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EC number: 931-536-1
CAS number: -
to technical issues in vitro mutagenicity testing with the
multi-constituent substance is not possible.
available Ames test with the stabilizer is negative without metabolic
activation and ambiguous with metabolic activation, the overall
conclusion for the stabilizer is negative for mutagenicity.
Ames test with SBP is negative and an MLA is ongoing.
is positive with metabolic activation in the Ames test and the MLA. A
comet assay is proposed to further investigate this endpoint.
data did not indicate the possibility of the multi-constituent substance
to be positive in the Ames test (see QSAR doc section 13 Appendix 2).
This has limited reliability since the molecular structure is not well
presented in the models. In other words there is no alert but there is
also no information on this chemistry in the data base.
on the available information (see QSAR doc section 13 Appendix 1), the
multi-constituent substance is concluded not to be a mutagen pending the
outcome of the proposed Comet assay.
- SBP has a negative In vivo micronucleus
- IPP and the stabilizer have negative In
vitro micronucleus assays.
- Based on the structural
similarities of IBP the same outcome is expected, see QSAR document
- Therefore, it can be
concluded that the multi-constituent substance is not a clastogen and no
further testing is required.
The robust summaries for the in vitro
studies are unfortunately not available to the registrant at the time of
The study was performed to assess the
potential of the test item to produce damage to chromosomes or
aneuploidy when administered to mice. The method was designed to be
compatible with the 1997 OECD Guidelines for Testing of Chemicals No.474
"Mammalian Erythrocyte Micronucleus Test", Method 812 of Commission
Regulation (EC) No. 440/2008 of 30 May 2008, the USE PA (TSCA) O P PTS
870.5395, E PA 712-C-98-226, August 1998 guidelines, and be acceptable
to the Japanese METl/MHLW/MAFF guidelines for testing of new chemical
A range-finding test was performed to
confirm a suitable dose level of the test item, route of administration,
and to investigate if there was a marked difference in toxic response
between the sexes. There was no marked difference in toxicity of the
test item between the sexes; therefore the main test was performed using
only male mice. The micronucleus test was conducted using the oral route
in groups of seven mice (males) at the maximum achievable dose of 1250
mg/kg with 625 and 312.5 mg/kg as the two lower dose levels. Animals
were killed 24 or 48 hours later, the bone marrow extracted, and
smear preparations made and stained.
Polychromatic ( PCE) and normochromatic (NCE) erythrocytes were scored
for the presence of micronuclei.
Additional groups of mice were given a
single oral dose of corn oil (7 male mice) or dosed orally with
cyclophosphamide (5 male mice), to serve as vehicle and positive
controls respectively. Vehicle and positive control animals were killed
after 24 hours.
There were no premature deaths at any dose
level. Clinical signs were observed in animals dosed with the test item
at and above 625 mg/kg and included hunched posture, ptosis and ataxia.
There was no evidence of any statistically
significant increases in the incidence of micronucleated polychromatic
erythrocytes in animals dosed with the test item when compared to the
vehicle control group. No statistically significant decreases in the
PCE/NCE ratio were observed at any test item dose level.
The positive control group showed a marked
increase in the incidence of micronucleated polychromatic erythrocytes
hence confirming the sensitivity of the system to the known mutagenic
activity of cyclophosphamide under the conditions of the test.
The test item was considered to be
non-clastogenic.under the conditions of the test.
Not classified based on the available
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