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Diss Factsheets
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EC number: 200-268-0 | CAS number: 56-35-9
- 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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Repeated dose toxicity: inhalation
Administrative data
- Endpoint:
- short-term repeated dose toxicity: inhalation
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- secondary literature
Data source
Reference
- Reference Type:
- review article or handbook
- Title:
- Unnamed
- Year:
- 1 986
- Report date:
- 1986
Materials and methods
Test guideline
- Qualifier:
- no guideline available
- Principles of method if other than guideline:
- During inhalation studies with TBTO over 29-32 days (on 5 days/week, i.e. 21-24 treatments) rats were exposed in nose-only chambers over 4 hour periods.
- GLP compliance:
- not specified
- Limit test:
- no
Test material
- Reference substance name:
- Bis(tributyltin) oxide
- EC Number:
- 200-268-0
- EC Name:
- Bis(tributyltin) oxide
- Cas Number:
- 56-35-9
- Molecular formula:
- C24H54OSn2
- IUPAC Name:
- tributyl[(tributylstannyl)oxy]stannane
- Details on test material:
- Reported as Tributyltin oxide (TBTO) , with the synonyms bis (tri-n-butyltin) oxide or hexa-n-butyldistannoxane
Constituent 1
Test animals
- Species:
- rat
- Strain:
- not specified
- Sex:
- not specified
Administration / exposure
- Route of administration:
- other: aerosol or vapour
- Type of inhalation exposure:
- nose only
- Vehicle:
- air
- Remarks on MMAD:
- MMAD / GSD: Aerosol had 90-100% inhalable particles within it
- Details on inhalation exposure:
- Figure of expemerimental design provided, components included regulator and rotameter for inlet air, washing bottles with test material for generation of aerosol or vapour, particle filter (which was omittede in case of aerosol) wahsing bottle with water for admixture of humid air, nose only exposure chamber 60L volume, regulator and rotameter for exhaust air with washing bottle for removal of test material, temperature and humidity control, absorption washing bottles for determination of actual concentration, optical particle counter.
- Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- Acutal chamber concentration and particle size distribution in the chamber were controlled repeatedly.
- Duration of treatment / exposure:
- 4 h
- Frequency of treatment:
- 5d/wk
21-24 treatments over 29-32 days
Doses / concentrationsopen allclose all
- Dose / conc.:
- 0.03 mg/m³ air (analytical)
- Remarks:
- vapour
- Dose / conc.:
- 0.16 mg/m³ air (nominal)
- Remarks:
- vapour
- Dose / conc.:
- 2.8 mg/m³ air (analytical)
- Remarks:
- aerosol
- No. of animals per sex per dose:
- 10/sex
- Control animals:
- yes, sham-exposed
- Positive control:
- No information
Results and discussion
Results of examinations
- Clinical signs:
- effects observed, treatment-related
- Description (incidence and severity):
- At 2.8 mg/m³ aerosol, 5 males and 6 females died; apathy and respiratory distress was observed
- Mortality:
- mortality observed, treatment-related
- Description (incidence):
- At 2.8 mg/m³ aerosol, 5 males and 6 females died; apathy and respiratory distress was observed
- Body weight and weight changes:
- effects observed, treatment-related
- Description (incidence and severity):
- At 2.8 mg/m³ aerosol, decreased weight gain
- Food consumption and compound intake (if feeding study):
- effects observed, treatment-related
- Description (incidence and severity):
- At 2.8 mg/m³ aerosol, decreased food consumption
- Food efficiency:
- not specified
- Water consumption and compound intake (if drinking water study):
- not specified
- Ophthalmological findings:
- not specified
- Haematological findings:
- effects observed, treatment-related
- Description (incidence and severity):
- At 2.8 mg/m³ aerosol, α1-, total α, β-globulin ↓, albumin-globulin ratio ↓)
- Clinical biochemistry findings:
- not specified
- Urinalysis findings:
- not specified
- Behaviour (functional findings):
- not specified
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Gross pathological findings:
- effects observed, treatment-related
- Description (incidence and severity):
- At 2.8 mg/m³ aerosol, inflammatory reactions with the total respiratory tract and lymphotoxic effects
- Histopathological findings: non-neoplastic:
- not specified
- Histopathological findings: neoplastic:
- not specified
Effect levels
open allclose all
- Dose descriptor:
- NOAEL
- Effect level:
- 0.16 mg/m³ air (analytical)
- Based on:
- test mat.
- Remarks:
- vapour
- Sex:
- male/female
- Dose descriptor:
- LOAEL
- Effect level:
- 2.8 mg/m³ air (analytical)
- Based on:
- test mat.
- Remarks:
- aerosol (90-100% inhalable particles)
- Sex:
- male/female
- Basis for effect level:
- body weight and weight gain
- clinical biochemistry
- clinical signs
- food consumption and compound intake
- histopathology: non-neoplastic
- mortality
Target system / organ toxicity
- Critical effects observed:
- not specified
Applicant's summary and conclusion
- Conclusions:
- In rats exposed to the 2.8 mg/m³ aerosol, 11/20 animals died and a decrease in food consumption and weight gain was observed; other effects at this concentration included changes in hematology parameters, inflammatory reactions in the respiratory tract, and lymphotoxic effects. The NOAEL was determined 0.16 mg/m³. The LOAEL was determined to be 2.8 mg/m³.
- Executive summary:
In an inhalation study with tributyltin oxide rats were exposed in nose only chambers for 4 hours 5 days a week for 21 -24 treatments for 29 -32 days. The acutal chamber concentration and particle size distribution in the exposure chamber were controlled repeatedly; dose groups included sham exposed animals, 0.03 mg/m³ vapour, 0.16 mg/m³ vapour, and 2.8 mg/m³ aerosol (90 -100% inhalable particles). The higher of the two vapour concentration corresponds to the equilibriium vapour pressure of the test material in the chamber atmosphere and can be regarded as a no-effect level. In rats exposed to the 2.8 mg/m³ aerosol, 11/20 animals died and a decrease in food consumption and weight gain was observed; other effects at this concentration included changes in hematology parameters, inflammatory reactions in the respiratory tract, and lymphotoxic effects. The NOAEL was determined 0.16 mg/m³. The LOAEL was determined to be 2.8 mg/m³.
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.
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