SummaryA reference database comprising body weight gain, exploratory activity, hot plate response, serum biochemistry, haematology, organ weight (%) and a complete anatomopathological study containing non-neoplastic and neoplastic lesions over 1200 Sprague-Dawley rats from 6 to 32 months is described. Comparisons between age and sex were analysed.Keywords Database; Sprague-Dawley rats, biological parameters Toxicology laboratories and other research institutions collect large bodies of reference data in order to support drug and chemical toxicity testing. However, many of these databases contain either a relatively small number of animals, a limited number of parameters, or poorly defined limitations by age, all of which limit their usefulness on a routine basis. In addition, it is often unclear whether the same test method was used throughout the data collection period. In our laboratory, we have set up and maintain a large reference database. The database covers not only the main physiological indicators, including results of the anatomicopathological studies, but also the major life span of this species. The data were classified into three main age groups, <6,6-18 and 18-32 months according to Wolford et a1. (1986), and sex. The present results correspond to data of special sentinel groups from different preclinical toxicological evaluations performed in our laboratory during the last 7 years.

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SummaryThis paper contains the reference data for the main physiological indicators of three species of laboratory animals: mice, rabbits and dogs. Data listed include the mean and the standard deviation of haematology, serum biochemistry and organ weight to body weight ratio. In addition, pathological studies including microscopical examination of organs and tissues were also done. Comparisons between sexes were analysed.

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Policosanol is a cholesterol-lowering drug purified from sugar cane. Previous toxicological studies have not demonstrated any policosanol-related toxicity, even with long-term oral administration at 500 mg/kg, a dose 1,724 times larger than the maximal therapeutic dose (20 mg/day) recommended to date. The present study was undertaken to investigate the oral toxicity of policosanol administered for 6 months in doses up to 5,000 mg/kg to Sprague-Dawley rats. Animals were randomly distributed in five groups (15 animals per dose per sex): a control and four groups given oral policosanol (50, 500, 2,500, or 5,000 mg/kg). Eight treated rats (6 males, 2 females) died during the study, five of them (4 males, 1 female) from among those receiving the highest dose (5,000 mg/kg). According to necropsy, all deaths were related to gavage manipulation of higher doses. Although the differences were not significant, body weight gain and food consumption in the groups receiving 2,500 or 5,000 mg/kg tended to be lower than in the control group. Nevertheless, no drug-related toxicity symptoms were detected. Analysis of blood biochemistry, hematology, organ weight ratios, and histopathological findings did not show significant differences compared with controls, nor any tendency with the dose. Therefore, the present study did not show any new evidence of oral toxicity of policosanol, and the findings observed were a consequence of long-term administration by gastric gavage of the highly concentrated suspensions needed to reach the higher doses. It is concluded that policosanol chronically administered by the oral route is safe and that no drug-related toxicity was demonstrated.