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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.