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Description of key information

Previous data indicates that TBTO is not sensitizing but local irritation was reported to make the performance of the test difficult.

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records
Reference
Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
other: summary of experimental results
Adequacy of study:
supporting study
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
secondary literature
Qualifier:
no guideline followed
Principles of method if other than guideline:
The paper presented a survey of the toxicological properties of the tributyltin compounds with the emphasis on data from their own testing laboratory. It’s main aim was to give an assessment of possible health hazards which may arise from contact at the work-place during manufacturing or use of wood-preservatives containing these compounds. The final part of the assessment consisted of assessing the risk which might originate from the use of such formulations for the protection of wood in interiors of dwellings.

Data concerning the potential for sensitisation by contact with TBTO to the skin is listed as a short abstract.
GLP compliance:
not specified
Type of study:
other: A review of existing data
Species:
guinea pig
Strain:
not specified
Sex:
not specified
Concentration / amount:
No information
Concentration / amount:
No information
No. of animals per dose:
No information
Details on study design:
No information
Challenge controls:
No information
Positive control substance(s):
not specified
Positive control results:
No data
Remarks on result:
no indication of skin sensitisation
Interpretation of results:
other: Not classified according to EU criteria
Conclusions:
In this review article, previous data indicates that TBTO is not sensitizing but local irritatation was reported to make the performance of the test difficult.
Executive summary:

In this review study, dermal sensitization from tri-n-butyltin oxide (TBTO) was not observed in the maximization test in guinea pigs in previously available literature. No indication of skin senstizing effect was observed; however the test was made difficult by the locally irritating potential of tributyltin compounds.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:

Schweinfuth, H et al (1986) was provided for informatory purposes only. The study is a review on the effects of tributyltin compounds on various toxicological parameters by assessing previously performed studies and published. As this is a secondary source and there is incomplete reporting of the data (e.g. as short abstracts), the study was assigned a reliability score of 4.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

The data presented is not sufficiently reliable to assign classification for sensitisation, however the available information does indicate that no classification would be appropriate for the susbtance. Furthermore, there is no indication from exposure to humans that the substance is a sensitiser in humans.

In addition, the harmonised classification for "tributyltin compounds", as inclued in Annex VI to Regulation (EC) No 1272/2008 with Index Number 050-008-00-3, does not include a hazard classification for sensitisation.