Ethyl 4-dimethylaminobenzoate

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

14 July 1987 to 28 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 402 (Acute Dermal Toxicity)

Version / remarks:

not precised

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.3 (Acute Toxicity (Dermal))

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]

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Age at study initiation: 7 to 10 weeks of age
- Weight at study initiation: 201 to 226 grams
- Fasting period before study: No
- Housing: Rats were allocated to cages within the treatment group. The rats were housed individually in metal cages with wire mesh floors.
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 6 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

Type of coverage:

occlusive

Vehicle:

water

Details on dermal exposure:

TEST SITE
- Area of exposure: Dorso-lumbar region (hair was removed with electric clippers on the day prior to application; no shaving or chemical depilation was used)
- % coverage: 10 % of the total body surface
- Type of wrap if used: Gauze used to cover the treated area was held in place with an impermeable dressing encircled firmly around the trunk.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): Warm (30 to 40 °C) water was used to wash the area before blotting it with absorbent paper.
- Time after start of exposure: 24 hours

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2000 g/kg at a volume of 2.60 mL/kg
- Concentration (if solution): 76.9 % w/v in distilled water
- For solids, paste formed: Yes; prepared as a 76.9 % w/v paste in distilled water on the day of dosing

Duration of exposure:

24 hours

Doses:

2000 mg/kg

No. of animals per sex per dose:

5 animals per sex 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 the remainder of day 1. On subsequent days the animals were observed twice daily. The treated areas of skin were examined daily for signs of dermal irritation and assessed for erythema and eschar and oedema formation. Bodyweights were recorded on Days 1, 8 and 15.
- Necropsy of survivors performed: Yes; on day 15 all animals were killed by cervical dislocation and subjected to macroscopic post mortem examination 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 the application of the test material.

Clinical signs:

other: There were no clinical signs of systemic reaction to treatment.

Gross pathology:

Terminal autopsy findings were normal.

Other findings:

DERMAL RESPONSES
At the site of application of the test material no irritation responses or dermal changes were observed.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Under the conditions of this study, the LD50 has been determined to be greater than 2000 mg/kg bodyweight.

Executive summary:

A study was conducted to investigate the acute dermal toxicity of the test material in accordance with the standardised guidelines OECD 402 and EU Method B.3.

Five male and 5 female rats received a dermal administration of the test material (as a paste made with distilled water) at a limit dose of 2000 mg/kg bodyweight. Gauze used to cover the treated area was held in place with an impermeable dressing encircled firmly around the trunk. The animals were exposed to the test material for 24 hours before it was washed off with warm water and blotted with absorbent paper. All animals were observed for 14 days after dosing before being terminated on day 15 and subjected to macroscopic examination at necropsy.

All animals survived to study termination and there were no clinical signs of toxicity noted throughout the 14-day study period. Slightly low bodyweight gains were recorded for one male and three females on Day 15. All other animals achieved anticipated bodyweight gains throughout the study. There were no gross pathological findings observed in any animals in the terminal autopsy.

Under the conditions of this study, the LD50 has been determined to be greater than 2000 mg/kg bodyweight.