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EC number: 943-403-5 | CAS number: -
A dose of 1000 mg/kg b.w. was administered. 1000 mg/kg b.w. of the test article was close to the maximum tolerated dose. 3 out of 12 treated animals died during the 28 days period (1 male, 2 females).
This study was performed to investigate the potential of the substance to induce micronuclei in polychromatic erythrocytes (PCE) in the bone marrow of the rat.
The test article was dissolved in deionized water. This solvent was used as negative control. The volume administered orally was 10 ml/kg b.w. The animals received the test article or negative control once per 24 +/- 2 h for 28 days. 24 hours after the last application the bone marrow cells were collected for micronuclei analysis.
Ten animals (5 males, 5 females) per test group with the exception of the test article group in which only 9 animals survived (5 males and 4 females) were evaluated for the occurrence of micronuclei. 1000 polychromatic erythrocytes (PCE) per animal were scored for micronuclei.
To describe a cytotoxic effect due to the treatment with the test article the ratio between polychromatic and normochromatic erythrocytes (NCE) was determined in the same sample and reported as the number of NCE per 1000 PCE.
After treatment with the test article the ratio between PCEs and NCEs was affected as compared to the corresponding negative control thus indicating a test article-dependent effect on the target cells.
In comparison to the corresponding negative controls there was neither for the females nor for the total collective of FAT 40'317/B treated animals a statistically significant enhancement in the frequency of the detected micronuclei.
An appropriate reference mutagen was administered once and used as positive control which showed a distinct increase of induced micronucleus frequency.
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