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:

Based on a weight of evidence of the available studies supported by absence of any known reported clinical cases for skin allergies during handling of the yeast extract and other available data (attached as files: expert statements, declarations of medical doctors, literature data), an overall weight-of-evidence approach was produced for this endpoint (also attached: "YEC Position paper Classification") which concluded that Saccharomyces cerevisiae extracts are not considered to be skin sensitising.


Migrated from Short description of key information:
Five LLNA studies were performed according to guidelines and in compliance with GLP, on Saccharomyces cerevisiae (yeast) extracts. One of the studies was concluded to be positive for skin sensitisation and all other were negative.

Respiratory sensitisation

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

Justification for classification or non-classification

Based on the position paper attached, the weight of evidence supports the non classification of Yeast extract as a skin sensitizer, as decided by the YEC Members on September 30th 2010. Furthermore, taking into account all relevant end-points, YESC does not respond to Dir 67/548 and CLP criteria for classification.