Registration Dossier

Administrative data

Description of key information

Key value for chemical safety assessment

Skin sensitisation

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

In this non-adjuvant sensitization test, an incidence of 10% was observed for each of the tested concentrations of 5% and 15% of test item in diglyme in the first challenge. However, as different animals responded, the overall incidence in this first challenge was 15%, which is the threshold for sensitizers as defined by the OECD and EC guidelines. Therefore, a second challenge was performed, again testing the same concentrations of 5% and 15%. In this second challenge, an incidence of 5% was observed for each of the tested concentrations of 5% and 15% of test item in diglyme in the second challenge and the overall incidence in this second challenge was 10%, which is below the 15% threshold. Taking into account that one animal of control group 1 also responded in the first challenge and the incidence of the skin reactions decreased in the second challenge, the observed skin reactions are attributed to a slight irritation of the skin and not to a true sensitization. Therefore, the test item is considered to be not sensitizing.


Migrated from Short description of key information:
The key study for sensitisation found the test material to be not sensitising in a reliable study carried out according to current OECD guideline and in compliance with GLP (Harlan 2012).

Justification for selection of skin sensitisation endpoint:
The selected study is the only available skin sensitisation study. It was conducted according to an appropriate OECD test guideline and in compliance with GLP

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

Based on the the findings in a non-adjuvant sensitization test in guinea pigs, conducted in accordance with Regulation (EC) No 1272/2008, Triethoxy(3-thiocyanatopropyl)silane does not have to be classified as a skin sensitizer.