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Additional information

The mutagenic potential of the test article was evaluated in the Bacterial Reverse Mutation Assay with S. typhimurium strains TA98, TA100, TA102, TA1535, and TA1537 in the presence and absence of a metabolic activation system (Aroclor induced-S9 mix). The study was performed in compliance with OECD GLP (1999). The test method was based on OECD No. 471 (1997), U.S. EPA: OPPTS 870.5100 (1998), and EC Directive 2000/32/EC B.13/B.14. All strains were exposed to dose levels of 50, 160, 500, 1600, or 5000 ug per plate by incorporation of the test article into the agar. Strain specific experiments were performed in the presence and absence of metabolic activation. Plates were incubated for 48 hours at 37 C in the dark. After incubation, revertant colonies were counted. No mutagenic responses were observed in any strain in the presence or absence of metabolic activation. Based on the results of the test, the test article is not mutagenic with or without metabolic activation in the Ames assay.

 

The potential clastogenicity of the test article was evaluated in the micronucleus test. The study was conducted according to OECD GLP (1997), US FDA GLP, and US EPA GLP regulations. The test method was based on EEC Directive 2000/32/EC, Part B.12 (June 8, 2000) and OECD Guideline 474 (July 21, 1997). The test material was administered as received. Five male rats per group were administered Milli-Q water (negative control), 50 mg/kg cyclophosphamide (CP, positive control) or the test article at 2000 (two group) mg/kg via oral intubation. Bone marrow was harvested at 24 hours (one test article group and negative control) and 48 hours (one test article group and positive control) after dosing. All animals were normal immediately after dose administration. The incidence of micronucleated polychromatic erythrocytes in the bone marrow of negative control animals was within the historical range and CP (positive control) induced a significant increase in the number of micronucleated polychromatic erythrocytes indicating that the assay was valid. No increase in the mean frequency of micronucleated polychromatic erythrocytes was observed in the bone marrow of animals treated with the test article. Animals treated with the test article showed no decrease in the ratio of polychromatic to normochromatic erythrocytes compared with the negative controls which indicated there was no toxic effect on the erythropoiesis. Based on the results of this test, the test article is not clastogenic.


Short description of key information:
In vitro and in vivo genetic toxicity studies have been conducted on MV 31. The results of the studies are:

Bacterial Reverse Mutation Assay: Negative when tested according to OECD 471.

Rat Micronucleus Test: Negative when tested according to OECD 474.

Endpoint Conclusion:

Justification for classification or non-classification

Criteria for classifying the test article as mutagenic are not met.