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Toxicological information

Repeated dose toxicity: oral

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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

Constituent 1
Chemical structure
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 / concentrationsopen allclose all
Remarks:
Doses / Concentrations:
0.3 %
Basis:
nominal in diet
Remarks:
Doses / Concentrations:
0.6 %
Basis:
nominal in diet
Remarks:
Doses / Concentrations:
1.25 %
Basis:
nominal in diet
Remarks:
Doses / Concentrations:
2.5 %
Basis:
nominal in diet
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.