Registration Dossier

Administrative data

Description of key information

Key value for chemical safety assessment

Skin sensitisation

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (sensitising)
Additional information:

No study is available for Tetraoctyltin however studies are available for other related compounds namely 2-ethylhexyl 10-ethyl-4-[[2-[(2-ethylhexyl)oxy]-2-oxoethyl]thio]-4-methyl-7-oxo-8-oxa-3 ,5-dithia-4-stannatetradecanoate (CAS: 57583-34-3) and 2-ethylhexyl 10-ethyl-4,4-dioctyl-7-oxo-8-oxa-3,5-dithia-4-stannatetradecanoate (CAS: 15571-58-1). Furthermore computer predictions run using DEREK for windows program indicate that all organotin compounds are potential skin sensitizers. As a positive result reflects the worst case scenario for this endpoint it is considered justified to utilize read across to the "worst case" results for other organotin substances in this case.


Migrated from Short description of key information:
No study addressing teh skin sensitization potential is available for Tetraoctyltin however studies are available for other related compounds namely 2-ethylhexyl 10-ethyl-4-[[2-[(2-ethylhexyl)oxy]-2-oxoethyl]thio]-4-methyl-7-oxo-8-oxa-3 ,5-dithia-4-stannatetradecanoate (CAS: 57583-34-3) and 2-ethylhexyl 10-ethyl-4,4-dioctyl-7-oxo-8-oxa-3,5-dithia-4-stannatetradecanoate (CAS: 15571-58-1). Furthermore computer predictions run using DEREK for windows program indicate that all organotin compounds are potential skin sensitizers. As a positive result reflects the worst case scenario for this endpoint it is considered justified to utilize read across to the "worst case" results for other organotin substances in this case.

Justification for classification or non-classification

The test substance is classified as a sensitizer using read across results based on a local lymph node assay that elicited a positive result in 2-ethylhexyl 10-ethyl-4-[[2-[(2-ethylhexyl)oxy]-2-oxoethyl]thio]-4-methyl-7-oxo-8-oxa-3 ,5-dithia-4-stannatetradecanoate (CAS: 57583-34-3).

2-ethylhexyl 10-ethyl-4-[[2-[(2-ethylhexyl)oxy]-2-oxoethyl]thio]-4-methyl-7-oxo-8-oxa-3 ,5-dithia-4-stannatetradecanoate (CAS: 57583-34-3) was found to be sensitising according to 67/548/EEC and should therefore be classified as R43 - May cause sensitisation by skin contact. Furthermore the substance is to be regarded as a Category 1 skin sensitizer in accordance with Regualtion (EC) No 1272/2008.