Registration Dossier
Registration Dossier
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EC number: 231-298-2 | CAS number: 7487-88-9
Acute Toxicity: oral
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:
- 2 000
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
- 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.
Constituent 1
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:
- other: All animals appeared active and healthy throughout the study period.
- 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.
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