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Additional information

The genotoxicity of NExBTL renewable diesel (a UVCB substance of similar composition to the substance: see analogue approach justification document) has been assessed in guideline mutation studies performed in vitro using 5 stains of Salmonella typhimurium (bacterial reverse mutation assay; method B13/14 of directive 2004/73/EC), human lymphocytes (chromosomal aberration test; method B10 of directive 2004/73/EC) and L5178Y TK cells (mammalian cell mutation assay; method B17 of directive 2004/73/EC). Testing was conducted at the maximum concentration required by each guideline with the inclusion of appropriate positive control substances and S9 fraction. The studies were GLP-compliant and the information is reliable and fully adequate for evaluation. No evidence of genotoxicity was apparent in any test, and it is concluded that NExBTL renewable diesel is not mutagenic or clastogenic in vitro. Due to structural similarities, no mutagenic or clastogenic activity is expected with the substance either. No further testing is required.

Short description of key information:

NExBTL renewable diesel (a UVBC substance of similar composition to the substance) was non-genotoxic when tested in modern, GLP-compliant, guideline studies for a potential to cause bacterial and mammalian cell gene mutation or mammalian cell chromosomal aberrations.

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

No evidence of genotoxicity for a related UVCB substance in 3 test systems in vitro; no classification required under Regulation EC 1272/2008.

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