Registration Dossier

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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

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.