Registration Dossier

Administrative data

Key value for chemical safety assessment

Genetic toxicity in vivo

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

Additional information

Additional information from genetic toxicity in vivo:

A mutagenicity test was performed with Bourgeonal according to a method of Ames et al. (1975).

It was concluded that the present results did not reveal any mutagenic activity of the test sample in the Salmonella/microsome mutagenicity test

Reading across to Flohydral, the read across substance was evaluated for its ability to induce chromosome breakage or spindle disturbances in vivo using the micronucleus assay in mouse bone marrow.

Doses of 1000 mg/kg and 2000 mg/kg bodyweight were evaluated. The test compound was administered by oral gavage. Some animals did not survive the administration of the top dose. However no antiproliferative effect on bone marrow cells in terms of a reduction of the PCE/NCE ratio was observed.

Bone marrow smears from three different sampling times (24, 48, 72 hours) were evaluated after administration of the higher dose and one sampling time (24 hours) was evaluated for the low dose.

Florhydral did not raise the frequency of MN-PCE and therefore no chromosome-breaking of spindle-disturbances producing activity was demonstrated at any of the sampling times.

The sensitivity of the test system was demonstrated by using procarbazine hydrochloride as a positive control substance. It increased the number of micronucleated polychromatic erythrocytes significantly.

It can be concluded that under the experimental conditions described in the report Florhydral did not show genotoxic activity in mouse bone marrow cells.

Justification for selection of genetic toxicity endpoint
no in-vivo effects observed in read across material

Justification for classification or non-classification

No effects observed in substance or read across material