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EC number: 411-380-6 | CAS number: 147315-50-2
mean maternal body weight change during gestation
Dunnett-test, two-sided, * p< = 0.05
Total indcidence of external malformations
Total soft tissue variations
Individual fetal skeletal malformations
Total fetal skeletal malformations
Total fetal skeletal variations
Occurrence of statistically significantly increased fetal skeletal variations (expressed as mean percentage of affected fetuses/litter)
For a better overview, all skeletal variations with statistically significant differences between the control and the treated groups were compiled in the table below. All incidences were expressed on a fetus per litter basis and any statistically significant differences, which were outside historical control ranges were marked in bold and italics types.
of parietal; unchanged cartilage
of sternebra; unchanged cartilage
HCD = Historical control data; % = per cent * = p ≤ 0.05 (Wilcoxon-test [one-sided]) ** = p ≤ 0.01 (Wilcoxon-test [one-sided])
As can be seen from the table above, the rate of incompletely ossified sternebra was statistically significantly increased and slightly outside the historical control range in the test group 5 (600 mg/kg bw/d). This minor change may represent a slight delay of ossification which did not affect morphology, as the underlying cartilage model was completely intact. As can be seen from the historical background data, increased incidences of such incomplete or nonossifications of skeletal elements are routinely quantified and are among the most frequently noted skeletal variants in control populations of this Crl:WI(Han) rat strain. This indicates that these findings reflect species-specific anatomic variation at the time around birth without any detrimental effects on further development. As the incidence in this study is still in the order of magnitude of the background rate the finding is neither considered as biologically relevant nor as adverse. Concerning the other statistically significant differences, no dose dependency was observed and all values were clearly inside the historical control range, thus, an association with the test substance and a toxicological relevance is not assumed.
In a prenatal developmental toxicity study the test substance was administered to pregnant Wistar rats daily by gavage from implantation to one day prior to the expected day of parturition (GD 6-19) to evaluate its potential maternal and prenatal developmental toxicity. Analyses confirmed the correctness of the prepared concentrations and the stability of the test substance in the vehicle. The test substance caused neither mortality nor clinical symptoms of systemic toxicity in any of the exposed groups. Two females of the high-dose group (600 mg/kg bw/d) showed transient (up to 10 minutes) salivation at two occasions during the treatment period (GD 14 and GD 17). Such transient salivation shortly after dosing most likely reflects a reaction of the animals to the taste and smell of the test substance. It is not considered to be a sign of systemic toxicity. The high-dose of the test substance (600 mg/kg bw/d) caused a decrease in body weight gain as well as a significant decrease in the corrected (net) body weight gain. These effects are considered minimal, but treatment-related and adverse. No toxicologically relevant clinical effect was noted for the animals exposed to 60, 200 or 300 mg/kg bw/d CGL 400. No differences of toxicological relevance between the control and the treated groups (60, 200, 300 or 600 mg/kg bw/d) were determined for any reproductive parameters, such as conception rate, mean number of corpora lutea, mean number of implantations, as well as preand postimplantation loss. Similarly, no influence of the test compound on fetal weight and sex distribution of the fetuses was noted at any dose. Overall, there was no evidence for toxicologically relevant adverse effects of the test substance on fetal morphology at any dose. Thus, the test item is not teratogenic in rats.
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