Basic copper zinc nitrate

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:

key study

Study period:

n.a.

Reliability:

1 (reliable without restriction)

Data source

Reference

Reference Type:

publication

Title:

Daily Reference Intakes for Vitamin A, Vitamin K, Arsenic, Boron, Chromium, Copper, Iodinie, Iron, Manganese, Moblybdenum, Nickel, Silicon, Vanadium and Zinc

Author:

U.S. Instiut of Medicine, Food and Nutrion Board

Year:

2002

Bibliographic source:

ISBN 0-309-07279-4

Materials and methods

Type of study / information:

Copper gluconate as pharmaceutical, health survilance study

Endpoint addressed:

repeated dose toxicity: oral

Test guideline

Qualifier:

no guideline required

Principles of method if other than guideline:

n.a.

GLP compliance:

not specified

Test material

Test material information

Constituent 1

Reference substance name:

Copper di-D-gluconate

EC Number:

208-408-2

EC Name:

Copper di-D-gluconate

Cas Number:

527-09-3

IUPAC Name:

copper(2+) bis(2,3,4,5,6-pentahydroxyhexanoate) (non-preferred name)

Constituent 2

Reference substance name:

Copper gluconate

IUPAC Name:

Copper gluconate

Details on test material:

pharmaceutical

Method

Details on study design:

Identification of a NOAEL and a LOAEL.
The NOAEL was identified on the basis of the reults the results of Pratt et al. (1985). In the 12 week, double-blind study,
10 mg of copper as copper glucobnaate capsules was consumed daily by seven adults. Liver function tests were normal.
From a case report, consumtion of 30 mg Cu / day as tabletes for two years, followed by 60 mg Cu / day for additional
periode of time, resulted in acute liver failure (O´Donohue et al. 1993)

Exposure assessment:

measured

Results and discussion

Results:

UL=(NOAEL/UF), with UF=1.0, UF=uncertainity factor, UL = upper tolerbale intake level

UL (Adults, 19 years and older) = 10 mg Cu / day
UL (Infans, 0-12 month) - not posible to establish; source of intake should be from food and formula only
UL (Children, 1-3 years)=1 mg Cu / day
UL (Children 4-8 years) = 3 mg Cu /day
UL (Children 9-13 years) = 5 mg Cu / day
UL (Adolescents, 14-18 years) = 8 mg Cu / day
UL (Pregnancy, 14-18 years) = 8 mg Cu / day
UL (Pregnancy, 19-50 years) = 10 mg Cu / day
UL (Lactation, 14-18 years) = 8 mg Cu / day
UL (Lactation, 19-50 years) = 10 mg Cu / day

Certain subgroups may be at increased risk of adverse effects from excess intake of copper. These induciuals with Wilson´s
discase (homozygous), ICT , and ICC. In addtion, heterizygoics for Wilson´s discase may be increased the risk of adverse effects
from copper intake.

Applicant's summary and conclusion

Conclusions:

The NOAEL for adults was determined to be 10 mg Cu / day, the uncertain factor is 1.

Further no adverse effect were reported in U.S. adults who consumed water conting 8.5 to 8.8 mg / L of copper for over
20 years beginning in the childhood ( aged 0 thorough 5 years) (Scheinberg et al, 1996)