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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:
supporting study
Study period:
Not reported
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
data from handbook or collection of data
Justification for type of information:
Results for a large number of compounds were reported in the publication. Generally acceptable for assessment; restrictions: prior to GLP, limited data documentation.

Data source

Reference
Reference Type:
publication
Title:
Range-Finding Toxicity Data: List VI
Author:
Smyth Jr HF, Carpenter CP, Weil CS, Pozzani UC & Striegel JA
Year:
1962
Bibliographic source:
Am. Ind. Hyg. Assoc. J. 23: 95-107

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
not specified
Remarks:
Limited documentation of methods and results are provided. It is not clear if a necropsy was performed.
Principles of method if other than guideline:
- Principle of test: The test substance is introduced into the stomach of the test animals by gavage. The dosages are arranged in a logarithmic series differing by a factor of 2. Based on the mortalities during a 14day observation period, the most probably LD50 value and its fiducial range are estimated by the method of Thompson using the tables of Weil.
GLP compliance:
no
Remarks:
Study conducted prior to inception of GLP
Test type:
other: Range-finding toxicity test with dosages are arranged in a logarithmic series differing by a factor of 2
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Cyclohexanol
EC Number:
203-630-6
EC Name:
Cyclohexanol
Cas Number:
108-93-0
Molecular formula:
C6H12O
IUPAC Name:
cyclohexanol
Test material form:
not specified
Details on test material:
Supplier: not specified.

Test animals

Species:
rat
Strain:
other: Carworth-Wistar
Sex:
male
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Maintained in the colony of the testing facility (appears to be the Mellon Institute of Industrial Research, Pittsburgh, Pennsylvania
- Age at study initiation: 4 to 5 weeks
- Weight at study initiation: 90 to 120 g
- Fasting period before study: No
- Diet: Rockland rat diet, complete

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
not specified
Details on oral exposure:
VEHICLE
The test material was administered g/kg in a suitable vehicle. Whenever possible, the material was administered undiluted. In the case of lesser concentration, the paper describes a solution in water, corn oil or suspension in semi-solid agar as the preferred expedient. Occasionally, a 1% solution of Tergitol Penetrant 7 (essentially an aqueous solution of 25% sodium 3,9-diethyl-6-tridecanol sulfate) was used as a dispersing agent. The paper did not specify which vehicle was used for the test material.
Doses:
Not reported. The dosages were arranged in a logarithmic series differing by a factor of 2.
No. of animals per sex per dose:
5 male animals/dose
Control animals:
not specified
Details on study design:
- Duration of observation period following administration: 14 days
Statistics:
Based on any mortalities observed during a 14 day observation period, the most probable LD50 value and its fiducial range were estimated by the method of Thompson using the tables of Weil.

Results and discussion

Effect levels
Key result
Sex:
male
Dose descriptor:
LD50
Effect level:
2 060 mg/kg bw
Based on:
test mat.
95% CL:
1 950 - 2 180
Other findings:
The single oral LD50 for rats was reported as 2.06 (1.95 - 2.18) g/kg. The figures in parentheses show limits of ± 1.96 standard deviations.

Applicant's summary and conclusion

Interpretation of results:
Category 5 based on GHS criteria
Conclusions:
Under the conditions of this study, the single oral LD50 for rats was reported as 2.06 (1.95 - 2.18) g/kg.
Executive summary:

The acute toxicity of the test material was investigated in a range-finding toxicity test following the principles of the OECD Testing Guideline 401.

Single oral dose toxicity was estimated by the gastric intubation of the substance to groups of five non-fasted, Carworth-Wistar male rats, four to five weeks of age and 90 to 120 grams in weight. The test material was administered g/kg in a suitable vehicle. The dosages were arranged in a logarithmic series differing by a factor of 2. Based on any mortalities observed during a 14 day observation period, the most probable LD50 value and its fiducial range was estimated by the method of Thompson using the tables of Weil. Under the conditions of this study, the single oral LD50 for rats was reported as 2.06 (1.95 - 2.18) g/kg. The figures in parentheses show limits of ± 1.96 standard deviations.