Fluoroethylene

Endpoint summary

Additional information

The substance was extensively evaluated for effects on genetic material. In vitro tests produced mixed results, but there was a tendency for positive (mutagenic) results in systems with metabolic activation.  

 

The substance was evaluated in vitro. The substance was tested for clastogenic (chromosome-damaging) activity in Chinese hamster ovary (CHO) cells at a maximum of 100% nominal concentration following 2-hour treatment with metabolic (S9) activation and 5-hour treatment without S9 activation. Under the conditions of this assay, the substance was positive.  The substance was also evaluated for mutagenic activity in the CHO-HRPT Gene Mutation Assay with and without S9 activation at nominal concentrations of 0, 20, 40, 60, 80 and 100% with and without S9 activation. The substance was judged positive in the CHO-HPRT gene mutation assay when tested with an activation system.

 

The substance was also evaluated in vivo. The substance was tested for its ability to induce micronuclei in bone marrow polychromatic erythrocytes of male and female mice. The animals were exposed whole-body to atmospheres of up to 388000 ppm for 6 hours, and bone marrow smears were prepared 24, 48, and 72 hours after the beginning of exposure. No significant depression in the ratio of young, polychromatic erythrocytes to mature, normochromatic erythrocytes was detected in either sex. At the 24-hour sampling time, females exposed to the intermediate and high dose levels, 191000 and 388000 ppm, respectively, showed statistically significant increases in the frequency of micronucleated polychromatic erythrocytes as compared to their concurrent air controls; a significant concentration-related trend was also present. The 24-hour treated males also showed increased frequencies of micronucleated polychromatic erythrocytes; however, these were not statistically significant. On the bases of these findings, the substance was judged equivocal in male mice and positive in female mice. The substance was also tested for its ability to induce DNA repair (UDS) in spermatocytes of male rats. Groups of 15 animals were exposed nose-only to an atmosphere of 20000 ppm in air for 6 hours per day for one, two, or five consecutive days. The substance did not inhibit the DNA repair response. The substance was also tested in a dominant lethal assay where groups of 40 sexually mature male rats were exposed 6 hours a day for 5 days to 0, 200, 2000, or 20000 ppm of the substance. Substance exposure had no adverse effects with respect to mortality rate, body weight gain, clinical signs of toxicity, or mating or fertility indices of the adult rats. Pregnancy rates and pre- and post-implantation losses were similar in control and treated dams. The substance exposure did not increase the frequency of dominant-lethal mutations, indicating that the test substance was not mutagenic to germ cells in the male rat. The NOEL was 20000 ppm.

The substance produced mixed genetic effects results when evaluated in vitro or in vivo. However, the substance was negative with respect to effects on germ cells.

Endpoint Conclusion:

Justification for classification or non-classification

The test substance produced mixed genetic effects results when evaluated in vitro or in vivo. However, the test substance was negative with respect to effects on germ cells. The substance meets Category 3 classification criteria mutagenicity according to EU Directive 67/548/EEC and Category 2 classification criteria for mutagenicity according to the EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008.