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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
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:
1980

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

Constituent 1
Chemical structure
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)

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:
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
Body weight:
normal
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)