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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:
Epidemiology investigation on chronic copper toxicity to children exposed via the public drinking water supply
Author:
B. P. Zietz, H. H. Dieter, M. Lakomek, H. Schneider, B. Keßler-Gaedtke and H. Dunkelberg
Year:
2003
Bibliographic source:
The Science of the Total Environment 302, (2003) 127 – 144

Materials and methods

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

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
See Executive summary

Method

Ethical approval:
confirmed, but no further information available
Details on study design:
This investigation was a cross sectional study including paediatric examinations of infants with elevated copper intake through tap water.
Exposure assessment:
measured
Details on exposure:
See Executive summary

Results and discussion

Results:
See Executive summary

Any other information on results incl. tables

See attached

Applicant's summary and conclusion

Conclusions:
See Executive summary
Executive summary:

Copper in drinking water has been associated with Non-Indian Childhood Cirrhosis (NICC), a form of early childhood liver cirrhosis. This epidemiological study examines the exposition of infants to increased copper concentrations through drinking water from public water supplies in Berlin, Germany; and if this dietary copper intake can cause liver damage in early childhood. In total, water samples from 2944 households with infants were tested for copper. Mean copper concentrations in the 2 different types of collected composite samples were 0.44 and 0.56 mg/l, respectively. Families having a copper concentration at or above 0.8 mg/l in one or both of the composite samples (29.9% of all sampled households) and a defined minimum ingestion of tap water of their infant were recommended to undergo a paediatric examination. Nearly every of the 541 recommended infants were examined by a local paediatrician and of these 183 received blood serum analysis, too. None of the infants had clear signs of a liver disease although a few serum parameters lay outside the accompanying reference range and abdominal ultrasound imaging gave slightly unusual results in 5 cases. Additionally, no signs of a negative health effect could be found in the statistical analysis of the serum parameters GOT, GPT, GGT, total bilirubin, serum copper or ceruloplasmin in relation to estimated daily and total copper intakes could be established. From the results of the study, no confirmed indication of a liver malfunction in infants whose food had been prepared using tap water with elevated copper concentration could be found and, therefore, no indication of a hazard due to copper pipes connected to public water supplied could be detected.