Registration Dossier

Administrative data

Key value for chemical safety assessment

Additional information

In vitro gene mutation studies in bacteria conducted on analogue substances Nonanal, Undec-10-enal and 2-methylundecanal were used as part of a weight of evidence. The studies concluded that the test substances were not genotoxic under the conditions of the test either with or without metabolic activation.

An in vitro mouse lymphoma study performed on the analogue substance Nonanal was negative with and without metabolic activation.

There was a negative result for an in vitro chromosome aberration study on the analogue substance Nonanal but a positive result for an in vitro sister chromatid exchange assay on Nonanal.

The result of an in vivo mouse micronucleus study conducted according to OECD guideline 474 on a structural analogue, Undec-10-enal, did not show any evidence of causing chromosome damage when administered orally.


Justification for selection of genetic toxicity endpoint
The results of an in vivo mouse micronucleus study conducted according to OECD guideline 474 on a structural analogue did not show any evidence of causing chromosome damage when administered orally.

Short description of key information:
In vitro gene mutation studies in bacteria conducted on analogue substances Nonanal, Undec-10-enal and 2-methylundecanal were used as part of a weight of evidence. The studies concluded that the test substances were not genotoxic under the conditions of the test either with or without metabolic activation.
An in vitro mouse lymphoma study performed on the analogue substance Nonanal was negative without and with metabolic activation.
There was a negative result for an in vitro chromosome aberration study on the analogue substance Nonanal but a positive result for an in vitro sister chromatid exchange assay on Nonanal.
The result of an in vivo mouse micronucleus study conducted according to OECD guideline 474 on a structural analogue, Undec-10-enal, did not show any evidence of causing chromosome damage when administered orally.

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

The results of an in vivo mouse micronucleus study conducted according to OECD guideline 474 on a structural analogue did not show any evidence of causing chromosome damage when administered orally.