Sulfonation products of disodium sulfite with (esterification products of C9-11 (branched and linear) Alkyl Polyglycosides with maleic anhydride)

Genetic toxicity: in vitro

Administrative data

Endpoint:

in vitro gene mutation study in bacteria

Remarks:

Type of genotoxicity: gene mutation

Type of information:

migrated information: read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Study period:

From December 14 to 22, 1995

Reliability:

2 (reliable with restrictions)

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1996

Report date:

1996

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)

GLP compliance:

yes

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

D-Glucopyranose, oligomers, monosulfosuccinate, coco alkyl glycosides, sodium salts

EC Number:

500-331-5

EC Name:

D-Glucopyranose, oligomers, monosulfosuccinate, coco alkyl glycosides, sodium salts

Cas Number:

151911-53-4

IUPAC Name:

151911-53-4

Constituent 2

Reference substance name:

Eucarol APG/SS

IUPAC Name:

Eucarol APG/SS

Details on test material:

- Name of test material (as cited in study report): EUCAROL APG/SS
- Physical state: liquid (aqueous solution 45% w/v)
- Lot/batch No.: 1953/I
- Expiration date of the lot/batch: May 26, 1996
- Storage condition of test material: 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

Metabolic activation:

with and without

Metabolic activation system:

S9 Mix

Test concentrations with justification for top dose:

First exp: 50, 150, 500, 1500 and 5000 ug/plate were tested
Second exp: 15, 50, 150, 500 and 1500 ug/plate were tested
Triplicate plates for each experimental point.

Vehicle / solvent:

water for injection

Controls

Untreated negative controls:

yes

Remarks:

solvent

Negative solvent / vehicle controls:

yes

Positive controls:

yes

Positive control substance:

other: hydrazine sulphate, 9-aminoacridine HCl monohydrate, Mitomycin C, Doxorubicine HCl, 2-aminoanthracene and 2-aminofluorene

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:

cytotoxicity

Remarks:

at 1500 ug/plate slightly cytotoxic

Untreated negative controls validity:

valid

Positive controls validity:

valid

Remarks on result:

other: all strains/cell types tested

Remarks:

Migrated from field 'Test system'.

Any other information on results incl. tables

The sterility checks with the compound proved negative for bacterial growth.

All the strains used proved sensitive to crystal violet.ùAmpicillin inhibited the growth of TA1535, TA1537 strains but did not inhibit that of the other strains.

In the first experiment, at 5000 ug/plate both with and without metabolic activation, the test article proved to be severely cytotoxic on the test system, making impossible the revertant colony growth. At 1500 ug/plate the test article proved to be slightly cytotoxic giving statistical significant reduction of revertant colony growth in comparison with the negative control.

In the second experiment again slight cytotoxic effects were observed at 1500 ug/plate, with and without metabolica activation, giving reduction in the number of revertant colonies in comparison with the negative control.

As regards mutagenicity, no appreciable increase in the number of reversions in comparison with the negative control was evident in either experiment at any of the doses for any strain, with or without metabolic activation.

Applicant's summary and conclusion

Conclusions:

Interpretation of results (migrated information):
negative

In the concentration range investigated, the test substance did not show any mutagenic activity with or without the addition of S9 liver homogenate fractions.