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Toxicological information

Endpoint summary

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Administrative data

Key value for chemical safety assessment

Genetic toxicity in vitro

Description of key information

No genetic toxicity study with fatty acids, C9 -13 neo, potassium salts is available, thus the genetic toxicity will be addressed with existing data on the individual constituents potassium and neodecanoate.

Fatty acids, C9 -13 neo, potassium salts is not expected to be genotoxic, since the two moieties potassium and neodecanoate have not shown gene mutation potential in bacteria.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (negative)

Genetic toxicity in vivo

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Potassium

Taking into consideration the biochemical role of potassium in the human body such as the membrane potential of nerve fibres and muscle cells, which is pivotal for its functioning and human health, and the recommended daily dietary requirements, an in vivo genotoxic effect is considered highly unlikely. Based on the existing information on the genotoxicity of potassium substances and the weight of evidence information, potassium is considered as not genotoxic.

 

Neodecanoate

Neodecanoic acid is not mutagenic in vitro in bacterial mutation assays (with and without metabolic activation). This data suggests that neodecanoic acid is not genotoxic in vitro and likely not genotoxic in vivo.

No classification for genetic toxicity is indicated according to the classification, labelling and packaging (CLP) regulation (EC) No 1272/2008.

 

 

Fatty acids, C9 -13 neo, potassium salts

Fatty acids, C9 -13 neo, potassium salts is not expected to be genotoxic, since the two moieties potassium and neodecanoic acid have not shown gene mutation potential in bacteria. Further testing is not required. Thus, fatty acids, C9 -13 neo, potassium salts is not to be classified according to regulation (EC) 1272/2008 as genetic toxicant. For further information on the toxicity of the individual constituents, please refer to the relevant sections in the IUCLID and CSR

Justification for classification or non-classification

Fatty acids, C9 -13 neo, potassium salts is not expected to be genotoxic, since the two moieties potassium and neodecanoate have not shown gene mutation potential in bacteria. Data on in vitro results in mammalian cells is lacking, thus no conclusion can be made.