Registration Dossier
Registration Dossier
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EC number: - | CAS number: -
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:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 976
- Report date:
- 1976
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Deviations:
- no
- GLP compliance:
- no
- Test type:
- standard acute method
- Limit test:
- no
Test material
- Reference substance name:
- Ammonium manganese diphosphate, monoclinic and triclinic
- Molecular formula:
- MnKx (NH4)1-x P2O7 (0 =< x =< 0.5)
- IUPAC Name:
- Ammonium manganese diphosphate, monoclinic and triclinic
- Details on test material:
- Lot X-1426
Constituent 1
Test animals
- Species:
- rat
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: 200-300 g
- Fasting period before study: yes, fasted for 24 h
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- propylene glycol
- Doses:
- 4000, 8000, 10000, 12500, 16000, 20000 and 32000 mg/kg
- No. of animals per sex per dose:
- Five animals per dose
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: Two weeks
- Frequency of observations: Animals were observed daily.
- Necropsy of survivors performed: No postmortem, or histopathology examinations were performed in this particular study.
Results and discussion
Effect levelsopen allclose all
- Key result
- Dose descriptor:
- LD50
- Effect level:
- 12 900 mg/kg bw
- Based on:
- test mat.
- 95% CL:
- 11 500 - 14 400
- Dose descriptor:
- LD0
- Effect level:
- 10 000 mg/kg bw
- Based on:
- test mat.
- Clinical signs:
- other: Ruffled, unkempt coats were evident at 4000 mg/kg. Lethargy, unkempt coats and nasal hemorrhage were prevalent in the animals dosed at 8000 mg/kg and 10000 mg/kg. Staggering gait, impaired locomotion, lethargy and nasal hemorrhage were noted at levels of
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Criteria used for interpretation of results: EU
- Conclusions:
- The oral LD50 was determined to be 12900 mg/kg.
- Executive summary:
An acute oral toxicity was performed using albino male and female rats. The oral LD50 was determined to be 12900 mg/kg (95% confidence limits = 11500 -14400 mg/kg).
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