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EC number: 215-958-7 | CAS number: 1461-22-9
- 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
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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:
- 08 January 2003 to 17 January 2003
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 003
- Report date:
- 2003
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- yes
- Remarks:
- See principles of method if other than guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- Deviations:
- not applicable
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- EPA OPPTS 870.5100 - Bacterial Reverse Mutation Test (August 1998)
- Deviations:
- not applicable
- Principles of method if other than guideline:
- Deviations from the protocol:
M. van der Kaaden was involved in this study instead of Ms. G.C.D.M. Bruyntjes-Rozier and Ms. M.J.M. van den Wijngaard.
This deviation is considered not to have influenced the integrity and outcome of the study. - GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Tributyltin chloride
- EC Number:
- 215-958-7
- EC Name:
- Tributyltin chloride
- Cas Number:
- 1461-22-9
- Molecular formula:
- C12H27ClSn
- IUPAC Name:
- tributylstannanylium chloride
- Test material form:
- liquid
- Details on test material:
- - Physical state: colourless liquid
- Storage condition of test material: at < -18 °C, in the absence of light
Constituent 1
Method
- Target gene:
- Histidine is the target gene for salmonela
Tryptophan is the target gene for E.coli
Species / strainopen allclose all
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Additional strain / cell type characteristics:
- not specified
- Species / strain / cell type:
- E. coli WP2 uvr A
- Additional strain / cell type characteristics:
- not specified
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9-mix
- Test concentrations with justification for top dose:
- In total six concentrations were tested: 0.1, 0.3, 0.8, 2.3, 7 and 21 µg/plate.
The actual concentrations of the test material in the test solutions were not determined. Therefore, the concentrations quoted in this report are nominal concentrations. - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: DMSO.
Controlsopen allclose all
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: 2-aminoanthracene
- Remarks:
- For TA1535, TA98, TA100 and E.coli WP2 uvrA in the presence of S9-mix.
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- benzo(a)pyrene
- Remarks:
- For TA1537 in the presence of S9-mix.
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- sodium azide
- Remarks:
- For TA1535 and TA100 in the absence of S9-mix.
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 9-aminoacridine
- Remarks:
- For TA1537 in the absence of S9-mix.
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 2-nitrofluorene
- Remarks:
- For TA98 in the absence of S9-mix.
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- ethylnitrosurea
- Remarks:
- For E.coli WP2 uvrA in the absence of S9-mix.
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar (plate incorporation)
DURATION
- Preincubation period: The plates were incubated at ca. 37 °C for 48-72 hours.
- Exposure duration: 48-72 hours.
NUMBER OF REPLICATIONS:
All determinations were made in triplicate
DETERMINATION OF CYTOTOXICITY
- Method: Cytotoxicity is defined as a reduction in the number of revertant colonies andlor a clearing of the background lawn of bacterial growth. - Evaluation criteria:
- The mutagenicity study is considered valid if the mean colony counts of the control values of the strains are within acceptable ranges, if the results of the positive controls meet the criteria for a positive response, and if no more than 5 % of the plates are lost through contamination or other unforeseen events.
A test material is considered to be positive in the bacterial gene mutation test if the mean number of revertant colonies on the test plates is concentration-related increased or if a reproducible two-fold or more increase is observed compared to that on the negative control plates.
A test material is considered to be negative in the bacterial gene mutation test if it produces neither a dose-related increase in the mean number of revertant colonies nor a reproducible positive response at any of the test points.
In case of an inconclusive first assay, a second independent assay was conducted. The first mutagenicity assay is regarded inconclusive if a positive or equivocal response at only one concentration is observed or if a positive or equivocal responses at several concentrations without a concentration-related increase are observed.
Omission of the second assay under these conditions is acceptable as a single assay does not or hardly results in false negative conclusions.
Positive results from the bacterial reverse mutation test indicate that a substance induces point mutations by base substitutions or frameshifts in the genome of either Salmonella typhimurium and/or Escherichia coli. Negative results indicate that under the test conditions, the test substance is not mutagenic in the tested strains. - Statistics:
- No statistical analysis was performed.
Both numerical significance and biological relevance are considered together in the evaluation.
Results and discussion
Test resultsopen allclose all
- Key result
- Species / strain:
- S. typhimurium, other: TA 1535, TA 1537, TA 98 & TA 100
- Metabolic activation:
- without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium, other: TA 1535, TA 98 and TA 100
- Metabolic activation:
- with
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 1537
- Metabolic activation:
- with
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- E. coli WP2 uvr A
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not specified
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- RANGE-FINDING/SCREENING STUDIES:
A dose range finding test to assess the toxicity of the test material to the bacteria was performed with TA98 both in the absence and presence of S9-mix. DMSO was chosen as vehicle. Just before use, the test material was diluted in the vehicle at 50 mg/mL. A transparent colourless solution was obtained. Serial 3-fold dilutions in DMSO were prepared and in total ten dilutions were tested, ranging from 0.3 to 5000 µg/plate.
Any other information on results incl. tables
The test material was diluted in DMSO. A dose range finding test was performed with TA98 in both the absence and the presence of S9-mix with ten different concentrations of the test substance, ranging from 0.3 - 5000 µg/plate. The test material was toxic at concentrations above 7 µg/plate.
In the main bacterial reverse mutation test six different concentrations were tested ranging from 0.1 - 21 µg/plate. Negative controls (solvent) and positive controls were run simultaneously with the test material.
In the absence of S9-mix, the test material was toxic to all Salmonella typhimurium strains at 7 and 21 µg/plate and in the presence of S9-mix to strain TA 1537 at 21 µg/plate, as was evidenced by the presence of pinpoints or a decrease in the mean number of revertant colonies compared to the negative controls.
In both the absence and the presence of S9-mix and in all strains, the test material did not cause a more than two-fold increase in the mean number of revertant colonies appearing in the test plates compared to the background spontaneous reversion rate observed with the negative control.
The mean number of his+ and trp+ revertant colonies of the negative controls were within the acceptable range, and the positive controls gave the expected increase in the mean number of revertant colonies.
It is concluded that the results obtained with the test material in Salmonella typhimurium strains TA 1535, TA 1537, TA 98 and TA 100, and in the Escherichia coli strain WP2 uvrA, in both the absence and the presence of the S9-mix, indicate that the test material was not mutagenic under the conditions employed in this study.
Applicant's summary and conclusion
- Conclusions:
- It is concluded that the results obtained with the test material in Salmonella typhimurium strains TA 1535, TA 1537, TA 98 and TA 100, and in the Escherichia coli strain WP2 uvrA, in both the absence and the presence of the S9-mix, indicate that the test material was not mutagenic under the conditions employed in this study.
- Executive summary:
In a Bacterial reverse mutation test, the results obtained with the test material in Salmonella typhimurium strains TA 1535, TA 1537, TA 98 and TA 100, and in the Escherichia coli strain WP2 uvrA, in both the absence and the presence of the S9-mix, indicate that the test material was not mutagenic under the conditions employed in this study.
In the absence of S9-mix, the test material was toxic to all Salmonella typhimurium strains at 7 and 21 µg/plate and in the presence of S9-mix to strain TA 1537 at 21 µg/plate, as was evidenced by the presence of pinpoints or a decrease in the mean number of revertant colonies compared to the negative controls.
The study was conducted to the OECD Guideline no. 471.
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