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EC number: 287-476-5
CAS number: 85535-84-8
In a 13-week GLP study, similar to OECD
Guideline 408, groups of male and female Fischer 344 rats (15/sex/dose)
were given a C10-12 chlorinated paraffin (58% chlorinated) in the diet
at nominal dose levels of 10, 100 and 625 mg/kg bw/day (actual intakes
were 10, 101 and 654 mg/kg bw/day for males and 10.3, 102 and 613 mg/kg
bw/day for females). During the study, animals were observed for
clinical signs of toxicity. Food and water consumption was determined
and haematological and urinary analyses performed. At the end of the
feeding period, animals were weighed and a range of organs examined for
gross and histopathological changes. Livers were also recovered for
No deaths occurred and no clinical signs of
toxicity (other than slight skin atonia in top-dose males) were observed
during the study. A slight reduction in body weight gain (9% compared to
controls) was noted in top-dose males after 13 weeks and a reduction in
water consumption was seen in top-dose males and females (11 and 20%,
respectively). This was associated with a decrease in urine volume and
an increase in specific gravity. Increases in blood total protein (13%),
cholesterol (54%), glucose (20%) and urea nitrogen (44%) were also seen
in top-dose animals and in glucose (20%), cholesterol and urea nitrogen
in mid-dose animals. Statistically significant increases in liver (about
20 and 140%) and kidney (10 and 30%) weights were seen in mid- and
top-dose animals, respectively, and in thyroid weight (about 32%) in
top-dose animals only. Histopathological changes seen included
hepatocellular hypertrophy in both mid- and top-dose males and females,
mild chronic nephritis in mid- and top-dose males and renal tubule
pigmentation in top-dose females, and thyroid hypertrophy and
hyperplasia in mid-dose males and top-dose males and females.
The no-observed-effect level (NOEL) in the
rat for the C10-12 chlorinated paraffin (58% chlorinated) investigated
in this study is 10 mg/kg bw/day.
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