Registration Dossier

Toxicological information

Endpoint summary

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Administrative data

Key value for chemical safety assessment

Genetic toxicity in vitro

Description of key information

Zinc dioctanoate is not expected to be genotoxic, since the two constituents zinc and octanoic acid have not shown gene mutation potential in a range of in vitro test systems addressing the endpoints gene mutation, chromosome mutation and genome mutation.

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

Genetic toxicity in vivo

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

Additional information

No genetic toxicity study with zinc dioctanoate is available, thus the genetic toxicity will be addressed with existing data on the dissociation products zinc and octanoic acid.

Zinc dioctanoate is not expected to be genotoxic, since the two constituents zinc and octanoic acid have not shown gene mutation potential in a range of in vitro test systems addressing the endpoints gene mutation, chromosome mutation and genome mutation. Thus, zinc dioctanoate is not to be classified according to regulation (EC) 1272/2008 as genetic toxicant. Further testing is not required. 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

Due to a complete absence of positive genetic toxicity findings in suitable in vitro and in vivo test systems with the dissociation products of zinc dioctanoate (i.e. zinc and octanoic acid) it is concluded that zinc dioctanoate does not possess genotoxic or mutagenic potential. Thus classification according to regulation (EC) 1272/2008 is not required.