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EC number: 413-110-2
CAS number: 135861-56-2
The substance was tested in two Ames tests (Hazelton Laboratories,1993
and Safepharm Laboratories,1998) using Salmonella Typhimurium TA98, TA
100, TA 1535, TA1537 and TA1538 and Escherichia coli WP2uvr/A and
concentrations ranging from 5000-50 micrograms/plate, with and without
metabolic activation (EU Annex V, B14 test method). Precipitation of the
test material from the dimethyl sulphoxide solvent was recorded between
1000-1500 micrograms/plate. There was no evidence of induction of
mutations by the test substance or its S9 induced metabolites in any of
the bacterial strains used in the test.
the key chromosome aberration study (Corning Hazleton Laboratories Ltd.,
1993), human peripheral lymphocytes were exposed in vitro to the test
substance, with and without metabolic activation, at concentrations of
3-50 micrograms/plate for 3h or 3, 20 and 44h respectively using the EEC
Annex V B10 test guideline. Fixation times were 20h for experiment 1 and
20 and 44h for experiment 2. 50
micrograms/plate was a saturated solution of the test substance in the
culture medium. There
was no evidence of induction of chromosome aberrations by the test
substance or its S9 induced metabolites in human lymphocytes
A mammalian cell gene mutation test (Corning Hazelton Laboratories Ltd.,
1998) was performed with the substance using mouse lymphoma LS178Y cells
and concentrations ranging from 6.25-50 micrograms/plate with and
without metabolic activation (EU Annex V method). Precipitation from the
dimethyl sulphoxide solvent was recorded at 50 micrograms/ml and
cytotoxicity above 50 micrograms/ml. No statistically significant
increases in mutation frequency were observed following treatment with
the test substance or its S9 induced metabolites. Mutation frequencies
in the negative control cultures fell within normal ranges, and clear
increases in mutation were induced by the positive controls.
The available in vitro test data are considered reliable and suitable
for classification purposes under regulation 1272/20008. The substance
is not therefore classified for mutagenicity under EU CLP criteria.
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