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EC number: 931-082-4
CAS number: -
Due to the nature and format of the tables,
please see the attached results tables.
Table 1: Group Mean Results of Chromosome
Results of Chromosome Aberration Test - 24-Hour Vehicle Control Group
Results of Chromosome Aberration Test - 24-Hour Positive Control Group:
Cyclophosphamide 25 mg/kg
Results of Chromosome Aberration Test - 48-Hour Test Item Group: 2000
Results of Chromosome Aberration Test - 24-Hour Test Item Group: 2000
Results of Chromosome Aberration Test - 24-Hour Test Item Group: 1000
Results of Chromosome Aberration Test - 24-Hour Test Item Group: 500
study was performed to assess the potential of the test item to produce
damage to chromosomes or the mitotic apparatus when administered to rats. The
method used is compatible with that described in the revised OECD
Guidelines for Testing of Chemicals No. 475 “Mammalian Bone MarrowChromosome
Aberration Test”, Method B11 of Commission Regulation (EC) No. 440/2008
of 30 May 2008 andUS,
EPA, TSCA and FIFRA guidelines.
range-finding test was not performed as the test item had been
previously investigated at Safepharm Laboratories Ltd*(Project
No 2041/0045) at a dose of 5000 mg/kg with no ill effects. Therefore,
the maximum recommended dose of 2000 mg/kg was used as the maximum dose
and at the request of the Sponsor only male animals were investigated
via the oral route.
chromosome aberration test was conducted using the oral route in groups
of seven rats at the maximum recommended dose (MRD) 2000 mg/kg for the
24-hour and 48-hour time points, with 1000 and 500 mg/kg as the lower
dose levels. Animals
were killed 24 or 48 hours later, the bone marrow was extracted,
processed and slide preparations made and stained. Bone
marrow cells were scored for the presence of chromosome aberrations.
group of rats for the 24-hour time point were given a single oral dose
of Arachis oil (seven rats) or dosed orally with Cyclophosphamide (five
rats) to serve as vehicle and positive controls respectively.
were no premature deaths seen in any of the test item dose groups. No
clinical signs were observed in animals dosed with the test item at any
marked decreases in the mitotic index mean value were observed in any of
the test item groups when compared to the vehicle control group.
was no evidence of a statistically significant increase in the incidence
of cells with chromosome aberrations excluding gaps in animals dosed
with the test item, when the dose groups were compared to the vehicle
test item did not induce any statistically significant increases in the
numbers of polyploid cells at any dose level in any of the exposure
positive control item produced a marked increase in the frequency of
test item did not induce any significant or dose-related increases in
the frequency of chromosome aberrations. The
test item was considered to be non-clastogenic to rat bone marrow cells in
the 9thNovember 2008 Safepharm Laboratories Ltd changed
its name to Harlan Laboratories Ltd.
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