Ethyl 4-dimethylaminobenzoate

Acute Toxicity: oral

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 guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Version / remarks:

not precised

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.1 (Acute Toxicity (Oral))

Version / remarks:

not precised

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

Test material information

Constituent 1

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

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:

LD0

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:

other: 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 behaviou

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:

GHS criteria not met

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.