Registration Dossier

Administrative data

Description of key information

Not skin sensitizing

Key value for chemical safety assessment

Skin sensitisation

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

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

According to the CLP Regulation (EC) No 1272/2008, 3.4 Respiratory or skin sensitisation section, skin sensitizer means a substance that will lead to an allergic response following skin contact.

In case of Guinea Pig Maximization Test, a substance can be considered as a skin sensitizer if at least 30 % of the animals respond to an intradermal induction higher than 1 %.

Based on the study outcomes, at the first challenge and second challenge exposure, 15 % of test group presented positive erythema reactions after the 24-hour reading (which were not present after 48 hours), after induction at doses higher than 1 %.

 

In conclusion, the substance does not meet the criteria to be classified as skin sensitizer, according to the CLP Regulation (EC) No 1272/2008.