Registration Dossier
Registration Dossier
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EC number: 614-283-9 | CAS number: 68127-59-3
Endpoint summary
Administrative data
Key value for chemical safety assessment
Additional information
Ames test (bacterial reverse mutation in vitro): Negative
Only a single study conducted under GLP according to a method equivalent to guideline OECD 471 is available (Callander 1984). The study is considered to be relevant, reliable with restrictions and adequate for the purposes of risk assessment, classification and labelling. No increase in the incidence of revertant colonies was elicited in strains S. typhimurium TA1535, TA1537, TA1538, TA 98, and TA 100, with and without metabolic activation, with one exception (strain TA98 without S9-mix, test/control ratios up to 2.4). The latter result showed no dose relation, was not reproducible in two further experiments, and was thus considered an artefact (due to exceptionally low background values). Under the conditions of the assay, the test material gave an unequivocal negative (non-mutagenic) response.
Chromosome aberration: Negative
Only a single study (in vitro cytogenetic test in human lymphocytes) conducted according to guideline OECD 473 and under GLP is available (Fox 1995). The study is considered to be relevant, reliable and adequate for the purposes of risk assessment, classification and labelling. Two independent experiments were performed with lymphocytes of two different donors (male and female), over a wide range of concentrations. Clear signs of cytotoxicity (reduction of mitotic index) were elicited by the test substance at higher doses. No statistically or biologically significant increase in the incidence of specific chromosomal aberrations was observed, with and without metabolic activation. The test material is not clastogenic to cultured human lymphocytes, under the conditions of the test.
Justification for selection of genetic toxicity endpoint
No study was selected since the results in both studies in vitro were negative.
Short description of key information:
Ames test: negative (non-mutagenic), S. typhimurium TA1535, TA1537, TA1538,TA98, and TA100, with + without metabolic activation, OECD 471, Callander 1984
Chromosome aberration: negative (non-clastogenic), human lymphocytes, with + without metabolic activation, OECD 473, Fox 1995
Endpoint Conclusion: No adverse effect observed (negative)
Justification for classification or non-classification
Based on the results of the available studies, the substance does not meet the criteria for classification under Directive 2001/59/EC, Annex VI, 4.2.2.3 and under Regulation (EC) No. 1272/2008 Annex I, Part 3, 3.5.2.
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