3-chloropropene

Endpoint summary

Additional information

- Genetic toxicity in vitro: The classification of 3 -chloropropene as positive for genetic toxicity in vitro is based on a weight of evidence consideration on the results of 29 different genetic toxicity tests. Different studies have been conducted including the bacterial reverse mutation assay (Ames Test), Aspergillus nidulans forward mutation assay, in-vitro cytogenetic assays in mammalian cell lines, UDS assays in mammalian and human cell lines and DNA binding studies. Positive and negative results depending on test system and conducting laboratory were found. The results are therefore ambiguous, following a conservative approach the substance can be regarded as positive for in vitro genotoxicity.

The DNA binding study was reported to be positive. For the other studies both positive and negative results have been found for 3-chloropropene with and without activation where results are usually more critical without activation. In general high concentrations are needed to elicit genotoxic effects.

- Genetic toxicity in vivo: All three available studies on in vivo genetic toxicity of 3 -chloropropene report negative results ( McGregor (1981) / (fruitfly, Sex-Linked Recessive Lethal Test); McGregor (1981) / (rat, chromosome aberration test); McGregor (1981) / (rat, dominant lethal test). But as the exposure concentrations in all experiments have been rather low (fruitfly: 5 d, 7h, 150 ppm; chromosome aberration assay and dominant lethal test: 5 d, 7 h, 1 and 25 ppm) a clear statement on the genetic toxicity in vivo of 3 -chlororpropene is not possible. No information on genetic toxicity in humans is available to date.

Short description of key information:
Short description of key information:
- Genetic toxicity in vitro: positive, (bacterial reverse mutation assay/Ames test): S. typhimuriurn TA 100, study Eder 1980 (OECD TG 471)
- Genetic toxicity in vivo: inconclusive, (Sex-linked Recessive Lethal Test in Drosophila melanogaster, OECD TG 477)

Endpoint Conclusion: Adverse effect observed (positive)

Justification for classification or non-classification

- Genetic toxicity in vitro: Negative and positive results were found in a variety of in vitro genotoxicity assays with 3 -chloropropene. Following a conservative approach 3 -chloropropene is regarded as positive concerning in vitro genotoxicity. DNA binding of 3 -chloropropene at high concentrations has been shown

- Genetic toxicity in vivo: Only negative results were found in in vivo tests on genetic toxicity of 3 -chloropropene. But as the exposure concentrations were rather low this data is not robust enough to allow a final decision on the in vivo genetic toxicity of 3 -chloropropene.

Taken together the information is not sufficient to make an unambiguous judgement on the genotoxic potential of 3 -chloropropene, but following a conservative approach 3 -chloropropene is classified as Category 2 (H341: Suspected of causing genetic defects) concerning mutagenicity in accordance with the recent classification by IARC (IARC Monographs on the Evaluation of Carcinogenic Risks to Humans, Volume 71, Re-evaluation of Some Organic Chemicals, Hydrazine and Hydrogen Peroxide, IARC Lyon, France, p. 1231; http://monographs.iarc.fr/ENG/Monographs/PDFs/index.php).

According to the annex 1 of Directives 67/548/EEC, Index No. 602-029-00-X, 3 -chloropropene is classified as "Mutagenicity Cat. 3; R68 Possible risk of irreversible effects." which is also in accordance with the above stated classification (please note the differences between CLP and Directive 67/548/EEC in naming of the mutagenicity categories, category 2 of CLP is equivalent to category 3 of Directive 67/548/EEC).