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EC number: 204-667-0
CAS number: 123-96-6
The acute oral toxicity of octan-2-ol
was evaluated in rats in a Fixed Dose Procedure study specified in EU
Method B1 bis. Octan-2-ol was administered without vehicle. All animals
(female Wistar strain rat) were dosed once only by gavage using a metal
cannula attached to a graduated syringe. The volume administered to each
animal was calculated according to its fasted bodyweight at the time of
dosing. Clinical observations were made ½, 1, 2, and 4 hours after
dosing and subsequently once daily for fourteen days. Morbidity and
mortality checks were made twice daily. Individual bodyweights were
recorded on Day 0 (the day of dosing) and on Days 7 and 14. At the end
of the observation period the animals were killed by cervical
dislocation. All animals were subjected to gross necropsy. This
consisted of an external examination and opening of the abdominal and
thoracic cavities. The appearance of any macroscopic abnormalities was
recorded. No tissues were retained.
Using available information on the
toxicity of the test material, 2000 mg/kg was chosen as the starting
dose on one female. In the absence of mortality, an additional group of
three animals was treated at a dose level of 2000 mg/kg.
There were no deaths during the course
of the study. Signs of systemic toxicity noted in all animals up to six
days after dosing were hunched posture, lethargy, ataxia, piloerection,
prostration, splayed gait, increased respiratory rate and noisy
respiration. Red/brown staining around the snout was also noted in one
animal one day after dosing. Noisy respiration persisted in one animal
throughout the observation period.
Animals appeared normal 3, 6 or 7 days
after dosing, except for one animal which showed signs of systemic
toxicity at all observations.
Four animals showed bodyweight loss
during the first week with expected gain in bodyweight during the second
week. The remaining animal showed expected gains in bodyweight during
the study. No abnormalities were noted at necropsy.
Thus, the acute oral median lethal
dose (LD50) of the test material in the female Wistar strain rat was
estimated to be greater than 2000 mg/kg bodyweight.
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