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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
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EC number: 212-449-1 | CAS number: 818-08-6
- 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)
Basic toxicokinetics
Administrative data
- Endpoint:
- basic toxicokinetics in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- no information
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 004
- Report date:
- 2004
Materials and methods
- Objective of study:
- other: to simulate the hydrolytic action by mammalian gastric contents and to determine if the tin-ligand bond breaks, leading to formation of the corresponding alkyltin chloride and release of the ligand.
- Principles of method if other than guideline:
- DBTO was tested under low pH (~1-2) conditions (0.07 N HCl) at 37 °C in order to simulate the hydrolytic action by mammalian gastric contents. The degree of hydroloysis for the test substance was studied by determination of the amount of DBTC formed after 0.5, 1, 2, and 4 hours, using GC-FPD.
- GLP compliance:
- not specified
Test material
- Reference substance name:
- Dibutyltin oxide
- EC Number:
- 212-449-1
- EC Name:
- Dibutyltin oxide
- Cas Number:
- 818-08-6
- Molecular formula:
- C8H18OSn
- IUPAC Name:
- dibutylstannanone
- Details on test material:
- - Name of test material (as cited in study report): Dibutyltin oxide (DBTO)
- Molecular formula (if other than submission substance): (C4H9)2SnO
- Molecular weight (if other than submission substance): 248.92
- Analytical purity: 99.2%
- Lot No: 1704
Constituent 1
- Radiolabelling:
- no
Test animals
- Species:
- other: No species were used - simulated gastric hydrolysis
- Strain:
- not specified
- Sex:
- not specified
- Details on test animals or test system and environmental conditions:
- DBTO was tested under low pH (~1-2) conditions (0.07 N HCl) at 37 °C in order to simulate the hydrolytic action by mammalian gastric contents. The degree of hydroloysis for the test substance was studied by determination of the amount of DBTC formed after 0.5, 1, 2, and 4 hours, using GC-FPD.
Administration / exposure
- Route of administration:
- other: test to simulate mammalian gastric contents
- Vehicle:
- other: insoluble in solvent; 'diluted' by thoroughly mixing with 811.17 mg of lactose
- Details on exposure:
- No information available.
- Duration and frequency of treatment / exposure:
- No information available.
Doses / concentrations
- Remarks:
- Doses / Concentrations:
50 mg of DBTO/lactose mixture (0.199 mg/mg) was added to 1000 ml of 0.07 N HCl.
- No. of animals per sex per dose / concentration:
- No information available.
- Control animals:
- no
- Positive control reference chemical:
- No further information required.
- Details on study design:
- Into a series of 4 PTFE vessels, 50 mg (accurately weighed) of the DBTO/lactose mixture (0.199 mg/mg) was added to 1000 ml of 0.07 N HCl (already at 37 degrees Celsius). In this way, the concentration of DBTO in the final 0.07 N HCl solution was approximately 10 mg/L. The solution was stirred, and the temperature was maintained using an oven.
- Details on dosing and sampling:
- A sample was taken from one of the Teflon vessels after 0.2, 1, 2, and 4 hours. Once a vessel was sampled, no other sample was collected from that vessel. Experiments were performed in duplicate.
- Statistics:
- The percentage of hydrolyzed organotin test substance based on the DBTC measurement was calculated as follows: The total amount of DBTC in solution that can be formed upon complete hydrolysis of the test substance was approximately 12 mg/l (DBTO) was weighed and thus varied slightly per sample. This level was calculated using the following formula:
50 (mg) * 0.20 (mg/mg)/1000 ml * Mw(DBTC)/Mw(DBTO).
Results and discussion
- Preliminary studies:
- The mean percentage of hydrolysis of DBTO is summarized in Table 7 (see below). Under chemical conditions intended to simulate mammalian gastric contents, as described in this report, DBTO was hydrolyzed to a great extent. Approximately 80% hydrolysis to DBTC occurred in 2 hours and percent hydrolysis to DBTC in 4 hours was 87%. The half life of DBTO was 3.5 hours.
Toxicokinetic / pharmacokinetic studies
- Details on absorption:
- No information available.
- Details on distribution in tissues:
- No information available.
- Details on excretion:
- No information available.
Toxicokinetic parameters
- Toxicokinetic parameters:
- half-life 1st: 3.5 hours
Metabolite characterisation studies
- Metabolites identified:
- yes
- Details on metabolites:
- The percentage of hydrolyzed organotin test substance was determined. DBTC in solution can be formed upon complete hydrolysis of DBTO.
Any other information on results incl. tables
Table 7. Summary of the results of the simulated gastric hydrolysis of DBTO | ||||||
Time | Mean percentage of hydrolysis (DBTC values) % | |||||
0.5 | 42.6 | |||||
1 | 64.8 | |||||
2 | 80.3 | |||||
4 | 87.3 |
Applicant's summary and conclusion
- Conclusions:
- DBTO may be hydrolyzed to a great extent in simulated mammalian gastric contents.
Under chemical conditions intended to simulate mammalian gastric contents, for DBTO the percent hydrolysis was 87.3% and the half life was 3.5 hours. - Executive summary:
Dibutyltin oxide was tested under pH 1 -2 conditions (0.07 N HCl) at 37 degrees C in order to simulate the hydrolytic action by mammalian gastic contents. The hypothesis was that in the hydrochloric acid solution, the tin-ligand bond breaks, leading to formation of the corresponding alkyltin chloride and simultaneous liberation of the ligand. The degree of hydrolysis was tested by GC-FPD. Where possible, the ligand was also analyzed. The analytical approach to the individual ligands, maleate, laurate and oxide, was different due to the unique chemical properties of each. It was not possible to carry out the simulated gastic hydrolysis study for dioctyltin oxide. DBTO hydrolyzed to 87.3% after 4 hours, with a half-life at 3.5 hours.
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