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EC number: 203-347-8
CAS number: 105-95-3
Table 7.6.2: Results from the
Strain and sex
N° of animals
Treatment (mg/kg bw)
Time after injection (h)
PCE (No. of analysed)
MPCE (No. Of scored)
fMPCE (per mille)
Col = Colchicine
* = Significant separated from the control
In an in vivo micronucleus assay
conducted similarly to OECD 474 guideline, female NMRI and male CD-1
mice were intraperitoneally injected with Ethylene Brassylate diluted in
rape oil. In experiment 1, males were dosed with 100, 1000 or 1600 mg/kg
bw whereas in experiment 2, females were dosed with 350, 700 or 1400
mg/kg bw. Peripheral blood samples were collected at 46 and 70 h in
experiment 1 and at 42 and 70 h in experiment 2.
All vehicle (solvent) controls had
frequencies of micronucleated polychromatic erythrocytes (fMPCE) within
the range expected for normal peripheral blood. The positive control
material, Colchicine, induced statistically significant increases in the
fMPCE at the first sampling time indicating the satisfactory performance
of the test.
A female dosed with 1400 mg/kg bw died
under anaesthesia. No other sign of toxicity was observed.
There was not a significant increase
in the frequency of micronucleated polychromatic erythrocytes in bone
marrow after any treatment time in both experiments.
Under the test conditions, the test
material is not classified according to the annex VI of the Regulation
EC No. 1272/2008 (CLP) and of the Directive 67/548/EEC.
The study is non-GLP, it did not use the
maximum tolerated dose or 2000 mg/kg bw, nor the minimum number of
animals required by the OECD guideline No. 474. However, 1600 and 1400
mg/kg bw are considered to be close to the maximum recommended dose
level of 2000 mg/kg bw, and 7 to 8 animals were used per dose level,
which is only 2 or 3 less than recommended. Also, the intraperitoneal
dose route was used, which is likely to achieve a greater exposure to
the bone marrow than the oral route, which is the standard route
currently used. Finally, a study done according to the current OECD
standard is unlikely to provide a different result, particularly as
there is no concern for genotoxicity in the other available in vitro
This study is therefore considered as
acceptable and satisfies the requirement for in vivo cytogenetic
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