Ethyl 2-ethylhexanoate

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:

guideline study with acceptable restrictions

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:

no

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:

mouse

Strain:

CF-1

Sex:

male

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Age at study initiation: young adult
- Weight at study initiation: approx. 24 g
- Fasting period before study: yes
- Housing: no data
- Diet (e.g. ad libitum): Altromin maintainance diet, Nr. 1324
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 5 d

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3
- Humidity (%): approx. 50%
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

CMC (carboxymethyl cellulose)

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 79 - 315 g/L
- Purity: 2% CMC/MED/Type 70

MAXIMUM DOSE VOLUME APPLIED: 20 cm³/kg bw for all dose levels

Doses:

1680, 1990, 3160, 3980, 5010, 5600, 6310 mg/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 observations and weighing: day 0 (prior to administration); after 48 h, 1 week, 2 weeks
- Necropsy of survivors performed: only 3-6 animals per dose group were examined after necropsy

Statistics:

Litchfield and Wilcoxon (J. Pharm. exptl. ther. 96, 99 - 108 (1949))

Results and discussion

Effect levels

Key result

Sex:

male

Dose descriptor:

LD50

Effect level:

4 450 mg/kg bw

Based on:

act. ingr.

95% CL:

>= 3 800 - <= 5 210

Mortality:

1680 mg/kg bw: 0/10 animals died;
1990 mg/kg bw: 1/10 animals died;
3160 mg/kg bw: 3/10 animals died;
3980 mg/kg bw:4/10 animals died;
5010 mg/kg bw: 5/10 animals died;
5600 mg/kg bw: 7/10 animals died;
6310 mg/kg bw: 10/10 animals died

Clinical signs:

reduced breathing frequency, reduced activity, abnormal posture

Body weight:

body weight gain of surviving animals was similar in all dose groups

Gross pathology:

no findings in examined animals

Applicant's summary and conclusion

Interpretation of results:

other: not classified according to CLP regulation

Conclusions:

Based on the results obtained after a single oral administration to male mice, the oral LD50 of 2-Ethyl ethyl capronate was determined to be 4450 mg/kg bw.

Executive summary:

In an acute oral toxicity study similar to OECD guideline 401, groups of 10 fasted male CF-1 mice were given a single oral dose of 2-Ethyl ethyl capronate at doses of 1680, 1990, 3160, 3980, 5010, 5600 and 6310 mg/kg bw and observed for 14 days.

The following mortality was observed: 0/10 at 1680 mg/kg bw; 1/10 at 1990 mg/kg bw; 3/10 at 3160 mg/kg bw; 4/10 at 3980 mg/kg bw; 5/10 at 5010 mg/kg bw; 7/10 at 5600 mg/kg bw; 10/10 at 6310 mg/kg bw.

The surviving animals showed reduced activity after 2 and 24 h, reduced breathing frequency after 2 h and abnormal posture after 2 h.

No changes in body weight gain were observed in the surviving animals throughout all dose groups.

The oral LD50 was determined to be 4450 mg/kg bw (95% c.i. 3800 – 5210 mg/kg bw).