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Toxicological information

Direct observations: clinical cases, poisoning incidents and other

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Administrative data

Endpoint:
direct observations: clinical cases, poisoning incidents and other
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Already evaluated by the Competent Authorities for Biocides and Existing Substance Regulations.

Data source

Reference
Reference Type:
publication
Title:
Lack of Effects of Copper Gluconate Supplementation.
Author:
Pratt, W.B., Omdahl, J.L. and Sorenson, R.J.
Year:
1985
Bibliographic source:
The American Journal of Clinical Nutrition, 42: 681 - 682

Materials and methods

Study type:
study with volunteers
Endpoint addressed:
not applicable
Test guideline
Qualifier:
no guideline available
Deviations:
not applicable
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Details on test material:
Test substance: Cu2+ as copper gluconate.

Method

Type of population:
general
Subjects:
Male/female
Number of persons: 7 (3 men and 4 women).
Mean age: 42 years.
Known diseases: All the subjects suffered from back pain.
Ethical approval:
other: Ethics: The study was approved by the Human research Review Committee. The study was double blind.
Route of exposure:
oral
Reason of exposure:
intentional
Exposure assessment:
not specified
Details on exposure:
Exposure period: 12 weeks.
Multiple doses. Subjects were dosed twice a day.
5 mg Cu2+ as copper gluconate
Control: yes, sham-exposed [Other information: Control subjects received placebo capsules.]
Examinations:
Subjects were seen every 2 weeks to evaluate their progress. Blood, serum, urine and hair samples were collected at the beginning of the study, after 6weeks of supplementation and at the end of the 12 week study.
Medical treatment:
Reason of exposure: As part of a study of back pain management.

Results and discussion

Clinical signs:
Clinical Signs: There were no clinical signs associated with treatment.
Results of examinations:
Results of examinations: There was no significant change in the level of copper, zinc or magnesium of the serum, urine or hair samples of the seven
subjects during the 12 weeks of the study. There was also no significant change in the haematocrit, mean corpuscular volume, serum cholesterol,
serum triglyceride, SGOT, serum alkaline phosphatase, serum GGT, or serum LDH (see Table 1). Serum potassium did change from a mean of
4.3 mEq/L to 4.0 mEq/L (p < 0.05). The incidence of nausea, diarrhoea, and heartburn was the same in the seven subjects receiving the copper
gluconate as it was among the seven other subjects receiving the placebo capsules.
Effectivity of medical treatment:
Not applicable.
Outcome of incidence:
Outcome: It was found that 10 mg/day of copper as copper gluconate had no detectable effect on the seven subjects. It was concluded that treated individuals excrete excess amounts of absorbed copper not needed to meet tissue needs or to maintain liver stores under homeostatic conditions.

Any other information on results incl. tables

Table 1. A comparison of serum levels before and after 12 weeks of supplementation with 10 mg of copper/day.

 

Cholesterol (mg/dL)

Triglyceride (mg/dL)

Copper

(µg/100 ml)

Zinc

(µg/100 ml)

Magnesium

(mg/100 ml)

Before Cu supplement

199.6 ± 26.8 mg/dL

112.4 ± 37 mg/dL

126 ± 22 µg/100 ml

1.47 ± 0.12 µg/100 ml

18.4 ± 1.5 mg/100 ml

After 12 week supplement

212.6 ± 40.7 mg/dL

101.8 ± 40 mg/dL

123 ± 16 µg/100 ml

1.44 ± 0.38 mg/ml

19.4 ± 1.6 mg/100 ml

Applicant's summary and conclusion

Conclusions:
10 mg copper/day, administered orally as copper gluconate for 12 weeks, had no detectable adverse effect on the livers or gastrointestinal tracts of
the seven test subjects.
Executive summary:

Materials and Methods

As part of a double-blind study of back pain management, 7 adult patients received an oral dose of 5 mg copper (as copper gluconate capsules) twice a day for 12 weeks.  Seven others received a placebo capsule over the exposure period.  Subjects were seen every 2 weeks to evaluate their progress.  Blood, serum, urine and hair samples were collected at the beginning of the study, after 6 weeks of supplementation and at the end of the 12 week study.  Parameters assessed were haematocrit, mean corpuscular volume, serum cholesterol, serum triglyceride, SGOT, serum alkaline phosphatase, serum GGT, serum LDH and serum potassium.  Copper, zinc and magnesium levels were also assessed in serum, urine and hair.

 

Results and Discussion

There was no toxicologically significant change in the level of copper, zinc or magnesium of the serum, urine or hair samples of the seven subjects during the 12 weeks of the study.  Similarly, there was no toxicologically significant change in the haematocrit, mean corpuscular volume, serum cholesterol, serum triglyceride, SGOT, serum alkaline phosphatase, serum GGT, or serum LDH.

 Serum potassium changed from a mean of 4.3 mEq/L to 4.0 mEq/L.  The incidence of nausea, diarrhoea, and heartburn was the same in subjects receiving copper gluconate as it was in the control group.

It was concluded that 10 mg/day of copper as copper gluconate had no detectable adverse effect on the seven test subjects.