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EC number: 500-092-7
CAS number: 36890-68-3
1: Individual and mean body weights (g) of male and female rats given a
single oral dose of CAPA 304
2 : Mean body weight gain (g) of groups of five male and female rats
given a single oral dose of CAPA 304
Day -1 to 2
Day 2 to 7
Day 7 to 14
Day -1 to 14
In this study ( method according to EEC – Directive 84-449, Annex V,
Part B1 ) groups of 5 male and 5 female Wistar rats were given a single
dose of CAPA 304 suspended in a 1.25% tragacanth solution in distilled
water via a stomach tube (oral gavage). Animals were observed for 14
days following dosing, and all animal were examined macroscopically.
Body weights were recorded one day before dosing (Day-1), at the day of
dosing prior to dose administration (Day 0) and at 2, 7 and 14 days
after treatment. No deaths were recorded for the duration of the study.
Fasting on the day prior to dosing caused a small weight loss in all
animals and there was a slight decrease in mean body weight gain between
day 2 and 7 in female rats. With one exception of lungs with the
appearance of emphysema observed in one female rat, no gross
abnormalities were noted for any of the animals when necropsied.
Clinical signs noticed only at the beginning of the study were; a
slightly hunched posture and gait. The LD50 value for male and female
animals was greater than 2000 mg/kg bw. Under the conditions of the
study, CAPA 304 was of low toxicity in rats therefore classification
according to Regulation (EC) No 1272/2008 is not required.
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