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EC number: 946-967-0 | CAS number: -
- 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
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Genetic toxicity: in vitro
Administrative data
- Endpoint:
- in vitro gene mutation study in bacteria
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- Study completion date - 25 July 1979
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 979
- Report date:
- 1979
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- no
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- 3(or5)-[[4-[benzylmethylamino]phenyl]azo]-1,2(or1,4)-dimethyl-1H-1,2,4-triazolium bromide
- EC Number:
- 289-660-0
- EC Name:
- 3(or5)-[[4-[benzylmethylamino]phenyl]azo]-1,2(or1,4)-dimethyl-1H-1,2,4-triazolium bromide
- Cas Number:
- 89959-98-8
- Molecular formula:
- C18H21N6.Br
- IUPAC Name:
- Reaction mass of 3-[{4-[Benzyl(methyl)amino]phenyl}diazenyl]-1,4-dimethyl-4H-1,2,4-triazol-1-ium bromide and 5-[{4-[Benzyl(methyl)amino]phenyl}diazenyl]-1,4-dimethyl-4H-1,2,4-triazol-1-ium bromide
- Test material form:
- solid
Constituent 1
- Specific details on test material used for the study:
- Name: FAT 31016/C
Purity: 85 %
Method
- Target gene:
- The experiments were performed to detect any properties of the test material or its metabolites to induce gene mutations in histidine-requiring strains of Salmonella typhimurium.
Species / strainopen allclose all
- Species / strain / cell type:
- S. typhimurium TA 98
- Details on mammalian cell type (if applicable):
- Not applicable
- Additional strain / cell type characteristics:
- not applicable
- Species / strain / cell type:
- S. typhimurium TA 1538
- Details on mammalian cell type (if applicable):
- Not applicable
- Additional strain / cell type characteristics:
- not applicable
- Metabolic activation:
- with and without
- Metabolic activation system:
- Rat liver S9 fraction
- Test concentrations with justification for top dose:
- 25, 75, 225, 675 and 2025 µg/0.1 ml
- Vehicle / solvent:
- Dimethylsulfoxyde
Controlsopen allclose all
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: daunorubicin-HCl for TA 98; 2-nitrofluorene for TA 1538
- Remarks:
- Without microsomal activation
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- cyclophosphamide
- Remarks:
- With microsomal activation
- Details on test system and experimental conditions:
- Bacterial cultures were prepared from frozen stocks or from colonies on plates, and on the following days the Standard Plate Test was carried out with and without the addition of activation mixture (rat liver microsomes and co-factors) .
The test was performed with the following concentrations of the trial substance with and without microsomal activation: 25, 75, 225, 675 and 2025 µg/0.1 ml. The substance was dissolved in DMSO. DMSO alone was used for the negative controls.
Each Petri dish contained:
1) approx. 20 ml of minimum agar (Difco agar noble, Difco Laboratories, Detroit, Michigan, U.S.A., Art.No.0142-01, plus salts (Vogel-Bonner Medium E) and glucose),
2) 0.1 ml of the solution of the test substance or the vehicle and 0.1 ml of a bacterial culture (in nutrient broth: Bacto Nutrient Broth dehydrated, Difco Laboratories, Detroit, Michigan, U.S.A., Art.No.0003 0.8 % plus 0.5 % NaCl) in 2.0 ml of soft agar. The soft agar was composed of: 100 ml of 0.6 % agar solution (Difco agar noble) with 0.6 % NaCl and 10 ml of a solution of 1-histidine, 0.5 mM (Fluka, Buchs, Switzerland, Art.No.14400) and +biotin 0.5 mM (Fluka, Buchs, Switzerland, Art .No .53320). In the experiments in which the substance was metabolically activated, 0.5 ml of an activation mixture was added also. 1 ml activation mixture contains: 0.3 ml S9 fraction of liver from rats induced with Aroclor 125 4 (Analabs, Inc., North Haven, Connecticut, U.S.A.,, No.RCS-088), 8 ymoles MgCl , 33 µmoles KCl, 5 µmoles glucose-6-phosphate, 4 µmoles NADP and 100 µmoles phosphate buffer, pH 7.4.
Positive control experiments were carried out simultaneously with the following substances: 1) for Strain TA 98: daunorubicin-HCl (DAUNOBLASTIN , Farmitalia, Montedison Farmaceutica GmbH, Freiburgi.Br., Germany), 5 and 10 µg/0.1 ml phosphate buffer; 2) for Strain TA 1538: 2-nitrofluorene (Fluka, Buchs, Switzerland, Art. No.73330), 5 and 10 µg/0.1 ml DMSO. The activation mixture was tested with Strain TA 15 35 and cyclophosphamide (ENDOXAN-ASTA , Asta-Werke, Bielefeld, Germany), 250 µg/0.1 ml phosphate buffer.
In the experiments with and without the addition of microsomal activation mixture three Petri dishes were prepared per strain and per group (i.e. per concentration or per control group). In the positive control experiments two Petri dishes were used per strain and per group.
The plates were incubated for about 48 hours at 37 °C in darkness. - Evaluation criteria:
- The test substance was considered to be non-mutagenic if the colony count in relation to the negative control was not doubled at any concentration.
- Statistics:
- When the colonies had been counted, the arithmetic mean was calculated.
Results and discussion
Test resultsopen allclose all
- Key result
- Species / strain:
- S. typhimurium TA 1538
- Metabolic activation:
- with
- Genotoxicity:
- positive
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with
- Genotoxicity:
- positive
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Key result
- Species / strain:
- other: TA 98 and TA 1538
- Metabolic activation:
- without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
Any other information on results incl. tables
In the experiments performed without microsomal activation, comparison of the number of histidine-prototrophic mutants in the controls and after treatment with FAT 31016/C revealed no marked differences.
In the experiments with microsomal activation, on the other hand, treatment with FAT 31 016/C led to an increase in the number of back-mutant colonies of Strains TA 98 and TA 1538. This effect was observed at the concentrations of 75 µg/0.1 ml and above. At the highest concentration there was again a reduction in the number of back-mutant colonies, due to a growth-inhibiting effect of the substance on the bacteria.
Applicant's summary and conclusion
- Conclusions:
- FAT 31016/C was found to exert a mutagenic effect on strains TA 98 and TA 1538 in the presence of metabolic activation.
- Executive summary:
FAT 31016/C was tested for mutagenic effects on histidine auxotrophic mutants of Salmonella typhimurium. This study was conducted according to method similar to OECD test guideline 471. The investigations were performed with the following concentrations of the trial substance with and without microsomal activation: 25, 75, 225, 675 and 2025 µg/0.1 ml. In the experiments performed without microsomal activation, comparison of the numbers of back-mutant colonies in the controls and the cultures treated with the various concentrations of FAT 31016/C revealed no marked deviations. In the experiments in which activation mixture was added to the cultures, the number of back-mutant colonies of Strains TA 98 and TA 1538 was distinctly greater after treatment with FAT 31016/C than in the controls. Hence, it can be concluded that FAT 31016/C was found to exert a mutagenic effect on strains TA 98 and TA 1538 in the presence of metabolic activation.
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