"Observations and examinations performed and frequency: CAGE SIDE OBSERVATIONS: Yes

- Time schedule: all animals were examined for overt signs of toxicity at least once per day. The day and week counting method was such that the first day of administration was considered day 1, the day before administration started day -1, and the week administration started week 1. Also, the day following the day administartion ended was considered day 1 (recovery), and the week recovery started considered to be week 1 (recovery)

BODY WEIGHT: Yes

- Time schedule for examinations: Body weights were recorded in all animals before administration on day-2 (when divided into groups), during the administration period on day 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24, 28 and during the recovery period on day 1, 3, 5, 8, 10, 12 and 14. Body weights were also recorded at necropsy.

FOOD CONSUMPTION AND COMPOUND INTAKE:

In all cases, this was measured once before administration and twice per week during the administration and recovery period.

FOOD EFFICIENCY:

- Body weight gain in kg/food consumption in kg per unit time X 100 calculated as timeweighted averages from the consumption and body weight gain data: No data

OPHTHALMOSCOPIC EXAMINATION: No data

HAEMATOLOGY: Yes

- Time schedule for collection of blood: day 28 and day 14 (recovery period groups)

- Anaesthetic used for blood collection: Yes (ether) - Animals fasted: Yes - How many animals: all animals

- Parameters checked in table [No.7.5.1/2] examined.

CLINICAL CHEMISTRY: Yes

- Time schedule for collection of blood: day 28 and day 14 (recovery period groups)

- Animals fasted: Yes

- How many animals: all animals

- Parameters checked in table [No.7.5.1/3] were examined.

URINALYSIS: Yes

- Time schedule for collection of urine: Carried out in all animals once during the administration period (day 28) and once during the recovery period (day 14). Urine was collected for a 16-hour period inside individual metabolic cages

- Metabolism cages used for collection of urine: Yes

- Animals fasted: No data

- Parameters examined: urinary volume and colour, pH, protein, ketone bodies, bilirubin, occult blood, glucose and urobilinogen.

NEUROBEHAVIOURAL EXAMINATION: No

Sacrifice and pathology: GROSS PATHOLOGY: Yes

- Organ Weight Measurement: in all animals, the weight of the following organs was measured: brain, liver, spleen, kidney, adrenal gland, testes (or ovaries) HISTOPATHOLOGY: Yes

Statistics: Absolute and relative organ weights, haematological and blood chemical data were analysed by one way analysis of variance incorporating "F-max" test for homogeneity of variance. Data showing heterogeneous variances were analysed using Kruskal wallis."

Male Crj:CD(SD) Rats