Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 225-590-9
CAS number: 4948-15-6
The repeated dose toxicity of the test article was investigated in
guideline and GLP compliant 28-day oral toxicity study by daily gavage
in the rat, followed by a 14-day recovery period. Based on the resutls
of a 5-day range finding study and in consultation with the sponsor, the
dose levels for the 28-day toxicity study were selected to be 0, 100,
300 and 1000 mg/kg/day. Each group consisted of 5 males and 5 females.
An extra 5 animals per sex in the control and high dose group were
allowed 14 days of recovery. Formulation analyses were conducted once
during treatment to assess accuracy, homogeneity and stability of
formulations. The following parameters were evaluated: clinical signs
daily; functional observation tests; body weight and food consumption
weekly; clinical pathology at the end of treatment; macroscopy at
termination; organ weights and histopathology on a selection of tissues.
Accuracy, homogeneity and stability over 5 hours of formulations of test
substance in Milli-U water were demonstrated by analyses. No
toxicologically relevant changes were observed in any of the parameters
determined in this study. No evidence for neurotoxicity or
immunotoxicity was obtained in this study. NOAEL was therefore
determined to be 1000 mg/kg.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
Welcome to the ECHA website. This site is not fully supported in Internet Explorer 7 (and earlier versions). Please upgrade your Internet Explorer to a newer version.
Do not show this message again