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Toxicological information

Additional toxicological data

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Administrative data

Endpoint:
additional toxicological information
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
supporting study
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
other: The article is in Japanese (English abstract available) The route of administration is not relevant for risk assessment purposes.

Data source

Reference
Reference Type:
publication
Title:
A 2-week toxicity study of magnesium sulphate administered by 24-hour intravenous infusion in Beagle dogs followed by a 2-week recovery period
Author:
Akagi, K. et al.
Year:
1998
Bibliographic source:
J. Tox. Sci. 23 (Suppl. 1): 37-49.

Materials and methods

Type of study / information:
repeated dose toxicity
Test guideline
Qualifier:
no guideline available
Principles of method if other than guideline:
Repeated dose toxicity (14-days), beagle dogs, i.v.
GLP compliance:
not specified

Test material

Constituent 1
Reference substance name:
Magnesium sulphate
EC Number:
231-298-2
EC Name:
Magnesium sulphate
IUPAC Name:
231-298-2
Constituent 2
Reference substance name:
7487-88-9
Cas Number:
7487-88-9
IUPAC Name:
7487-88-9
Constituent 3
Reference substance name:
magnesium sulfate
IUPAC Name:
magnesium sulfate
Test material form:
not specified
Details on test material:
- Name of test material (as cited in study report): magnesium sulfate
No further details available.

Results and discussion

Any other information on results incl. tables

One of 2 animals in the 200 mg/kg/hour group died approx. 32 hours after the start of infusion. At the same time, the remaining 1 animal of the same group was sacrificed in a moribund state. Changes attributable to the treatment of magnesium sulfate were decreased food consumption and body weight gain, anemia, mild prolongation of conduction time in electrocardiogram and tubular basophilia in the kidneys in the animals treated with 100 mg/kg/hour. Furthermore, decreased calcium level was recorded in the animals treated with 50 mg/kg/hour or more. These changes disappeared after drug withdrawal, and reversibility was suggested. Judging from the mode of occurrence, since the change in calcium level observed in the group treated with 50 mg/kg/hour was slight, it was considered to be toxicologically insignificant.

Applicant's summary and conclusion

Conclusions:
In conclusion, the nontoxic dosage level of magnesium sulfate was judged to be 50 mg/kg/hr under the condition of the present study.

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