Zinc fluoride

Direct observations: clinical cases, poisoning incidents and other

Administrative data

Endpoint:

direct observations: clinical cases, poisoning incidents and other

Type of information:

experimental study

Adequacy of study:

key study

Study period:

Not reported

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Reference

Reference Type:

publication

Title:

Zinc Lowers High-Density Lipoprotein-Cholesterol Levels

Author:

Hooper PL, Visconti L, Garry PJ & Johnson GE

Year:

1980

Bibliographic source:

JAMA. 244(17): 1960-1961

Materials and methods

Study type:

study with volunteers

Endpoint addressed:

repeated dose toxicity: oral

Principles of method if other than guideline:

A clinical trial was conducted on healthy human volunteers for five weeks to evaluate the effect of the test material on plasma lipoproteins.

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

Zinc sulphate

EC Number:

231-793-3

EC Name:

Zinc sulphate

Cas Number:

7733-02-0

Molecular formula:

H2O4S.Zn

IUPAC Name:

zinc sulfate

Details on test material:

- Name of test material (as cited in study report): Zinc sulfate

Method

Type of population:

general

Subjects:

- Number of subjects exposed: 20 (treatment group: 12, control: 8)
- Sex: Male
- Age: 23-35 yr
- Other: Subjects were asked not to change their lifestyle pattern and particularly habits known to alter lipid metabolism (ingestion of alcohol, diet, exercise and smoking)

Ethical approval:

confirmed and informed consent free of coercion received

Route of exposure:

oral

Reason of exposure:

intentional

Exposure assessment:

measured

Details on exposure:

Clinical trial: 80 mg Zn (as 220 mg ZnSO4) or placebo was administered to healthy volunteers twice a day for five weeks.

Examinations:

- Estimation of plasma lipoproteins: Total cholesterol, triglyceride, HDL & LDL-cholesterol was estimated on a weekly basis (from week 1 to 7 and at week 16)

Medical treatment:

No

Results and discussion

Clinical signs:

No data

Results of examinations:

Plasma lipoproteins:
- HDL-cholesterol: Decreased (25 %) from 40.5 to 30.1 mg/dL
- Total cholesterol, triglyceride & LDL-cholesterol: Unchanged

For details please see 'Table 1' of reference

Effectivity of medical treatment:

Not applicable

Outcome of incidence:

Not applicable

Any other information on results incl. tables

Table 1: Serum Lipid, Lipoprotein, and Plasma Zinc Levels in Subjects Receiving Zinc*

	Baseline	5^thweek	7^thweek	16^thweek
Total cholesterol, mg/dL	164.8 ± 18.1	161.8 ± 19.2	163.7 ± 17.0	171.7 ± 21.1
Triglyceride, mg/dL	111.1 ± 40.1	117.9 ± 35.6	123.2 ± 39.7	115.0 ± 41.0
Low-density lipoprotein, mg/dL	102.1 ± 16.1	104.2 ± 17.7	10.9.0 ± 16.4	110.2 ± 17.0
High-density lipoprotein, mg/dL	40.5 ± 6.5	33.5 ± 5.0	30.1 ± 5.4	38.4 ± 6.3
Zinc, µg/dL	94.8 ± 16.9	145.7 ± 69.08	--	89.7 ± 12.2

*Mean ± SD for 12 determinations

Applicant's summary and conclusion

Conclusions:

Under the test conditions, the test material reduced plasma HDL-cholesterol levels whereas total cholesterol, triglyceride & LDL-cholesterol remain unchanged.

Executive summary:

A clinical trial was conducted on 20 healthy male human volunteers for five wks to evaluate the effect of the test material (80 mg Zn as ZnSO4 or placebo, twice a day) on plasma lipoproteins.

 

Under the test conditions, the test material reduced plasma HDL-cholesterol levels whereas total cholesterol, triglyceride & LDL-cholesterol remain unchanged.