Registration Dossier

Administrative data

Key value for chemical safety assessment

Additional information

Salmonella typhi. strains TA1535, TA100, TA1537, TA98 and Escherichia coli strain WP2 uvrA.

The assay was performed in two independent experiments both with and without liver microsomal activation.

Concentrations: 33, 100, 333, 1000, 2500, 5000 ug/plate.

No visible reduction of the background growth was observed up to 5000 ug/plate with and without metabolic activation in both experiments.

In exp. I, minor toxic effects were observed with S9 mix in strain TA 1535 and WP uvrA at 5000 ug/plate. No relevant toxic effects were observed in the second experiment.

No substantial increase in revertant colony numbers of any of the five tester strains was observed following treatment with FEBA1 at any dose level, neither in the presence nor absence of metabolic activation. There was also no tendency of higher mutation rated with increasing concentrations in the range below the generally acknowledged border of biological relevance.


Justification for selection of genetic toxicity endpoint
One available study

Short description of key information:
The Ames study was not conducted under GLP in compliance with the OECD guidelines no. 471 "Bacterial Reverse Mutation Test" and Commission Directive 2000/32/EC, L1362000, Annexe 4D, May 19, 2000.

Testing facility: RCC Ltd, Switzerland
Study no. 842960 (73550 RCC-CCR) performed on July 22, 2002.

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

The test item was considered to be non-mutagenic in this Salmonella typhi. and Escherichia coli reverse mutation assay.