Ethyl acetate

Direct observations: clinical cases, poisoning incidents and other

Administrative data

Endpoint:

direct observations: clinical cases, poisoning incidents and other

Type of information:

experimental study

Adequacy of study:

supporting study

Study period:

1997

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: see 'Remark'

Remarks:

Not a standard study. Original study report is not available and owners are not prepared to make it available. However, it is summarised in detail in the OECD SIAR and the criteria document for the UK occupational exposure standard and regarded as reliable by both the OECD and UK HSE, therefore it is regarded as reliable here.

Data source

Reference

Reference 1

Reference Type:

secondary source

Title:

Ethyl acetate SIDS initial assessment profile.

Author:

OECD

Year:

2004

Bibliographic source:

OECD SIAM 14, Paris, 2002

Report date:

2002

Reference 2

Reference Type:

study report

Title:

Unnamed

Year:

1997

Reference 3

Reference Type:

secondary source

Title:

Criteria document for ethyl acetate exposure limit

Author:

UK ACTS/WATCH committee

Year:

2001

Bibliographic source:

EH64 D113 (UK HMSO)

Reference 4

Reference Type:

secondary source

Title:

Recommendation from scientific expert group on occupational exposure limits for ethyl acetate

Author:

European Commission

Year:

1997

Bibliographic source:

SEG/SUM/1D October 1997

Materials and methods

Study type:

study with volunteers

Endpoint addressed:

eye irritation

respiratory irritation

Test guideline

Qualifier:

no guideline available

Principles of method if other than guideline:

The purpose of the study was to characterize the URT irritancy effects experienced from human volunteer exposure to ethyl acetate vapour, including the exposure-response relationship and the time course of the effects.  The study was part of a larger project to develop and test out an irritancy questionnaire which was the method to assess the subjective effects experienced.

GLP compliance:

not specified

Test material

Test material information

Constituent 1

Reference substance name:

Ethyl acetate

EC Number:

205-500-4

EC Name:

Ethyl acetate

Cas Number:

141-78-6

Molecular formula:

C4H8O2

IUPAC Name:

ethyl acetate

Details on test material:

- Name of test material (as cited in study report): ethyl acetate

Method

Type of population:

occupational

Subjects:

- Number of subjects exposed: 9 volunteers

Ethical approval:

confirmed and informed consent free of coercion received

Route of exposure:

inhalation

Reason of exposure:

intentional

Exposure assessment:

measured

Details on exposure:

Concentrations used: 200, 400, 600, 800 and 1000 ppm.
Exposure duration: 200/400ppm: 4 hours. 600/800/1000ppm 15 minutes.
The vapour was generated by bubbling compressed air through glass vessels containing ethyl acetate at 25 degreesC.
The concentration of ethyl acetate in the exposure chamber was by two methods: infrared spectrometry analysis continuous sampling and gas chromatographic analysis (FID) every 30 minutes.  

Examinations:

Measurements included eye blink rates redness (both measured offline from video recordings taken during exposure.), and perceived irritancy/odour using a questionnaire.  Full details of the questionnaire and results are recorded in the report.  Symptoms recorded included pricking, itching, burning, dryness, watering, soreness, stinging of the eyes, nose, mouth and throat.  Other symptoms recorded included runny, dry or blocked nose, sneezing, swollen glands and coughing (dry, tickly or other.)

Medical treatment:

not applicable.

Results and discussion

Clinical signs:

Exposure to 200ppm was clearly without effect. Exposure to 400ppm for 4 hours produced marginal subjective sensations of mild to medium eye soreness in 2 out of 6 individuals. Exposure to high levels (600-1000ppm) for short periods produced increasing subjective sensations, albeit only mild to medium in the eyes, nose and throat of some volunteers. No changes in eye redness were observed. There was a wide variation in blink rate between individuals and there was no correlation with exposure.

Applicant's summary and conclusion

Executive summary:

The irritancy effects from exposure to ethyl acetate, the exposure-response relationship and the time course of the effects were studied in human volunteers.  Exposure to 200ppm was clearly without effect. Exposure to 400ppm for 4 hours produced marginal subjective sensations of mild to medium eye soreness in 2 out of 6 individuals. Exposure to high levels (600-1000ppm) for short periods produced increasing subjective sensations, albeit only mild to medium in the eyes, nose and throat of some volunteers. No changes in eye redness were observed. There was a wide variation in blink rate between individuals and there was no correlation with exposure.