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EC number: -
CAS number: -
key bacterial reversion assay (Ames test) was conducted on Diurea 8
together with a chromosomal aberration assay in human lymphocytes. In
the Ames test, no significant increases in the frequency of revertant
colonies were recorded for any of the strains of bacteria at any dose
level, up to the maximum recommended, either with or without metabolic
activation or exposure method. In the chromosome aberration test there
was no increase in the frequency of cells with chromosome aberrations in
either the presence or absence of a liver enzyme metabolising system in
either of the experiments. In
the case of both studies the results were negative, therefore Diurea 8
was considered to be non-mutagenic and non-clastogenic under the
conditions of these tests.
a consequence of the negative Ames test and chromosome aberration assay
an in vitro mammalian cell mutation assay was undertaken, under Annex
VIII requirements, to determine the potential for mutagenicity on the
thymidine kinase locus of mouse lymphoma cells. In this study, dose
levels up to the maximum, chosen on the basis of toxicity demonstrated
in previous tests, did not induce any toxicologically significant
dose-related increases in the mutant frequency at any dose level either
with or without metabolic activation.
Not classified for genetic toxicity based on
negative results in all three in vitro studies conducted.
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