentration levels were
used: IMPW and MP were administered at 0.02, 0.2, and 2.0% and LMPW at
2.0% only. All animals were monitored for weight gain, food uptake and
clinical condition throughout the study. An ophthalmic examination was
conducted prior to treatment and prior to necropsy on the animals in the
main study and those in the reversibility study.
were no effects on food intake, growth rate, or clinical conditions of
animals fed paraffin waxes (LMPW, IMPW, or MP). There were some
increases in organ weights which included increased spleen and liver
weights (0.2 and 2.0% groups). Although some reductions were noted
during the reversal period, the weights were still higher in the 2.0%
group. Mesenteric lymph node weights were also increased in the high
dose group animals, and, like the spleen and liver weights, did not
return completely to control weights during the reversal period. There
were also changes in haematological parameters with a greater response
observed in females. Serum enzymes including alanine aminotransferase
(ALAT), aspartate aminotransferase (ASAT), and gamma glutamyl
transferase (GGT) were elevated in females from the 0.2 and 2% groups
treated with paraffin wax (LMPW) and a mix of paraffin and
microcrystalline waxes (MP) and from the 2% group treated with
intermediate melting point paraffin wax (IMPW) and in males from the 2%
LMPW, MP, and IMPW groups. Serum bilirubin was also elevated in females
from the 2% dose group. Histopathological changes in most organs were
considered to be consistent with the age of the animals and not
treatment-related, but changes in the liver, MLNs, and the cardiac
mitral valve were considered to have been treatment-related. The effects
were dose-related, more severe in females than males, and greater with
LMPW than IMPW and MP.
NOAEL could not be determined because
adverse effects were noted at the lowest dose (0.02% in diet).
study received a Klimisch score of 1 and is classified as reliable
without restriction. The study was conducted according to Good
Laboratory Practices and adhered to OECD guideline 408.
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