Reaction products of tetraisopropyl titanate (4+), hydroxyalkaloic acid and substituted alkanol

Endpoint summary

Key value for chemical safety assessment

Genetic toxicity in vitro

Description of key information

Not genotoxic

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (negative)

Genetic toxicity in vivo

Endpoint conclusion

Endpoint conclusion:

no study available

Justification for classification or non-classification

The test item was examined for the ability to induce gene mutations in tester strains of Salmonella typhimurium and Escherichia coli, as measured by reversion of auxotrophic strains to prototrophy, according to OECD guideline 471. The three tester strains TA98, TA100 and WP2 uvrA were used. Experiments were performed both in the absence and presence of metabolic activation, using liver S9 fraction from rats pre-treated with phenobarbitone and betanaphthoflavone. The modified 6 well bacterial mutation method was used. The test item was used as a solution in sterile water for injection.

In the Main Assay, using the preincubation method, the test item was assayed at a maximum dose level of 1250 µg/plate, corresponding to 5000 µg/plate when the standard method (OECD guideline No. 471) is used, and at seven lower dose levels: 625, 313, 156, 78.1, 39.1, 19.5 and 9.77 µg/plate.

No precipitation of the test item was noted at the end of the incubation period at any concentration, in the absence or presence of S9 metabolism. A slight reduction of revertant colonies was observed with TA100 tester strain at the highest dose level in the absence of S9 metabolism, indicating a possible toxic effect. No

relevant increase in revertant numbers was observed after treatment with the test item at any dose level, in any tester strain, in the absence or presence of S9 metabolism.