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EC number: 700-177-0
CAS number: 467430-13-3
In the acute toxicity study by oral route, no deaths were observed in 6 animals (both males and females) given 2000 mg/kg bw.
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.
According to Directive 67/548/EEC and to Regulation (EC) n. 1272/2008,
the substance should not be classified for oral acute toxicity.
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