Disodium hydroxy(sulfonato)acetate

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:

February 19, 2009 - June 19, 2009

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: see 'Remark'

Remarks:

GLP-guideline study: The study was conducted in accordance with hte following guidelines: OECD-guidelines for the testing of chemicals Part 471, adopted July 21, 1997 "Bacterial Reverse Mutation Test" and EU-Guideline B.13/14 adopted may 31, 2008 "Mutagenicity-Salmonella typhimurium reverse mutation assay"

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2009

Report date:

2009

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

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

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Type of assay:

bacterial reverse mutation assay

Test material

Reference

Name:

Unnamed

Type:

Constituent

Method

Target gene:

Five genetically manipulated strains of Salmonella typhimurium (TA 97a, TA 98, TA 100, TA 102 and TA 1535) were exposed to the test item.
plate incorboration method (first experiment)
pre-incubation method (second and third experiment)

Species / strain

Species / strain 1

Species / strain / cell type:

other: TA97a

Additional strain / cell type characteristics:

other: hisD6610, uvrB, pKM 101, rfa

Species / strain 2

Species / strain / cell type:

S. typhimurium TA 98

Additional strain / cell type characteristics:

other: hisD3052, uvrB, pKM 101, rfa

Species / strain 3

Species / strain / cell type:

S. typhimurium TA 100

Additional strain / cell type characteristics:

other: hisG46, uvrB, pKM 101, rfa

Species / strain 4

Species / strain / cell type:

S. typhimurium TA 102

Additional strain / cell type characteristics:

other: hisG428, pKM 101, rfa

Species / strain 5

Species / strain / cell type:

S. typhimurium TA 1535

Additional strain / cell type characteristics:

other: hisG46, uvrB, rfa

Metabolic activation:

with and without

Metabolic activation system:

S9

Test concentrations with justification for top dose:

First Experiment:
Five concentrations of the test item, dissolved in deionised water (ranging from 5014 to 50 µg/plate) were used.
concentrations tested: 5014/1504/501/150/50 µg/plate
Second Experiment:
To verify the results of the first experiment, a second experiment was performed, using five concentrations of the test item (ranging from 4999 to 312.5 µg/plate) and a modification in study performance (pre-incubation method).
Concentrations tested: 4999/2500/1250/625/312.5 µg/plate
Third Experiment:
To verify the results of the first experiment, a third experiment was performed, using five concentrations of the test item (ranging from 5004 to 312.5 µg/plate) and a modification in study performance (pre-incubation method).
Concentrations tested: 5004/2502/1251/625/312.5 µg/plate

Controls

Controls 1

Untreated negative controls:

yes

Remarks:

water and DMSO (historical data of the laboratory)

Negative solvent / vehicle controls:

yes

Remarks:

water

True negative controls:

yes

Positive controls:

yes

Positive control substance:

other: 4-Nitro-1,2-phenylene diamine (Strains 97a, 98, 102)

Remarks:

without metabolic activation system

Controls 2

Untreated negative controls:

yes

Remarks:

water and DMSO (historical data of the laboratory)

Negative solvent / vehicle controls:

yes

Remarks:

water

True negative controls:

yes

Positive controls:

yes

Positive control substance:

sodium azide

Remarks:

without metabolic activation system Migrated to IUCLID6: Strains 100 and 1535

Controls 3

Untreated negative controls:

yes

Remarks:

water and DMSO (historical data of the laboratory)

Negative solvent / vehicle controls:

yes

Remarks:

water

True negative controls:

yes

Positive controls:

yes

Positive control substance:

benzo(a)pyrene

Remarks:

with metabolic activation system Migrated to IUCLID6: Strain 98

Controls 4

Untreated negative controls:

yes

Remarks:

water and DMSO (historical data of the laboratory)

Negative solvent / vehicle controls:

yes

Remarks:

water

True negative controls:

yes

Positive controls:

yes

Positive control substance:

other: 2-Aminoanthracene (Strains 97a, 100, 102, 1535)

Remarks:

with metabolic activation system

Results and discussion

Test results

Species / strain:

other: TA97a, TA98, TA100, TA102, TA1535

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

no cytotoxicity

Vehicle controls validity:

valid

Untreated negative controls validity:

valid

Positive controls validity:

valid

Remarks on result:

other: all strains/cell types tested

Any other information on results incl. tables

Solubility and Toxicity (all three experiments):

No signs of toxicity towards the tested strains could be observed. The backround lawn was visible an the number of revertant colonies was not reduced.

Mutagenicity (all three experiments):

No significant increase of the number of revertant colonies in the treatments with and without metabolic activation could be observed. No concentration-related increase over the tested range was found.

Applicant's summary and conclusion

Conclusions:

Interpretation of results (migrated information):
negative

The test item is not mutagenic in the Bacterial Reverse Mutation Test.