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EC number: 200-521-5
CAS number: 61-82-5
7.6.1/1: Experiment 1: Summary of aberration results
Mean % aberrant cells
Without metabolic activation, 4 h treatment time, 24 h fixation interval
Positive control (ethylmethanesulphonate)
With metabolic activation, 4 h treatment time, 24 h fixation interval
Positive control (cyclophosphamide)
7.6.1/2: Experiment 2: Summary of aberration results
Without metabolic activation, 24 h treatment time, 24 h fixation interval
In an in vitro chromosome aberration test
performed according to OECD guideline 473 and in compliance with GLP,
human primary lymphocyte cultures were exposed to the test item in the
RPMI 1640 medium at concentration range of 7.8-5000 µg/mL without and
with metabolic activation (S9 liver microsomal fraction of Phenobarbital
and ß-Naphthoflavone induced Wistar rats) for a preliminary experiment.
In the main test, two experiments were performed at concentrations up to
5000 µg/mL without and with S-9 and the following concentrations were
selected for microscopic analysis:
- Experiment 1: with and without metabolic
activation, 4 h treatment, 24 h preparation interval: 1000, 2500 and
- Experiment 2: without metabolic
activation, 24 h treatment, 24 h preparation interval: 500, 1000, and
2500 µg/mL; with metabolic activation, 4 h treatment, 24 h preparation
interval: 3000, 4000 and 5000 µg/mL
No precipitation of the test item was noted
with and without metabolic activation in experiments 1 and 2. Toxic
effect of the test item was observed only in experiment 2 without
metabolic activation (long time exposure) at a concentration of 2500
µg/mL. In both experiments, no biologically relevant increase of the
aberration rates or in the frequency of polyploid cells was noted after
treatment with the test item with and without metabolic activation as
compared to the controls. The positive controls ethylmethanesulphonate
and cyclophosphamide induced distinct and biologically relevant
increases in cells with structural chromosomal aberrations.
Under the test conditions, the test item did
not induce structural chromosomal aberrations in human lymphocyte cells,
and was not considered as clastogenic in human lymphocytes.
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