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:

A skin sensitisation test was performed with 2,4,6,8 -Tetramethylcyclotetrasiloxane,

using a modified Buehler method (Ritz and Buehler, 1980) The study was conducted according to OECD Guidelines for Testing of Chemicals, Number 406 "Skin Sensitization”.

After a three-week induction period with a 75% solution of the test substance in acetone, there was no skin reaction in the control and test group after the challenge procedure performed with 5% of the test substance in acetone. The acetone itself did not show any local skin reactions and was, therefore, considered to be suitable for this type of study.

Migrated from Short description of key information:
Skin sensitisation test in guinea pigs, Buehler test OECD Guideline 406 (Skin Sensitisation): negative

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

Justification for classification or non-classification

Based on the findings observed in a non-adjuvant sensitization test in guinea pigs, 2,4,6,8-Tetramethylcyclotetrasiloxane does not have to be classified and labelled as a skin sensitizer.