3-ethoxy-1,1,5-trimethylcyclohexane

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1981

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Remarks:

Study performed similarly to the OECD guideline 401 with minor deviation: material tested as a suspension in CMC; it could have been tested undiluted. Certificate of analysis of the test substance is not included, some details on test material and tested animals are missing.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1981

Report date:

1981

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

yes

Remarks:

material tested as a suspension in CMC; it could have been tested undiluted. Certificate of analysis of the test substance is not included, some details on test material and tested animals are missing.

Principles of method if other than guideline:

not applicable

GLP compliance:

no

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

3-ethoxy-1,1,5-trimethylcyclohexane

EC Number:

266-722-5

EC Name:

3-ethoxy-1,1,5-trimethylcyclohexane

Cas Number:

67583-77-1

Molecular formula:

C11H22O

IUPAC Name:

3-ethoxy-1,1,5-trimethylcyclohexane

Test material form:

liquid

Details on test material:

- Name of test material (as cited in study report): 3,3,5-Trimethylcyclohexyl-ethyl-ether

Test animals

Species:

mouse

Strain:

CF-1

Sex:

male

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: no data
- Average weight : 26 g
- Diet (e.g. ad libitum): Altromin No. 1324 ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3
- Humidity (%): about 50
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

CMC (carboxymethyl cellulose)

Details on oral exposure:

The application volume was a constant volume of 20 cm3/kg bw
The test material was suspended in 2% CMC
The concentration of the solution was 99.5 g/L

Doses:

1.99 g/kg bw

No. of animals per sex per dose:

10

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of weighing: before administration, 2, 7 and 14 days after administration
- Necropsy of survivors performed: 2 animals

Statistics:

none

Results and discussion

Preliminary study:

not applicable

Effect levels

Key result

Sex:

male

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

None

Clinical signs:

other: The following symptoms could be observed: decreased activity, prone position, decreased respiratory rate

Gross pathology:

No effect

Other findings:

None

Any other information on results incl. tables

Table 7.2.1/1 : Mean body weights (g)

Before application	48 h	1 week	2 weeks
25.8	27.02	31.35	34.69

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Under the test conditions, 3,3,5-Trimethylcyclohexyl-ethyl-ether is not classified according to the annex VI of the Regulation EC No. 1272/2008 (CLP) and to the GHS. Oral LD50 males > 2000 mg/kg bw

Executive summary:

In an acute oral toxicity study performed similarly to OECD guideline 401, 10 adult male CF-1 mice were administered a single oral dose of test compound suspended in CMC at 2000 mg/kg bw by gavage. The animals were observed for mortality, clinical signs and body weight for 14 days and some of them were necropsied for macroscopic observations.

No mortality was observed. The following symptoms could be observed: decreased activity, prone position, decreased respiratory rate. However, bodyweight increased normally. In these test conditions, oral LD50 in males was considered higher than 2000 mg/kg bw.

Under the test conditions, 3,3,5-Trimethylcyclohexyl-ethyl-ether is not classified according to the annex VI of the Regulation EC No. 1272/2008 (CLP) and to the GHS.

 

This study is considered as acceptable and satisfies the requirement for acute oral toxicity endpoint.