Magnesium

Acute Toxicity: other routes

Administrative data

Endpoint:

acute toxicity: other routes

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: Well documented study which meets basic scientific principles

Data source

Reference

Reference Type:

publication

Title:

A single dose toxicity study of magnesium sulfate in rats and dogs

Author:

Mochizuki M, Akagi K, Inoue K and Shimamura K

Year:

1998

Bibliographic source:

The journal of toxicological sciences 23(Supp 1): 31-35

Materials and methods

Test guideline

Qualifier:

no guideline followed

Principles of method if other than guideline:

Magnesium sulphate was infused for 6 hours intravenously in dogs.

GLP compliance:

no

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Magnesium sulfate

IUPAC Name:

Magnesium sulfate

Constituent 2

Reference substance name:

Magnesium sulphate

EC Number:

231-298-2

EC Name:

Magnesium sulphate

Cas Number:

7487-88-9

IUPAC Name:

7487-88-9

Test material form:

solid - liquid: suspension

Remarks:

migrated information: dispersion

Details on test material:

- Molecular formular: MgSO4
- Supplier: Fukuda Pharmaceutical company, Japan
- Lot No.: 5F1122
- Purity: 99.87%
- Storage condition: Not reported

Test animals

Species:

dog

Strain:

Beagle

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
-The dogs were 6 months of age.
- Fasting period before study: Not reported
- Housing: Metallic cage
- Diet (e.g. ad libitum): Solid feed
- Water (e.g. ad libitum): Tap water
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 to 26 °C
- Humidity (%): 30 to 70 %
- Air changes (per hr): 10 to 15 hours
- Photoperiod (hrs dark / hrs light): 12 / 12 hours

Administration / exposure

Route of administration:

intravenous

Vehicle:

other: 10% Glucose

Details on exposure:

Magnesium sulphate was infused for 6 hours at doses of 75, 300 and 1200 mg/kg (12.5, 50 and 200 mg/kg/hr)

Doses:

Magnesium sulphate was infused for 6 hours at doses of 75, 300 and 1200 mg/kg (12.5, 50 and 200 mg/kg/hr)

No. of animals per sex per dose:

The dogs were 6 months of age/female

Control animals:

yes

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: 1 2, 3, 7, 10 and 14 days
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs and body weight

Statistics:

LD50 and 95% Confidence Limits : Van der Waerden method

Results and discussion

Effect levels

Sex:

female

Dose descriptor:

LD50

Effect level:

> 1 200 mg/kg bw

Based on:

test mat.

Mortality:

No deaths occurred in any dose group

Clinical signs:

Vomiting, decreased spontaneous movement, staggering gait, prone position and flush of the conjunctiva and ear auricles were observed in the 1200 mg/kg group. The animals returned to a normal state by 1 hour after dosing.

Body weight:

There were no changes in body weight.

Gross pathology:

There were no changes in gross pathology.

Other findings:

There were no changes in food consumption.

Applicant's summary and conclusion

Conclusions:

It can be concluded that the LD50 value for magnesium sulfate adminstered intravenously is greater than 1200 mg/kg (200 mg/kg/hr).