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:

No data gaps were identified. The available data are adequate for risk assessment and classification and labelling purposes.


Migrated from Short description of key information:
The aim of the sensitization study was to assess the allergenic potential of Quillaja Liquid Agri QL Agri 35-15 according to the test method described by EV Buehler, (OECD 406).
Following dose levels were used: 100% w/v solution of Quillaja Liquid Agri QL Agri 35-15 in the the induction phase, 100% w/v solution of Quillaja Liquid Agri QL Agri 35-15 in the challenge phase.
Quillaja Liquid Agri QL Agri 35-15 didn't cause skin sensitization on the Guinea pigs skin. Animals behaved normally and their external appearance was not influenced by the treatment.

Justification for selection of skin sensitisation endpoint:
One reliable study is available.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

In an OECD Guideline 406 study (Skin Sensitisation: Bühler Test), no signs of skin sensitisation were observed.

According to the CLP Regulation (EU GHS Regulation (EC) No 1272/2008) no classification and labelling is required for skin sensitisation of Quillaja saponaria ext..