Registration Dossier
Registration Dossier
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EC number: 307-037-4 | CAS number: 97488-98-7
Endpoint summary
Administrative data
Key value for chemical safety assessment
Additional 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 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
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 :
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.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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