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EC number: 201-039-8 | CAS number: 77-58-7
- 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
- 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
- Remarks:
- Type of genotoxicity: gene mutation
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- March 5-18, 2002
- 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:
- 2 002
- Report date:
- 2002
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- yes
- Remarks:
- The test substance was stored at ,-20 degrees Celsius, instead of between -16 and -20 degrees celsius. However, it was stated in the test substance information sheet that the storage conditions should be <-18 degrees Celsius, therefore the deviation is c
- Principles of method if other than guideline:
- No further information required.
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- dibutyloxostannane
- IUPAC Name:
- dibutyloxostannane
- Reference substance name:
- di-n-butyltin oxide
- IUPAC Name:
- di-n-butyltin oxide
- Reference substance name:
- Dibutyltin oxide
- EC Number:
- 212-449-1
- EC Name:
- Dibutyltin oxide
- Cas Number:
- 818-08-6
- IUPAC Name:
- dibutyl(oxo)stannane
- Details on test material:
- - Name of test material (as cited in study report): dibutyloxostannane
- Molecular formula (if other than submission substance): C8 H18 OSn
- Molecular weight (if other than submission substance): 248.92
- Structural formula attached as image file (if other than submission substance): see Fig.
- Substance type: white powder
- Analytical purity: 98.09% Dibutyltin oxide
- Composition of test material, percentage of components: 98.09% Dibutyltin oxide, 0.49% di-(i,n)-butyltin oxide, 0.40% monobutyltin oxide, 0.86% tetrabutyldiethyl distannane, 0.17% tributyltin oxide
- Lot/batch No.: 1704
- Expiration date of the lot/batch: October 2003
- Stability under test conditions:
- Storage condition of test material: at <-20 degrees C, in the absence of light
- Other: received 12 October 2003
- Expiry date: October 2003
- Supplier: sent to TNO at the request of ORTEP Asociation Stabilizer Task Force
- TNO Test Substance No.: IMW-01040160B
Constituent 1
Constituent 2
Constituent 3
Method
- Target gene:
- rfa, uvrB/A,and R-factor
Species / strainopen allclose all
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Species / strain / cell type:
- E. coli WP2 uvr A
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9 liver homogenate (S9-mix)
- Test concentrations with justification for top dose:
- Assay 1: 7, 21, 62, 185, 556, 1667, 5000 µg/plate.
Assay 2: 1.25, 2.5, 5, 10, 20 µg/plate - Vehicle / solvent:
- Methanol
Controlsopen allclose all
- Untreated negative controls:
- yes
- Remarks:
- solvent
- Positive controls:
- yes
- Positive control substance:
- sodium azide
- Remarks:
- For strain TA1535 and strain TA100 in the absence of the S9-mix
- Untreated negative controls:
- yes
- Remarks:
- solvent
- Positive controls:
- yes
- Positive control substance:
- 9-aminoacridine
- Remarks:
- For strain TA1537 in the absence of the S9-mix
- Untreated negative controls:
- yes
- Remarks:
- solvent
- Positive controls:
- yes
- Positive control substance:
- other: 2-aminoanthracene
- Remarks:
- For strain TA1535, TA98, TA100, and WP 2 uvrA in the presence of the S9-mix
- Untreated negative controls:
- yes
- Remarks:
- solvent
- Positive controls:
- yes
- Positive control substance:
- 2-nitrofluorene
- Remarks:
- For strain TA98 in the absence of the S9-mix
- Untreated negative controls:
- yes
- Remarks:
- solvent
- Positive controls:
- yes
- Positive control substance:
- other: N-ethyl-N-nitrosourea
- Remarks:
- For strain WP 2 uvrA in the absence of the S9-mix
- Untreated negative controls:
- yes
- Remarks:
- solvent
- Positive controls:
- yes
- Positive control substance:
- benzo(a)pyrene
- Remarks:
- For strain TA1537 in the presence of the S9-mix
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar (plate incorporation)
DURATION
- Exposure duration: 37 degrees Celsius for 48-72 hours - 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 of other unforeseen events.
