Glycine max. (L.) Merr. (Fabacee) aqueous alcoholic ext., concentrate by sequential extractions and filtration

Genetic toxicity: in vitro

Administrative data

Endpoint:

in vitro gene mutation study in bacteria

Remarks:

Type of genotoxicity: gene mutation

Type of information:

experimental study

Adequacy of study:

key study

Study period:

May 15 - June 07, 2013

Reliability:

1 (reliable without restriction)

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2013

Report date:

2013

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)

Test guideline 3

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.5100 - Bacterial Reverse Mutation Test (August 1998)

GLP compliance:

yes (incl. QA statement)

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

Glycine max. (L.) Merr. (Fabacee) aqueous alcoholic ext., concentrate by sequential extractions and filtration

EC Number:

938-980-5

IUPAC Name:

Glycine max. (L.) Merr. (Fabacee) aqueous alcoholic ext., concentrate by sequential extractions and filtration

Test material form:

solid: particulate/powder

Remarks:

migrated information: powder

Details on test material:

Name: Soybean (Glycine max) dry purified extract
Batch No.: 30432/M1
Physical State: powder
Colour: yellow to light brown
Purity: 100%
Storage Conditions: at room temperature

Method

Target gene:

histidine

Species / strain

Species / strain / cell type:

S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and TA 102

Additional strain / cell type characteristics:

not specified

Metabolic activation:

with and without

Metabolic activation system:

S9 mix

Test concentrations with justification for top dose:

The test item concentrations to be applied in the main experiments were chosen according to the results of the pre-experiment.
5000 μg/plate was selected as the maximum concentration. The concentration range covered two logarithmic decades. Two independent experiments were performed with the following concentrations:
31.6, 100, 316, 1000, 2500 and 5000 μg/plate
As the results of the pre-experiment were in accordance with the criteria described above, these were reported as a part of the main experiment I.

Vehicle / solvent:

DMSO

Controls

Untreated negative controls:

yes

Remarks:

distilled water

Negative solvent / vehicle controls:

no

Remarks:

distilled water

Positive controls:

yes

Positive control substance:

4-nitroquinoline-N-oxide

sodium azide

methylmethanesulfonate

other: 2-aminoanthracene

Results and discussion

Test results

Species / strain:

S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and TA 102

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

not specified

Remarks on result:

other: all strains/cell types tested

Remarks:

Migrated from field 'Test system'.

Any other information on results incl. tables

The test item Soybean (Glycine max) dry purified extract was investigated for its potential to induce gene mutations according to the plate incorporation test (experiment I) and the pre-incubation test (experiment II) using Salmonella typhimurium strains TA 98, TA 100, TA 1535, TA 1537 and TA 102.

In two independent experiments several concentrations of the test item were used. Each assay was conducted with and without metabolic activation. The concentrations, including the controls, were tested in triplicate. The following concentrations of the test

item were prepared and used in the experiments:

Experiment I and II:

31.6, 100, 316, 1000, 2500 and 5000 μg/plate

No precipitation of the test item was observed in any tester strain used in experiment I and II (with and without metabolic activation).

Toxic effects of the test item were noted in three tester strains evaluated in experiment II.

In tester strain TA 100 toxic effects of the test item were observed at concentrations of 1000 μg/plate and higher (without metabolic activation). In tester strains TA 1535 and TA 1537 toxic effects of the test item were noted at concentrations of 2500 μg/plate and

higher (without metabolic activation).

No biologically relevant increases in revertant colony numbers of any of the five tester strains were observed following treatment with Soybean (Glycine max) dry purified extract at any concentration level, neither in the presence nor absence of metabolic activation in experiment I and II.

The reference mutagens induced a distinct increase of revertant colonies indicating the validity of the experiments.

Applicant's summary and conclusion

Conclusions:

Interpretation of results (migrated information):
negative with and without metabolic activation

Soybean (Glycine max) dry purified extract did not cause gene mutations by base pair changes or frameshifts in the genome of the tester
strains used.
Therefore, Soybean (Glycine max) dry purified extract is considered to be non-mutagenic in this bacterial reverse mutation assay.