GULFTENE C16-18 ISOMERISED OLEFINS - NICNAS

treatment free period of 4 weeks for high dose and control
animals
Number/sex of animals: 10/sex/treatment and control groups;
10/sex/recovery groups (control and 1 000 mg/kg/day)
Test method: OECD TG 408
Mortality: Nil
Clinical observations:
No treatment related signs were observed on clinical signs, bodyweight, opthalmoscopy or
neurobehaviour.
Clinical chemistry/Haematology
Clinical chemistry:
Significantly increased glucose levels at Week 13 in 500 and 1 000 mg/kg/day males.
Glucose levels were normal in males of 1 000 mg/kg/day group at the end of the recovery
period.
Haematology:
Decreased erythrocyte indices (packed cell volume of males and females, haemoglobin
values of males and erythrocyte count of females) and prolonged haemostatic indices
(males) in animals of the 1 000 mg/kg/day groups at Week 13. All indices were normal
after the recovery period. Significantly increased platelet counts persisted in males of the
1 000 mg/kg/day at the end of the recovery period.
Pathology:
Organ weights:
Females at all treatment doses had significantly higher group mean liver weight. No dosage
response was apparent. Males receiving 1 000 mg/kg/day had slightly increased mean body
weight-adjusted liver weight. These changes were not apparent at the end of the recovery
period. Significantly higher group mean absolute adrenal weights in females receiving 500
and 1 000 mg/kg/day. These changes were not apparent at the end of the recovery period.
Macroscopic:
No treatment related effects.
Microscopic:
Minimal centrilobular hepatocyte hypertrophy was observed in a small number of females
of all treated groups, the incidence attaining statistical significance at the 1 000 mg/kg/day
group. Significantly increased incidence of adrenal cortical hypertrophy in females of the
1 000 mg/kg/day group. Significantly increased incidence of epithelial hyperplasia of the
limiting ridge 4 of the stomach in males receiving 1 000 mg/kg/day. None of these lesions
4 This is considered to reflect local irritation of the test material in corn oil and since humans do not have a
limiting ridge this effect is considered to be of no toxicological significance.
FULL PUBLIC REPORT 26 April 2000
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