Registration Dossier

Administrative data

Description of key information

Although a long-term mammalian test of carcinogenicity has not been conducted for any of the FLL Substances, the three mutagenicity studies can also provide evidence with respect to carcinogenicity. According to the European Classification, Labelling and Packaging (CLP) Regulation: “it is recognised that genetic events are central in the overall process of cancer development. Therefore evidence of mutagenic activity in vivo may indicate that a substance has a potential for carcinogenic effects.” 
Although mutagenicity has not been tested in vivo, the tests do provide consistent results indicating a general lack of a potential for in vivo mutagenicity (and by extrapolation, carcinogenicity) for the FLL Substances. A further line of evidence is that decision-tree modelling according to the Begnini-Boss Rulebase (ToxTree v.1.6) did not identify any alert for carcinogenic activity for a fish oil derivative and a vegetable oil derivative representing the FLL Substances .
Thus, it appears unlikely, based on the available information, that any of the FLL Substances could be carcinogenic and act with a non-threshold mode of action. However, the lack of in vivo data precludes a definitive classification at this time and therefore, an overall conclusion of “not classifiable” is recommended for the FLL Substances

Key value for chemical safety assessment

Justification for classification or non-classification

Although a long-term mammalian test of carcinogenicity has not been conducted for any of the FLL Substances, the three mutagenicity studies can also provide evidence with respect to carcinogenicity. According to the European Classification, Labelling and Packaging (CLP) Regulation: “it is recognised that genetic events are central in the overall process of cancer development. Therefore evidence of mutagenic activity in vivo may indicate that a substance has a potential for carcinogenic effects.”

Although mutagenicity has not been testedin vivo, the tests do provide consistent results indicating a general lack of a potential forin vivomutagenicity (and by extrapolation, carcinogenicity) for the FLL Substances. A further line of evidence is that decision-tree modelling according to the Begnini-Boss Rulebase (ToxTree v.1.6) did not identify any alert for carcinogenic activity for a fish oil derivative and a vegetable oil derivative representing the FLL Substances.

Thus, it appears unlikely, based on the available information, that any of the FLL Substances could be carcinogenic and act with a non-threshold mode of action. However, the lack of in vivo data precludes a definitive classification at this time and therefore, an overall conclusion of “not classifiable” is recommended for the FLL Substances


Additional information