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EC number: 229-066-0 | CAS number: 6408-72-6
The purpose of this study was to establish the effects of repeated oral administration of the test item to rats over a period of twenty-eight consecutive daysand this study is compatible with the following regulatory guidelines:
· Commission Directive 96/54/EC (Method B7).
· The OECD Guidelines for Testing of Chemicals No. 407 "Repeated Dose 28 Day Oral Toxicity Study in Rodents" (adopted 03 October 2008).
· Commission Regulation (EC) No 440/2008 of 30 May 2008, test methods pursuant to Regulation (EC) No 1907/2006 of the European Parliament and of the Council on the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH).
The test item was administered by gavage to three groups, each of five male and five female Wistar Han™:RccHan™:WIST strain rats, for twenty-eight consecutive days, at dose levels of 100, 300 or 1000 mg/kg bw/day. A control group of five males and five females was dosed with vehicle alone (Arachis oil BP).
Clinical signs,functional observations, body weight change, dietary intake and water consumption were monitored during the study. Hematology and blood chemistry were evaluated for all animals at the end of the study.
All animals were subjected to gross necropsy examination and histopathological evaluation of selected tissues from the 1000 mg/kg bw/day and control animals was performed.
There were no unscheduled deaths during the study.
Throughout the dose administration period, there were no clinical signs considered to be related to the toxicity of the test item.
There were no treatment-related changes in the behavioral parameters measured.
Functional Performance Tests
There was no effect of treatment with the test item at any dose level on functional performance in animals of either sex.
Sensory Reactivity Assessments
Sensory reactivity scores across all test item-treated dose groups were similar to controls.
There was no adverse effect of treatment with the test item on body weight development in animals of either sex.
There was no adverse effect of treatment with the test item on food consumption or food conversion efficiency for animals of either sex.
There was no adverse effect of treatment with the test item on water consumption for animals of either sex.
No toxicologically significant effects were detected in animals of either sex at any dose level.
Neither the type, incidence or distribution of macroscopic observations in animals of either sex indicated any adverse effect of treatment up to a dose level of 1000 mg/kg bw/day.
Histopathological examination of the selected tissues from the 1000 mg/kg bw/day animals of either sex did not reveal any treatment-related abnormalities.
The oral (gavage) administration of to Wistar Han™:RccHan™:WIST strain rats, for twenty-eight days at dose levels of 100, 300 or 1000 mg/kg bw/day was well tolerated and did not result in any toxicologically significant effects. The ‘No Observed Adverse Effect Level’ (NOAEL) for systemic toxicity was 1000 mg/kg bw/day (high dose) within the confines of this study type.
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.
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