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EC number: 222-583-2 | CAS number: 3542-36-7
- 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
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- Water solubility
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- 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
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- Additional physico-chemical information
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- Nanomaterial crystalline phase
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- Endpoint summary
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- Environmental data
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- 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
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- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
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- Repeated dose toxicity
- Genetic toxicity
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- Specific investigations
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- Additional toxicological data

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:
- 6th December 1988 - 21st February 1989
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study conducted in compliance with agreed protocols, with no or minor deviations from standard test guidelines and/or minor methodological deficiencies, which do not affect the quality of the relevant results.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 989
- Report date:
- 1989
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 476 (In Vitro Mammalian Cell Gene Mutation Test)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- mammalian cell gene mutation assay
Test material
- Reference substance name:
- Dichlorodioctylstannane
- EC Number:
- 222-583-2
- EC Name:
- Dichlorodioctylstannane
- Cas Number:
- 3542-36-7
- Molecular formula:
- C16H34Cl2Sn
- IUPAC Name:
- dichlorodioctylstannane
- Details on test material:
- Purity is 96.3%
Constituent 1
Method
- Target gene:
- The gene for the enzyme HGPRT (Hypoxanthine-Guanine Phos-phoribosyl Transferase) is located on the X-chromosome of the Chinese hamster.
Species / strain
- Species / strain / cell type:
- Chinese hamster lung fibroblasts (V79)
- Details on mammalian cell type (if applicable):
- NDA
- Additional strain / cell type characteristics:
- other: HGPRT
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9 fraction from liver of male Sprague-Dawley rats
- Test concentrations with justification for top dose:
- Without metabolic activation (µM): 1, 5, 10, 20, 30, 50, (first test); 1, 5, 7.5, 10, 15, 20, 30 (repetition).
With metabolic activation (µM): 1, 5, 10, 20, 30, 50, 75 (first test); 1, 5, 10, 20, 30, 40, 50 (repetition). - Vehicle / solvent:
- DMSO
Controlsopen allclose all
- Untreated negative controls:
- yes
- Remarks:
- blank medium
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- ethylmethanesulphonate
- Remarks:
- without metabolic activation
- Untreated negative controls:
- yes
- Remarks:
- blank medium
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 7,12-dimethylbenzanthracene
- Remarks:
- with metabolic activation
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in medium
DURATION
- Preincubation period: 2 days
- Exposure duration: 3 hours
- Expression time (cells in growth medium): 7 days
- Selection time (if incubation with a selection agent): 4 days
- Fixation time (start of exposure up to fixation or harvest of cells): 10 - 11 days
SELECTION AGENT (mutation assays): 6-Thioguanine
SPINDLE INHIBITOR (cytogenetic assays): N/A
STAIN (for mutagenic assays): 10 % methylene blue in 0.01 n KOH
NUMBER OF REPLICATIONS: Subcultured into 5 cells per flask per concentration.
NUMBER OF CELLS EVALUATED: 5 x 10^5 cells per flask
DETERMINATION OF CYTOTOXICITY
The toxicity of the test material was checked in a pilot test. 500 cells per 5 ml medium were seeded in 25cm^2 flasks; two flasks per concentration were used. After 24 hours the medium was replaced by medium without serum containing different doses of the test compound for 3 hours. After washing the cells, new nutrient medium was added. The cells were grown for 5 days, then the colonies were stained and counted. The toxicity test was performed without and with metabolic activation - Evaluation criteria:
- The test substance is classified as mutagenic if there is a reproducible statistically significant dose-dependent increase in the mutation rate. This increase should be three times higher than the spontaneous mutation rate.
The mutation rate is enhanced by mutagenic substances with different mechanisms: base substitutions, frameshifts and chromosome rearrangements. The number of living cells in the selective medium, which contains purine analogues, is therefore a criterion for the mutagenic properties of a substance. - Statistics:
- The statistical method to be used, if required is the U-test according to Mann-Whithney.
Because the results were obviously negative in this case, no statistical analysis was performed.
Results and discussion
Test results
- Species / strain:
- Chinese hamster lung fibroblasts (V79)
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- Toxic to the cells at concentrations of 30 uM and above without metabolic activation and of 50 RM and above with metabolic activation.
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- RANGE-FINDING/SCREENING STUDIES:
The toxicity of the test material was checked in a pilot test. 500 cells per 5 ml medium were seeded in 25cm^2 flasks; two flasks per concentration were used. After 24 hours the medium was replaced by medium without serum containing different doses of the test compound for 3 hours. After washing the cells, new nutrient medium was added. The cells were grown for 5 days, then the colonies were stained and counted. The toxicity test was performed without and with metabolic activation
COMPARISON WITH HISTORICAL CONTROL DATA:
NDA
ADDITIONAL INFORMATION ON CYTOTOXICITY:
The pre-test for toxicity of the substance showed a steep slope of the dose-response curve. Without metabolic activation the substance is not toxic for the cells at 20 µM/mL, but at 50 µM/mL the toxicity was nearly 100 %. With metabolic activation there was no toxicity at 20 µM/mL , at 50 µM/mL about 67 % of the cells were growing compared to the control and at 100 µM/mL no cells were growing. - Remarks on result:
- other: strain/cell type: HGPRT
- Remarks:
- Migrated from field 'Test system'.
Any other information on results incl. tables
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative
Under the conditions of this assay the test material ZK 21979 had no mutagenic effect. - Executive summary:
An in vitro test was performed to assess the potential mutagenic activity of ZK 21979 (dioctyltin dichloride) in the HGPRT-test with the Chinese hamster cell line V79. The study was conducted as per OECD 476 to GLP standard.
Under the conditions of this assay the test material ZK 21979 had no mutagenic effect without or with metabolic activation.
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