Registration Dossier
Registration Dossier
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EC number: 448-060-0 | CAS number: 727678-39-9
Endpoint summary
Administrative data
Key value for chemical safety assessment
Additional information
The potential of genetic toxicity of UY-330 was assessed in three in vitro tests.
The in vitro genetic toxicity of UY-330 was investigated in a bacterial reverse mutation assay (Ames test) according to OECD 471 and GLP (Buskens, 2003). The plate incorporation method was conducted with S. typhimurium strains TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2 uvr A at concentrations up to 333 µg/plate with and without metabolic activation. The test substance did not induce reversions in any of the strains tested with or without metabolic activation. The test substance precipitated at the highest concentration. No cytotoxicity was observed in any strain and at any concentration tested. The used positive controls were valid.
In an in vitro cytogenetic assay according to OECD 473 and GLP, the clastogenic properties of UY-330 were investigated in cultured peripheral human lymphocytes (Buskens, 2004). The chromosome aberration test was conducted in the presence and absence of S9 mix with test substance concentrations of 33, 100 and 333 µg/mL culture medium.
No increase in chromosomal aberrations was observed in the first experiment after 3 h incubation with the test substance with and without metabolic activation. The test substance caused no cytotoxic effects and the positive controls were valid.
Because of the negative results of the short-term treatment, a second experiment without metabolic activation was performed with continuous treatment (24 and 48 h). Again, there was no increase in chromosomal aberration at any time point.
Gene mutation of UY-330 in mammalian cells was investigated using a HPRT test according to OECD 476 and GLP (Lazová, 2013). Chinese hamster lung fibroblasts (V79) were incubated for 3 hours with test substance concentrations of 31.25, 62.5, 125, 250, 500 and 1000 µg/mL culture medium in the absence and presence of S9 mix. No increase in mutations at the hprt locus of V79 cells was observed in any concentration tested in two independent experiments. The test substance caused no cytotoxicity and no precipitation of the test substance in culture medium was observed up to the highest concentration tested. The controls were valid and the values of the solvent control were within the range of the historical control.
Justification for selection of genetic toxicity endpoint
No study was selected, since all three in vitro tests were negative.
Short description of key information:
In vitro
Bacterial reverse mutation assay, Ames test (OECD 471): negative
Mammalian cytogenetic assay, chromosome aberrations (OECD 473): negative
Mammalian cell gene mutation assay, HPRT test (OECD 476): negative
Endpoint Conclusion: No adverse effect observed (negative)
Justification for classification or non-classification
The available data on genetic toxicity of the test substance does not meet the criteria for classification according to Regulation (EC) 1272/2008 or Directive 67/548/EEC, and is therefore conclusive but not sufficient for classification.
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