Mortality: one female from the high dose was killed in extremis on day 14; there were no further deaths during the study Clinical observations: animals in the high dose exhibited increased salivation, hunched posture, piloerection, noisy respiration, diuresis, fur loss, red/brown staining and wetness of the fur; isolated instances of lethargy, shedding of bloody tears (chromodacyorrhea) and tiptoe gait were also observed; food intake of animals in the high dose group was unaffected by treatment, however males in this group showed a decreased weight gain during the first 2 weeks of treatment when compared with controls animals in the mid dose group showed increased salivation; animals in the low dose group showed no clinical signs during treatment clinical signs found in rats in the mid and high dose groups were no longer evident following the 2 week treatment free period Clinical no toxicologically significant changes were found in haematological parameters in any of the treatment groups increased mean alanine aminotransferase levels were found in female animals in the high dose group – this effect was no longer evident at the end of the two week treatment free period diuresis and reduced urine specific gravity was noted in three males and one female in the high dose group; this was no longer evident at the end of the treatment free period Gross Pathology: animals of either sex in the high dose group showed an increased mean liver weight (both absolute and relative to bodyweight) in comparison with controls; these changes are consistent with increased hepatic activity associated with
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