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Toxicological information

Exposure related observations in humans: other data

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Administrative data

Endpoint:
exposure-related observations in humans: other data
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Already evaluated by the Competent Authority for Biocides.

Data source

Reference
Reference Type:
publication
Title:
Copper concentration in tap water and possible effects on infant’s health – Results of a study in Lower Saxony, Germany
Author:
B. P. Zietz, J. Dassel de Vergara and H. Dunkelberg
Year:
2003
Bibliographic source:
Environmental Research 92 (2003) 129-138

Materials and methods

Type of study / information:
See Executive study
Endpoint addressed:
repeated dose toxicity: oral
Test guideline
Qualifier:
no guideline available
Deviations:
not applicable
Principles of method if other than guideline:
See Executive study.
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent

Method

Ethical approval:
confirmed, but no further information available
Details on study design:
See Executive study
Exposure assessment:
measured
Details on exposure:
See Executive study

Results and discussion

Results:
See Executive study

Any other information on results incl. tables

See attached.

Applicant's summary and conclusion

Conclusions:
See Executive study
Executive summary:

Copper in drinking water has been associated with non-Indian childhood cirrhosis (NICC), a form of liver cirrhosis in childhood. This epidemiological study examines the exposure of infants to increased copper concentration through drinking water from public water supplies in southern Lower, Saxony, Germany, and whether this dietary copper intake causes liver damage in early childhood. In total, water samples from 1674 households with infants were tested for copper. The mean copper concentration was 0.81 mg/l in the 1619 collected stagnation samples and 0.11 mg/l in the 1660 random daytime samples. There were notable regional differences in copper values. In 10.3% of all sampled households a copper value of 0.5 mg/l or more was found. These families were requested top additionally collect 2 composite samples. An increased level of copper in the drinking water with copper concentrations at or above 0.8 mg/l in the composite samples and a defined minimum ingestion of tap water was followed by a recommendation of a paediatric examination. Fourteen infants were examined by a paediatrician and of these 11 received a blood serum analysis. None of the examined infants showed any signs of liver malfunction. From the results of the study, no indication of a hazard due to copper pipes connected to public water supplies could be found.