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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:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
supporting study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: reasonably well-documented publication
Cross-reference
Reason / purpose for cross-reference:
reference to same study

Data source

Reference
Reference Type:
publication
Title:
Bioavailability of oral magnesium supplementation in female students evaluated from elimination of magnesium in 24-hour urine
Author:
Bohmer, T. et al.
Year:
1990
Bibliographic source:
Magnes. Trace Res. 9, 272-278

Materials and methods

Study type:
study with volunteers
Endpoint addressed:
basic toxicokinetics
Test guideline
Qualifier:
no guideline available
Principles of method if other than guideline:
Toxicokinetics, oral absorption (human)
GLP compliance:
no

Test material

Constituent 1
Reference substance name:
Magnesium chloride
EC Number:
232-094-6
EC Name:
Magnesium chloride
Cas Number:
7786-30-3
IUPAC Name:
magnesium dichloride
Details on test material:
- Name of test material (as cited in study report): magnesium chloride
No further details are given.

Method

Type of population:
general
Subjects:
- Number of subjects exposed: 18
- Sex: female
- Age: 22-40 years
- Known diseases: All had normal serum creatinine, sodium, potassium, calcium and magnesium.
- Other: 55 +/- 4.7 kg weight; none were pregnant, lactating, using drugs, or had known allergy
No further details are given.
Ethical approval:
confirmed and informed consent free of coercion received
Route of exposure:
oral
Reason of exposure:
intentional
Exposure assessment:
not specified
Details on exposure:
All 18 subjects were tested on four different Mg treatment periods (A, B, C and D) and two placebo periods (E1 and E2) in a randomised manner. The study period for each treatment period was 24 hours.
A: Mg chewable tablets 120 mg (5 mmol) containing Mg lactate and Mg citrate corresponding to 110 mg and 10 mg Mg, respectively.
B: Mg chewable tablets 120 mg (5 mmol) containing Mg lactate and Mg hydroxide corresponding to 90 mg and 30 mg Mg, respectively.
C: Emgesan containing Mg hydroxide (10.3 mmol) corresponding to 250 mg Mg.
D: A solution containing Mg chloride (0.5 mmol/L).
E: Placebo chewing tablets.
A, B and E were administered 3 times daily. The total daily dose of Mg (A and B) was 15 mmol. Preparation C was administered twice daily. The total dose of Mg was 20.6 mmol. The tablets were chewed before swallowing followed by intake of 125 ml water. Preparation D, 10 ml of Mg chloride solution was administered 3 times daily. The total daily dose of Mg was 15 mmol.
Examinations:
Urine was quantitatively collected for 24 hours, excluding the first morning urine on the experimental day and including the urine the following morning. Urine was analysed for Mg concentration by atomic absorption spectrophotometry. The creatinine concentration in urine was determined.
Medical treatment:
no medication

Results and discussion

Clinical signs:
no data
Results of examinations:
All the different regimens significantly increased (p<0.05) the urine Mg excretion compared to placebo treatment. There was no significant difference between the two placebo periods in urine Mg (3.63 mmol/24 hours), or in urine volume or creatinine. Urine Mg concentrations (mmol/L) increased significantly in all the treatment groups (p<0.05) and the Mg/creatinine ratios increased significantly (p<0.05) compared to placebo in groups A, B and C, but not in group D. The urine volume in group C was significantly lower (p=0.05) but without any reduction in creatinine excretion in this group. There was no significant difference in Mg excretion calculated as mmol/24 hours, mmol/L, or Mg/creatinine ratio, urine volumes, or creatinine excretion between the different groups given active treatment.
The mean increase in Mg elimination was 0.9-1.3 mmol/24 hours, not higher for Mg hydroxide given in the highest dose (group C 20.3 mmol).
Effectivity of medical treatment:
not observed
Outcome of incidence:
no data

Applicant's summary and conclusion

Conclusions:
There was no significant difference in Mg excretion calculated as mmol/24 hours, mmol/L, or Mg/creatinine ratio, urine volumes, or creatinine excretion between the different groups given active treatment.