Registration Dossier
Registration Dossier
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EC number: 295-362-1 | CAS number: 92044-83-2
Endpoint summary
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.
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