Registration Dossier
Registration Dossier
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EC number: 202-676-4 | CAS number: 98-52-2
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
- Remarks:
- limited documentation
Data source
Referenceopen allclose all
- Reference Type:
- other: Report to Research Institute for Fragrance Materials, Inc. (RIFM)
- Title:
- Unnamed
- Year:
- 1 973
- Report date:
- 1973
- Reference Type:
- secondary source
- Title:
- Monographs on Fragrance Raw Materials: 4-tert-BUTYLCYCLOHEXANOL
- Author:
- Opdyke, D.L.J.
- Year:
- 1 974
- Bibliographic source:
- Food Cosmet Toxicol 12: 833
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Deviations:
- not specified
- GLP compliance:
- no
- Remarks:
- study performed prior to implementation of GLP
- Test type:
- standard acute method
- Limit test:
- no
Test material
- Reference substance name:
- 4-tert-butylcyclohexanol
- EC Number:
- 202-676-4
- EC Name:
- 4-tert-butylcyclohexanol
- Cas Number:
- 98-52-2
- Molecular formula:
- C10H20O
- IUPAC Name:
- 4-tert-butylcyclohexan-1-ol
Constituent 1
Test animals
- Species:
- rat
- Strain:
- not specified
- Sex:
- not specified
Administration / exposure
- Route of administration:
- oral: unspecified
- Vehicle:
- not specified
- Doses:
- 2000, 2500, 3200, 4000 and 5000 mg/kg bw
- No. of animals per sex per dose:
- 10 animals per dose (no data on sex)
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
Results and discussion
Effect levels
- Sex:
- not specified
- Dose descriptor:
- LD50
- Effect level:
- 4 200 mg/kg bw
- Based on:
- test mat.
- 95% CL:
- > 3.62 - < 4.87
- Mortality:
- - 2000 mg/kg bw: 0/10
- 2500 mg/kg bw: 1/10 (The animal died on day 3 of the observation period.)
- 3200 mg/kg bw: 2/10 (The animals died on day 1 and 3 of the observation period, respectively.)
- 4000 mg/kg bw: 4/10 (3 animals died on day 1 and one animal on day 2 of the observation period.)
- 5000 mg/kg bw: 8/10 (7 animals died on day 1 and one animal on day 2 of the observation period.) - Clinical signs:
- other: Immediate stimulation followed by ataxia were observed.
Applicant's summary and conclusion
- Interpretation of results:
- Category 5 based on GHS criteria
- Remarks:
- Migrated information
- Conclusions:
- A single dose oral toxicity test of 4-tert-butylcyclohexanol in rats revealed an LD50 value of 4200 mg/kg bw.
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