Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Endpoint:
acute toxicity: oral
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
other:
Justification for type of information:
In regard to following documents, Sylibum marianum extract is considered as safe by oral route :
1) Cosmetic Ingredient Review on plant derived fatty acid oils used in cosmetics (march 4, 2011), "Oils derived from edible vegetables, fruits, seeds, and tree and ground nuts have been safely consumed by humans for millennia"
2) EFSA Journal 2012;10(5):2663, Annexe B
3) Milk Thistle (Silybum marianum) for the Therapy of Liver Disease, Kenneth Flora MD et al., American Journal of Gastroenterology volume93, pages139–143 (1998)

Data source

Materials and methods

Results and discussion

Applicant's summary and conclusion