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Toxicological information

Acute Toxicity: oral

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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: A limited documented study according to test guidelines and GLP.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2000

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 425 (Acute Oral Toxicity: Up-and-Down Procedure)
GLP compliance:
yes
Test type:
up-and-down procedure

Test material

Constituent 1
Reference substance name:
Potassium magnesium sulphate
IUPAC Name:
Potassium magnesium sulphate
Details on test material:
Substance tested is potassium magnesium sulphate. No furhter details reported.

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals or test system and environmental conditions:
According to test guidelines, no further information

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Details on oral exposure:
Prior to use, the test substance was ground in a coffee mill and administered by gavage as a 60% w/w suspension in distilled water (preliminary solubility testing indicated that suspensions in excess of 60% were too viscous to be administered properly).
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
3
Control animals:
not specified
Details on study design:
An initial dose of two thousand milligrams of the test substance per kilogram of bodyweight was administered to one healthy female rat by oral gavage. Due to the absence of mortality in this animal a second female received the same dose level. Following the completion of dosing and 100% survival in a total of three females, a group of three males was tested (simultaneously) at the above dose level. All animals were observed for mortality, signs of gross toxicity, and behavioral changes at least once daily for 14 days after dosing. Bodyweights were recorded prior to administration and again on Days 7 and 14 (termination) after dosing. Necropsies were performed on all animals at terminal sacrifice.
Statistics:
no data

Results and discussion

Preliminary study:
not relevant
Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Mortality:
All animals survived.
Clinical signs:
All animals appeared active and healthy throughout the study period.
Body weight:
All animals gained weight
Gross pathology:
No signs of toxicity were observed.
Other findings:
no

Applicant's summary and conclusion

Conclusions:
Potassium magnesium sulphate is considered not harmful for acute oral toxicity.