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Administrative data

Key value for chemical safety assessment

Additional information

The substance cyclododecanol tel quel represents a reaction mass consisting of cyclododecanol and cyclododecanone. No studies regarding in vitro genetic toxicity especially regarding bacterial reverse mutation assay (Ames test) were made with the reaction mass. However studies with the components cyclododecanol and cyclododecanone were performed. These studies were used in a read across approach.

In vitro genetic toxicity - bacterial reverse mutation assay (Ames test):

Cyclododecanol and cyclododecanone showed no mutagenic effects under the conditions of the bacterial reverse mutation assay (Ames test), both in the presence and in the absence of Aroclor-induced liver microsomes.

Based on the studies of the substances cyclododecanol and cyclododecanone it is concluded that the reaction mass cyclododecanol tel quel consisting of cyclododecanol and cyclododecanone would also show no mutagenic effects in a bacterial reverse mutation assay (Ames test). Further genetic toxicity studies in vivo:

No studies regarding in vivo genetic toxicity are available for the reaction mass. Only an in vivo genetic toxicity study (in vivo mouse micronucleus test) is available for the substance cyclododecanol, which represents one component of the substance cyclododecanol tel quel. Under the test conditions, cyclododecanol did not induce micronucleated polychromatic erythrocytes in male and female mice.


Short description of key information:
The substance cyclododecanol tel quel represents a reaction mass consisting of cyclododecanol and cyclododecanone. No studies regarding in vitro genetic toxicity especially regarding bacterial reverse mutation assay (Ames test) were made with the reaction mass. However studies with the components cyclododecanol and cyclododecanone were performed. These studies were used in a read across approach. Based on the studies of the substances cyclododecanol and cyclododecanone it is concluded that the reaction mass cyclododecanol tel quel consisting of cyclododecanol and cyclododecanone would also show no mutagenic effects in a bacterial reverse mutation assay (Ames test).

Endpoint Conclusion:

Justification for classification or non-classification

According to the criteria of EC Directive 67/548/EEC and EC Regulation 1272/2008 and based on the results of the studies the substance cyclododecanol tel quel is not classified regarding this endpoint.