Orthoboric acid, compound with 2,2',2''-nitrilotriethanol

Endpoint summary

Key value for chemical safety assessment

Genetic toxicity in vitro

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (negative)

Genetic toxicity in vivo

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

In vitro gene mutation in Bacteria

The potential of the test material to cause mutagenic effects in bacteria was asessed in accordance with the standardised guideline OECD 471 under GLP conditions. The study was assigned a reliability score of 1 according to the criteria of Klimisch (1997)

Salmonella typhimurium strains TA98, TA100, TA1535 and TA1537) and Escherichia coli strain WP2uvrA were tested with the test material, using the plate incorporation and pre-incubation methods at various dose levels, both with and without metabolic activation.

In the dose-range finding test, the test item was tested up to concentrations of 5000 µg/plate in the absence and prescence of S-9 mix in strains TA100 andWP2UVRA. TEA did not percipitate on the plates at this dose level. The bacterial background lawn was not reduced at any of the concentrations tested and no biologicallu relevant decrease in the number of revertants was observed.

Based on the results of the dose range finding test, the test item was tested in the first mutation assay at a concentration rangeof 52 to 5000 µg/plate in the absence and presenceof 5% (v/v) S9 -mix in the tester strains TA 1535, TA 1537 and TA98. TEA Borate did not percipitate on the plates at this dose level. The bacterial background lawn was not reduced at any of the concentrations tested and no biologically relevant decrease in the number of revertants as observed.

In a follow up experiment of the assay with additional parameters, the test item was tested at a concentration range of 492 to 5000 µg/plate in the absence and presence of 10% (v/v) S9 -mix in the tester strains TA1535, TA 1537, TA98, TA100 and WP2urvA. The test item did not precipitate on the plates at this dose level. The bacterial background lawn was not reduced at any of the concentrations tested and no biologically relevant decrease in the number of revertants was observed.

TEA borate did not induce a significant dose-related increase in teh number of revertant (His+) colonies in each of the four tester strains and in the number of revertant (trp+) colonies in the tester strian WP2urvA both in the absence and presence of S9 -metabolic activation.

In conclusion, based on the results f this study it is concluded that TEA borate is not mutagenic in the salmonella typhimurium reverse mutation assay and in the Escherichia coli reverse mutation assay

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