Magnesium methanolate

Repeated dose toxicity: oral

Administrative data

Endpoint:

short-term repeated dose toxicity: oral

Type of information:

migrated information: read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Guideline study without detailed documentation.

Data source

Reference

Reference Type:

publication

Title:

Unnamed

Year:

1994

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 408 (Repeated Dose 90-Day Oral Toxicity Study in Rodents)

GLP compliance:

not specified

Test material

Test material information

Constituent 1

Reference substance name:

Magnesium chloride

EC Number:

232-094-6

EC Name:

Magnesium chloride

Cas Number:

7786-30-3

Molecular formula:

Cl2Mg

IUPAC Name:

magnesium dichloride

Test animals

Species:

mouse

Strain:

B6C3F1

Sex:

male/female

Administration / exposure

Route of administration:

oral: feed

Vehicle:

other: Oriental MF powdered diet and corn oil

Duration of treatment / exposure:

13 weeks

Doses / concentrations

Doses / concentrations 1

Remarks:

Doses / Concentrations:
0.3 %
Basis:
nominal in diet

Doses / concentrations 2

Remarks:

Doses / Concentrations:
0.6 %
Basis:
nominal in diet

Doses / concentrations 3

Remarks:

Doses / Concentrations:
1.25 %
Basis:
nominal in diet

Doses / concentrations 4

Remarks:

Doses / Concentrations:
2.5 %
Basis:
nominal in diet

Doses / concentrations 5

Remarks:

Doses / Concentrations:
5 %
Basis:
nominal in diet

No. of animals per sex per dose:

10 mice per sex per dose.

Control animals:

yes, plain diet

Results and discussion

Effect levels

Dose descriptor:

LOAEL

Effect level:

2.5 other: %

Sex:

male/female

Basis for effect level:

other: This was the minimum toxic dose tested.

Target system / organ toxicity

Critical effects observed:

not specified

Any other information on results incl. tables

No treatment related effects were noted at any dose levels for survival, clinical observation, hematology or blood biochemistry. The average body weights of both sexes fed the diet containing 5 % magnesium chloride were lower than those fed the control diet. Significant increases in the relative weights of some organs were observed in both sexes of the 2.5 and 5 % groups. However, no blood biochemical or histopathological changes were found. A significant decrease in the relative spleen weight was noted in the male 2.5 and 5 % groups. Organ weight changes were considered to be simply related to the lower body weight, since no hematological or histopathological alterations were seen. Renal cell vacuolation was found in high dose males (but not in females). This change might reflect reabsorption of magnesium, but as this alteration was not linked with change in any blood biochemical parameters indicating renal failure, its toxicological significance was considered to be minimal.

Applicant's summary and conclusion

Conclusions:

In conclusion, only high levels of magnesium chloride (2.5 and 5 %) exert any toxic effects and these are limited to minimal renal tubular changes in male mice. Therefore the toxic hazard of magnesium chloride is negligible.

Executive summary:

Clinical signs and hematological or blood biochemistry parameters showed no treatment-related effects. Vacuolation of kidney tubular cells was apparent in males in high dose groups. This study demonstrated that a diet containing over 2.5 % magnesium chloride exerts toxic effects in mice. In conclusion, a level of 2.5 % in the diet is the minimal toxic dose.