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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
Remarks:
limited documentation

Data source

Referenceopen allclose all

Reference Type:
other: Report to Research Institute for Fragrance Materials, Inc. (RIFM)
Title:
Unnamed
Year:
1973
Report Date:
1973
Reference Type:
secondary source
Title:
Monographs on Fragrance Raw Materials: 4-tert-BUTYLCYCLOHEXANOL
Author:
Opdyke, D.L.J.
Year:
1974
Bibliographic source:
Food Cosmet Toxicol 12: 833

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
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
Name:
Unnamed
Type:
Constituent

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:
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.