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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
Study period:
1.4.-6.5.1994
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1994
Report date:
1994

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
Deviations:
not specified
GLP compliance:
no
Type of assay:
bacterial gene mutation assay

Test material

Constituent 1
Chemical structure
Reference substance name:
Trisodium 5-[[4-chloro-6-(ethylphenylamino)-1,3,5-triazin-2-yl]amino]-4-hydroxy-3-[(4-methyl-2-sulphonatophenyl)azo]naphthalene-2,7-disulphonate
EC Number:
277-616-3
EC Name:
Trisodium 5-[[4-chloro-6-(ethylphenylamino)-1,3,5-triazin-2-yl]amino]-4-hydroxy-3-[(4-methyl-2-sulphonatophenyl)azo]naphthalene-2,7-disulphonate
Cas Number:
73816-74-7
Molecular formula:
C28H24ClN7O10S3.3Na
IUPAC Name:
trisodium 5-[[4-chloro-6-(ethylphenylamino)-1,3,5-triazin-2-yl]amino]-4-hydroxy-3-[(4-methyl-2-sulphonatophenyl)azo]naphthalene-2,7-disulphonate
impurity 1
Chemical structure
Reference substance name:
Sodium chloride
EC Number:
231-598-3
EC Name:
Sodium chloride
Cas Number:
7647-14-5
Molecular formula:
ClNa
IUPAC Name:
sodium chloride
Test material form:
solid: particulate/powder
Details on test material:
- Name of test material (as cited in study report): Reactive Red 45:1
- Physical state: red solid powder
- Analytical purity: 85% (w/w)
- Impurities (identity and concentrations): NaCl (CAS: 7647-14-5) 15% (w/w)
- Lot/batch No.: 7010
- Expiration date of the lot/batch: unlisted
- Storage condition of test material: The test substance should be stored in dry room in dark in closed container at the room temperature.

Method

Target gene:
gene for synthesis histidine
Species / strainopen allclose all
Species / strain / cell type:
S. typhimurium TA 97
Additional strain / cell type characteristics:
other: histidine dependent strain
Species / strain / cell type:
S. typhimurium TA 98
Additional strain / cell type characteristics:
other: histidine dependent strain
Species / strain / cell type:
S. typhimurium TA 100
Additional strain / cell type characteristics:
other: histidine dependent strain
Species / strain / cell type:
S. typhimurium TA 1535
Additional strain / cell type characteristics:
other: histidine dependent strain
Metabolic activation:
with and without
Metabolic activation system:
supernatant of rat liver and mixture of cofactors
Test concentrations with justification for top dose:
10-5000 µg per plate
Vehicle / solvent:
- Vehicle(s)/solvent(s) used: water
Controlsopen allclose all
Untreated negative controls:
yes
Negative solvent / vehicle controls:
yes
Positive controls:
yes
Positive control substance:
sodium azide
Untreated negative controls:
yes
Negative solvent / vehicle controls:
yes
Positive controls:
yes
Positive control substance:
other: 4-nitro-o-phenylendiamine
Untreated negative controls:
yes
Negative solvent / vehicle controls:
yes
Positive controls:
yes
Positive control substance:
other: 2-aminofluorene
Untreated negative controls:
yes
Negative solvent / vehicle controls:
yes
Positive controls:
yes
Positive control substance:
other: 2-aminoanthracene
Details on test system and experimental conditions:
METHOD OF APPLICATION: in agar (plate incorporation)

NUMBER OF REPLICATIONS:
Two series of experiments were performed with each strain - without metabolic activation and with a supernatant of rat liver and a mixture of cofactors.
Evaluation criteria:
The main criterion for evaluation of results was modified two-fold increase rule, its using is comperable with using of statiistical method (3,4). After this rule the result is positive, when reproducible dose-efftect and/or doubling of ratio Rt/Rc is reached.

Results and discussion

Test resultsopen allclose all
Key result
Species / strain:
S. typhimurium TA 97
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
not determined
Vehicle controls validity:
valid
Untreated negative controls validity:
valid
Positive controls validity:
valid
Key result
Species / strain:
S. typhimurium TA 1535
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
not determined
Vehicle controls validity:
valid
Untreated negative controls validity:
valid
Positive controls validity:
valid
Key result
Species / strain:
S. typhimurium TA 98
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
not determined
Vehicle controls validity:
valid
Untreated negative controls validity:
valid
Positive controls validity:
valid
Key result
Species / strain:
S. typhimurium TA 100
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
not determined
Vehicle controls validity:
valid
Untreated negative controls validity:
valid
Positive controls validity:
valid

Applicant's summary and conclusion

Conclusions:
Under the above-described experimental design, the test substance was non mutagenic for all Salmonella typhimurium strain in experiments without as well as with metabolic activation.
Executive summary:

The test substance was assayed for mutagenicity by the bacterial Reverse Mutation Test.

Four indicator Salmonell typhimurium strains TA 98, TA 97, TA 100 and TA 1535 strai were used. The test substance was dissolved in water and assayed in doses of 10 -5000 µg which were applied to plate. Two series of experiments were performed with each strain without metabolic activation and with a supernatant of rat liver and a mixture of cofactors.

In the arrangement given above, the test substance was nonmutagenic for all the used bacterial strains with as well as without metabolic activation.

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