Ethyl 2-ethylhexanoate

Acute Toxicity: inhalation

Administrative data

Endpoint:

acute toxicity: inhalation

Type of information:

experimental study

Adequacy of study:

supporting study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Acceptable, well-documented study report which meets basic scientific principles.

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:

Male Wistar rats were exposed to 1 percent of the test item in 40 percent alcohol for 2 h (whole body exposure).

GLP compliance:

no

Remarks:

study performed before implementation of GLP

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Ethyl 2-ethylhexanoate

EC Number:

221-043-3

EC Name:

Ethyl 2-ethylhexanoate

Cas Number:

2983-37-1

Molecular formula:

C10H20O2

IUPAC Name:

ethyl 2-ethylhexanoate

Details on test material:

- Name of test material (as cited in study report): 2-ethyl-ethyl-capronat
- Analytical purity: no data

Test animals

Species:

rat

Strain:

Wistar

Sex:

male

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Winkeimann GmbH, Borchen, Germany
- Age at study initiation: young adult
- Weight at study initiation: 130 - 150 g
- Fasting period before study: no
- Housing: in type 3 makrolon cages
- Diet (e.g. ad libitum): Altromin maintainance diet, 1324, ad libitum
- Water (e.g. ad libitum): tap water, ad libitum
- Acclimation period: 5 d

ENVIRONMENTAL CONDITIONS
- Temperature (°C): approx. 22
- Humidity (%): approx. 50
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:

inhalation: aerosol

Type of inhalation exposure:

whole body

Vehicle:

other: 40% ethanol

Details on inhalation exposure:

GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus: inhalation exsiccator
- Exposure chamber volume: no data
- System of generating particulates/aerosols: nebuliser

TEST ATMOSPHERE
- Brief description of analytical method used: no data

VEHICLE
- Composition of vehicle (if applicable): 40% EtOH
- Concentration of test material in vehicle (if applicable): 1%
- Justification of choice of vehicle: relatively intoxic to rat

TEST ATMOSPHERE (if not tabulated)
- Particle size distribution: no data

Analytical verification of test atmosphere concentrations:

not specified

Duration of exposure:

2 h

Concentrations:

1%

No. of animals per sex per dose:

5

Control animals:

yes

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: no data
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, histopathology of upper trachea, mid trachea, lung (3 test animals + 3 control animals)

Results and discussion

Effect levels

Effect levels 1

Sex:

male

Dose descriptor:

LC0

Effect level:

1 other: %

Based on:

other: test item in 40% EtOH

Exp. duration:

2 h

Remarks on result:

other: corresponds to 100 mg/animal/2 h

Effect levels 2

Sex:

male

Dose descriptor:

LC0

Effect level:

7.4 mg/L air (nominal)

Based on:

act. ingr.

Exp. duration:

2 h

Remarks on result:

other: recalculated from exposure/animal

Effect levels 3

Sex:

male

Dose descriptor:

LC50

Effect level:

3.7 mg/L air (nominal)

Based on:

act. ingr.

Exp. duration:

4 h

Remarks on result:

other: extrapolated from 2 h value

Mortality:

no animals died

Clinical signs:

other: no clinical signs apart from temporarily impaired general condition directly after inhalation exposure

Body weight:

no data

Gross pathology:

Pathologically and histologically no compound specific alterations of the target organs (respiratory tract) could be observed.

Any other information on results incl. tables

recalculation from 100 mg / animal to concentration in air:

- respiratory volume (rat) = 0.048 m³/ h / kg bw

- body weight of animal in study: 130 - 150 g (taken for calculation 140 g)

- > respiratory volume per animal in 2 h = 0.048 * 2 h * 0.14 kg = 0.01344 m³

-> 100 mg/animal corresponds to atmospheric concentration of 100 mg/0.01344 m³ = 7440 mg/m³ = 7.4 mg/L air

Applicant's summary and conclusion

Interpretation of results:

study cannot be used for classification

Remarks:

no toxicity observed up to the maximum dose

Conclusions:

The 2 h LC0 of 2-Ethyl ethyl capronate in male rats was 7.4 mg/L.

Executive summary:

In an acute inhalation toxicity study, groups of 5 male young adult Wistar rats were exposed by inhalation route to 2-Ethyl ethyl capronate in 40% Ethanol for 2 hours to whole body at concentrations of 0 and 1%.  Animals then were observed for 14 days.

No animals died at the limit concentration of 1% in 40% Ethanol. No clinical signs apart from temporarily impaired general condition directly after inhalation exposure were observed. Pathologically and histologically no compound specific alterations of the target organs (respiratory tract) could be observed.

The 2 h LC0 was >= 1% test substance in 40% Ethanol, corresponding to 100 mg/animal/2 h.

This value was recalculated to mg/L air using mean animal weights (140 g) and standard respiratory rate (0.048 m³ / h / kg bw) to 7.4 mg/L air (nominal).

“The ranges of the acute toxicity estimates (ATE) for inhalation toxicity [according to Regulation (EC) No 1272/2008] are based on 4-hour testing exposures. Conversion of existing inhalation toxicity data which have been generated using a 1-hour exposure can be carried out by dividing by a factor of […] 4 for dusts and mists.”

Based on this, a factor of 2 was used to extrapolate from 2 h exposure to 4 h exposure, resulting in a 4 h LC0 Males >=  3.7 mg/L.