Registration Dossier

Administrative data

Key value for chemical safety assessment

Additional information

In vitro gene mutation study in bacteria:

Key study: An in-vitro bacterial reverse assay (Ames test) was performed on OS-2200 in accordance with OECD Guideline 471, 472 and EU methods B.13/14 (GLP study) in Salmonella typhimurium, strains TA1535, TA1537, TA98, TA100 and Escherichia coli, strain WP2 uvrA trp. No evidence of mutagenic activity was seen at any concentration of OS-2200 in either mutation test with and without metabolic activation up to 5000 µg/plate.

In vitro cytogenicity study in mammalian cells:

Key study: An in-vitro chromosomal aberrations test in human lymphocytes was performed according to OECD Guideline 473 and EU method B.10 (GLP study). In both the absence and presence of metabolic activation, OS-2200 caused no statistically significant increase in the proportion of metaphase figures containing chromosomal aberrations, at any dose level, when compared with the solvent control, in either test. In conclusion, no evidence of clastogenic activity was observed in this in vitro cytogenetic test system.

In vivo micronucleus assay:

Key study: An in-vivo mammalian erythrocyte micronucleus test was performed in with test item according to EU method B.12 and OECD guideline 472 (GLP study). Mice were treated with a single intraperitoneal administration of the test substance at dose levels of 0 (control) 160, 320 and 640 mg/kg bw in dry corn oil (based on preliminary tests). Bone marrow smears were obtained from 5 animals per sex 24 and 48 hours after dosing. Since the test substance did not cause any significant increase in the incidence of micronucleated immature erythrocytes or any substantial decrease in the proportion of immature erythrocytes, it was concluded that the test item did not show any evidence of causing chromosome damage or bone marrow cell toxicity when administered by intraperitoneal injection in-vivo to mice.

Based on this battery of in vitro and in vivo studies, a weight of evidence analysis indicates that OS-2200 is not genotoxic.


Justification for selection of genetic toxicity endpoint
No study was selected, since all genetic toxicity studies had high quality and gave negative results.

Short description of key information:
In vivo and in vitro genetic toxicity studies indicate that OS 2200 is not genotoxic.

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

Based on the available experimental data, OS2200 was determined to be non-genotoxic, and therefore it is not classified in accordance with CLP Regulation (EC) no. 1727/2008.