Registration Dossier
Registration Dossier
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EC number: 200-268-0 | CAS number: 56-35-9
Developmental toxicity / teratogenicity
Administrative data
- Endpoint:
- developmental toxicity
- Type of information:
- other: summary of experimental results
- Adequacy of study:
- supporting study
- Study period:
- 1986
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- secondary literature
Data source
Reference
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 1 986
- Report date:
- 1986
Materials and methods
Test guideline
- Qualifier:
- no guideline available
- Principles of method if other than guideline:
- A review of available data concerning teratogneic effects of tributyltin compounds.
- GLP compliance:
- not specified
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 TBTO
Constituent 1
Test animals
- Species:
- other: rat and mouse
- Strain:
- not specified
Administration / exposure
- Route of administration:
- not specified
- Vehicle:
- not specified
- Details on exposure:
- No information
- Analytical verification of doses or concentrations:
- not specified
- Details on mating procedure:
- No information
- Duration of treatment / exposure:
- No information
- Frequency of treatment:
- No information
- Duration of test:
- No information
Doses / concentrations
- No. of animals per sex per dose:
- No information
Examinations
- Maternal examinations:
- No information
- Ovaries and uterine content:
- No information
- Fetal examinations:
- No information
- Statistics:
- No information
Results and discussion
Results: maternal animals
Maternal developmental toxicity
- Details on maternal toxic effects:
- Maternal toxic effects:yes
Details on maternal toxic effects:
No information
Results (fetuses)
- Details on embryotoxic / teratogenic effects:
- Embryotoxic / teratogenic effects:no effects. Remark: at non maternal toxic doses
Details on embryotoxic / teratogenic effects:
No information
Effect levels (fetuses)
- Dose descriptor:
- NOAEL
- Effect level:
- other: unknown
- Based on:
- other: non-maternal toxic dose level
- Basis for effect level:
- other: embryotoxicity
Fetal abnormalities
- Abnormalities:
- not specified
Overall developmental toxicity
- Developmental effects observed:
- not specified
Any other information on results incl. tables
TBTO was employed in an in vitro system, the “mouse limb bud culture test”, TBTO produced changes at a concentration of 0.03 µg/mL and above which can be interpreted as a consequence of cytotoxic effects of the compound.
In in vivo studies in mice and rats TBTO at non-maternal toxic dose levels did not reveal embryotoxic incl. teratogenic effects. Therefore, based on the knowledge available, no embryotoxic hazard for humans by tributyltin compounds can be assumed.
Applicant's summary and conclusion
- Conclusions:
- The test material was not teratogenic at non-maternal toxic dose levels.
- Executive summary:
In this review article, in vivo studies in mice and rats with tri-n-butyltin oxide at non-maternal toxic dose levels did not reveal embryotoxic, including teratogenic effects.
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