Registration Dossier

Diss Factsheets

Administrative data

Endpoint:
epidemiological data
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Published study

Data source

Reference
Reference Type:
publication
Title:
Association of Petrochemical Exposure with Spontaneous Abortion
Author:
Xu, X., Cho S-I., Sammel, M., You, L., Cui, S., Huang, Y., Ma, G., Padungtod, C., Pothier, L., Niu, T., Christiani, D., Smith, T., Ryan, L., Wang, L.
Year:
1998
Bibliographic source:
Occupational and Environmental Medicine, 55(1): 31-36

Materials and methods

Study type:
cohort study (retrospective)
Endpoint addressed:
developmental toxicity / teratogenicity
Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
A retrospective cohort study investigating worker exposure and spontaneous abortion
GLP compliance:
not specified
Remarks:
: not relevant for this study type

Test material

Constituent 1
Chemical structure
Reference substance name:
Ammonia, anhydrous
EC Number:
231-635-3
EC Name:
Ammonia, anhydrous
Cas Number:
7664-41-7
Molecular formula:
H3N
IUPAC Name:
ammonia
Details on test material:
Ammonia

Method

Type of population:
occupational
Ethical approval:
not specified
Details on study design:
The study was a retrospective epidemiological study in a large petrochemical complex in Beijing, China to assess the association between petrochemical exposure and spontaneous abortion. In total, 2853 non-smoking women who were 20-44 years of age and had been pregnant at least once participated in the study. 97 women were found to have been exposed to ammonia. Women and their husbands were interviewed collecting information on reproductive history, pregnancy outcomes, employment history, alcohol consumption, indoor air pollution, and demographic variables. Exposure during the pre-conception period and the first trimester of pregnancy was calculated from information on perceived ammonia exposure. Exposure during the first, second, and third trimesters was recorded separately for each pregnancy.
Exposure assessment:
not specified
Details on exposure:
Women were exposed to ammonia in an occupational setting; a large petrochemical complex in Beijing China.
Statistical methods:
Only results from the women’s first pregnancies were analysed using multiple logistic regression.

Results and discussion

Results:
Data analyses did not show any effect on spontaneous abortion (Odds Ratio: 1.2; 95% CI: 0.5-2.6).
Confounding factors:
Actual exposure levels were unknown.
Strengths and weaknesses:
Data analyses did not show any effect on spontaneous abortion (Odds Ratio: 1.2; 95% CI: 0.5-2.6), but actual exposure levels were unknown.

Any other information on results incl. tables

Data analyses did not show any effect on spontaneous abortion (Odds Ratio: 1.2; 95% CI: 0.5-2.6), but actual exposure levels were unknown.

Applicant's summary and conclusion

Conclusions:
Data analyses did not show any effect on spontaneous abortion (Odds Ratio: 1.2; 95% CI: 0.5-2.6), but actual exposure levels were unknown.
Executive summary:

The study was a retrospective epidemiological study in a large petrochemical complex in Beijing, China to assess the association between petrochemical exposure and spontaneous abortion. In total, 2853 non-smoking women who were 20-44 years of age and had been pregnant at least once participated in the study. Women and their husbands were interviewed collecting information on reproductive history, pregnancy outcomes, employment history, alcohol consumption, indoor air pollution, and demographic variables. 97 women were exposed to ammonia in the occupational setting. Data analyses did not show any effect on spontaneous abortion (Odds Ratio: 1.2; 95% CI: 0.5-2.6), but actual exposure levels were unknown.