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Key value for chemical safety assessment

Additional information

Short description of key information:
In vitro mutagenicity has been studied for two or more of the FLL Substances tested using a combination of three tests. Briefly, the results of the mutagenicity tests include :
- In vitro gene mutation study in bacteria (FLL Samples 2, 3, 4 and 6) – not mutagenic in bacteria (AMES test with S. typhirium and E. coli)
- In vitro cytogenicity study in mammalian cells (FLL Samples 3 and 4) – not clastogenic in human lymphocytes
- In vitro gene mutation study in mammalian cells (FLL Samples 3 and 4) - not mutagenic to L5178Y cells

These studies provide consistent results indicating a general lack of mutagenicity potential for the FLL Substances. A further line of evidence is that decision-tree modelling according to the Begnini-Boss Rulebase (ToxTree v.1.6; IdeaConsult) did not identify any alert for mutagenicity for a fish oil derivative and a vegetable oil derivative representing the FLL Substances .
Thus, the weight of evidence provided by the in vitro data indicates that the FLL Substances should not be classified as germ cell mutagens.

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

In vitro mutagenicity has been studied for two or more of the FLL Substances tested using a combination of three tests. Briefly, the results of the mutagenicity tests include :

  • In vitro gene mutation study in bacteria (FLL Samples 2, 3, 4 and 6) – not mutagenic in bacteria (AMES test with S. typhirium and E. coli)
  • In vitro cytogenicity study in mammalian cells (FLL Samples 3 and 4) – not clastogenic in human lymphocytes
  • In vitro gene mutation study in mammalian cells (FLL Samples 3 and 4) - not mutagenic to L5178Y cells

These studies provide consistent results indicating a general lack of mutagenicity potential for the FLL Substances. A further line of evidence is that decision-tree modelling according to the Begnini-Boss Rulebase (ToxTree v.1.6; IdeaConsult) did not identify any alert for mutagenicity for a fish oil derivative and a vegetable oil derivative representing the FLL Substances . Thus, the weight of evidence provided by the in vitro data indicates that the FLL Substances should not be classified as germ cell mutagens.