Registration Dossier

Toxicological information

Epidemiological data

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Administrative data

Endpoint:
epidemiological data
Type of information:
other: epidemiology
Adequacy of study:
supporting study
Rationale for reliability incl. deficiencies:
other: Only abstract available (study in Chinese)

Data source

Reference
Reference Type:
publication
Title:
Chronic toxic effect of chloroethanol
Author:
Yu X, Li Y, Wang Y, Lui J, Li M
Year:
1997
Bibliographic source:
Gongye Weisheng Yu Zhiyebing 23(1): 31-32

Materials and methods

Study type:
cohort study (retrospective)
Endpoint addressed:
repeated dose toxicity: inhalation
Principles of method if other than guideline:
Toxic effects in workers exposed during working shift to the test substance for more than 2 years
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
no details

Method

Details on study design:
Contact level and chronic toxic effects in 61 workers in a chloroethanol workshop studied; 60 workers without toxic substance contact history served as controls .
Exposure assessment:
measured

Results and discussion

Results:
In analytical workers the incidence of neurothenia and anorexia were significantly increased; blood cholesterol level was significantly higher (comment: comparison to normal range questionable).
Two cases of salivary antipyrine clearance below 30 ml/min., indicating possible mixed function oxidase inhibition; RUN, glutathione content, LDH isoenzyme, transpeptidase, urinary beta .2-microglobulin, blood and urine routine, liver function test, EGG and EEG were normal.
No further data
Confounding factors:
no data
Strengths and weaknesses:
not assignable

Any other information on results incl. tables

Small cohort size

Applicant's summary and conclusion

Conclusions:
In a chinese cohort study on workers exposed to an average of 4 mg/m³ per shift for more than 2 years a significant increase in the incidence of neurothenia and anorexia was found, however, the study was hampered by small cohort size.
Executive summary:

Chronic toxic effects in 61 chinese workers in a chloroethanol workshop were studied and compared with 60 workers without toxic substance contact history (only abstract available, no details). The average exposure level was 4 mg/m³ and the average exposure duration 11 years. The incidence of neurothenia and anorexia were significantly increased; blood cholesterol level was significantly higher.

Conclusion: In a chinese cohort study on workers exposed to an average of 4 mg/m³ per shift for more than 2 years a significant increase in the incidence of neurothenia and anorexia was found, however, the study was hampered by small cohort size.