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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:
comparable to guideline study with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1981
Report date:
1981

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
yes
Remarks:
no data on substance purity, prior to GLP, limited reporting on study design and methods
GLP compliance:
no
Test type:
standard acute method

Test material

Constituent 1
Chemical structure
Reference substance name:
cyclohexanol; cyclohexanone
EC Number:
906-627-4
Molecular formula:
Unspecified
IUPAC Name:
cyclohexanol; cyclohexanone
Specific details on test material used for the study:
Composition: no data

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female

Administration / exposure

Route of administration:
oral: unspecified
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
- MAXIMUM DOSE VOLUME APPLIED: not reported
Doses:
794, 1000, 1260, 1580 mg/kg bw
No. of animals per sex per dose:
5 animals/sex/dose
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: no data
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs

Results and discussion

Effect levelsopen allclose all
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
1 120 mg/kg bw
Based on:
test mat.
95% CL:
1 030 - 1 220
Sex:
male
Dose descriptor:
LD50
Effect level:
1 120 mg/kg bw
Based on:
test mat.
95% CL:
970 - 1 290
Sex:
female
Dose descriptor:
LD50
Effect level:
1 120 mg/kg bw
Based on:
test mat.
95% CL:
1 010 - 1 250
Mortality:
794 mg/kg bw: males 0/5; females 0/5
1000 mg/kg bw: males 2/5; females 1/5
1260 mg/kg bw: males 3/5; females 4/5
1580 mg/kg bw : males 5/5; females 5/5
All deaths occured within 2 days
Clinical signs:
other: Lethargy (lastuing up to 7 days), increasing weakness, ocular discharge, collapse and death
Gross pathology:
Decedents: Hemorrhagic lungs, liver hyperemia, discoloration of liver, kidneys and spleen, and acute gastrointestinal infolammation;
Survivors: Viscera appeard normal

Applicant's summary and conclusion