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Toxicological information

Direct observations: clinical cases, poisoning incidents and other

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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

Referenceopen allclose all

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 Type:
study report
Title:
Unnamed
Year:
1997
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 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

Reference
Name:
Unnamed
Type:
Constituent
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.