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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
Dermal absorption
Administrative data
- Endpoint:
- dermal absorption in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- 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:
- 1 985
- Report date:
- 1985
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- The percutaneous absorption of 113Sn-labelled ZK 21 955 through the intact abdominal skin was studied in vivo in baboons. Two male baboons (animal no. A89, 16.8 kg and no. A92 14.6 kg) were fixed lying on the back and 0.5 mL (=370 kBq) was applied to two areas of 25 cm² intact abdominal skin.
After 7 hours of exposure the unabsorbed substance on the surface of the skin was wiped off by swabs of cotton-wool and the stratum corneum removed by 20 strips of adhesive tape. Urine and faeced were collected up to 16 days after application. Radioactivity in swabs, horny layer strips and in excreta (urine and faeces) was determined by direct counting of an aliquot in the auto-gamma scintillation spectrometer (Type 5285, Mess. Packard, Illinois, USA). - GLP compliance:
- yes
- Remarks:
- 40 CFR Part 792
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:
- - Name of test material : Tributyltin oxide (TBTO)
- Locations of the label (if radiolabelling): (n-C4H9)3-Sn*-O-Sn*-(n-C4H9)3
Constituent 1
- Radiolabelling:
- yes
- Remarks:
- 113 Sn
Test animals
- Species:
- primate
- Strain:
- other: baboon
- Sex:
- male
Administration / exposure
- Type of coverage:
- not specified
- Vehicle:
- unchanged (no vehicle)
- Duration of exposure:
- 7 hours
- Doses:
- 0.5mL of radiolabled Sn TBTO on two 25 cm² area of abdominal skin (250 uL/25cm²); [NOTE - table indicates it was only 20 µl so some discrepancy between text and table.]
- No. of animals per group:
- 2
- Control animals:
- no
- Details on study design:
- Baboons (2) were fixed lying on the back and 0.5 mL (~370 kBq) of 113SnZk21.955 was applied to two areas of 25 cm² on the intact abdominal skin. After 7 hours of exposure, the unabsorbed substance on the skin was wiped off by swabs of cotton-wool and the stratum corneum removed by 20 strips of adhesive tape. Urine and feces were collected up to 16 d after application. Radioactivity in swabs horny layer and in excreta were determined by direct counting of an aliquot in the auto gamma-scilntillation spectrometer.
Results and discussion
- Signs and symptoms of toxicity:
- not specified
- Dermal irritation:
- yes
- Remarks:
- within 3 days after application, severe inflammation of the skin accompanied by exsudation and partial separation of the epdiermis. Lesions were larger than area of application indicating that substance easily spreads over skin
- Absorption in different matrices:
- After 7 h,
~15.4% of the applied dose could be removed with cotto/wool swab
~17.5% of the applied dose was found in the horny layer; radioactivity within the stratum corneum decreased from most distal to proximal layers by approximately 1 deade; the horny layer works as a penetration barrier for TBTO
~8.9% of applied dose was eliminated within 16 d in the feces
~1.37% of the applied dose was exreted within 13 d in urine
Note: fecal to:urine excretion rate was similar in both animals but great variation in excretion rates was observed between them.
Animal 1 excretion half life was 3-3.5 d; Animal 2 excretion half life was~8 d
>90% of the absorbed dose was eliminated from animal 1 (~12% of the applied dose) (higher excretion rate)
~75% of the absorbed dose was eliminated from animal 1 (~7.5% of the applied dose) - Total recovery:
- The poor total recoveryof radioactivity of < 50% may be mainly the result of incomplete remova of unabsorbed substance on the skin surface due to the extensive spreading of the substance beyond the marked site of application
- Conversion factor human vs. animal skin:
- No data
Any other information on results incl. tables
Summary of recovery of radiolabel on the skin, in horny layer (strips), urine and feces
% of dose per skin area
Animal No. 1a 1b 2a 2b Mean
recovery from surface of skin 15.56 17.17 14.15 13.60 15.12
Horny layer of skin (sum of 20 strips) 19.37 18.90 14.52 17 17.45
Urine (half life) 1.45 (3.71) 1.29 (7.67) 1.37 (5.69)
Feces 10.55 (3.18) 6.22 (8.87) 8.39 (6.02)
Applicant's summary and conclusion
- Conclusions:
- Radiolabeled 113Sn tri-n-butyltin oxide was percutaneously aborobed (10-15%) after 7 h abdominal dermal application on baboons. Severe skin irritation was observed and spread beyond the site of application. The test material was removed from the body, with a half life ranging from 3 to 8 days.
- Executive summary:
In a non-guideline study, after dermal application of undiluted 113Sn radiolabelled tri-n-butytin oxide (TBTO) to the intact abdominal skin of two baboons, severe skin reactions occurred and the substance spread beyond its marked site of application. Undiluted TBTO was percutaneously absorbed. Within and exposure time of 7 h, 10 -15% of the dose became systemically available. Absorbed TBTO is slowly removed from the body with half lives ranging from 3 to 8 days in baboons. Daily dermal contact could lead to an accumulation of substance in the body if similar excretion half-lives are anticipated in humans.
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