Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
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: 483-270-6 | CAS number: 54068-28-9
- 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
Endpoint summary
Administrative data
Key value for chemical safety assessment
Genetic toxicity in vitro
Description of key information
Link to relevant study records
- 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:
- Sep 2010 - Feb 2011
- Reliability:
- 1 (reliable without restriction)
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 476 (In Vitro Mammalian Cell Gene Mutation Test)
- Deviations:
- no
- GLP compliance:
- yes
- Type of assay:
- mammalian cell gene mutation assay
- Target gene:
- HPRT (hypoxanthine-guanine phosphoribosyl transferase)
- Species / strain / cell type:
- Chinese hamster lung fibroblasts (V79)
- Additional strain / cell type characteristics:
- not specified
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9-mix
- Test concentrations with justification for top dose:
- The concentrations evaluated (in bold) in the different experiments were:
4-hour first experiment:
without S9-mix: 100p, 50p, 25p, 12.5p, 6.25, 3.13, 1.56, 0.78, 0.39 and
0.2 μg/mL.
with S9-mix: 100p, 50p, 25, 12.5, 6.25, 3.13, 1.56, 0.78, 0.39 and
0.2 μg/mL.
6-hour second experiment:
without S9-mix: 25p, 12.5p, 6.25, 3.13, 1.56, 0.78, 0.39 and 0.2 μg/mL.
with S9-mix: 50p, 25p, 12.5, 6.25, 3.13, 1.56, 0.78 and 0.39 μg/mL.
p precipitation
In all cases, the highest concentration in the culture medium did not change the osmolality of
more than 50 mOsm/kg and did not change the pH value of more than 1.0 unit compared to the
concurrent negative control - Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- other: Ethyl methanesulfonate (-S9); 7,12-dimethylbenz[a]anthracene (+S9)
- Species / strain:
- Chinese hamster lung fibroblasts (V79)
- Metabolic activation:
- with and without
- Genotoxicity:
- other: not mutagen
- Cytotoxicity / choice of top concentrations:
- other: not mutagen
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
- Conclusions:
- Interpretation of results (migrated information):
negative
In conclusion, under the experimental conditions of the study, TIB KAT 223 was found negative
in the mutation assay with V79 Chinese Hamster cells at the HPRT (hypoxanthine-guanine
phosphoribosyl transferase) locus in the presence or absence of metabolic activation up to
concentrations exhibiting test article precipitation
Reference
The purpose of this study was to evaluate the potential of TIB KAT 223 to induce forward mutation at the HPRT (hypoxanthine-guanine phosphoribosyl transferase) locus in V79 Chinese Hamster lung cells with and without metabolic activation by liver homogenate (supplemented with cofactors and salts, ie, S9-mix) obtained from rats pretreated with Aroclor. TIB KAT 223 was suspended and diluted in cell culture medium. Depending on the experiment, cells were exposed to TIB KAT 223 for 4 or 6 hours with and without S9-mix. At the end of the exposure period the cloning efficiency was evaluated in microtiter plates. After a phenotypic expression period of 3 to 4 days, cells were cloned for 7 days in 75 cm2 flasks containing the selection agent 6-thioguanine (TG) for the determination of mutant frequency and in nonselective medium to measure the cloning efficiency. In addition, the number of the mutant colonies was determined. In a solubility pre-test concentrations from 0.01 to 5 mg/mL were investigated using the unaided eye for solubility, homogeneity and precipitation evaluation of the test compound in cell culture medium. In this pre-test all concentrations (except 0.01 mg/mL) were found to be suspensions. However, at 0.1 mg/mL (100 μg/mL) we observed a homogenous distribution of the particles. Therefore, 100 μg/mL was chosen as top treatment concentration in accordance to the OECD 476 Guidline. The highest evaluated concentrations were limited by test article precipitation observed at 12.5 μg/mL and above without S9 mix and 50 μg/mL (Exp. 1) respectively 25 μg/mL (Exp. 2) and above with S9 mix.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Additional information
The three performed in vitro genetic toxicity tests (OECD 471, 473, 476) show no evidence of genetic toxicity. In due to the results form the in vitro testing and according Annex IIX of the regulation 1907/2006/EC no in vivo testing is required.
Additional an in-vivo study for the hydrolysis product Dioctlytin oxid is citeted, the outcome of this study is negative, too.
Justification for classification or non-classification
OECD Guideline 471 (Bacterial Reverse Mutation Assay): negative
OECD Guideline 473 (In vitro Mammalian Chromosome Aberration Test): negative
OECD Guideline 476 (In vitro Mammalian Cell Gene Mutation Test): negative
OECD Guideline 474 (Mammalian Erythrocyte Micronucleus Test)
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.