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Toxicological information

Acute Toxicity: oral

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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
20 October 2009 to 10 November 2009
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2010
Report Date:
2010

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
EU Method B.1 bis (Acute Oral Toxicity - Fixed Dose Procedure)
Deviations:
no
Qualifier:
according to
Guideline:
OECD Guideline 420 (Acute Oral Toxicity - Fixed Dose Method)
Deviations:
no
GLP compliance:
yes (incl. certificate)
Test type:
fixed dose procedure
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid

Test animals

Species:
rat
Strain:
Wistar
Sex:
female
Details on test animals and environmental conditions:
Female Wistar strain rats were supplied by Harlan Laboratories UK Limited, Bicester, Oxon, UK. On receipt the animals were randomly allocated to
cages. The females were nulliparous and non-pregnant. After an acclimatisation period of at least five days the animals were selected at random
and given a number unique within the study by indelible ink marking on the tail and a number written on a cage card. At the start of the study the
animals were eight to twelve weeks of age. The bodyweight variation did not exceed ± 20% of the initial/mean bodyweight of any previously dosed animal(s).
The animals were housed in groups of up to four in suspended solid floor polypropylene cages furnished with woodflakes. With the exception of
an overnight fast immediately before dosing and for approximately three to four hours after dosing, free access to mains drinking water and food
(2014 Teklad Global Rodent diet supplied by Harlan Teklad, Blackthorn, Bicester, Oxon, UK) was allowed throughout the study. The diet, drinking
water and bedding were routinely analysed and were considered not to contain any contaminants that would reasonably be expected to affect the
purpose or integrity of the study.
The temperature and relative humidity were set to achieve limits of 19 to 25°C and 30 to 70% respectively. Any occasional deviations from these
targets were considered not to have affected the purpose or integrity of the study. The rate of air exchange was at least fifteen changes per hour
and the lighting was controlled by a time switch to give twelve hours continuous light (06:00 to 18:00) and twelve hours darkness.
The animals were provided with environmental enrichment items which were considered not to contain any contaminant of a level that might have
affected the purpose or integrity of the study.

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
All animals 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.
Doses:
2000 mg/kg
No. of animals per sex per dose:
5 (females only)
Control animals:
no
Details on study design:
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.
Statistics:
Not applicable

Results and discussion

Preliminary study:
A single animal was tested at a dose level of 2000 mg/kg. No mortality was observed.
Effect levels
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
There were no deaths during the course of the study.
Clinical signs:
Signs of systemic toxicity noted in all animals up to six days after dosing were hunched posture, lethargy, ataxia, pilo erection, 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.
Body weight:
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.
Gross pathology:
No abnormalities were noted at necropsy.
Other findings:
None

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
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.
Executive summary:

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.