Registration Dossier

Administrative data

Key value for chemical safety assessment

Additional information

Under the above-described experimental design, the test substance Dust, steelmaking was non-mutagenic for all the Salmonella typhimurium as well as Escherichia coli strains both in experiments without as well as with metabolic activation.

During the described in vitro chromosomal aberration test and under reported experimental conditions, the test item Dust, steelmaking, did not induce structural chromosomal aberrations in the V79 Chinese hamster cell line. The test item Dust, steelmaking, is considered to be non-clastogenic in this chromosome aberration test.

Due to results of the In vitro Mammalian Cell Gene Mutation Assay the test item Dust, steelmaking is considered to be equivocal in the mouse lymphoma thymidine kinase locus using the cell line L5178Y.

Both bacterial reverse mutation test and chromosome aberration assay gave to negative results. Result of the In vitro Mammalian Cell Gene Mutation Assay was inconclusive. The test item may be rated as non-mutagenic.


Short description of key information:
Test substance Dust, steelmaking was assayed for the mutagenicity by the Bacterial Reverse Mutation Test. The test was performed according to EU method B.13/14 Mutagenicity - Reverse mutation test using bacteria, which is analogous to the OECD Test Guideline No. 471.
To investigate the potential of Dust, steelmaking to induce structural chromosome aberrations in Chinese hamster V79 cells, an in vitro chromosome aberration assay was carried out. The test was performed according to OECD Guideline 473 (In vitro Mammalian Chromosome Aberration Test).
The test item Dust, steelmaking was assessed for its potential to induce mutations at the mouse lymphoma thymidine kinase locus using the cell line L5178Y. The test was performed according to OECD Guideline for Testing of Chemicals, No. 476, "In vitro Mammalian Cell Gene Mutation Tests".
All the above mentioned tests were practised in accordance with GLP.

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

Both bacterial reverse mutation test and chromosome aberration assay gave to negative results. Result of the In vitro Mammalian Cell Gene Mutation Assay was inconclusive. The test item may be rated as non-mutagenic.