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Administrative data

Key value for chemical safety assessment

Additional information

The genotoxic potential of Fyrolflex SOL-DP was investigated by 3 in vitro gene mutation studies (Salmonella- Escherichia coli/Mammalian-Microsome Reverse Mutation Screening Study, a full bacterial Reverse mutation assay and chromosome aberration in human lymphocyte cells) and by 1 in vivo study (Bone marrow micronucleus assay).

The substance was found to be not mutagenic in both screening Study and the full Reverse mutation tests and was not clastogenic in the chromosome aberration test. SOL-DP was found to be not mutagenic also in the in vivo Micronucleus Assay in mouse bone marrow.

Further to the results of these studies it can be concluded that SOL-DP is not mutagenic.


Short description of key information:
3 in vitro and one in vivo Genetic toxicity studies are available:
Salmonella- Escherichia coli/Mammalian-Microsome Reverse Mutation Screening Study
Bacterial Mutation Assay (S. typhimurium and E. coli)
In vitro Mammalian Chromosome Aberration test in human lymphocytes.
In Vivo Mouse Bone Marrow Micronucleus Assay

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

Fyrolflex SOL-DP did not show any genotoxic potential in the available in vitro and in vivo studies.

Therefore, it can be concluded that the substance is not mutagenic and does not need to be classified for mutagenicity according to the EEC criteria for classification and labelling for Dangerous Substances and Preparations (67/548/EEC) and the CLP Regulation (EC No 1272/2008).