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Key value for chemical safety assessment

Additional information

LAS TEA:

In an Ames test, strains TA98, TA100, TA1535, TA1537 and TA1538 of S. typhimurium were exposed to LAS TEA at concentrations of 0, 8.4, 43, 217, 1090, and 5430 µg/plate in the presence and absence of mammalian metabolic activation according to the direct plate incorporation method and 0, 68, 136, 272, 543, and 1090 µg/plate in the presence and absence of mammalian metabolic activation according to the preincubation method. There was no evidence of induced mutant colonies over background and hence, LAS TEA was not mutagenic under the conditions of this test.

Based on the read-across approach the other genotoxicity endpoints for LAS TEA are adressed only by using the available data for LAS Na and Tritehanolamine (TEA).

TEA:

TEA was tested in the Ames reverse mutation assay using S. typhimurium strains TA 1535, TA 1537, TA 97, TA 98 and TA 100 at a concentration up to 10000 µg/plate with and without metabolic activation. Treatment with TEA was not associated with reverse mutations in any of the strains tested (Mortelmans, 1986).

Triethanolamine was tested in cultured Chinese hamster ovary (CHO) cells for induction of chromosomal abberations, both in the presence and absence of metabolic activation.The results revealeved no induction of chromosomal abberations with or without S9 (Galloway, 1987).

In a mammalian cell gene mutation assay (L5178Y TK+/-), mouse lymphoma L5178Y cells culturedin vitrowere exposed to triethanolamine in distilled water at concentrations of 0, 50, 100, 250, 500, 1000 and 1500 µg/ml in the presence and absence of mammalian metabolic activation. There was no evidence or a concentration related positive response of induced mutant colonies over background (Dow Chemical Company, 2010).

LAS Na:

LAS Na was not mutagenic in the Ames test.

The potential of the test substance LAS Na to cause chromosomal aberrations in mammalian cells was examined. Chinese hamster ovary cells were exposed to concentrations of 0.32 to 78 ug/ml with S9, and 1.25 to 156 ug/ml without S9. Positive responses were seen at cytotoxic concentrations only in the presence of S9. Concentrations below the level of cytotoxicty with S9 did not show positive results. The test substance is not clastogenic in the absence of metabolic activation, or with metabolic activation below cytotoxic concentrations. Chromosomal abberations seen at cytotoxicity levels can be considered as a secondary effect. The result suggests that LAS is not clastogenic (Murrie & Innes, 1997).

In another test Chinese Hamster Ovary (CHO) cells were exposed to concentrations of 0, 0.6, 1, 1.8, 3, and 6 ug/ml without S9, and 0, 6, 10, 18, 30, and 60 ug/ml with S9. Preliminary tests show the test substance was cytogenic at concentrations of 50 ug/ml or greater with metabolic activation, and 100 ug/ml or above without metabolic activation. There was no biologically significant increase in mutation frequency in the treated groups and hence, LAS is considered not mutagenic to CHO cells both in the presence and absence of S9 (ANON, 1995).


Justification for selection of genetic toxicity endpoint
No study was selected since all in vitro studies are negative.

Short description of key information:
Negative in vitro studies, bith with and without metabolic activation.

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

Based on the results of the aforementioned studies LAS TEA shall not be classified as genotoxic substance.