2-(2-ethoxyethoxy)ethyl acetate

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:

data from handbook or collection of data

Data source

Reference

Reference Type:

publication

Title:

The single dose toxicity of some glycols and derivatives

Author:

Smyth, H. et al.

Year:

1941

Bibliographic source:

Journal of Industrial Hygiene and Toxicology, 23:259-268

Materials and methods

Principles of method if other than guideline:

Single oral administration by stomach tube in male rats.

GLP compliance:

no

Test type:

standard acute method

Test material

Test material information

Constituent 1

Reference substance name:

2-(2-ethoxyethoxy)ethyl acetate

EC Number:

203-940-1

EC Name:

2-(2-ethoxyethoxy)ethyl acetate

Cas Number:

112-15-2

Molecular formula:

C8H16O4

IUPAC Name:

2-(2-ethoxyethoxy)ethyl acetate

Details on test material:

- Name of test material (as cited in study report): Diethylene glycol monoethyl ether acetate
- Analytical purity: no data

Test animals

Species:

rat

Strain:

other: albino Wistar

Sex:

male

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Weight at study initiation: 90 - 120 g
- Diet: Purina chows, supplemented by fresh vegetables
- Water: ad libitum

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Details on oral exposure:

VEHICLE
- Concentration in vehicle: maximal concentration 500 mg/mL

MAXIMUM DOSE VOLUME APPLIED: Individual dose levels were not reported for any of the substances tested including the test substance considered herein. According to the authors, the highest dose level which could safely be hold at one time by the animal was just over 10% of the animal’s bodyweight, corresponding to approx. 50 g/kg bw, when a substance was administered as a 50% solution. This is equivalent to a dose volume of 100 mL/kg bw.
Furthermore, it was reported that in most cases 10 animals were dosed to determine the toxicity of a particular dosage and enough dosages were given to include those at which no mortality occurred and those at which all tested animals died.
The test substance was administered as a 50% solution and based on the information above and the resulting LD50 value, it appears unlikely that the test substance could have been administered at a dose volume > 100 mL/kg bw.
It is therefore assumed that the maximum dose volume applied was 100 mL/kg bw corresponding to a maximum dose level of 50000 mg/kg bw.

Doses:

Not specified (presumably up to 50000 mg/kg bw)

No. of animals per sex per dose:

ca. 10

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs

Statistics:

The data were calculated by the method of probits, described by Bliss C.I. (1935. The calculation of the dosage-mortality curve. Ann. Appl. Biol. 22:134-167).

Results and discussion

Effect levels

Sex:

male

Dose descriptor:

LD50

Effect level:

11 000 mg/kg bw

Based on:

test mat.

95% CL:

10 400 - 11 590

Remarks on result:

other: slope: 21.21

Mortality:

Mortality data were summarised for all substances tested. Therefore, no substance specific data were reported.
According to the authors, most deaths occurred within the first 48 h post-dose, but all deaths within 14 days post-administration were taken into account for calculation of LD50 values. In particular for ethers, death was delayed about a week.

Clinical signs:

other: The test substance was tested along with other glycol ethers. For this group, narcosis was observed but in most cases only at the LD50 or above.

Gross pathology:

Gross pathology findings were summarised for all substances tested. According to the authors, all doses caused some degree of irritation of the digestive tract. The primary target organ was the kidney; blood in urine and free blood beneath the capsule were seen at the highest dosages. The liver was less affected, but orange or reddish bile was often observed.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

CLP: not classified
DSD: not classified

Executive summary:

Median lethal dose (LD50) following administration of a single oral dose to the rat was in excess of 2000 mg/kg body weight.