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Administrative data

Key value for chemical safety assessment

Additional information

In a reverse gene mutation assay in bacteria (Venkatasubramani R, 2008), strains TA 98, TA 100, TA 102, TA 1535, TA 1537 of S. typhimurium were exposed toVegeflux soy diluted in DMSO at concentrations of 5, 1.58, 0.5, 0.158, and 0.05 µL per plate in the presence and absence of mammalian metabolic activation. The direct plate incorporation method was used. The test item was tested up to limit concentration.

 

Vegeflux soy did not induce mutagenic response in any of the five tester strains up to the highest concentration. There was no evidence of induced mutant colonies over background. The positive controls induced the appropriate responses in the corresponding strains.

In a mammalian cell cytogenetics assay (chromosome aberration) (Venkatasubramani R, 2008), human lymphocytes were exposed to Vegeflux Soy in DMSO at concentrations of 2.5, 1.25 and 0.625 µl/ml with and without metabolic activation. Vegeflux soy was tested up to the cytotoxic concentration. The test was performed according to OECD guideline 473 and GLP.

 

Positive controls induced the appropriate response. There was no evidence of chromosome aberration induced over background at any concentration in the two main experiments.

In a mammalian cell gene mutation assay at thymidine kinase (TK) locus (Wollny H.E., 2011) according to OECD TG 476 and GLP, mouse lymphoma L5178Y cells cultured in vitro were exposed to VEGEFLUX SOY in ethanol at the following concentrations in the presence and absence of mammalian metabolic activation:

Experiment I:

-      without S9 mix: 10.0; 20.0; 40.0; 60.0; and 80.0 µg/mL

-      with S9 mix: 10.0; 20.0; 40.0; 80.0; 120.0; 160.0 µg/mL

Experiment IA (repeated part of experiment I):

-      without metabolic activation: 20.0; 40.0; 60.0; 80.0; and 100.0 µg/mL

Experiment II:

-      without S9 mix: 20.0; 40.0; 80.0; 120.0, 160.0 µg/mL

-      with S9 mix: 40.0; 80.0; 100.0; 120.0; 140.0 µg/mL 

 

VEGEFLUX SOY was tested up to cytotoxic and phase separation.

No substantial and reproducible dose dependent increase in mutant colony numbers was observed in both main experiments up into the range of phase separation. No relevant shift of the ratio of small versus large colonies was observed up into this range. An increase of the mutation frequency noted at the maximum concentration of the second experiment with and without metabolic activation was judged as artefact caused by the prominent phase separation at this concentration.

Appropriate reference mutagens were used as positive controls and showed a distinct increase in induced mutant colonies, indicating that the tests were sensitive and valid.

In conclusion it can be stated that during the mutagenicity test described and under the experimental conditions reported the test item did not induce mutations in the mouse lymphoma thymidine kinase locus assay using the cell line L5178Y in the absence and presence of metabolic activation.

Therefore, VEGEFLUX SOY is considered to be non-mutagenic in this mouse lymphoma assay.


Short description of key information:
Vegeflux soy was tested in the Ames' test (OECD 471, GLP), in-vitro chromosomal aberration test (OECD 473, GLP) and in-vitro mammalian gene mutation test (OECD 476, GLP).
The results of these tests are negative.

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

Based on the classification criteria of Annex VI Directive 67/548/CEE or UN/EU GHS, and considering the negative results in the three in vitro genetic toxicity tests using Vegeflux Soy, no classification for mutagenicity is required.