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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
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: The study was conducted according to a test protocol that is comparable to the appropriate OECD test guideline. It was not compliant with GLP.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1965
Report date:
1965

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
GLP compliance:
no
Test type:
other: LD50
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Hexan-1-ol
EC Number:
203-852-3
EC Name:
Hexan-1-ol
Cas Number:
111-27-3
Molecular formula:
C6H14O
IUPAC Name:
hexan-1-ol

Test animals

Species:
rat
Strain:
other: Holtzman albino
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS

- Weight at study initiation: 200-265g

- Fasting period before study: Over night

- Housing: Group housing (5 of each sex per cage), in metal cages provided with white pine and cheddar shavings.

- Diet: Purina Laboratory Chow, ad libitum.

- Water: ad libitum




Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: Exploratory doses were administered to 8 rats to estimate the order of toxicity of the test compound. Based on the preliminary estimation, groups of 10 rats (5M, 5F) were administered the test compound at graded dosage levels designed to blanket the toxicity range.
Doses:
1.17, 1.65, 2.33, 3.28, 4.64 and 6.55 gm/kg
No. of animals per sex per dose:
5 female, 5 male
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days

- Frequency of observations and weighing: Regular intervals on the day of dosing and daily thereafter for 14 days.

- Necropsy of survivors performed: yes

- Other examinations performed: clinical signs, body weight,organ weights, histopathology, other: Gross necropsies were performed on all  survivors and any animals which died during the observation period. Body weights of survivors were recorded prior to sacrifice.
Statistics:
Confidence Interval 2.85 ml (2.35 gm) to 5.34ml (4.39gm)/kg body weight. Slope function 1.88, with confidence interval of 1.26 to 2.80.

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
3 210 mg/kg bw
Mortality:
All deaths occurred within 24 hours of dosing. See table. 

.
Clinical signs:
Animals at all dose levels exhibited weakness and ataxia. They became comatose and breathing was laboured while comatose. 
Animals  which survived appeared normal within 24 hours other than top dose animals (6.55 g/kg) where the rats appeared unwell up to 48 hours 
after dosing. 
Body weight:
Weight gain amongst survivors was within normal limits.
Gross pathology:
Necropsy of animals which died showed congestion of  the lungs and adrenals in most animals. In some cases gastric 
congestion  was also observed. There were no remarkable gross findings in animals sacrificed at the end of the observation period.
Other findings:
- Organ weights: Not recorded

- Histopathology: Not available

- Potential target organs: No conclusion drawn

- Other observations: No sex specific differences were reported, mortality represented as a combined value so no independent assesment can be made.

Any other information on results incl. tables

Table 1: Number of animals dead within the 14 day study period.

 

Dose
ml (and gm.) kg./body weight

Mortality (# dead/total)

Time of death (day)

Male

Female

Combined

1.42 (1.17)

 

 

0/10 

 

2.00 (1.65)

 

 

 1/10

 1

2.83 (2.33)

 

 

4/10

 1

3.99 (3.28)

 

 410

 1

5.64 (4.64)

 

 

8/10

1

7.96 (6.55)

 

 

8/10

1

 

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The LD50 value of 3.21 g/kg was determined in a reliable study conducted according to an appropriate test protocol. Not conducted according to GLP.