Registration Dossier
Registration Dossier
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EC number: 231-818-8 | CAS number: 7757-79-1
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2000
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study without detailed documentation
- Remarks:
- Well performed, but limited documented study performed according to OECD and/or EC guidelines and according to GLP principles. However, since the study was performed with a substance analogue and the data are read across, the Klimisch score is 2.
Data source
Reference
- Reference Type:
- other company data
- 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)
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- up-and-down procedure
Test material
- Reference substance name:
- Potassium sodium nitrate
- IUPAC Name:
- Potassium sodium nitrate
- Test material form:
- other: crystals or granular
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 60%
DOSAGE PREPARATION:
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 b.w.
- No. of animals per sex per dose:
- 3
- Control animals:
- no
- Details on study design:
- 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.
Results and discussion
Effect levels
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Mortality:
- All animals survived
- Clinical signs:
- other: All animals gained weight
- Gross pathology:
- No signs of toxicity were observed.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Remarks:
- Not classified according to Regulation (EC) 1272/2008
- Conclusions:
- LD50 > 2000 mg/kg bw
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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