Registration Dossier
Registration Dossier
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EC number: 939-053-8 | CAS number: -
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
- Study period:
- 2005-03-04 to 2015-04-01
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline study with GLP
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 015
- Report date:
- 2015
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- 2015-04-08
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Reaction mass of 1,3-benzene disulfonic acid and sulfuric acid
- Molecular formula:
- H2SO4 C6H6O6S2
- IUPAC Name:
- Reaction mass of 1,3-benzene disulfonic acid and sulfuric acid
- Test material form:
- other: liquid
- Details on test material:
- - Name of test material (as cited in study report): Reaction mass of 1,3-benzene disulfonic acid and sulfuric acid, aqueous solution
Constituent 1
Method
Species / strainopen allclose all
- Species / strain / cell type:
- S. typhimurium, other: 97a
- Species / strain / cell type:
- S. typhimurium TA 98
- Species / strain / cell type:
- S. typhimurium TA 1535
- Species / strain / cell type:
- S. typhimurium TA 100
- Species / strain / cell type:
- S. typhimurium TA 102
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9-mix, rat liver S9-mix induced by Aroclor 1254
- Test concentrations with justification for top dose:
- Experiments 1a and 1b: 5000 / 1500 / 500 / 150 / 50 µg/plate
Experiment 2a and 2b: 5000 / 2500 / 1250 / 625 / 313 µg/plate - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: water
- Justification for choice of solvent/vehicle: soluble in a nominal concentration of 50 g/L in demin. water
Controls
- Negative solvent / vehicle controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- sodium azide
- benzo(a)pyrene
- other: 4-Nitro-1,2-phenylene diamine, 2-Amino-Anthracene
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in medium; Experiments 1a and 1b in agar (plate incorporation); Experiments 2a and 2b preincubation
DURATION
- Preincubation period: 20 min
- Exposure duration: 48 h
SELECTION AGENT (mutation assays): Histidin requirement
NUMBER OF REPLICATIONS: 3 plates per strain/dose with and without S9 mix; 2 independent experiments
DETERMINATION OF CYTOTOXICITY
- Method: back ground lawn - Evaluation criteria:
- The increase factor f(I) of revertant induction (mean revertants divided by mean spontane-ous revertants) and the absolute number of revertants, mean revertants less mean spontaneous revertants) were also calculated.
A test item is considered to have mutagenic potential, if a significant, reproducible increase of revertant colonies per plate (increase factor >/= 2) in at least one strain can be observed. A concentration-related increase over the range tested can also be taken as a sign of mutagenic activity.
Results and discussion
Test resultsopen allclose all
- Species / strain:
- S. typhimurium, other: 97a
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium 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
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 102
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative
Under the test conditions, the test item is not mutagenic in the Bacterial Reverse Mutation Test using Salmonella typhimurium, strains TA97a, TA98, TA100, TA102 and TA1535. - Executive summary:
In a reverse gene mutation assay in bacteria according to OECD Guideline 471, the strains TA 1535, TA 97a, TA 98, TA 100 and TA 102 of S. typhimurium were exposed to Reaction mass of 1,3-benzene disulfonic acid and sulfuric acid in the presence and absence of mammalian metabolic activation (rat liver S9-mix induced by Aroclor 1254).
Strains were exposed to the test item, diluted in water, at concentrations of 50, 150, 500, 1500 and 5000 µg / plate in the first experiments (1a and 1b) and to 313, 625, 1250, 2500 and 5000 µg/plate in the second experiments (2a and 2b). The first experiments were conducted using the plate incorporation method; in the second experiments the pre-incubation method was used.
In neither of the tests precipitation or signs of toxicity towards the bacteria were observed at any concentration.
There was no evidence of induced mutant colonies over background up to the limit concentration of 5000 µg/plate.
The positive controls induced the appropriate responses in the corresponding strains and activity of metabolic system was confirmed. Values for the spontaneous revertants of the negative controls were in the normal range.
This study satisfies the requirement for Test OECD 471 for in vitro mutagenicity (bacterial reverse gene mutation) data.
The test item is considered as not mutagenic under the conditions of the test.
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