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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

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..