Ethyl acrylate

Acute Toxicity: inhalation

Administrative data

Endpoint:

acute toxicity: inhalation

Type of information:

experimental study

Adequacy of study:

supporting study

Study period:

01 Mar 1988 - 06 Feb 1989

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Well documented, acceptable study (comparable to guideline study with acceptable restrictions)

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1989

Report date:

1989

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 403 (Acute Inhalation Toxicity)

Deviations:

yes

Remarks:

Exposure time: 1 h

Principles of method if other than guideline:

Three groups, each containing five male and five female Sprague-Dawley albino rats, were exposed once for one hour to ethyl acrylate vapor at nominal concentrations of 10048, 8335, and 6143 ppm. Animals were observed for 14 days post exposure and the LC50 value was determined. Mean measured concentrations (± SD) of ethyl acrylate for the three exposures were 8882 (± 331), 7421 (± 273), and 5843 (± 657) ppm corresponding to approximately 35.3, 29.5, and 23.2 mg/L.

GLP compliance:

yes

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Ethyl acrylate

EC Number:

205-438-8

EC Name:

Ethyl acrylate

Cas Number:

140-88-5

Molecular formula:

C5H8O2

IUPAC Name:

ethyl acrylate

Details on test material:

- Name of test material (as cited in study report): Ethyl acrylate
- Analytical purity: 99.8 %
- Impurities: Inhibitor MEHQ 14 ppm, water 0.03 %
- Supplier: Union Carbide Corporation, Hahntown, LA
- Purity test date: 13 May 1989

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Harlan Sprague-Dawley, Inc., Indianapolis, IN
- Age at study initiation: 45-49 days
- Housing: five per sex in 23.5 x 40 x 18 cm stainless steel wire-mesh cages on carriers for quarantine and postexposure periods; during exposures the rats were individually housed in 17.5 x 12 x 18 cm wire-mesh cages
- Diet: Pelleted feed (Pro Lab RMH #3000, Agway, Inc .) Ad Iibitum
- Water: Tap water (Municipal Authority of Westmoreland County, Greensburg, PA) Ad Iibitum


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18-26
- Humidity (%): 31-58
- Photoperiod (hrs dark / hrs light): 12h

Administration / exposure

Route of administration:

inhalation: vapour

Type of inhalation exposure:

whole body

Vehicle:

other: unchanged (no vehicle)

Details on inhalation exposure:

GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus: Glass and stainless steel chamber
- Exposure chamber volume: 900 l
- Source and rate of air: Liquid ethyl acrylate was metered from a piston pump (Fluid Metering Inc., Oyster Bay, NJ) into a heated evaporator (147 - 156 °C) similar in design to that by Carpenter et al. (1975). The resultant vapour was carried into the chamber by an inlet air stream. The airflow rate was 200 L/min.


TEST ATMOSPHERE
- Brief description of analytical method used: A Perkin-Elmer Sigma 2000 gas chromatograph (GC) equipped with a flame ionization detector was used to monitor the ethyl acrylate vapour concentration in the chambers.
- Samples taken from breathing zone: yes

Analytical verification of test atmosphere concentrations:

yes

Remarks:

The exposure chamber atmospheres were analyzed for ethyl acrylate five or six times during each of the three one-hour exposures. Mean concentrations were 5843, 7421, and 8882 ppm.

Duration of exposure:

1 h

Concentrations:

5843, 7421, and 8882 ppm (corresponding to approx. 23.2, 29.5 and 35.3 mg/L)

Conversion of ppm in mg/L based on conversion factor given in study report: 1 mg/L = 251.7 ppm at 735 mmHg (980 hPa) and 24 °C; molecular weight of EA = 100.12 g/mol; specific gravity at 20/20 °C = 0.9225 g/mL

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days.
- Frequency of observations and weighing: All animals were observed for signs of toxic effects on the day of exposure and daily following exposure.The animals were weighed prior to exposure and on postexposure Days 7 and 14.
- Necropsy of survivors performed: yes (complete necropsy for all animals)
- Other examinations performed: clinical signs, body weight, histopathology (lungs, liver, kidneys from selected female animals)

Statistics:

The mean and standard deviation of the body weights, body weight changes, and exposure concentrations were calculated. No statistical comparisons were made. The LC50 was determined by the moving average method of Thompson (1947) for males, females, and the combined sexes using all exposure groups .

Results and discussion

Effect levels

Effect levels 1

Sex:

male/female

Dose descriptor:

LC50

Effect level:

ca. 25.8 mg/L air (analytical)

95% CL:

21.7 - 30.6

Exp. duration:

1 h

Effect levels 2

Sex:

male/female

Dose descriptor:

LC50

Effect level:

ca. 12.9 mg/L air (analytical)

Exp. duration:

4 h

Remarks on result:

other: (recalculated)

Mortality:

Mortality rate (male and females) of 5/5, 3/5 and 2/5 was observed in dose group of 8882, 7421 and 5843 ppm, respectively.

Clinical signs:

other: On the day of exposure, clinical signs were observed for all groups and included blepharospasm, lacrimation, perinasal and perioral wetness, and a slow surface-righting reflex. Additional signs observed for the 8882 and 7421 ppm groups on the day of expo

Body weight:

Loss of body weight or depression in body weight gain was observed for the 7421 ppm group (both sexes) during the first week of the postexposure period. However, body weight gain was observed for this group during the second week post exposure. Body weight gains were observed for all animals in the 5843 ppm group on post exposure Days 7 and 14.

Gross pathology:

Macroscopic lesions observed in animals that died included a dark red or mottled discoloration of lungs, liver and kidneys, and clear fluid in trachea and thoracic cavity, and gas filled stomachs. No macroscopic lesions were observed in animals sacrificed at the end of the 2-week postexposure period.

Any other information on results incl. tables

Chamber concentrations:

The analytical/nominal concentration ratios were 0.88, 0.89, and 0.95, respectively (uncorrected for EA purity of 99.8 %).

Environmental chamber and housing conditions:

The temperature and relative humidity in the animal housing room ranged from 18 to 26 °C and from 31 to 58 %, respectively, throughout the study period.

LC 50 determination:

The 1-hr LC 50 value (with 95% confidence limits) for the combined sexes was 6493 (5474 to 7702) ppm corresponding to 25.8 mg/L. For classification purposes, this value has to be converted to a 4-hour equivalent by dividing the 1-hour value by a factor of 2. The resulting 4-hr LC50 is approx. 12.9 mg/L.

Applicant's summary and conclusion

Interpretation of results:

harmful

Remarks:

Migrated information Criteria used for interpretation of results: EU