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EC number: 237-424-2 | CAS number: 13780-06-8
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 7 February - 7 March 1985
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Remarks:
- Good quality study, conducted to GLP. The discrepancy in acclimation period is not expected to influence the validity of the results. No details given on vehicle.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 985
- Report date:
- 1985
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- other: US EPA TSCA Test rules (40 CFR Part 772.112-121 Subpart C)
- Version / remarks:
- 26 July 1979
- Deviations:
- no
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Deviations:
- yes
- Remarks:
- Acclimation period of 3 days was used (guideline recommends at least 5 days)
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- no
Test material
- Reference substance name:
- Calcium nitrite
- EC Number:
- 237-424-2
- EC Name:
- Calcium nitrite
- Cas Number:
- 13780-06-8
- Molecular formula:
- Ca.2HNO2
- IUPAC Name:
- calcium nitrite
- Test material form:
- solid: particulate/powder
- Details on test material:
- - Density: 2.23 g/ml
- Other: pH: 11.5
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: Charles River Breeding Laboratories (Wilmington, MA)
- Females (if applicable) nulliparous and non-pregnant: yes
- Age at study initiation: 8-12 weeks
- Weight at study initiation: 200-400 g
- Fasting period before study: Night prior to dosing
- Housing: Individually in suspended, stainless steel wire mesh cages
- Diet (e.g. ad libitum): Commercial rodent ration (Agway Prolab 3000) ad libitum
- Water (e.g. ad libitum): Municipal tap water ad libitum
- Acclimation period: 3 days [current OECD guideline recommends 5 days]
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 72 ± 3°F (20.6-22.9°C)
- Humidity (%): 50 ± 15%
- Air changes (per hr): 10-13
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: no data
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- other: not specified, presumably water
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: no data
- Amount of vehicle (if gavage): up to 0.86 mL (females) or 1.53 mL (males) (20 mL/kg)
- Justification for choice of vehicle: no data - Doses:
- Main test: 100, 200, 300 or 400 mg/kg bw
[Preliminary test: 100, 300, 600, 900 or 1200 mg/kg bw] - No. of animals per sex per dose:
- 5
[3 males/group in preliminary test] - Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: daily (clinical observations and mortality only)
- Necropsy of survivors performed: yes
- Other examinations performed: no - Statistics:
- Calculation of the LD50, probit slope, and 95% confidence limit (CL) for the LD50 were achieved using an Applie II Plus Computer with a programme by Tallarida RJ and Murray RB (1981).
Results and discussion
- Preliminary study:
- Mortalities were 0, 2, 2, 3 and 3 at respective doses of 100, 300, 600, 900 and 1200 mg/kg bw
Effect levels
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- 283 mg/kg bw
- Based on:
- test mat.
- 95% CL:
- >= 233 - <= 343
- Mortality:
- In the main test there was no mortality at the lowest tested dose (100 mg/kg bw), while all animals died at the highest tested dose (400 mg/kg bw). A single animal of each sex died at 200 mg/kg bw; 1 male and 4 females died at 300 mg/kg bw.
- Clinical signs:
- other: At 300 mg/kg bw, bluish cyanotic ears and feet as well as abnormally slow respiration were observed in three males, two of which also showed tremors and convulsions; such effects were also seen in a single female.
- Gross pathology:
- Necropsy of those animals displaying treatment-related mortality revealed moderate haemorrhaging in the stomach and small intestine. Other observations included a very pale integument, subcutis and liver, along with dusky leaden lungs which contained very little blood when sectioned. Mortailty was attributed to asphyxiation.
No significant lesions were observed in surviving animals. - Other findings:
- - Organ weights: no data
- Histopathology: no data
- Potential target organs: no data
Applicant's summary and conclusion
- Interpretation of results:
- Category 3 based on GHS criteria
- Conclusions:
- In a guideline study, to GLP, the acute oral LD50 of calcium nitrite was determined to be 283 mg/kg bw in rats.
- Executive summary:
The acute oral toxicity of calcium nitrite (anhydrous powder) was investigated in Sprague-Dawley rats, in a US EPA TSCA guideline study (essentially equivalent to OECD Test Guideline 401), conducted according to GLP. Animals (5/sex/group) were administered the test substance (dissolved in an unspecified vehicle, presumably water) by oral gavage at doses of 100, 200, 300 or 400 mg/kg bw, and observed for up to 14 days. The dose range used in the main test was informed by a preliminary test involving gavage administration at levels of 100, 300, 600, 900 or 1200 mg/kg bw to male rats (3/group).
All animals died at the top dose (400 mg/kg bw) in the main test, while there were 2 and 5 deaths at the intermediate doses (200 and 300 mg/kg bw respectively). Deaths occurred within hours of test material administration and were attributed to asphyxiation. No mortality was observed in the low dose group (100 mg/kg bw). In the animals that died, clinical signs of toxicity were limited to discolouration of the ears/feet, tremors and reduced respiration in certain animals in the 300 mg/kg bw dose group. Upon necropsy, toxic effects included moderate haemorrhaging of the stomach and small intestine as well as effects on the skin, liver and lungs. No significant lesions were observed in surviving animals.
The acute oral LD50 was determined (using probit analysis) to be 283 mg/kg bw in rats (95% CL 233-343 mg/kg bw). Based on the results of this study, the test material should be classified for acute oral toxicity (category 3) according to EU CLP criteria (EC 1272/2008).
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