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EC number: 603-837-5
CAS number: 134605-64-4
Analytical verification of doses:
The mean test article concentrations in the vehicle were
83.2%, 85.0% and 97.7% of the nominal concentrations in dose group 2, 3
and 4, respectively. The test material was found to be homogeneously
distributed and to be stable in the vehicle under actual conditions of
administration over the period of dosing.
The study was performed according the requirements of
OECD Guidelines for Testing of Chemicals No. 410 under GLP conditions.
The study was performed to investigate the potential toxicity of the
test material to male and female Tif: RAif (SPF), hybrids of RIII1 x
RIII2 (Sprague-Dawley derived) rats when administered topically 5 days a
week for 4 weeks. The dermal route was used as this represents a
possible route of exposure in humans. Four groups of 5 male and 5 female
rats were dosed with the test material in vehicle (0.5 % (w/v)
carboxymethylcellulose in 0.1% (w/v) aqueous polysorbate 80) at 0, 10,
100 or 1000 mg/kg bw/day 5 times a week for 4 weeks. Test material was
applied under occlusive dressing for a 6 hour period. Clinical
observations, body weight and food consumption were recorded daily.
Animals were humanely sacrificed at the end of the study. At
termination, blood samples were taken for haematology and blood
chemistry investigations. Selected organs were weighed and specified
tissues/organs were processed for histopathological examination.
Tissues/organs from control and high dose animals were examined by light
microscopy, together with all macroscopic abnormalities in any group.
Analytical data confirmed the suitability of the dosing
preparations used in the study. There were no adverse treatment-related
effects on clinical observations, body weights, food consumption. There
were no toxicologically significant effects on haematology, blood
chemistry. There were no treatment-related macroscopic or microscopic
findings in any organ at examination post mortem. The no effect level
(NOEL) in this study was 1000 mg/kg bw/day.
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