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Diss Factsheets

Toxicological information

Genetic toxicity: in vitro

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Administrative data

Endpoint:
in vitro gene mutation study in bacteria
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
test procedure in accordance with generally accepted scientific standards and described in sufficient detail

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1986
Report date:
1986

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: Ames et al. 1973, 1975
Principles of method if other than guideline:
The test method followed the procedure described at Ames et al, 1973 and Ames et al, 1975.
GLP compliance:
yes
Type of assay:
bacterial reverse mutation assay

Test material

Constituent 1
Chemical structure
Reference substance name:
Lithium sodium hydrogen 4-amino-6-(5-(5-chloro-2,6-difluoropyrimidin-4-ylamino)-2-sulfonatophenylazo)-5-hydroxy-3-(4-(2-(sulfonatooxy)ethylsulfonyl)phenylazo)naphthalene-2,7-disulfonate
EC Number:
401-560-2
EC Name:
Lithium sodium hydrogen 4-amino-6-(5-(5-chloro-2,6-difluoropyrimidin-4-ylamino)-2-sulfonatophenylazo)-5-hydroxy-3-(4-(2-(sulfonatooxy)ethylsulfonyl)phenylazo)naphthalene-2,7-disulfonate
Cas Number:
108624-00-6
Molecular formula:
C28H(21-x-y)ClF2Li(x)N8Na(y)O16S5
IUPAC Name:
Lithium sodium hydrogen-4-amino-6-(5-(5-chloro-2,6-difluoropyrimidine-4-ylamino)-2-sulfonatophenylazo)-5-hydroxy-3-(4-(2-(sulfonatooxy)ethylsulfonyl)phenylazo)naphthalene-2,7-disulfonate
Test material form:
solid: particulate/powder
Details on test material:
Reactive Blue FC 05717

Method

Species / strain
Species / strain / cell type:
S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
Metabolic activation:
with and without
Metabolic activation system:
S9-mix from rat liver
Test concentrations with justification for top dose:
First plate incorporation test, with and without S9 mix:
0 (negative control), 16, 80, 400, 2000 and 10,000 µg/plate
Positive control:
sodium azide: 10 µg/plate (only TA 1535)
nitrofurantoin: 0.2 µg/plate (only TA 100)
4-nitro-o-phenylendiamine: 10 µg/plate (only TA 1537)
4-nitro-o-phenylendiamine: 0.5 µg/plate (only TA 98)
2-aminoanthracene: 3 µg/plate

Second plate incorporation test, with and without S9 mix:
The doses of test substance were increased to 625 - 10,000 µg/plate as no toxicity was observed.
Vehicle / solvent:
Deionized water
Controlsopen allclose all
Untreated negative controls:
yes
Negative solvent / vehicle controls:
yes
Positive controls:
yes
Positive control substance:
sodium azide
Remarks:
Only for TA 1535
Untreated negative controls:
yes
Negative solvent / vehicle controls:
yes
Positive controls:
yes
Positive control substance:
other: Nitrofurantoine
Remarks:
Only for TA 100
Untreated negative controls:
yes
Negative solvent / vehicle controls:
yes
Positive controls:
yes
Positive control substance:
other: 4-nitro-o-phenylendiamine
Remarks:
Only for TA 1537 and TA 98
Untreated negative controls:
yes
Negative solvent / vehicle controls:
yes
Positive controls:
yes
Positive control substance:
other: 2-aminoanthracene
Evaluation criteria:
Criteria for a positive response
A response is considered positive if there is a reproducible dose-dependent increase in the number of mutants in at least one strain, with numbers reaching approximately the double of those of the negative control.

Results and discussion

Test results
Key result
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:
no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
Untreated negative controls validity:
valid
Positive controls validity:
valid
Remarks on result:
other: all strains/cell types tested

Applicant's summary and conclusion

Conclusions:
Under the study conditions, the test substance was not found to be mutagenic in the bacterial reverse mutation assay.
Executive summary:

An in vitro study was performed to investigate the potential of the test substance to induce gene mutations according to the method of Ames (1973, 1975), in compliance with GLP. Two independent assays were conducted, using the plate incorporation method, in the absence and presence of a metabolizing system derived from a rat liver homogenate (i.e. S9 mix). The substance was tested at five concentrations in the range of 16 - 10,000 µg/plate in the first assay and, as no toxicity occurred, at 625 - 10,000 µg/plate in the second assay. The tested strains were Salmonella typhimurium TA 1535, TA 1537, TA 98 and TA 100. Doses up to and including 10,000 µg/plate did not induce any bacteriotoxic effects. The total bacteria counts remained unchanged. No inhibition of growth was observed. Evidence of mutagenic activity of the test substance was not found. Neither a dose-related doubling of mutant counts nor a biologically relevant increase in the same, in comparison with the negative controls, was seen. The positive controls had a marked mutagenic effect. Under the study conditions, the test substance was not found to be mutagenic in the bacterial reverse mutation assay (Herbold, 1986).