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Diss Factsheets
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EC number: 422-210-5 | CAS number: 68957-94-8 T3P
- 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
![](https://echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
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:
- 1995-05-16 to 1995-05-26
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 995
- Report date:
- 1995
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Version / remarks:
- T
- Deviations:
- no
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- Deviations:
- no
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: PPA 4/94
- Expiration date of the lot/batch: September 1995
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: darkness, appr. 20 °C
- Stability under test conditions: stable
TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing: On the day of the experiment the test substance was dissolved in DMSO at appropriate concentrations.
Method
- Target gene:
- Salmonella typhimurium: Histidine operon
E. Coli: trpE gene, uvrA gene
Species / strain
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2
- Details on mammalian cell type (if applicable):
- CELLS USED
- Source of cells: Salmonella typhimurium strains were obtained from B. N. Ames, Biochemistry Department, University of California, Berkeley, California 94720, USA, in April 1987. Escherichia coli strain was obtained from M. H. L. Green, MRC. Cell mutation, University of Sussex, Falmer Brighton, BNI 90G (England), in April 1987.
MEDIA USED
- Type and identity of media: Bacteria were grown overnight in nutrient broth (25 g Oxoid Nutrient Broth No. 2 /liter). Inoculation was performed with stock cultures which had been stored at approx. -80 °C.
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9-mix from rat liver, Aroclor 1254 induced
- Test concentrations with justification for top dose:
- Concentration range in the main test (with metabolic activation): 0, 4, 20, 100, 500, 2500, 5000 µg/plate
Concentration range in the main test (without metabolic activation): 0, 4, 20, 100, 500, 2500, 5000 µg/plate - Vehicle / solvent:
- - Vehicle solvent used: DMSO
Controls
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 9-aminoacridine
- 2-nitrofluorene
- sodium azide
- other: N-Methyl-N-nitro-N-nitrosoguanidine, (without metabolic activation, WP2uvrA); 2-Aminoanthracene (with metabolic activation, all strains)
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar (plate incorporation)
DURATION
- Exposure duration: 48 h
SELECTION AGENT (mutation assays): histidine (Salmonella strains) and tryptophan (E. coli)
NUMBER OF REPLICATIONS:2
DETERMINATION OF CYTOTOXICITY
- Method: relative total growth - Rationale for test conditions:
- The test compound did not precipitate on the plates up to the highest investigated dose of 5000 microgram/plate and cytotoxicity was observed at the two highest doses.
- Evaluation criteria:
- A test article is classified as mutagenic if it has either of the following effects:
a) a test article produces at least a 2-fold increase in the mean number of revertants per plate of at least one of the tester strains over the mean number of revertants per plate of the appropriate vehicle control at complete bacterial background lawn
b) a test article induces a dose-related increase in the mean number of revertants per plate of at least one of the tester strains over the mean number of revertants per plate of the appropriate vehicle control in at least two to three concentrations of the test article at complete bacterial background lawn.
The test results must be reproducible. - Statistics:
- not applicable
Results and discussion
Test results
- Key result
- Species / strain:
- other: all strains tested
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- in the experiment for cytotoxicity conducted with strain TA100 the number of revertants at the dose groups 2500 and 5000 µg/plate was reduced compared to the lower dose groups
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Precipitation: The test compound did not precipitate on the plates up to the highest investigated dose of 5000 microgram/plate.
ADDITIONAL INFORMATION ON CYTOTOXICITY:
- Measurement of cytotoxicity used: number of revertants
Any other information on results incl. tables
For details on results, please refer to the attached document.
Applicant's summary and conclusion
- Conclusions:
- The test substance was not mutagenic in bacterial cells with and without metabolic activation in this assay.
- Executive summary:
The test substance was tested for mutagenicity with the strains TA 100, TA 1535, TA 1537 and TA 98 of Salmonella typhimurium and Escherichia coli WP2uvrA.
The mutagenicity studies were conducted in the absence and in the presence of a metabolizing system derived from rat liver homogenate. The test substance was dissolved in DMSO and a dose range of 6 different doses from 4 microgram/plate to 5000 microgram/plate was used (0, 4, 20, 100, 500, 2500, 5000 µg/plate). An experiment for cytotoxicity conducted with strain TA100 revealed a decrease in the number of revertants at the two highest doses compared to the lower doses, indicating cytotoxicity. In the main test this was not confirmed.
Control plates without mutagen showed that the number of spontaneous revertant colonies was similiar to that described in the literature. All the positive control compounds gave the expected increase in the number of revertant colonies.
In the absence of the metabolic activation system the test compound did not show a dose dependent increase in the number of revertants in any of the bacterial strains. Also in the presence of a metabolic activation system, treatment of the cells with the test compound did not result in relevant increases in the number of revertant colonies.
Summarizing, it can be stated that the test compound is not mutagenic in these bacterial test systems either with or without exogenous metabolic activation at the dose levels investigated.
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.
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