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EC number: 222-048-3
CAS number: 3327-22-8
From EU RA, 2008
In group 2, which was
the only treated group, clinical symptoms included slightly red
discoloured salivation, alopecia in the fore legs or neck. One female
performed strenuous respiration, tremor and piloerection on day 20. Two
females died 10 minutes after the second administration and were
replaced by spare animals. However, the authors did not consider this
substance related. Neither the food consumption nor the bodyweight
development was affected significantly by the treatment. The reflexes,
eyes, hearing and teeth had no abnormalities. Haematological parameters
of the treated group had no statistically significant changes when
compared to the control group. Clinical chemistry showed a slightly but
statistically significantly decreased (-26 %) glucose value to control
group. The female rats had a decreased creatinine concentration while
the creatinine kinase (202 %) and aspartate aminotransferase (ASAT)
values were slightly increased but were within the normal range of this
strain of rats. The change in ASAT was only slight (22 %) but
significant. The creatine kinase values, which are known to vary over a
wide range, were within the historical controls. No morphological
changes were found to correlate with the increased creatine kinase
values. Urinalysis did not produce any substance-related findings. The
only statistically significant, although slight, change in organ weights
was a decrease of absolute (-16 %) and relative body weight (-14 %)
heart weight in males and a 20 % increase of relative kidney weight in
males. Females had no statistically significant changes in their organ
weights. In the macroscopical examination of the necropsy, focal
alopecia of the forepaws (1 male) and neck (1 female) and
reddening of the proximal parts of the small intestine or the glandular
stomach was seen. The latter finding was only observed in the animals
that died on day 2 of the study for non-substance related reasons.
Microscopically, slight or moderate vacuolisation of proximal tubule
cells of the inner cortical and outer medullar region of the kidney were
seen in 5/10 male animals but not in females. This was not observed in
control animals. In addition, this region had minimal tubular
hyperplasia (4/5 males, 2/5 females) and minimal or slight hypertrophy
(5/5 males 0/5 females). Control animals had no hyperplasia or
hypertrophy. The female rat with alopecia was diagnosed to have moderate
atrophy of hair glands and sebaceous glands in the affected skin areas.
The causes of the two deaths of the female rats in the group 2 were
unresolved by the necropsy examination.
In a short-term repeated toxicity
study, the test item CHPTAC was applied by gavage to young adult
Bor:WISW rats (5/sex/dose) at dose levels of 0 and 1085 mg/kg bw. Slight
morphological findings in the kidney (fine, diffuse vacuolisation of
tubular cells, slight tubular cell hyperplasia and hypertrophy) were
observed. The findings were more pronounced in males than in females.
Based on these kidney changes, the LOAEL for CHPTAC after oral
administration is 1085 mg/kg bw/day.
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