Registration Dossier

Administrative data

Endpoint:
epidemiological data
Type of information:
experimental study
Adequacy of study:
supporting study
Study period:
1987
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
Original study cited not reviewed. Included for completion only using information from a secondary source. Study covers mixed solvent exposure therefore of little use for identifying effects of ethyl acetate alone unless study is completely negative.

Data source

Reference
Reference Type:
publication
Title:
No information
Author:
Tuohimaa, P., Wichmann, L.
Year:
1987
Bibliographic source:
Chapter 5 In Hemminki, K. et al. (eds.): Occupational Hazards and Reproduction, Hemisphere Publishing Corp., Washington DC

Materials and methods

Study type:
other: no data
Endpoint addressed:
toxicity to reproduction / fertility
Principles of method if other than guideline:
no further information available.
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent

Method

Type of population:
occupational
Details on study design:
SETTING: printing factory workers occupationally exposed (for an undisclosed time) to an atmosphere reportedly containing ethyl acetate at 150 ppm (549 mg/m3) and other organic solvents.

STUDY POPULATION
- Total number of subjects participating in study: 11

HEALTH EFFECTS STUDIED
- Other health effects: sperm count.
Exposure assessment:
not specified

Results and discussion

Results:
No effects on sperm count were detected

Applicant's summary and conclusion

Executive summary:

No effects on sperm count were detected in a study of eleven printing factory workers occupationally exposed (for an undisclosed time) to an atmosphere reportedly containing ethyl acetate at 150 ppm (549 mg/m3) and other organic solvents. The study covered mixed solvent exposure but since the result was negative, it can be concluded that ethyl acetate causes no adverse effects in this exposure setting.