Registration Dossier
Registration Dossier
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EC number: 214-688-7 | CAS number: 1185-81-5
Endpoint summary
Administrative data
Description of key information
Key value for chemical safety assessment
Skin sensitisation
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (sensitising)
- Additional information:
Read-across between dibutyltin compounds concerning toxicological endpoints was considered appropriate as dibutyltins are known, through industry, to hydrolyse rapidly in water and form dibutyltin dichloride under simulated gastric hydrolysis conditions, and so on this basis, it is possible to read-across between the different dibutyltin compounds to address Toxicity endpoints. As no skin sensitisation data is available for dibutylbis(dodecylthio)stannane this endpoint has been addressed by using a read across approach from 2-ethylhexyl 4,4-dibutyl-10-ethyl-7-oxo-8-oxa-3,5-dithia-4-stannatetradecanoate (DBT(2-EHMA) (10584-98-2)).
- The key study (Maurer, 1986) was performed on a similar substance to determine sensitization. 10 week old male and female Pirbright White Guinea Pigs were exposed to DBT(2-EHMA) in a maximisation test. The test substance was found to be sensitising according to 67/548/EEC and should therefore be classified as R43 - May cause sensitisation by skin contact.
The study has been performed to GLP and in line with appropriate guidelines but was tested on DBT(2-EHMA) and not the registration substance and so has been allocated a Klimisch score of 2 on the basis that it has been used for read-across purposes.
Migrated from Short description of key information:
In a dermal sensitisation study according to OECD 406, 10 week old male and female Pirbright White Guinea Pigs were exposed to DBT 2 EHMA in a maximisation test. The test substance was found to be sensitising according to 67/548/EEC and should therefore be classified as R43 - May cause sensitisation by skin contact.
Due to the similarity between these molecules it is considered justified to read across to this study for the registration substance.
Justification for classification or non-classification
The test substance analogue was found to be sensitising according to 67/548/EEC and should therefore be classified as R43 - May cause sensitisation by skin contact. Accordingly, in line with regulation (EC) No 1272/2008, the substance should be labelled as Skin Sens. 1 with H317: May cause an allergic skin reaction.
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