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Key value for chemical safety assessment

Genetic toxicity in vitro

Description of key information

Three in vitro genetic toxicity studies have been conducted on PPVE. The results of the studies are:

 

Bacterial Reverse Mutation Assay: Negative when tested according to OECD 471 (1997).

 

Chromosome Aberration Test: Negative when tested according to OECD 473.

 

Chinese Hamster Ovary V79 assay: Negative when tested according to OECD 476.

 

Additional information

The mutagenic activity of the test article was evaluated in the Bacterial Reverse Mutation Assay with S. typhimurium (strains: TA1535, TA97, TA98, and TA100) and E. coli (strain: WP2uvrA) in the presence or absence of a metabolic activation system (S9-mix: Aroclor 1254-induced rat liver). This study was performed in accordance with EPA GLP 40CFR792 and OECD GLP C(81)30(Final), Annex 2. The study design was based on OECD 471 (1997). The maximum concentration was limited to one half of the lower explosion limit (1%) because of the volatility of the test substance. The test article was exposed to the cells at 0.1, 0.2, 0.3, 0.4, and 0.5% in the presence or absence of S9-mix. Dry compressed air was used for the negative control. Strain specific positive controls were tested in parallel. Two independent trials were performed for each concentration. Positive and negative 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. Based on the results of the study, the test article was negative in the Bacterial Reverse Mutation assay in the presence and absence of metabolic activation (S9 mix).

 

The clastogenic potential of the test article was evaluated in human lymphocytes in the presence or absence of metabolic activation (S9-mix: Aroclor 1254-induced rat liver). This study was performed in compliance with OECD GLP regulations. The study design was based on OECD 473. The maximum concentration was limited to one half of the lower explosion limit (1%) because of the volatility of the test substance. The test article was administered to the cells at 0.1, 0.2, 0.3, 0.4, and 0.5% in the presence or absence of S9-mix. Dry compressed air was used for the negative control. Metabolic activation specific positive controls were tested in parallel. The exposure interval was 3-4 hours and harvest time was approximately 18 hours post-treatment. In the second trial a supplemental harvest time of approximately 43 hours post-treatment was included to detect any delayed increases in chromosome aberrations. Two independent trials were performed for each concentration. No substantial or reproducible dose dependent increase of mutation frequency was observed under any tested parameters. All criteria for a valid study were met. Based on the results of this study, the test article is not clastogenic in human lymphocytes.

 

The mutagenic potential of the test article was evaluated in Chinese hamster ovary V79 cells in the presence or absence of metabolic activation (S9-mix: Aroclor 1254-induced rat liver). The study was performed in compliance with OECD GLP regulations. The study design was based on OECD 476. The maximum concentration was limited to one half of the lower explosion limit (1%) because of the volatility of the test substance. The test article was administered to the cells at 0.1, 0.2, 0.3, 0.4, and 0.5% in the presence or absence of S9-mix. Dry compressed air was used for the negative control. Metabolic activation specific positive controls were tested in parallel. Two independent trials were performed for each concentration. No substantial or reproducible dose dependent increase of mutation frequency was observed under any tested parameters. All criteria for a valid study were met. Based on the results of this study, the test article is not mutagenic at the HPRT locus in Chinese hamster ovary V79 cells in the presence or absence of metabolic activation.

Justification for classification or non-classification

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