Registration Dossier

Administrative data

Endpoint:
acute toxicity: other routes
Type of information:
experimental study
Adequacy of study:
other information
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
other: Documentation is insufficient for assessment

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1975
Report Date:
1975

Materials and methods

Principles of method if other than guideline:
Mice were exposed once to the test substance by intraperitoneal application.
GLP compliance:
no
Remarks:
study performed prior to implementation of GLP

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
mouse
Strain:
not specified
Sex:
not specified

Administration / exposure

Route of administration:
intraperitoneal
Vehicle:
CMC (carboxymethyl cellulose)
Remarks:
0.5% in water
Details on exposure:
Concentration of test substance in vehicle: 6-20% (suspension)
Doses:
no data
No. of animals per sex per dose:
no data
Control animals:
not specified
Details on study design:
- Duration of observation period following administration: 7 days
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs

Results and discussion

Effect levels
Sex:
not specified
Dose descriptor:
LD50
Effect level:
ca. 700 mg/kg bw
Based on:
test mat.
Clinical signs:
Dyspnea, apathy, tremor, clonic convulsions, atony, exsiccosis, prone position, and partially opisthotonos were noted.
Gross pathology:
Slight intraabdominal test substance residues and accumulations were observed.

Applicant's summary and conclusion

Conclusions:
A single intraperitoneal application of 4-tert-butylcyclohexanol in mice resulted in an LD50 value of 700 mg/kg bw. Only limited information on test method (test animals, applied concentrations, mortality etc.) is provided and thus documentation is insufficient for assessment.