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EC number: 446-990-1
CAS number: -
The study was designed to investigate the systemic toxicity of the test
material. It complies with the requirements for notification of a new
chemical substance in the EC and follows the testing method described in
Commission Directive 96/54/EC (Method B7) and OECD Guidelines for
Testing of Chemicals No. 407 "Repeated Dose 28 Day Oral Toxicity Study
in Rodents" (Adopted 27 July 1995). This study complies with the GLP.
The test material was administered by oral gavage to three groups, each
of five male and five female Sprague-Dawley Crl:CD® (SD) IGS BR strain
rats, for twenty-eight consecutive days, at dose levels of 15, 150 and
1000 mg/kg/day. A control group of five males and five females was dosed
with vehicle alone (Distilled water).
Clinical signs, functional observations, bodyweight development and food
and water consumption were monitored during the study. Haematology 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 high dose and
control animals was performed.
Mortality. There were no unscheduled deaths during the study. Clinical
Observations. No clinically observable signs of toxicity were detected
in test or control animals throughout the treatment period. Behavioural
Assessment. There were no treatment-related changes detected. Functional
Performance Tests. There were no treatment-related changes detected.
There were no treatment-related changes detected. Bodyweight. No adverse
effect on bodyweight development was detected.
Food Consumption. No adverse effect on dietary intake or food efficiency
Water Consumption. No overt intergroup differences were detected.
Haematology. No treatment-related haematological effects were detected.
Blood Chemistry. No treatment-related blood chemical effects were
Organ Weights. No treatment-related organ weight changes were detected.
Necropsy. No treatment-related macroscopic abnormalities effects were
Histopathology. No treatment-related microscopic abnormalities effects
Oral administration of test item to rats for a period of twenty-eight
days, at dose levels of up to 1000 mg/kg/day, produced no
toxicologically significant effects in
the parameters investigated.
The ‘No Observed Effect Level’ (NOEL) was therefore considered to be
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