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Toxicological information

Genetic toxicity: in vitro

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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:
1999

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
GLP compliance:
yes (incl. QA statement)
Type of assay:
bacterial reverse mutation assay

Test material

Constituent 1
Chemical structure
Reference substance name:
-
EC Number:
429-240-8
EC Name:
-
Cas Number:
212652-59-0
Molecular formula:
Hill formula: C25 H22 F N8 Na3 O13 S4 CAS formula: C25 H25 F N8 O13 S4 · 3 Na
IUPAC Name:
trisodium 3-amino-4-[2-(4-{[4-({2-[2-(ethenesulfonyl)ethoxy]ethyl}amino)-6-fluoro-1,3,5-triazin-2-yl]amino}-2-sulfophenyl)diazen-1-yl]-5-hydroxynaphthalene-2,7-disulfonate

Method

Species / strain
Species / strain / cell type:
bacteria, other: Salmonella typhimurium TA 1535, TA 1537, TA 98, TA 100 Escherichia coli WP2 and WP2 uvrA
Metabolic activation system:
S9 liver fractions of rats induced with phenobarbital/ ß-naphthoflavone.
Test concentrations with justification for top dose:
Concentration range in the main test (with metabolic activation): 33.3 ... 5000 µg/plate
Concentration range in the main test (without metabolic activation): 33.3 ... 5000 µg/plate
Vehicle / solvent:
Solvent: deionised water

Results and discussion

Test resultsopen allclose all
Species / strain:
other: as specified above
Metabolic activation:
with
Cytotoxicity / choice of top concentrations:
cytotoxicity
Remarks:
(>=5000 µg/plate)
Species / strain:
other: as specified above
Metabolic activation:
without
Cytotoxicity / choice of top concentrations:
cytotoxicity
Remarks:
(>=5000 µg/plate)
Additional information on results:
Observations:
----
Remarks on result:
other: other: preliminary test
Remarks:
Migrated from field 'Test system'.

Any other information on results incl. tables

This study was performed to investigate the potential of FAT 40'574/B to induce gene

mutations according to the plate incorporation test (experiment I) and the pre-incubation

test (experiment II) using the Salmonella typhimurium strains TA 1535, TA 1537, TA 98

and TA 100 and in addition the Escherichia coli strain WP2 uvrA.

The assay was performed in two independent experiments both with and without liver

microsomal activation. Each concentration, including the controls, was tested in triplicate.

The test article was tested at the following concentrations:

33; 100; 333; 1000; 2500; and 5000 ug/plate

No relevant toxic effects, evident as a reduction in the number of revertants, occurred in the

test groups with and without metabolic activation.

The plates incubated with the test article showed normal background growth up to

5000 ug/plate with and without metabolic activation in both independent experiments.

No substantial increase in revertant colony numbers of any of the five tester strains was

observed following treatment with FAT 40'574/B at any dose level, neither in the presence

nor absence of metabolic activation (S9 mix). There was also no tendency of higher mutation

rates with increasing concentrations in the range below the generally acknowledged

border of biological relevance.

Appropriate reference mutagens were used as positive controls and showed a distinct increase

of induced revertant colonies.

Applicant's summary and conclusion

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