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EC number: 270-128-1
CAS number: 68411-46-1
Table 1: Absolute changes in organ weights
Terminal body weight
* : p <=
0.05, **: p <= 0.01
Table 2: Relative changes in organ weights (note reduced body weight
gain in males at 1000 mg/kg bw)
* : p <=
0.05, **: p <= 0.01
Histopathology in liver
No. of animals
Single cell necrosis
Fatty change, midzonal
Fatty change, peripheral
Table 4: Histopathology in thyroid
Table 5: Red blood cell + coagulation parameters in males
Statistic Profile = Kruskal-Wallis + Wilcoxon test (two-sided), *
p<=0.05, ** p <=0.01, X = Group excluded from statistics
Regarding clinical examination, incipient general systemic
toxicity was observed in males of the high dose group (1000 mg/kg bw/d).
These animals showed a significantly and moderately lower body weight
(-14.6%), as well as a corresponding significant and moderate impairment
of body weight gain (-24.2%).
Regarding clinical pathology, liver was the target organ.
Mainly the liver cell metabolism was affected. This was indicated by
lower albumin and bile acid synthesis in rats of both sexes of test
group 3 (1000 mg/kg bw/d for albumin and bile acids) and test group 2
(300 mg/kg bw/d for bile acids, only) as well as by prolonged
prothrombin time in males of test group 3 (1000 mg/kg bw/d) due to a
decreased synthesis of coagulation factors. Higher alkaline phosphatase
(ALP) activities in rats of both sexes of test groups 2 and 3 (300 and
1000 mg/kg bw/d), as well as higher g-glutamyltransferase (GGT)
activities in females of test group 3 (1000 mg/kg bw/d) indicated a
liver cell swelling. Increased glucose levels in females of test group 3
(1000 mg/kg bw/d) and triglyceride levels in females of test group 2 and
3 (300 and 1000 mg/kg bw/d) may be due to a higher energy demand of
these individuals which was accomplished by increased lipolysis and
Regarding pathology, liver was the target organ. Males and
females of all treatment groups revealed a liver cell hypertrophy and
fatty change in the midzonal area or peripheral zone, respectively.
Three females revealed a macroscopically observed prominent acinar
pattern. That was regarded to have been caused by the fatty change.
Males showed in addition a minimal increase in single cell necrosis,
when compared to control animals. Also the liver weight increase in
males of all treated test groups and females of test group 2 and 3(300
and 1000 mg/kg bw/d) were regarded to be consequence of the liver cell
changes observed.Taken all these findings together and also the findings
in clinical pathology according to Hall et al. (2012)
the liver cell hypertrophy was regardedto be treatment
related and adversein test group 1-3 (100, 300 and 1000 mg/kg bw/d) in
males and females.
The hypertrophy/hyperplasia and altered colloid of follicular cell
in the thyroid gland of males and females of all treated test groups was
regarded to be a secondary event to the liver cell changes and most
likely induced by liver enzyme induction. Therefore it was regarded to
be treatment-related but not adverse.
Elcombe CR, Foster JR, Harada T, Kaufmann W, Knippel A, Küttler K,
Malarkey DE, Maronpot RR, Nishikawa A, Nolte T, Schulte A, Strauss
V, York MJ (2012) Liver
Hypertrophy : A Review of Adaptive (Adverse and Non-adverse)
Changes--Conclusions from the 3rd International ESTP Expert Workshop.Toxicol
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