Registration Dossier

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:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
no
GLP compliance:
yes (incl. certificate)
Test type:
acute toxic class method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
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 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.