Registration Dossier
Registration Dossier
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EC number: 212-414-0 | CAS number: 814-94-8
Basic toxicokinetics
Administrative data
- Endpoint:
- basic toxicokinetics in vivo
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 4 (not assignable)
Data source
Reference
- Reference Type:
- publication
- Title:
- Studies on the kinetics of bis(tris-«-butyl-ll3tin) oxide (TBTO).
- Author:
- Humpel, M. Kuhne. G. Tauber. U., Schulze. P. E.
- Year:
- 1 986
- Bibliographic source:
- Toxicology atid Analytics of the Tributyltins: The Present Status. Ortepa Workshop, Berlin: Verlag Ortepa Association. pp. 122-142
Materials and methods
- Objective of study:
- absorption
- distribution
- GLP compliance:
- not specified
Test material
- Reference substance name:
- Tributyltins
- IUPAC Name:
- Tributyltins
- 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:
- hexabutyldistannoxane
- Details on test material:
- - Name of test material (as cited in study report):113Sn-labelled TBTO [bis(tributyltin) oxide]- Molecular formula (if other than submission substance):C24H54OSn2- Molecular weight (if other than submission substance):596.112 g/mol - Substance type:Organic- Physical state:Liquid- Analytical purity:NA
Constituent 1
Constituent 2
- Radiolabelling:
- yes
Test animals
- Species:
- rat
- Strain:
- not specified
- Sex:
- not specified
Administration / exposure
- Route of administration:
- oral: unspecified
- Vehicle:
- not specified
- Details on exposure:
- Absorption and distribution pattern was observed following a single oral administration of 113Sn-labelled TBTO
- Duration and frequency of treatment / exposure:
- Single oral exposure
Doses / concentrations
- Remarks:
- Doses / Concentrations:25 mg/kg bw
- No. of animals per sex per dose / concentration:
- Details not available
- Control animals:
- no
Results and discussion
Main ADME resultsopen allclose all
- Type:
- absorption
- Results:
- In rats TBTO was absorbed incompletely and slowly from the gastro-intestinal tract.
- Type:
- distribution
- Results:
- Distribution in the organism was rapid. Maximum plasma levels were reached after about 1 day.
- Type:
- distribution
- Results:
- High residues of radiolabel were found in the liver and kidney (I to 3 days after dosing) of which only a small amount was unchanged TBTO. The liver contained more than 95% of radiolabel as TBTO metabolites.
- Type:
- distribution
- Results:
- Other organs and tissues (e.g.,brain and fatty tissue) showed lower concentrations but the fraction of unchanged TBTO was higher.
- Type:
- distribution
- Results:
- Whole body autoradiography did not demonstrate high levels of radiolabel in peripheral tissues as compared to excretory organs and contents of gastro-intestinal tract.
Toxicokinetic / pharmacokinetic studies
- Details on absorption:
- Not applicable as the chemical does not have pharma application.
- Details on distribution in tissues:
- Not applicable as the chemical does not have pharma application.
Transfer into organs
- Test no.:
- #1
- Transfer type:
- other: Liver and Kidney
- Observation:
- other: Organs exhibiting radioactivity
Metabolite characterisation studies
- Metabolites identified:
- no
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information): other: •Bio-accumulation potential cannot be judged based on study resultsBis(tributyltin) oxide was found to be absorbed incompletely and slowly from the gastro-intestinal tract. Distribution in the organism was rapid. The liver contained more than 95% of radiolabel as TBTO metabolites. However, in the absence of information related to excretion out of the living system of Rat; the bio-accumulation potential cannot be judged based on study results.
- Executive summary:
Bis(tributyltin) oxide was found to beabsorbed incompletely and slowly from the gastro-intestinal tract. Distribution in the organism was rapid. The liver contained more than 95% of radiolabel as TBTO metabolites. However, in the absence of information related to excretion out of the living system of Rat; the bio-accumulation potential cannot be judged based on study results.
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