Registration Dossier
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 263-731-6 | CAS number: 62780-89-6
- 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 gene mutation study in bacteria
- Remarks:
- Type of genotoxicity: gene mutation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1987-06-16 to 1987-06-26
- 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:
- 1 987
- Report Date:
- 1987
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- yes
- Remarks:
- : Only two tester strains were used instead of five
- GLP compliance:
- yes (incl. certificate)
- Type of assay:
- bacterial reverse mutation assay
Test material
Reference
- Name:
- Unnamed
- Type:
- Constituent
- Test material form:
- solid: particulate/powder
- Details on test material:
- - Name of test material (as cited in study report): JNJ-119717-AAA (T001036)
- Physical state: solid
- Specific details on test material used for the study:
- - Stability of the test article: known
- Storage condition of test material: at room temperature in closed containers
- Other: The test substance was synthesized in the Janssen Pharmaceutica Research Laboratories and passed the specifications of the chemical quality department.
Method
- Target gene:
- histidine locus
Species / strain
- Species / strain / cell type:
- S. typhimurium, other: TA98 and TA100
- Metabolic activation:
- with and without
- Metabolic activation system:
- Arochlor 1254 induced rat liver S9 at 20 and 50 µg/plate
- Test concentrations with justification for top dose:
- - Preliminary dose range finding study: 0, 10, 100, 250, 500, 1000, 2500 and 5000 µg/plate
- Initial and repeat experiments: 0, 10, 100, 250, 500, 1000, 2500 and 5000 µg/plate - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: dimethyl sulfoxide (DMSO)
- Justification for choice of solvent/vehicle: In a preliminary solubility assay, the test substance (100 mg) was introduced in a test tube, with 2 mL distilled water and mixed vigorously. The test substance was still not soluble upon warming up to 45 °C, so a new solution was prepared in absolute ethanol following the same procedure. Since the test substance was not more soluble in ethanol than water, DMSO was chosen as the vehicle.
Controlsopen allclose all
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 2-nitrofluorene
- Remarks:
- without metabolic activation; TA98
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- sodium azide
- Remarks:
- without metabolic activation; TA100
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: 2-aminoanthracene at 1.0 µg/plate dissolved in DMSO
- Remarks:
- with metabolic activation; for TA98 and TA100
- Details on test system and experimental conditions:
- METHOD OF APPLICATION:
- in agar (plate incorporation)
The following procedure was used for the plate incorporation assay: 0.1 mL of an overnight culture in nutrient broth (Oxoid) is introduced into test tubes. This corresponds to an average of 1-6 x 10^8 viable bacteria per tube. The histidine-biotine (0.05 mM) or tryptophane (5 µg) supplemented top agar (2 mL) is then added, followed by the substrate dilution (0.1 mL). When specified S-9 mix is then added (0.5 mL) and the content of the test tube well mixed. This mixture is then layered on minimal glucose agar (Vogel Bonner E medium) containing petri dishes following the method of Ames et al. The minimal glucose containing petri dishes are used within the week that they were prepared.
DURATION
- Exposure duration: 48 hours at 37°C in the dark
NUMBER OF REPLICATIONS: 3
DETERMINATION OF CYTOTOXICITY: Method: reduction of the background lawn
OTHER EXAMINATIONS:
Before use of any test culture, the growth requirements and the genetic identity of the strains, their sensitivity to UV radiation and crystal violet and their resistance to ampicillin were checked. Each strain must present a spontaneous reversion rate within the historical control data of the testing facility.
After incubation of the plates the number of revertant are counted manually. The sensitivity of the strains and the activity of the metabolizing system are confirmed by testing specific mutagens. Historical control data on spontaneous revertants and on revertants in the positive and solvent control grops of each strain used in the study were included. - Evaluation criteria:
- Reversion values were considered as positive if:
1) there was a significant increase in the number of revertant colonies (i.e., at least a two-fold increase compared to the solvent control;
2) a dose effect relationship was observed; and
3) these effects could be reproduced.
When equivocal results are obtained, more assays may be required, in order to evaluate the mutagenic potential of the test substance. - Statistics:
- Based on the evaluation criteria, no statistical analysis was required.
Results and discussion
Test resultsopen allclose all
- Species / strain:
- S. typhimurium TA 98
- 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
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- positive
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS:
- Effects of pH: no data
- Effects of osmolality: no data
- Evaporation from medium: no data
- Water solubility: no data
- Precipitation: In the preliminary toxicity test, low precipitation of the test substance occurred at 5000 µg/plate both with and without S9. No precipitation was reported in the main experiment.
RANGE-FINDING/SCREENING STUDIES:
A preliminary plate incorporation test was performed to determine the non-inhibitory concentrations of the test substance. In this pre-test, strain TA100 was tested with 6 concentrations of the test substance ranging from 100 - 5000 µg/plate with and without S9 metabolic activation. Toxic effects were evident by a clear reduction of the background lawn. The highest concentration that does not precipitate and that is not toxic for the bacteria, or the lowest concentration that gives visible toxic effects, was used as the highest one in the main assay.
COMPARISON WITH HISTORICAL CONTROL DATA:
Vehicle and positive control values were within historical data control range. The positive control substances induced marked increases in revertant colony numbers with all strains.
The test substance was toxic to the strain TA100 at 5000 µg/plate as the number of revertant colonies was found to be strongly reduced (pin-point colonies). Toxic action of the test substance to TA100 was also detected by a thinning of the bacterial lawn at 5000 µg/plate. Considering the reversion rate of TA100 to prototrophy with the test substance, a significant increase in the number of revertant colonies could be evidenced from dose levels of 250 µg/plate in the absence or in the presence of rat metabolic activation system.
ADDITIONAL INFORMATION ON CYTOTOXICITY:
- In the preliminary dose range finding study toxicity to the strain TA100 was observed at 5000 µg/plate as the number of revertant colonies was found to be stronglyl reduced (pin-point colonies). Toxic action was also detected by a thinning of the bacterial background lawn at 5000 µg/plate.
- In the initial test in the absence and presence of S9, moderate toxicity was observed at 5000 µg/plate for TA98. For TA100, moderate and low toxicity were observed at 5000 µg/plate in the absence and presence of S9, respectively.
- In the repeat test in the absence of S9, low and moderate toxicity was observed for TA98 at 2500 and 5000 µg/plate, respectively. For TA100, moderate toxicity was observed at 5000 µg/plate. In the presence of S9, low toxicity was observed at 5000 µg/plate for both TA98 and TA100.
Any other information on results incl. tables
TA100 showed increased reversion to prototrophy at doses of 250 µg/plate and higher both in the presence and absence of S9. These findings were confirmed in the repeat test. The increased amount of S9 used (20 µL/plate-initial test increased to 50 µL/plate-repeat test) resulted in an increased reversion to prototrophy.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results:
positive in strain TA100
The test substance was evaluated for mutagenic potential using the Ames Assay. Based on the increase of the reversion rates, it can be concluded that the test substance has mutagenic properties towards Salmonella typhimurium TA100 in the absence and in the presence of rat metabolic activation system. The test substance was negative towards TA98.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.

Route: .live2