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Additional information

The mutagenic potential of the test article (Viscous yellow liquid, Lot 565093, Purity: 91.4% ) was evaluated in the Bacterial Reverse Mutation Assay with S. typhimurium strains TA98, TA100, TA1535 and TA1537 and E. coli strain WP2 uvrA in both the presence and absence of a metabolic activation system (S9-mix: Aroclor-induced rat liver). This study was performed in accordance with USFDA GLP and OECD GLP (1997). The study design was based on OECD 471 (1998). The test article was prepared in DMSO for addition to the test system. Doses were selected based on an initial toxicity-mutation assay. In the confirmatory assay, the test article was tested at 50, 150, 500, 1500 and 5000 ug per plate in the presence and absence of metabolic activation. Precipitate was observed beginning at 1500 ug/plate and no toxicity was observed. No increase in revertant colonies was observed in either the presence or absence of S9-mix for any strain. 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 either the presence or absence of metabolic activation.

 

The mutagenic activity of the test article (liquid, batch unknown) was evaluated in the Bacterial Reverse Mutation Assay with S. typhimurium (strains: TA1535, TA1537, TA1538, TA98, and TA100) in the presence or absence of a metabolic activation system (S9-mix: liver microsomal fraction) following procedures described by Ames (1973). The test article was diluted in DMSO for both the pretest and main mutation test. A concentration of 10000 ug/plate MTDID 15655 was toxic in a pretest dose rangefinder. The test article was administered to the cells at 150, 500, 1500, or 5000 ug/plate in the presence or absence of S9-mix. Strain specific positive controls were tested in parallel. Each concentration was evaluated in triplicate. Positive controls performed as expected indicating that all criteria for a valid study were met. No substantial increases in revertant colonies were observed in test article-treated cultures in the presence or absence of S9-mix. 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:
Two in vitro bacterial reverse mutation assays (Ames Assays) have been conducted on Z-Acetate. The results of the studies are:

Bacterial Reverse Mutation Assay: Negative when tested according to OECD 471 (1998).

Bacterial Reverse Mutation Assay: Negative.

Endpoint Conclusion:

Justification for classification or non-classification

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