Octasodium 2-(3,4-bis(sulfonatooxy)-2,5-bis(sulfonatooxymethyl)tetrahydrofuran-2-yloxy)-3,5-bis(sulfonatooxy)-6-sulfonatooxymethyltetrahydropyran-4-oxysulfonate

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

Reliability:

1 (reliable without restriction)

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:

other: 92/69/EWG, B.14; OECD 471

Test guideline 2

Qualifier:

according to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

GLP compliance:

yes

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

Natrium Sucroseoctasulfat

IUPAC Name:

Natrium Sucroseoctasulfat

Test material form:

solid: particulate/powder

Remarks:

migrated information: powder

Method

Species / strain

Species / strain / cell type:

bacteria, other: sat TA 98, 100, 1535, 1537

Metabolic activation system:

CCR S9-Mix, Arochlor induziert "ENGLISH" CCR S9-mix, arochlor induced

Test concentrations with justification for top dose:

Concentration range in the main test (with metabolic activation): 8 ... 5000 µg/plate
Concentration range in the main test (without metabolic activation): 8 ... 5000 µg/plate

Vehicle / solvent:

Solvent: Destilliertes Wasser (dist. water)

Results and discussion

Test results

Species / strain:

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

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

cytotoxicity

Remarks:

( 5000 µg/plate)

Untreated negative controls validity:

valid

Positive controls validity:

valid

Additional information on results:

Observations:
Keine Toxizität auch bei der höchsten Substanzkonzentration.

"ENGLISH"

No toxicity also at the highest substance concentration.

Remarks on result:

other: other: main test

Remarks:

Migrated from field 'Test system'.

Applicant's summary and conclusion

Conclusions:

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

Executive summary:

Natrium Sucroseoctasulfat was assayed in a bacterial gene mutation assay (Ames test) using the strains TA 100, TA 1535, TA 98 and TA 1537 according to the current EEC and OECD guidelines. Induced his +-revertants werde determined both in the absence and presence of metabolic activation by a rat liver pots-mitochondrial function (S9) from Aroclor 1254 included animals.

Depending on a preliminary cytotoxicity test, cells were exposed to concentrations of 8.00, 40.00, 200.00, 1000.00 and 5000.00 microgramm per plate (1st assay) and 61.72, 185.18, 555.55, 1666.66 and 5000.00 microgra,, per plate (2nd assay) with and without metabolic activation.

In order to demonstrate the sensitivity of the assay system, postiv control agents were used and marked increses in his +-revertants were induced in all tester-strains.

In the 1st and 2nd assay Natrium-Sucroseoctasulfat did not induce cytotoxicity nor significant or biologically relevant increases in histidine-prototrophy revertants in any tester-strains with and without metabolic activation in the tested concentration range.

It is thus concluded that Natrium-Sucroseoctasulfat did not induce gene mutations in the bacterial mutagenicity assay with an dwithout metabolic activation in vitro when tested under the experimental conditions reported