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Administrative data

Key value for chemical safety assessment

Genetic toxicity in vitro

Description of key information

No data were available for the registered substance, but key read across data from Butanedioic acid, 2(or 3)-sulfo-, 4-[2-[(1- oxo(C12-C18(even numbered) and C18 unsaturated)alkyl))amino]ethyl]esters, disodium salts were available for bacterial and mammalian mutagenicity and chromosomal aberration. In a key Ames test no increase in mutations were observed in different Salmonella typhimurium strains with and without metabolic activation up to cytotoxic concentrations of 5000 µg/plate.In a key mammalian gene mutation test in HPRT cells, the test item did not induce mutations up to cytotoxic concentrations of 1000 µg test item/mL in the absence and presence of metabolic activation, respectively. In a key in vitro Micronucleus study in human peripheral lymphocytes, the test item did not induce chromosomal damage up to a cytotoxic concentration of

125 µg/mL in the absence and in the presence of metabolic activation employing two exposure times.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (negative)

Genetic toxicity in vivo

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Bacterial mutagenicity

No data were available for the registered substance, but read across data were available from a key study with subgroup member Butanedioic acid, 2(or 3)-sulfo-, 4-[2-[(1- oxo(C12-C18(even numbered) and C18unsaturated)alkyl))amino]ethyl]esters, disodium salts which was examined in the 5 Salmonella typhimuriums trains TA 98, TA 100, TA 102, TA 1535 and TA 1537 in two independent experiments, each carried out without and with metabolic activation (a microsomal preparation derived from Aroclor 1254-induced rat liver). The first experiment was carried out as a plate incorporation test and the second as a preincubation test. Six concentrations ranging from 3.16 to 5000 µg act. ingr./plate were employed in the plate incorporation test and in the preincubation test, each carried out without and with metabolic activation.No signs of cytotoxicity were noted in the plate incorporation test and in the preincubation test, each carried out without and with metabolic activation up to the top concentration of 5000 µg act. ingr./plate in all test strains.

No increase in revertant colony numbers as compared with control counts was observed up to a concentration of 5000 µg act. ingr./plate, in any of the 5 test strains in two independent experiments without and with metabolic activation, respectively (plate incorporation and preincubation test). Under the present test conditions the read-across test substance tested up to a concentration of 5000 µg act. ingr./plate, caused no mutagenic effect in the Salmonella typhimuriumstrains TA 98, TA 100, TA 102, TA 1535 and TA 1537 neither in the plate incorporation test nor in the preincubation test each carried out without and with metabolic activation.

Mammalian mutagenicity

No data were available for the registered substance, but read across data were available from a key study with subgroup member Butanedioic acid, 2(or 3)-sulfo-, 4-[2-[(1- oxo(C12-C18(even numbered) and C18unsaturated)alkyl))amino]ethyl]esters, disodium salts tested in a gene mutation assay in cultured mammalian cells (V79, genetic marker HPRT) both in the presence and absence of metabolic activation. The duration of the exposure with the test item was 4 hours or 24 hours in the experiments without S9 mix and 4 hours in the experiments with S9 mix. 125 µg test item/mL were employed as the top concentration for the mutagenicity tests in the absence and 1000 µg/mL in the presence of metabolic activation. Five concentrations 7.81,15.63, 31.3, 62.5 or 125 and 62.5, 125, 250, 500 or 1000 µg test item/mL were selected for the experiments without and with metabolic activation, respectively.  Under the present test conditions, the read-across test item tested up to cytotoxic concentrations in the experiments without and with metabolic activation, was negative in the HPRT-V79 mammalian cell mutagenicity test under conditions where positive controls exerted potent mutagenic effects.

Chromosome aberration

No data were available for the registered substance, but read across data were available from a key study with category member Butanedioic acid, 2(or 3)-sulfo-, 4-[2-[(1- oxo(C12-C18(even numbered) and C18unsaturated)alkyl))amino]ethyl]esters, disodium salts tested in anin vitro micronucleus test using human peripheral lymphocytes both in the presence and absence of metabolic activation by a rat liver post-mitochondrial fraction (S9 mix) from Aroclor 1254 induced animals.The test was carried out employing 2 exposure times without S9 mix: two experiments with an exposure time of 4 hours and two different concentration ranges and one experiment with an exposure time of 20 hours. The experiment with S9 mix was carried out threefold with one exposure time of 4 hours employing two different concentration ranges. The harvesting time was 24 hours after the end of exposure. Each treatment was conducted in duplicate. In the main study cytotoxicity was noted starting at a concentration of 125 µg active ingredient/mL in the experiments without and with metabolic activation. Under the present test conditions, the read-across test item tested up to cytotoxic concentrations, in the absence and in the presence of metabolic activation employing two exposure times (without S9) and one exposure time (with S9) revealed no indications of any chromosomal damage in the in vitro micronucleus test.

Justification for classification or non-classification

As there was no indication for genotoxic potential, classification for genotoxicity is not warranted according to CLP (No. 1272/2008 of 16 December 2008).

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