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EC number: 807-040-5
CAS number: 4538-42-5
The substance was assessed for its potential to induce micronuclei in
human lymphocytes in vitro in accordance to OECD Guideline 487. In two
independent experiments the cells were exposed either for 4 hours (pulse
exposure) with or without S9 mix, or for 20 hours (continuous exposure)
without S9 mix. The highest concentration applied (1542.0 µg/mL of the
test item, approx. 10 mM) was chosen with regard to the molecular weight
of the test item and with respect to the current OECD Guideline 487.
In this study, at both treatment intervals, a biologically relevant
cytotoxicity indicated by not evaluable concentrations could be observed
(in the absence of S9 mix at a concentration of 771.0 μg/mL and above,
in the presence of S9 mix at a concentration of 385.5 μg/mL). In both
experiments, in the absence and presence of S9 mix, no biologically
relevant increase in the number of cells carrying micronuclei was
observed. The micronucleus rates of cells after treatment with the test
item (0.35-1.05 %) surpassed the range of the solvent controls
(0.30-0.45 %) as well as the negative controls (0.40- 0.55 %), but were
within the range of the laboratory historical control values for organic
solvents other than EGDE.
The positive controls used (Demecolcin, MMC or CPA) showed distinct
increases in cells with micronuclei.
Thus, the test item was considered to be non-mutagenic in this in vitro
micronucleus test, when tested up to the highest evaluable concentration.
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