Reaction mass of sodium sulphate and disodium dodecanedioate and Dodecanoic acid, 12-amino-, sodium salt (1:1)

Endpoint summary

Additional information

1/ OECD Guideline 471 (Bacterial Reverse Mutation Assay)

The study was performed according to the international guidelines (OECD 471 and Commission Directive No. B13/14) and in compliance with the principles of Good Laboratory Practice. The test item was then tested in two independent experiments, with and without a metabolic activation system, the S9 mix, prepared from a liver post-mitochondrial fraction (S9 fraction) of rats induced with Aroclor 1254. The test item Reaction mass of sodium sulfate, sodium amino-12-dodecanoate and sodium dodecanoedioate was dissolved in water for injections.

Under our experimental conditions, the test item Reaction mass of sodium sulfate, sodium amino-12-dodecanoate and sodium dodecanoedioate did not show any mutagenic activity in the bacterial reverse mutation test withSalmonella typhimurium.

2/ OECD Guideline 476 (In vitro Mammalian Cell Gene Mutation Test)

The study was performed according to the international guidelines (OECD 476 and Commission Directive B17) and in compliance with the principles of Good Laboratory Practice. After a preliminary toxicity test, the test item Reaction mass of sodium sulfate, sodium amino-12-dodecanoate and sodium dodecanoedioate was tested in two independent experiments, with and without a metabolic activation system, the S9 mix, prepared from a liver microsomal fraction (S9 fraction) of rats induced with Aroclor 1254. Cytotoxicity was measured by assessment of adjusted relative total growth (Adj. RTG) and relative suspension growth (Adj. RSG) as well as cloning efficiency following the expression time (CE2). The test item was dissolved in culture medium (RPMI). In either experiment, no noteworthy increase in the mutation frequency was noted in comparison to the vehicle control.

Under our experimental conditions, the test item Reaction mass of sodium sulfate, sodium amino-12-dodecanoate and sodium dodecanoedioate (batch No. T710/712) did not show any mutagenic activity in the mouse lymphoma assay.

3/ OECD Guideline 473 (In vitro Mammalian Chromosome Aberration Test).

The study was performed according to the international guidelines (OECD 473, Commission Directive No. B10) and in compliance with the Principles of Good Laboratory Practice Regulations. The test item was tested in two independent experiments, both with and without a liver metabolizing system (S9 mix), and in a third experiment without S9 mix. The S9 was obtained from rats previously treated with Aroclor 1254. The test item Reaction mass of sodium sulfate, sodium amino-12-dodecanoate and sodium dodecanoedioate was dissolved in culture medium (RPMI 1640). The frequency of cells with structural chromosome aberrations of the vehicle and positive controls was as specified in the acceptance criteria. The study was therefore considered as valid. No significant increase in the frequency of cells with structural chromosomal aberrations was noted in both experiments and at both harvest times.

Under our experimental conditions, the test item Reaction mass of sodium sulfate, sodium amino-12-dodecanoate and sodium dodecanoedioate did not induce chromosome aberrations in cultured human lymphocytes.

Short description of key information:
Three in vitro studies were available for this endpoint : OECD Guideline 471 (Bacterial Reverse Mutation Assay), OECD Guideline 476 (In vitro Mammalian Cell Gene Mutation Test) and OECD Guideline 473 (In vitro Mammalian Chromosome Aberration Test).
Results of these stdies are negative, therefore, the test substance is not mutagenic.

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

According to Directive 67/548/EEC andto regulation EC no.1272/2008 (CLP), Reaction mass of sodium sulfate, sodium amino-12-dodecanoate and sodium dodecanoedioate is not classified for genetic toxicity endpoint.

Justification : Negative result in all three tests (Bacterial Reverse Mutation Assay, In vitro Mammalian Cell Gene Mutation Test and In vitro Mammalian Chromosome Aberration Test).