4-tert-butylcyclohexanol

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

Reference

Reference 1

Reference Type:

other: Report to Research Institute for Fragrance Materials, Inc. (RIFM)

Title:

Unnamed

Year:

1973

Report date:

1973

Reference 2

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

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

Test material information

Constituent 1

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

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.