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The mutagenic potential of the test article was evaluated in the Bacterial Reverse Mutation Assay with S. typhimurium strains TA98, TA100, TA1535, and TA1537 and E. coli strain WP2 uvrA in the presence and absence of a metabolic activation system (Aroclor induced - S9 mix). The study was performed in compliance with FDA GLP 21 CFR 58 and OECD GLP C(97)186/Final. The test method was based on OECD No. 471 (1997). The test article was diluted in DMSO and dosed at 15, 50, 150, 500, 1500 and 5000 ug/plate. Strain specific controls and vehicle controls were also prepared. Separate experiments were performed in the presence and absence of metabolic activation. Precipitation was noted at 500 or 1500 mg/plate. No toxicity was observed. 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 was not mutagenic in the Bacterial Reverse Mutation Assay in the presence or absence of metabolic activation.

 

The mutagenic potential of the test article (liquid, batch P2274001) was evaluated in the Bacterial Reverse Mutation Assay with S. typhimurium (strains: TA98, TA100, TA1535 and TA1537) in the presence and absence of a metabolic activation system (S9-mix: phenobarbital and beta-Naphthoflavone-induced rat liver). This study was performed in accordance with the Chemicals Act of Germany (1994) and OECD GLP (1981). The study design was based on OECD 471 (1983) and EEC Directive 92/69 L383A An V, B.14 (1992). The test material was diluted in DMSO prior to administration to the cells. The test article was not toxic at up to 5000 ug/plate. The mutagenic assay was performed in each strain at 33, 100, 333, 1000, 2500 or 5000 ug/plate in the presence or absence of S9-mix. Strain specific positive controls were performed in parallel. All treatments were tested in triplicate. No increase in revertant colonies was observed in the presence or absence of S9-mix. All criteria for a valid study were met as described in the protocol. Under the conditions of this study, the test article was not mutagenic in the Bacterial Reverse Mutation Assay in the presence or absence of S9-mix.


Short description of key information:
In vitro genetic toxicity studies have been conducted on Procrylat. The results of the studies are:

Bacterial Reverse Mutation Assay: Not mutagenic when tested according to OECD 471 (1997).

Bacterial Reverse Mutation Assay: Not mutagenic when tested according to OECD 471 (1983).

Endpoint Conclusion:

Justification for classification or non-classification

Criteria for classifying the test article as genotoxic or mutagenic were not met.