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Diss Factsheets
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EC number: 500-062-3 | CAS number: 28390-91-2
- 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 mammalian cells
- Remarks:
- Type of genotoxicity: gene mutation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1984
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: No guideline cited but according to published method
Cross-reference
- Reason / purpose for cross-reference:
- reference to same study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 984
- Report date:
- 1984
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- Method according to Clive, D. and Spector, J. (1975). Laboratory procedure for assessing specific locus mutations at the TK locus in cultures L5178Ylymphoma cells. Mutation Research 31, 17 - 29.
- GLP compliance:
- yes
- Type of assay:
- mammalian cell gene mutation assay
Test material
Constituent 1
Method
- Target gene:
- TK -locus
Species / strain
- Species / strain / cell type:
- mouse lymphoma L5178Y cells
- Details on mammalian cell type (if applicable):
- heterozygous subline , TK +/- obtained from Dr. D. Clive
- Additional strain / cell type characteristics:
- not specified
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9 from Aroclor induced rat livers
- Test concentrations with justification for top dose:
- without metabolic activation: 0, 1.28, 2.56, 5.12, 10.25, 20.5 micrograms/ml
with metabolic activation: 0, 4.17, 8.33, 16.67, 33.35, 66.7 microgram/ml - Vehicle / solvent:
- DMSO
Controls
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- ethylmethanesulphonate
- Remarks:
- Migrated to IUCLID6: 0.75 microgram/ml
- Details on test system and experimental conditions:
- Preliminary cytotoxicity test: highest concentration for mutagenicity assay causes 85% growth reduction after 4-hour treatment and 72 -hour suspension growth. Cells were grown in Fishers medium F10, with 10% horse serum. Final DMSO concentration was always < 1%.
Cells were exposed for 4 hours at seven concentrations of 15.63 - 1000 micrograms/ml. Total growth inhibition (cytotoxicity) achieved at 250 micrograms/ml within 48 hours.
Main experiment: 3 x 105 cells were seeded per culture and were treated for 4 hours with TGMDA in the presence or absence of S9 activating liver enzymes, followed by a growth period of 3 days without exposure. After this expression phase cells were plated in soft-agar in petri-dishes containing 50 micrograms/ml of BUdR, and additional 14 days of incubation followed. With a colony counter the colonies were counted .
The results are expressed as number of induced TK-/- mutants/106 cells. - Evaluation criteria:
- To be a positive result, the colony count of the treated plates has to be 2.5 times higher than the solvent control.
- Statistics:
- no statistical methods were applied
Results and discussion
Test results
- Species / strain:
- mouse lymphoma L5178Y cells
- Metabolic activation:
- with and without
- Genotoxicity:
- positive
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- 3 tests without metabolic activation and one test with metabolic activation was performed. In all experiments the highest concentration yielded the highest amount of mutant colonies, but at growth rates of 0.3 - 1.7 % (or cytotoxicity of >98%). (see tables)
Nevertheless, the result was consitant throughout the three experiments and was judged to be positive. - Remarks on result:
- other: strain/cell type: not determined
- Remarks:
- Migrated from field 'Test system'.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
positive
Under the conditions of the test in mouse lymphoma cells, the test material was mutagenic with and without S9-activating enzymes. - Executive summary:
Under the conditions of the test in mouse lymphoma cells, the test materialwas mutagenic with and without S9-activating enzymes.
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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