Evaluation of a Test Article in the Salmonella typhimurium/Ecscherichia coli Plate Incorporation Mutation Assay in the Presence and Absence of Induced Rat Liver S-9. Test Article: Ethylenediamine Dinitrate (EDDN)

Ethylenediamine dinitrate (EDDN) (99.5% pure) was tested for mutagenic potential with Salmonella typhimurium strains, TA 98, TA 100, TA 1535, TA 1537 and Escherichia coli strain WP2 uvrA by plate incorporation method according to OECD TG 471 in compliance with Good Laboratory Practice, EDDN was tested at doses 100, 500, 1000, 3000 ug/plate and 5000 ug/plate. The results showed that EDDN was not mutagenic in Salmonella typhimurium and Escherichia coli both with and without activation in tster strains (TA 98, TA 1535, and TA 1537) but it showed positive increase in TA 100 tester stain without activation (3.1-fold) at 5000 ug/plate. This was also verified with confirmatory mutation assay at concentrations up to 5000 ug/plate with activation and also found positive (2.5 fold) in TA 100. No positive increases were observed with other tester strains (TA 98, TA 1535, TA 1537) with or without activation. Based on the positive response was only in one strain TA 100 observed at the highest dose under conditions oftest and according to criteria set for evaluating test results, the EDDN was weak positive in this system both with and without activation.