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EC number: 926-000-9
CAS number: 1180524-77-9
In vitro gene mutation study in bacteria:
The test item was evaluated in an Ames Test on Salmonella
typhimurium strains TA 1535, TA 100, TA, 1537, TA 98, and TA 102,
performed according to OECD TG 471. Doses of up to and including 5000 µg
per plate did not produce bacteriotoxic effects. Substance precipitation
occurred at 5000 µg per plate. The test material was considered to be
non-mutagenic without and with S9 mix in the plate incorporation as well
as in the preincubation modification of the Salmonella/microsome test.
Positive controls increased the mutant counts to well over those of the
negative controls, thus demonstrated the system´s sensitivity.
In vitro micronucleus study:
The test item was examined for mutagenic activity (chromsome
breakage and misdistribution of chromosomes) in the in vitro
micronucleus test using Chinese Hamster V79 cells in accordance to OECD
Guideline 487. The negative control and appropriate positive controls
with known mutagens demonstrated the suitability and sensitivity of the
test system. The test item showed no biologically relevant increase in
the frequency of micronucleus containing V79 cells in the absence (both
pulse and continuous treatment) or in the presence of S9 mix (pulse
treatment) when tested up to cytotoxic concentrations.
In vitro gene mutation study in mammalian cells
The test item was tested in an in vitro gene mutation assay in V79
cells (HPRT) according to OECD TG 476. The vehicle control and
appropriate positive controls with known mutagens demonstrated the
sensitivity of the test system and the activity of the metabolic
activation system. No substantial and reproducible dose dependent
increase of the mutation frequency was observed for the test item in the
cultures with and without S9 mix when tested up to cytotoxic
concentrations. Based on these results the test substance is considered
to be non-mutagenic in this V79/HPRT test under the conditions tested.
Based on the available study results (negative in Ames test, HPRT test
and micronucleus test, in vitro)
a classification according to EU-Directive 67/548/EEC, Annex VI
and according to Regulation (EC) No 1272/2008, Annex I is
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