Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 240-521-2 | CAS number: 16470-24-9
The test article was assessed for its potential to induce structural chromosome aberrations in V79 cells of the Chinese hamster in vitro in the absence and presence of metabolic activation by S9 mix.
Preparation of chromosomes was done 7 h (high dose), 18 h (low, medium and high dose) and 28 h (high dose) after start of the treatment with the test article. The treatment interval was 4 h. In each experimental group two parallel cultures were used. Per
culture 100 metaphases were scored for structural chromosome aberrations.
The following dose levels were evaluated:
Experiment I both with and without S9 mix:
7 h: 1.0 mg/ml
18 h: 0.3; 2.0; 5.0 mg/ml
28 h: 5.0 mg/ml
Experiment II with S9 mix:
7 h: 5.0 mg/ml
In the pre-experiment on toxicity (colony forming ability) in the absence and presence of S9 mix the colony forming ability was reduced with 1.0 mg/ml and higher (without S9 mix) and 3.0 mg/ml and higher (with S9 mix). Higher concentrations than 5.0 mg/ml were not applied.
Also, in the cytogenetic experiments the mitotic index was reduced at least after treatment with the highest dose level at fixation intervals 7 and 18 h (in the absence of S9 mix) and 28 h (in the absence and presence of S9 mix).
In the rirst experiment in the absence of S9 mix the test article did not increase the frequency of cells with aberrations at any fixation interval. At fixation interval 7 h, in one test group (1.0 mg/ml) the statistical analysis revealed a significant result. This effect was due to the randomly extremely low control rate. As the aberration rate of the test group is near to the control range of this study and within our historical control data the statistical result is not regarded as biologically relevant.
In the presence of S9 mix, at fixation interval 7 h the aberration rate was distinctly increased after treatment with 5.0 mg/ml as compared to the corresponding· solvent control. This result could not be confirmed. In addition, the metaphase quality was relatively poor so that an accurate scoring was partially inhibited. Similar observations were made on the slides treated with lower dose levels on which not enough scorable cells could be found.
A second experiment was performed to clarify the effects observed in the first experiment. In this experiment II, there was no incidence of an increased aberration rate after treatment with 5.0 mq/ml. On both slides enough scorable cells with good spreading quality could be scored.
Therefore, the finding observed in experiment I is not regarded as biologically relevant. At fixation intervals 18 and 28 the aberration rates were not biologically relevantly increased as compared to the solvent controls.
In the occurence of polyploid metaphases evaluation no relevant deviation from the control data was found after treatment with the test article.
In conclusion, it can be stated that in the described study and under the experimental conditions reported, the test article did not induce structural chromosome aberrations in the V79 Chinese Hamster cell line.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
Welcome to the ECHA website. This site is not fully supported in Internet Explorer 7 (and earlier versions). Please upgrade your Internet Explorer to a newer version.
Close Do not show this message again