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EC number: 266-564-7
CAS number: 67075-37-0
Table 1: Linear trend-test
Corrected Mutation frequency without S9 mix
Corrected Mutation frequency with S9 mix
* The linear trend-test testing for an increased mutant frequency is significant (significance level of 5%), if the one-sided p-value is lower than 0.05 and the slope is greater than 0.
Table 2: Summary of results
[per 106 cells]
* Microscopically visible precipitation in culture medium at the end of exposure period
** Mutant frequency MFcorr.: mutant colonies per 106 cells corrected with the CE2 value
*** Cloning efficiency related to the respective vehicle control
s Mutant frequency statistically significantly higher than corresponding control values (p ≤ 0.05)
n.c. Culture was not continued since a minimum of only four analysable concentrations is required
n.c.1 Culture was not continued since only one concentration beyond the solubility limit is required
n.d. Not determined
VC vehicle control
PC positive control
1 Acetone 1% (v/v) 2 EMS 400 μg/mL 3 DMBA 1.25 μg/mL
Table 3: HISTORICAL NEGATIVE CONTROL DATA
Summary (all vehicles)
Period: March 2016 - December 2019
Without S9 mix
With S9 mix
Corrected Mutant Frequency**
95% Lower Control Limit
95% Upper Control Limit
No. of Experiments
* = culture medium, water 10% (v/v), DMSO 1% (v/v), acetone 1% (v/v)
** = mutant frequency (per 1 million cells) corrected with the cloning efficiency at the end of the expression period (CE2)
Table 4: HISTORICAL POSITIVE CONTROL DATA
400 µg/mL ethyl methanesulfonate (EMS)
With S9 mix
1.25 µg/mL 7,12-Dimethylbenz[a]anthracene (DMBA)
Corrected Mutant Frequency*
* = mutant frequency (per 1 million cells) corrected with the cloning efficiency at the end of the expression period (CE2)
The test substance was evaluated for genotoxic potential in a HPRT locus assay using CHO cells according to OECD TG 476 (GLP compliant). In one experiment a dose range from 0.05 to 5 µg/ml was tested, both with and without the addition of liver S9 mix from phenobarbital and β-naphthoflavone induced rats. Based on the results of the present study, the test substance did not cause any biologically relevant increase in the mutant frequencies either without or after the addition of the metabolizing system (S9 mix). No cytotoxicity could be observed, but a precipitation of the test materials was seen after 4 h exposure at dose 1.54 and above. Overall, the test item was considered to be non-mutagenetic under the conditions of the test.
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