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EC number: 248-502-0 | CAS number: 27503-81-7
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Genetic toxicity: in vitro
Administrative data
- Endpoint:
- in vitro cytogenicity / chromosome aberration study in mammalian cells
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- from July 18, 2002 to Oct. 07, 2002
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 002
- Report date:
- 2002
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 473 (In Vitro Mammalian Chromosome Aberration Test)
- Deviations:
- not specified
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.10 (Mutagenicity - In Vitro Mammalian Chromosome Aberration Test)
- GLP compliance:
- yes
- Type of assay:
- other: In vitro mammalian chromosome aberration test
Test material
- Reference substance name:
- 2-phenyl-1H-benzimidazole-5-sulphonic acid
- EC Number:
- 248-502-0
- EC Name:
- 2-phenyl-1H-benzimidazole-5-sulphonic acid
- Cas Number:
- 27503-81-7
- Molecular formula:
- C13H10N2O3S
- IUPAC Name:
- 2-phenyl-1H-benzimidazole-5-sulphonic acid
Constituent 1
Method
- Target gene:
- Chromosomal aberations in human peripheral blood lymphocytes
Species / strain
- Species / strain / cell type:
- other: human peripheral blood lymphocytes
- Additional strain / cell type characteristics:
- not specified
- Metabolic activation:
- with and without
- Metabolic activation system:
- a liver homogenate fraction (S9) from Aroclor 1254 treated male rats
- Test concentrations with justification for top dose:
- 0.33 mM, 3.3 mM, and 10 mM in the tests with 24 hours of treatment without a metabolic activation system,
1.0 mM, 3.3 mM, and 10 mM in the tests with 3.5 hours of treatment with and 4 hours of treatment without a metabolic activation system. - Vehicle / solvent:
- distilled water
Controlsopen allclose all
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- Remarks:
- distilled water
- True negative controls:
- no
- Positive controls:
- yes
- Remarks:
- 0.5 µg/ml
- Positive control substance:
- mitomycin C
- Remarks:
- without s9
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Remarks:
- 25 µg/ml
- Positive control substance:
- cyclophosphamide
- Remarks:
- with s9
- Details on test system and experimental conditions:
- Test system:
Lymphocyte cultures
Samples of human peripheral blood were obtained by venipuncture from a male healthy donor, who was not undergoing any drug treatment and collected in heparinised vessels. Lymphocyte cultures were established by addition of small inocula of whole blood (0.4 ml) to each culture tube containing 5 ml of Ham's F10 complete medium, to which 0.1 ml of phytohaemagglutinin was added. The tubes were sealed and incubated at 37 °C.
Metabolic Activation System
The rat liver homogenate fractions used were obtained from King & Hamasch GmbH (Lot KH1501)S Kirchzarten. The preparation of the 9000g supernatant of liver homogenates (S9) from Sprague Dawley male rats (8-10 weeks old, Harlan Winkelman, D-33176 Borchen) induced with Aroclor 1254 (500 mg/kg body weight) is in accordance with the method recommended by Ames et al. (1975).
The S9 preparations (in 0.15 M KC1) were stored in liquid nitrogen.
S9-mix containing 25% S9 was freshly prepared for each mutagenicity assay. The concentrations of the cofactors in the S9-mix are: NADP, 4 mM; glucose-6-phosphate, 25 mM, MgCl2, 8 mM; KC1, 33 mM; phosphate buffer pH 7*4, 100 mM. This solution is filter sterilized by passage through a 0.2 µm filter. S9-mix was kept on ice. - Evaluation criteria:
- A significant increase of mutant cells by the test compound will be stated, when the frequency of cells with aberrations in the concurrent negative controls and the frequency of cells with aberrations at each dosage level differ significantly.
- Statistics:
- The statistical significance was determined according to the methods of Kastenbaum and Bowman (1970).
Results and discussion
Test results
- Key result
- Species / strain:
- other: human peripheral blood lymphocytes
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Additional information on results:
- The highest concentration tested induced 69% (1st exp., 24h) and 27 % cytotoxicity (2nd exp., 4h) in the absence and 58 % (1st exp.) and 52 % (2nd exp.) cytotoxicity in the presence of S9-mix.
Test substance did not induce any increase in the number of chromosome aberrations in cultured human blood lymphocytes in the absence and presence of a metabolizing system. - Remarks on result:
- other:
Applicant's summary and conclusion
- Conclusions:
- Based on the results of this study, test article did not cause clastogenic effects in human peripheral blood lymphocytes with and without metabolic activation system.
- Executive summary:
The chromosome aberration study was undertaken to examine the mutagenic effect of test article for its capability to induce chromosome damage in human peripheral blood lymphocytes in vitro. All tests were carried out both in the presence and absence of metabolic activation system. Two independent experiments were performed. A sampling time at 1.5 times the normal cell-cycle length from the beginning of the treatment (24 h) was used in the first and second experiment. The two experiments without S9-mix differ in the duration of the exposure to the test substance. In the first experiment the cells were treated in the absence of S9 for 24 hours with the test compound, whereas in the second experiment without S9 the test compound was washed away 4 hours after the start of the treatment. In the test with a metabolic activation system, the cells were always exposed to the test substance for 3.5 hours. The following concentrations of test article were tested: 0.33 mM, 3.3 mM, and 10 mM in the tests with 24 hours of treatment without a metabolic activation system 1.0 mM, 3.3 mM, and 10 mM in the tests with 3.5 hours of treatment with and 4 hours of treatment without a metabolic activation system.
At the concentrations tested, the test article did not induce any increase in the number of chromosome aberrations in cultured human blood lymphocytes in the absence and presence of a metabolizing system. In conclusion, the results indicate that, under the experimental conditions described, the test article was not mutagenic in the in vitro mammalian chromosome aberration test with human peripheral blood lymphocytes.
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