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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
16 July 1987 to 30 July 1987
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1987
Report date:
1987

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.1 (Acute Toxicity (Oral))
Deviations:
no
GLP compliance:
not specified
Remarks:
The study was conducted in accordance with quality assurance procedures.
Test type:
standard acute method
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Ethyl 4-dimethylaminobenzoate
EC Number:
233-634-3
EC Name:
Ethyl 4-dimethylaminobenzoate
Cas Number:
10287-53-3
Molecular formula:
C11H15NO2
IUPAC Name:
ethyl 4-(dimethylamino)benzoate
Test material form:
other: crystalline/powdery solid
Details on test material:
- Appearance: White crystalline/powdery solid
- Storage conditions of test material: Ambient temperature in the dark

Test animals

Species:
rat
Strain:
Sprague-Dawley
Remarks:
CD [Crl: COBS CD (SD) BR]
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Age at study initiation: Four to six weeks old
- Weight at study initiation: 104 to 120 grams
- Fasting period before study: Overnight before dosing and for four hours post dosing (restricted access to food only)
- Housing: Rats were allocated to cages within the treatment group, housed in groups by sex in metal cages with wire mesh floors.
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 8 days

ENVIRONMENTAL CONDITIONS
- Temperature: 21 to 22 °C
- Humidity: 69 % (relative)
- Air changes: Approximately 15 per hour
- Photoperiod: 12 hours of artificial light in each 24 hour period

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
corn oil
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 20 % (w/v)
- Stability: Not determined; the test material was prepared on the day of dosing

MAXIMUM DOSE VOLUME APPLIED: 10.0 mL/kg
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
5 males and 5 females per dose
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Animals were observed soon after dosing and at frequent intervals for day 1. On subsequent days, observations took place twice daily. Individual bodyweights were recorded on days 1, 8 and 15.
- Necropsy of survivors performed: All animals were killed on day 15 by cervical dislocation and macroscopic post mortem examination took place which consisted of opening the abdominal and thoracic cavities.

Results and discussion

Effect levels
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Remarks on result:
not determinable due to absence of adverse toxic effects
Mortality:
There were no deaths following a single oral dose of test material at 2000 mg/kg bodyweight.
Clinical signs:
Signs of reaction to treatment observed shortly after dosing in all animals were pilo-erection, abnormal body carriage (hunched posture), abnormal gait (waddling), lethargy and pallor of extremities. Recovery, as judged by external appearance and behaviour, was advanced by Day 2 and complete by Day 3.
Body weight:
Slightly low bodyweight gains were recorded for the majority of animals on Day 8. Anticipated bodyweight gains were recorded for all animals on day 15.
Gross pathology:
Terminal autopsy findings were normal.

Any other information on results incl. tables

Table 1: Signs of reaction to treatment observed

Signs

No. of animals in group of 5 showing signs at 2000 mg/kg

Male

Female

Pilo-erection

5

5

Hunched posture

5

5

Waddling

5

5

Lethargy

5

5

Pallor of extremities

5

5

Table 2: Individual bodyweights

Sex

Bodyweight (g) at Day

1

8

15

Male

120

104

120

112

119

195

163

186

175

182

248

207

234

229

236

Female

107

114

111

119

112

147

152

148

169

155

169

182

173

197

184

Applicant's summary and conclusion

Interpretation of results:
other: Not classified in accordance with EU criteria
Conclusions:
Under the conditions of this study the acute lethal oral dose was found to be greater than 2000 mg/kg bodyweight.
Executive summary:

The acute oral toxicity of the test material was investigated in accordance with the standardised guidelines OECD 401 and EU Method B1.

A group of 5 male and 5 female rats were exposed to the test material in corn oil at a limit dose of 2000 mg/kg bw. Fasted animals were dosed via a syringe and plastic catheter. All animals were observed for 14 days after dosing before being terminated on day 15 and subjected to macroscopic examination at necropsy.

There were no cases of mortality during the study. Signs of reaction to treatment observed shortly after dosing in all animals were pilo-erection, abnormal body carriage (hunched posture), abnormal gait (waddling), lethargy and pallor of extremities. Recovery, as judged by external appearance and behaviour, was advanced by Day 2 and complete by Day 3. Terminal autopsy findings were normal.

Under the conditions of this study the acute lethal oral dose was found to be greater than 2000 mg/kg bodyweight.