Cyclohexanemethanol, 4-(1-methylethyl)-

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1978

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Remarks:

Study appears to follow OECD 401 with the following deviation: Sex of the animal and purity of the test substance not reported.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1978

Report date:

1978

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

yes

Remarks:

Sex of the animal and purity of the test substance not reported.

GLP compliance:

no

Remarks:

Study pre-dates GLP

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

cis-4-(isopropyl)cyclohexanemethanol

EC Number:

237-539-8

EC Name:

cis-4-(isopropyl)cyclohexanemethanol

Cas Number:

13828-37-0

Molecular formula:

C10H20O

IUPAC Name:

cis-(4-propan-2-ylcyclohexyl)methanol

Constituent 2

Reference substance name:

trans-(4-propan-2-ylcyclohexyl)methanol

Cas Number:

13674-19-6

Molecular formula:

C10H20O

IUPAC Name:

trans-(4-propan-2-ylcyclohexyl)methanol

Test material form:

not specified

Test animals

Species:

rat

Strain:

not specified

Sex:

not specified

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: AMR Biological Research, Inc .
- Age at study initiation: no data
- Weight at study initiation: see table 1
- Fasting period before study:24 hours
- Housing: individually housed
- Diet (e.g. ad libitum): yes
- Water (e.g. ad libitum): yes
- Acclimation period: no data

ENVIRONMENTAL CONDITIONS
- Temperature (°C): no data
- Humidity (%): no data
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): no data

IN-LIFE DATES: From: To: no data

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

VEHICLE: no data
MAXIMUM DOSE VOLUME APPLIED: 10,000 mg/kg
CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: no data

Doses:

10,000 mg/kg bw

No. of animals per sex per dose:

18

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: daily
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs and body weight were recorded

Statistics:

not required

Results and discussion

Preliminary study:

not applicable

Effect levels

Key result

Sex:

not specified

Dose descriptor:

LD50

Effect level:

> 10 000 mg/kg bw

Based on:

test mat.

Mortality:

no

Clinical signs:

other: no effects

Gross pathology:

no effects

Other findings:

Food consumption and water intake were normal.

Any other information on results incl. tables

Table 1. Summary of animal data from an acute oral toxicity study in rat
Animal No.	Initial weight (grams)	Final weight (grams)	Dose (g/kg)	Mortality
5	340	349	10	euthanized
6	234	245	10	euthanized
39	233	241	10	euthanized
40	241	246	10	euthanized
41	226	242	10	euthanized
42	230	242	10	euthanized
43	218	230	10	euthanized
44	222	226	10	euthanized
45	226	227	10	euthanized
46	239	248	10	euthanized
47	231	229	10	euthanized
48	221	227	10	euthanized
49	218	230	10	euthanized
50	248	262	10	euthanized
51	212	220	10	euthanized
52	228	235	10	euthanized
53	237	245	10	euthanized

observation of toxic symptoms
Animal No.	Time post admin.	Observation	Necropsy observation
5,6, 39-53	15 minutes	none	-
5,6, 39-53	8 hours	none	-
5,6, 39-53	24 hours	none	-
5,6, 39-53	48 hours	none	-
5,6, 39-53	72 hours	none	-
5,6, 39-53	4 days -7 days	none	-
5,6, 39-53	8 days -10 days	none	-
5,6, 39-53	11 days -14 days	none	none

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

LD50 oral, rat >10,000 mg/kg.

Executive summary:

The acute toxicity of the test substance was evaluated in an oral (gavage) study in albino rats. The test compound was administered at a single dose level of 10,000 mg/kg body weight via oral gavage. The animals were observed over a period of 14 days for clinical signs of toxicity. No mortalities or toxic effects were induced by the administration of the test compound at this dose level. Therefore, the oral LD50 of the substance was considered to be greater than 10,000 mg/kg body weight in rats.