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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Description of key information

In the acute toxicity study by oral route, no deaths were observed in 6 animals (both males and females) given 2000 mg/kg bw.

Key value for chemical safety assessment

Additional information

The conclusions of the full study report provided by Cilag AG reflect the classification rules into force in 2001: according to Directive 93/21/EEC, the the acute oral median lethal dose (LD50) of the test material in the Sprague-Dawley CD (Crl: CD(R) (SD) IGS BR) strain rat was estimated as being greater than 2500 mg/kg bodyweight.

According to the new Regulation (EC) N. 440/2008 - Method B.1.ter - Annex 1 D, the acute oral median lethal dose (LD50) of the test material in the Sprague-Dawley CD (Crl: CD(R) (SD) IGS BR) strain rat is now estimated as being greater than 5000 mg/kg bodyweight.

Justification for classification or non-classification

According to Directive 67/548/EEC and to Regulation (EC) n. 1272/2008, the substance should not be classified for oral acute toxicity.