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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

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

Toxicological information

Developmental toxicity / teratogenicity

Currently viewing:

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:
1986
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

Constituent 1
Chemical structure
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

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.