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:
Migrated from Short description of key information:
Due to the high volatility of the substance a study is technically not feasible to conduct. However, the test substance was not a skin sensitizer when evaluated in a repeated insult patch test (RIPT) study conducted under specific conditions in humans and described in IUCLID section 7.10.4. Furthermore, in repeated dose inhalation toxicity studies, including those conducted using whole body exposure. no sign of skin sensitisation was observed.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:
Migrated from Short description of key information:
In repeated dose inhalation toxicity studies no signs of respiratory sensitisation were observed.

Justification for classification or non-classification

The test substance was not a skin sensitizer when evaluated in a repeated insult patch test (RIPT) study conducted under specific conditions in humans and described in IUCLID section 7.10.4. Furthermore, in repeated dose inhalation toxicity studies, including those conducted using whole body exposure, no sign of skin or respiratory sensitisation was observed. It can therefore be concluded that the substance does not need to be classified for skin or respiratory sensitisation according to EU Directive 67/548/EEC (DSD) and EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulations (EC) No. 1272/2008.