Registration Dossier
Registration Dossier
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EC number: 231-554-3 | CAS number: 7631-99-4
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1980
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
- Remarks:
- Non GLP
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 980
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Principles of method if other than guideline:
- full LD50 performed
- GLP compliance:
- no
- Test type:
- other: LD50
- Limit test:
- no
Test material
- Reference substance name:
- Sodium nitrate
- EC Number:
- 231-554-3
- EC Name:
- Sodium nitrate
- Cas Number:
- 7631-99-4
- Molecular formula:
- HNO3.Na
- IUPAC Name:
- sodium nitrate
- Test material form:
- solid
- Details on test material:
- - Name of test material (as cited in study report): Natronsalpeter (Sodium Nitrate)
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: WIGA
- Weight at study initiation: 230-250 (males), 170-190 (females)
- Fasting period before study: 15-20 h
- Diet: Herilan MRH-Haltung, H. Eggersmann KG
IN-LIFE DATES: From: 2 Oct 1980 To: 22 Oct 1980
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 68.1, 46.4, 31.6, 21.5, 14.7 %
DOSE VOLUME APPLIED: 10 mL/kg - Doses:
- 6810, 4640, 3160, 2150, 1470 mg/kg body weight
- No. of animals per sex per dose:
- 5 males, 5 females
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of weighing: Before start, Day 2-4, Day 7, Day 13
- Necropsy of survivors performed: yes
- Other examinations performed: histopathology of liver of dead animals - Statistics:
- Probit analysis (Finney)
Results and discussion
Effect levels
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- ca. 3 430 mg/kg bw
- Mortality:
- 6810 mg/kg body weight: 5 males, 5 females died
4640 mg/kg body weight: 5 males, 4 females died
3160 mg/kg body weight: 1 males, 3 females died
2150 mg/kg body weight: 0 males, 0 females died
1470 mg/kg body weight: 0 males, 0 females died - Clinical signs:
- other: dyspnoe, apathy, abnormal posture, ataxia, atonia, pain reflex absent, cornea reflex absent, comatose condition, spasms, tremor, piloerection, trismus, cyanosis, dehydration, ptosis, paresis, poor general condition
- Gross pathology:
- heart: acute congestion,
lungs: multiple acute dilations. discolouration
stomach: red discolouration of glandular stomach, , bloody ulceration or large bleedings
intestine: atonia, diarrhoea,
kidney: pallor - Other findings:
- histology liver: vacuolar degeneration
Applicant's summary and conclusion
- Interpretation of results:
- Category 5 based on GHS criteria
- Remarks:
- Not classified according to Regulation (EC) 1272/2008
- Conclusions:
- LD50 = 3500 mg/kg (males)
LD50 = 3200 mg/kg (females)
LD50 = 3430 mg/kg (males and females combined)
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