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EC number: 419-050-3
CAS number: 79944-37-9
Hematological parameters showing statistically significant differences to the control group which are not considered to be compound-related effects
Reticulocyte count (rel + abs)
R: values within the historical-reference range
D: lack of dose-dependence
↑: increase ↓: decrease
Biochemical parameters showing statistically significant differences between control and treatment groups that were not considered compound-related
Total β-globin, rel.
Total γ-globin, abs.
Macroscopic findings observed in controls and ZK 38.199-treated animals which were sacrificed at study termination
- cysts, watery
- pelvic dilatation
- reduced in size
- cystic dilatation
- areas with alopecia
- thinning of fur
- diminished in size
Changes in absolute and relative organ weights in animals treated with ZK 38.199 in comparison to the controls
Terminal body weight
Pituitary gland (relative)
Adrenal glands (relative)
Submandibular gland (relative)
* = significantly different from the control group with p < 0.05
** = significantly different from the control group with p < 0.01
n.s. = not significant
Microscopic findings in sacrificed animals that are considered as clear or suspected effects of the test item
Group 1 control
vacuolation of macrophages in red pulp
- hemopoiesis increased in red pulp
- focal cell degeneration in red pulp
- megakaryocytosis in red pulp
- increased number of corpora lutea
- focal granulomatous inflammation, partly centrilobular
Grading: 1 = minimal; 2 = slight; 3 = moderate; 4 = marked
In a subcacute toxicity study according to OECD test guideline 407 (1981) Aminodioxepan (100% a.i.)] was administered to 10 Wistar rats /sex/dose by gavage at dose levels of 0, 100, 300, and 1000 mg/kg bw/d.
Several changes were noted during this subacute toxicity study, e.g.: reddening and swelling of the skin following the first treatment with 1000 mg test item, increase of the spleen, occurrence of a megakaryocytosis in three animals of the high dose group, hematological findings of slight anemia and elevated reticulocyte counts in male animals at 1000 mg/kg, also focal vacuolation of macrophages in the red pulp of the spleen could be detected with increasing incidence. Corpora lutea were increased in the 300 mg/kg and the 1000 mg/kg treatment group, however, alterations in other female genital organs were not observes thus indicating that the estrous cycle is not affected. Furthermore, focal inflammatory infiltration in the liver with granulomatous appearance was detected with high incidence in all groups. Considering the slightly elevated mean severity of this finding in the high dose group and the corresponding change in serum enzyme levels (GPT, AP) as well as in biochemical parameters indicatinga disturbance of the metabolic functions of the liver (serum glucose, cholesterol and total protein), this change was considered to be a compound-related effect but to be a non-specific change in the animals due to high loading of the organism with a foreign compound.
A compound-related decrease in thymus weight in both sexes of the high dose group was not correlated with a microscopic finding. Lymphocytic degeneration, although apparent in 18 animals of the high dose group could be observed in the control group with approximately the same frequency (17 animals). Even the mean severity did not differ between the two groups. Thus, the relevance of this organ weight change remains doubtful.
Based on the present results a NOAEL of 100 mg/kg bw/d is assumed for Aminodioxepan in male and female Wistar rats.
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