Registration Dossier
Registration Dossier
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EC number: 906-627-4 | CAS number: -
Acute Toxicity: oral
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:
- 1 981
- 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
- Reference substance name:
- Reaction mass of cyclohexanol and cyclohexanone
- EC Number:
- 906-627-4
- Molecular formula:
- Unspecified
- IUPAC Name:
- Reaction mass of cyclohexanol and cyclohexanone
Constituent 1
- 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
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