Copper sulphate

Exposure related observations in humans: other data

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

Test material information

Constituent 1

Reference substance name:

Cu2+ as copper in drinking water

IUPAC Name:

Cu2+ as copper in drinking water

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.