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Administrative data

Key value for chemical safety assessment

Genetic toxicity in vitro

Description of key information

Based on the prediction done using the OECD QSAR toolbox version 3.3 with log kow as the primary descriptor and considering the five closest read across substances, gene mutation was predicted for sodium 2-[(1-oxododecyl)amino]ethanesulphonate. The study assumed the use of Salmonella typhimurium strains TA 1535, TA 1537, TA 98, TA 100 and TA 102 with S9 metabolic activation system. sodium 2-[(1-oxododecyl)amino] ethanesulphonate was predicted to not induce gene mutation in Salmonella typhimurium strains TA 1535, TA 1537, TA 98, TA 100 and TA 102 in the presence of S9 metabolic activation system and hence, according to the prediction made, it is not likely to classify as a gene mutant in vitro.

Based on the predicted result it can be concluded that the substance is considered to be not toxic as per the criteria mentioned in CLP regulation.

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

Genetic toxicity in vivo

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Gene mutation in vitro:

Prediction model based estimation and data from read across chemicals were reviewed to determine the mutagenic nature of

sodium 2-[(1-oxododecyl)amino]ethanesulphonate. The studies are as mentioned below:

Based on the prediction done using the OECD QSAR toolbox version 3.3 with log kow as the primary descriptor and considering the five closest read across substances, gene mutation was predicted for sodium 2-[(1-oxododecyl)amino]ethanesulphonate. The study assumed the use of Salmonella typhimurium strains TA 1535, TA 1537, TA 98, TA 100 and TA 102 with and without S9 metabolic activation system. sodium 2-[(1-oxododecyl)amino] ethanesulphonate was predicted to not induce gene mutation in Salmonella typhimurium strains TA 1535, TA 1537, TA 98, TA 100 and TA 102 in the presence and absence of S9 metabolic activation system and hence, according to the prediction made, it is not likely to classify as a gene mutant in vitro.

Gene mutation toxicity was predicted for sodium 2-[(1-oxododecyl)amino]ethanesulphonate using the battery approach from Danish QSAR database (2017). The study assumed the use of Salmonella typhimurium bacteria in the Ames test. The end point for gene mutation has been modeled in the Danish QSAR using the three software systems Leadscope, CASE Ultra and SciQSAR. Based on predictions from these three systems, a fourth and overall battery prediction is made. The battery prediction is made using the so called Battery algorithm. With the battery approach it is in many cases possible to reduce “noise” from the individual model estimates and thereby improve accuracy and/or broaden the applicability domain. Gene mutation toxicity study as predicted by Danish QSAR for sodium 2-[(1-oxododecyl)amino]ethanesulphonate is negative and hence the chemical is predicted to not classify as a gene mutant in vitro.

The ability of sodium 2-[(1-oxododecyl)amino]ethanesulphonate to induce chromosomal aberration was predicted using Chinese hamster lung (CHL) cells using Danish QSAR database (2017). The end point for chromosome aberrations has been modeled in the Danish QSAR using the three software systems Leadscope, CASE Ultra and SciQSAR. Based on predictions from these three systems, a fourth and overall battery prediction is made. The battery prediction is made using the so called Battery algorithm. With the battery approach it is in many cases possible to reduce “noise” from the individual model estimates and thereby improve accuracy and/or broaden the applicability domain. Sodium 2-[(1-oxododecyl)amino]ethanesulphonate does notinduce chromosome aberrations in Chinese hamster lung (CHL) cells and hence is predicted to not classify as a gene mutant in vitro.

In a study for 70 -80% structurally similar read across chemical by Zeiger et al (Environmental Mutagenesis, 1987), Salmonella/microsome test in the absence of exogenous metabolic activation and in the presence of liver S-9 from Aroclor-induced male Sprague-Dawley rats and Syrian hamsters was performed to evaluate the mutagenic nature of Lauryl ethanolamide (RA CAS no 142 -78 -9) using S. typhimurium tester strains TA1535, TA97, TA98 and TA100. The study was performed as per the preincubation assay and the preincubation time was 20 mins and the plates were incubated for 48 hrs. The test compound was dissolved in DMSO and was used at a dosage level of 0, 3.3, 10, 33.0, 100, 333, 1000 or 3333 µg/plate in the preincubation assay of 48 hrs. Concurrent solvent and positive control chemicals were included in the study. Lauryl ethanolamide did not induce a reproducible, dose-related increase in his+revertants over the corresponding solvent in the S. typhimurium tester strains TA1535, TA1537, TA98 and TA100 in the presence and absence of S9 metabolic activation system and hence is negative for mutation in vitro.

Mortelmans et al (Environmental Mutagenesis, 1986) performed another gene mutation toxicity study was performed for 70 -80% structrally similar read across chemical Sodium dodecyl sulfate (RA CAS no 151 -21 -3) to evaluate its mutagenic nature. The study was performed as per the preincubation protocol using Salmonella typhimurium strain TA100, TA1535, TA1537, TA98 both in the presence and absence of S9 metabolic activation system at doses of 0, 3, 10, 33, 100, 333 or 1000µg/plate. Water was used as the vehicle. The plates were incubated for 48 hrs after 20 mins preincubation before the evaluation of the revertant colonies could be made. Sodium dodecyl sulfate did notinduce mutation in theSalmonella typhimurium strain TA100, TA1535, TA1537, TA98 both in the presence and absence of S9 metabolic activation system and hence the chemical is not likely to classify as a gene mutant in vitro.

Based on the data available for the target chemical and its read across, sodium 2-[(1-oxododecyl)amino]ethanesulphonate does not exhibit gene mutation vitro. Hence the test chemical is not likely to classify as a gene mutant in vitro.

Justification for classification or non-classification

Based on the data available for the target chemical and its read across, sodium 2-[(1-oxododecyl)amino]ethanesulphonate (CAS no 70609 -66 -4) does not exhibit gene mutation vitro. Hence the test chemical is not likely to classify as a gene mutant in vitro.