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EC number: 943-548-4 | CAS number: -
The study was conducted to investigate the potential of the test substance to induce micronuclei in polychromatic erythrocytes (PCE) in the bone marrow of the rat according to OECD Guideline 474, EPA OPPTS 870.5395 and EU Method B.12, in compliance with GLP.
The test compound was dissolved in deionized water and was given twice at an interval of 24 hours as oral doses of 2000 mg per kg body weight to male and female rats (Hsd:Sprague Dawley). At study start the animals were 6 weeks of age and had mean body weights of 181.4 g (M) and 146.5 g (F). According to the test procedure the animals were killed 24 hours after the last administration.
Endoxan® was used as positive control substance and was administered once orally at a dose of 40 mg per kg body weight.
The number of polychromatic erythrocytes containing micronuclei was not significantly increased compared with the control. The ratio of polychromatic erythrocytes to total erythrocytes in both male and female animals remained unaffected by the treatment with the test substance and differed less than 20 % from the control value.
Endoxan®induced a marked statistically significant increase in the number of polychromatic cells with micronuclei, indicating the sensitivity of the test system. The ratio of polychromatic erythrocytes to total erythrocytes was not changed to a significant extent.
Under the conditions of the present study the results indicate that the test substance is not clastogenic in the micronucleus testin vivo.
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