2-tert-butylcyclohexyl ethyl carbonate

Acute Toxicity: inhalation

Administrative data

Endpoint:

acute toxicity: inhalation

Type of information:

experimental study

Adequacy of study:

disregarded due to major methodological deficiencies

Study period:

1979

Reliability:

3 (not reliable)

Rationale for reliability incl. deficiencies:

other: see 'Remark'

Remarks:

Exposure of the animals was not optimal as the animals were exposed to the test substance at only 1% in 40% alcohol for only 2 h. Table results and individual results are not reported. Whole body necropsy was not performed; only 3/5 animals were processed and histopathologically examined (limited to respiratory tract). Lack of details about the atmosphere generated (indirect measurement of concentration) and about animal data. Also, certificate of analysis of the test substance is not included and details on test material are missing.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1979

Report date:

1979

Materials and methods

Test guideline

Qualifier:

no guideline followed

Principles of method if other than guideline:

Rats were exposed to a 1% solution of the test product in 40% alcohol for 2 h. After a 14-day observation period, 3/5 animals were examined for macroscopic and microscopic findings.

GLP compliance:

no

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

2-tert-butylcyclohexyl ethyl carbonate

EC Number:

267-184-4

EC Name:

2-tert-butylcyclohexyl ethyl carbonate

Cas Number:

67801-64-3

Molecular formula:

C13H24O3

IUPAC Name:

2-tert-butylcyclohexyl ethyl carbonate

Test material form:

liquid

Details on test material:

- Name of test material (as cited in the study report): Ethyl-2-tert.butylcyclohexyl-carbonat

Test animals

Species:

rat

Strain:

Wistar

Sex:

male

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Breeder Winkelmann GmbH, D Borchen
- Weight at study initiation: 130-150 g
- Fasting period before study: none
- Diet (e.g. ad libitum): Altromin maintenance diet No. 1324, ad libitum except during exposure period
- Water (e.g. ad libitum): ad libitum except during exposure period
- Acclimation period: 5 days

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

Administration / exposure

Route of administration:

inhalation: aerosol

Type of inhalation exposure:

whole body

Vehicle:

other: alcohol

Details on inhalation exposure:

GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus: inhalation desiccator
The substance solution was nebulized with a nebulizer and the spray was directed into the experimental animal room. The effluent air stream was measured through a gas meter to measure the flow. The exposure to test item was deduced from consumption of substance and air flow during the inhalation time.

Analytical verification of test atmosphere concentrations:

no

Duration of exposure:

2 h

Concentrations:

1% in 40% alcohol

No. of animals per sex per dose:

5 males

Control animals:

yes

Details on study design:

- Duration of observation period following administration: 14 days
Histopathology: upper trachea (thyroid area), middle trachea, 3 parts of lungs (left lobe transverse, right lobe I, II longitudinal) were embedded in Paraplast, and 5 μm thick cuts were made. Three treated animals and three controls were studied.

Statistics:

None

Results and discussion

Effect levels

Key result

Sex:

male

Dose descriptor:

LC50

Remarks:

qualitative results

Exp. duration:

2 h

Remarks on result:

not determinable due to absence of adverse toxic effects

Remarks:

Only a fast transient reduction of the general condition was observed after exposure

Mortality:

No mortality occured

Clinical signs:

other: Only transient reduction in general condition just after exposure

Body weight:

No effect

Gross pathology:

No effect

Other findings:

Histopathology: no effect

Any other information on results incl. tables

None

Applicant's summary and conclusion

Interpretation of results:

study cannot be used for classification

Conclusions:

The only symptom observed in rats after a 2-hour inhalation period of a 1% solution of the test product in 40% alcohol was a fast transient reduction of the general condition after exposure. No other substance-related findings were noted macroscopically and microscopically.

Executive summary:

5 male Wistar rats were exposed to an aerosol of a 1% solution of the test product in 40% alcohol for 2 h. 5 control animals were similarly exposed to the vehicle only.

The only symptom observed in treated rats was a fast transient reduction of the general condition after exposure. No other substance-related findings were noted macroscopically and microscopically for 14 days after exposure.

These results cannot be used for classification puposes because the concentration of exposure was low and the duration of exposure was short (only 2 h).