2-ethoxy-1-methylethyl acetate

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1985

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Guideline study (OECD 401)

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1985

Report date:

1985

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test type:

acute toxic class method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

2-ethoxy-1-methylethyl acetate

EC Number:

259-370-9

EC Name:

2-ethoxy-1-methylethyl acetate

Cas Number:

54839-24-6

Molecular formula:

C7H14O3

IUPAC Name:

2-ethoxy-1-methylethyl acetate

Details on test material:

- Name of test material (as cited in study report): Ethoxypropyl acetate
- Physical state: Liquid
- Analytical purity: >98.5%
- Storage condition of test material: At ambient temperature

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Each animal was identified by cage number and ear punching.
- Source: Interfauna UK Ltd., Huntingdon, Cambridgeshire, England
- Age at study initiation: Approximately 4 to 6 weeks
- Weight at study initiation: 100 to 127 g prior to dosing (Day 1) in the main study.
- Fasting period before study: Access to food only was prevented overnight prior to and approximately 4 hours after dosing.
- Housing: Animals were housed in groups by sex in metal cages with wire mesh floors.
- Diet: Ad libitum access to a standard laboratory rodent diet (Labsure LAD 1), except during the fasting period
- Water: Ad libitum access to tap water
- Acclimation period: A minimum of 5 days prior to start of the main study.

ENVIRONMENTAL CONDITIONS
- Temperature: The mean daily minimum and maximum temperature of the animal room were 21 degrees C and 23 degrees C.
- Humidity: The mean daily relative humidy value of the animal room was 63%.
- Air changes: Approximately 15 changes per hour.
- Photoperiod: 12 hours of artificial light in each 24 hour period.

IN-LIFE DATES: From: 20 August, 1985 To: 3 September, 1985

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

MAXIMUM DOSE VOLUME APPLIED:
The test substance was administered as supplied at a constant volume of 5.3 ml/kg (specific gravity = 0.94).
CLASS METHOD (if applicable)
- Limit dose

Doses:

5 g/kg bodyweight

No. of animals per sex per dose:

Preliminary study – 2 males and 2 females
Main study – 5 males and 5 females

Control animals:

no

Details on study design:

- Duration of observation period following administration: Preliminary study – 5 days
Main study – 14 days
- Frequency of observations and weighing: Animals were observed soon after dosing; then at frequent intervals for the remainder of Day 1. On subsequent days the animals were observed at least twice per day. Individual body weights were recorded on Days 1 (day of dosing), 8 and 15 of the main study.
- Necropsy of survivors performed: yes
- Other examinations performed: Clinical signs were recorded at each observation interval.

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LDLo

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

Mortality:

There were no mortalities.

Clinical signs:

Signs of reaction to treatment observed shortly after dosing in all rats were piloerection, hunched posture, abnormal gait (waddling), lethargy, pallor of the extremities and increased salivation.

Body weight:

All animals in the main study gained weight during the study period.

Gross pathology:

Terminal necropsy findings were normal.

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The acute lethal oral dose to rats of ethoxypropyl acetate was greater than 5.0 g/kg bodyweight.

Executive summary:

In a GLP and guideline acute oral toxicity study in rats, a single dose of ethoxypropyl acetate administered by gavage at the limit dose of 5.0 g/kg did not produce lethality.