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EC number: 410-800-5
CAS number: 143239-08-1
Table 7.6.2/3: Results of in vivo micronucleus test with ITC
ITC 288/S (1000 mg/kg)
Number of cells evaluated
Sampling time (h)
Number of erythro-cytes
polychromatic with micronuclei
Ratio of erythrocytes
Normochromatic with micronuclei
polychromatic erythrocytes/Normochromatic erythrocytes (PCE/NCE)
1.5 +/- 0.15
- Number of PCE with Micronuclei per 1000 PCE (positive control 24
hour sampling time): 30.6 +/- 11.4
- PCE/NCE Ratio (positive control 24 -hour sampling time): 0.9
- Number of NCE with Micronuclei per 1000 NCE (positive control 24
hour sampling time): 1.0 +/- 1.4
In a micronucleus test (Durward R, 1993), groups of ten mice (five males
and five females) were given a single i.p. dose of ITC 288 at 1000
mg/kg. Animals were killed 24, 48, or 72 hours later, the bone marrow
extracted and smear preparations made and stained. Polychromatic and
normochromatic erythrocytes were scored for the presence of micronuclei.
Further groups of mice were dosed with distilled water or
cyclophosphamide, to serve as vehicle and positive control respectively.
There was no evidence of an increase in the incidence of micronucleated
polychromatic or normochromatic erythrocytes (NCE or PCE) in animals
dosed with ITC 288 when compared to the concurrent vehicle control
groups. No significant change in the NCE/PCE ratio was observed after
dosing with ITC 288.The positive control material induced the
appropriate responses. Under the conditions of this test, ITC 288 was
considered to be non-genotoxic.
This study is classified as acceptable. This study satisfies the
requirement for Guideline OECD 474 for in vivo Mammalian
Erythrocyte Micronucleus Test.
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