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EC number: 604-086-6
CAS number: 138577-01-2
Bacterial reverse mutation assay/Ames test: negative (OECD 471;
In vitro mammalian cell gene mutation test: negative (OECD 476;
In vitro human lymphocyte micronucleus assay: positive (OECD 487,
Table 1: Historical data
without S9 mix
with S9 mix
Mean = mean value of revertants/plate
SD = standard deviation
Min = minimal value/Max = maximal value
Cesium fluoroaluminate was assessed in a bacterial reverse
mutation assay using the plate incorporation and the pre-incubation test
with S. typhimurium TA 1535, TA 1537, TA 98, TA 100, and E. coli WP2
uvrA. The assay was performed in two independent experiments both with
and without liver microsomal activation in triplicate up to the limit
concentration of 5000 µg/plate.
Cesium fluoroaluminate was not mutagenic at the hprt locus in
mouse lymphoma L5178Y cells when tested up to toxic or precipitating
concentrations for 3 hours in the absence and presence of a rat liver
metabolic activation system (S9), respectively.
Cesium fluoroaluminate did induce micronuclei in cultured human
peripheral blood lymphocytes following 24+24 hour treatment in the
absence of S9. When tested up to precipitating concentrations in the
absence and presence of S9 (3+21 hour treatments) in the same test
system, no biologically relevant increases in micronuclei were observed.
The substance shows a clastogenic or aneugenic response in
cultured human lymphocytes. Based on the criteria for classification in
accordance with regulation 1272/2008, a decision on classification shall
be based on reliable in vivo heritable germ cell or in vivo somatic cell
mutagenicity tests in mammals. Such studies are not available, thus a
decision on classification as germ cell mutagen cannot be made.
Based on the positive finding in an in vitro micronucleus assay,
an in vivo micronucleus assay in rats is proposed (cf. regulation
1907/2008, Annex VIII, Section 8.4, Column 2).
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