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Key value for chemical safety assessment

Additional information

On the one hand, Flue Dust gave a clastogenic test result under the conditions of the in vitro micronucleus test with cultered human bronchial epithelial BEAS-2B cells. This clastogenic effect was only statistically significant for a flue dust concentration, more than two times higher as for the reference sample.

On the other hand, a complex in vitro study with cultered human lung epithelial cells A549 on eleven cement related samples came to the conclusion, that cement (dusts) can not be regarded as genotoxic. In this study both, an in vitro micronucleus test and a comet assay has been performed. Because Flue Dust accrued at the Portland cement clinker production, Flue Dust consists mainly on the same constituents as Portland cement clinker or common cements (cements are made from Portland cement clinker and further constituents, like calcium sulfate, limestone, slag or fly ash). Therefore, read-across to these study results is justified.

According to Regulation (EC) 1907/2006, Annex III, section 8.4, column 2, an appropriate in vivo mutagenicity study shall be considered in case of a positive result in any of the genotoxicity studies in Annex VII or VIII. Therefore, the registrant proposed to perform such a study.


Short description of key information:
A clastogenic potential was found in an in vitro micronucleus study, at the highest concentration. Together with available information from read-across, no clear conclusion is possible.

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

No classification for genotoxicity. The available information are not conclusively.