A test substance 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 substance 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 reproducivle positive response at any of the test points.
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 E. coli. Negative results indicate that under the test conditions, the test substance is not mutagenic in the tested strains.
In case of an inconclusive first assay, a second independant assay was conducted. The first mutagenicity assay is regarded inconclusive if a positive or equivocal response at only one concentrations is observed or if a positive or equivocal responses at several concentrations without a concentration-related increase are observed. - Statistics:
- No statistical analysis was performed. Both numerical significance and biological relevance are considered together in the evaluation.
Results and discussion
Test results
- Species / strain:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- not specified
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- Genotoxic effects: negative both with and without metabolic action.
In both the absence and presence of S9-mix and in all strains, dibutyloxostannane did not cause a more than two-fold or a dose-related 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. - Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'. Remarks: all strains
Any other information on results incl. tables
Table 1. Bacterial reverse mutation test with dibutyloxostannane (first assay) | ||||||||||
Average number of revertants per plate | ||||||||||
Dose ug/plate | TA 1535 | TA1537 | TA98 | TA 100 | E-coli | |||||
without S9 | with S9 | without S9 | with S9 | without S9 | with S9 | without S9 | with S9 | without S9 | with S9 | |
0 | 25 | 24 | 17 | 12 | 35 | 51 | 168 | 171 | 37 | 40 |
7 | 17 | 17 | 20 | 12 | 34 | 49 | 155 | 169 | 34 | 39 |
21 | 11 | 15 | 5 | 5 | 23 | 29 | 109 | 105 | 26 | 25 |
62 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 24 | 13 |
185 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 11 | 5 |
556 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
1667 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
5000 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Positive control | 713 | 525 | 1220 | 348 | 2078 | 810 | 886 | 2013 | 228 | 1720 |
Table 2. Bacterial reverse mutation test with dibutyloxostannane (second assay) | ||||||||||
Average number of revertants per plate | ||||||||||
Dose ug/plate | TA 1535 | TA1537 | TA98 | TA 100 | E-coli | |||||
without S9 | with S9 | without S9 | with S9 | without S9 | with S9 | without S9 | with S9 | without S9 | with S9 | |
0 | 26 | 24 | 12 | 15 | 25 | 35 | 153 | 161 | 21 | 27 |
1.25 | 19 | 23 | 13 | 14 | 25 | 38 | 174 | 169 | 25 | 26 |
2.5 | 11 | 17 | 5 | 9 | 20 | 31 | 142 | 180 | 25 | 26 |
5 | 16 | 21 | 9 | 8 | 23 | 35 | 153 | 174 | 25 | 21 |
10 | 13 | 17 | 6 | 6 | 20 | 35 | 132 | 138 | 21 | 32 |
20 | 10 | 12 | 3 | 4 | 16 | 18 | 95 | 95 | 23 | 22 |
Positive control | 489 | 428 | 811 | 295 | 1170 | 965 | 509 | 1635 | 195 | 1045 |
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative In both the absence and presence of S9-mix, and in all strains
It is concluded that the results obtained with the test substance in Salmonella typhimurium strains TA 1535, TA 1537, TA 98, and TA 100, and in the E. coli strain WP2 uvrA, in both the absence and presence of the S9-mix, indicate that dibutyloxostannane was not mutagenic under the conditions employed in this study. - Executive summary:
Dibutyloxostannane was examined for mutagenic activity in the bacterial reverse mutation test using the histidine-requiring Salmonella typhimurium strains TA 1535, 1537, 98 and 100 and the tryptophan-requiring E. coli strain WP2 uvrA, and a liver fraction of Aroclor 254 -induced rats from metabolic activation (S9 -mix). In both the absence and the presence of S9 -mix and in all strains, dibutyloxostanane did not cause a more than two-fold or a dose-related 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 dibutyloxostannane was not mutagenic under the conditions employed in this study.
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