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:

Tin bis(2 -ethylhexanoate) was evaluated in the Guinea Pig Maximization test protocol. This study was assigned a reliability rating of K-1. Female Himalayan albino guinea pigs (SPF-quality, approximately 9 weeks old) were used in the study. Intradermal induction concentrations were 2% w/w tin bis(2 -ethylhexanoate) in propylene glycol and also 4% tin bis(2 -ethylhexanoate) in solution emulsified in 50:50 Freunds Complete Adjuvant. After one week, test animals were treated with 0.5 ml of a 50% solution of the test substance in propylene glycol applied epidermally on a moistened patch secured with tape between the injection sites. Control animals were treated with propylene glycol only. After 48 hours, the dressings and residual test material were removed, and the reaction sites were immediately assessed for erythema and edema. Test and control guinea pigs were challenged two weeks after the epidermal application with 10%, 5%, or 2% solutions of tin bis (2 -ethylhexanoate) in propylene glycol. Challenge applications were performed using Square chambers attached to Micropore tape and held in place with elastic bandages. Dressings and residual test substance were removed after 24 hours. Sites were assessed for redness and swelling 24 and 48 hours after removal of the dressing. In the challenge test, 20, 16 and 13 test animals showed a positive skin reaction in response to the 10%, 5% and 2% test substance concentrations, respectively. A sensitization rate of 85% was determined. [Air Products test]

 


Migrated from Short description of key information:
Guinea pig sensitisation: sensitising

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

This study indicates that tin bis(2 -ethylhexanoate) has dermal sensitization properties in studies in guinea pigs. Under GHS classification, tin bis(2 -ethylhexanoate) will be labeled (Warning; May cause allergic skin reaction).