Registration Dossier

Administrative data

Endpoint:
health surveillance data
Type of information:
other: Case history study
Adequacy of study:
supporting study
Study period:
n/a
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
documentation insufficient for assessment
Remarks:
Only a poor quality report that is very difficult to read is available.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1977
Report Date:
1977

Materials and methods

Study type:
health record from industry
Endpoint addressed:
not applicable
Principles of method if other than guideline:
Case history study on operators in a plant for exposure to D4
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent

Method

Details on study design:
A health evaluation of employees exposed to D4 was undertaken to determine whether measurable health effects are produced by long-term exposure to typical levels of D4 in the workplace. The study consisted of 2 basic parts: 1. an industrial hygiene D4 chemical vapor exposure evaluation; 2. a medical department evaluation of the medical records for the employees in the study group.

Results and discussion

Results:
The 8 hour TWA exposure to D4 was found to range from 0.17 to 2.2 ppm with an average of 0.75 ppm. The  highest level found during the survey was 4.4 ppm. The medical records survey revealed that none of the  cases presented any abnormality which was of significance, or which could not be accounted for by an incorrect normal value reading (except one case which presented some abnormalities of the SGOT, not confirmed by other laboratory studies). The results indicate that there are no measurable health effects produced by long-term exposures to typical levels of D4 found in the workplace.

Applicant's summary and conclusion

Conclusions:
In a health evaluation of employees exposed to D4 conducted to determine whether measurable health effects are produced by long-term exposure to typical levels of D4 in the workplace (reliability score 4), the 8 hour TWA exposure to D4 was found to range from 0.17 to 2.2 ppm with an average of 0.75 ppm. The  highest level found during the survey was 4.4 ppm. The results indicate that there are no measurable health effects produced by long-term exposures to typical levels of D4 found in the workplace.