Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 231-818-8 | CAS number: 7757-79-1
- 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: inhalation
Administrative data
- Endpoint:
- acute toxicity: inhalation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- June-October 2008
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 008
- Report date:
- 2008
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 403 (Acute Inhalation Toxicity)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- acute toxic class method
- Limit test:
- yes
Test material
- Reference substance name:
- Potassium nitrate
- EC Number:
- 231-818-8
- EC Name:
- Potassium nitrate
- Cas Number:
- 7757-79-1
- Molecular formula:
- HNO3.K
- IUPAC Name:
- potassium nitrate
- Test material form:
- solid: crystalline
- Details on test material:
- - Name of test material (as cited in study report): potassium nitrate, NPC
- Physical state: Solid, crystalline
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Animal Breeding Facility, Jai Research Foundation.
- Age at study initiation: 8-9 weeks.
- Weight at study initiation: males between 244-279 g and females between 175-197 g.
- Housing: 5 rats/cage according to group and sex in solid polipropylene rat cages (stainless steel grip on top)
- Diet (e.g. ad libitum): rat pellet, ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: Minimum period of 5 days prior to exposure
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-24
- Humidity (%): 65-68
- Air changes (per hr): Minimum 15 per hour.
- Photoperiod (hrs dark / hrs light): 12 hours light/12 hours dark.
Administration / exposure
- Route of administration:
- inhalation: dust
- Type of inhalation exposure:
- nose/head only
- Vehicle:
- other: unchanged (no vehicle)
- Details on inhalation exposure:
- GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus: Inhalation chamber, model head/nose only
- Exposure chamber volume: 63.5 L
- Method of holding animals in test chamber: portholes with transparent perspex rat exposure tubes.
- Source and rate of air: compressed air, 40 liters perminute (inflow)
- Method of conditioning air: air filters and moisture separator.
- System of generating particulates/aerosols: Fluidized bed dust generator system (In-Tox Products, USA)
- Method of particle size determination: Seven stage cascade impactor (Model No 02-150).
- Treatment of exhaust air: 1% sodium hydroxide solution and moisture traps containing silica gel.
- Temperature, humidity, pressure in air chamber: temperature 21.2-23.7 °C, relative humidity 42.1-58.9%, pressure 40 psi
TEST ATMOSPHERE
- Brief description of analytical method used: A open sampler with glass microfibre papers (Whatman International Ltd, Maidstone, England) was used to assess the breathing zone concentration. A suitable measured volume of air (1.77 L per minute) was extracted from the inhalation chamber. At the end of air sampling (1 minute), the glass microfibre papers with the test substance were weighed to determine the concentration of potassium nitrate at the breathing zone of the rats.
- Samples taken from breathing zone: yes, every one hour of exposure.
VEHICLE
- Composition of vehicle: No vehicle
TEST ATMOSPHERE
- MMAD (Mass median aerodynamic diameter) / GSD (Geometric st. dev.): MMAD 50% 3.13 u, GSD 2.75 - Analytical verification of test atmosphere concentrations:
- yes
- Remarks:
- gravimetric concentration analysis
- Duration of exposure:
- 4 h
- Concentrations:
- the maximum achievable concentration (4 hour mean measured value by gravimetric analysis) of potassium nitrate in the air at breathing zone of rats was 0.527 mg/L air.
- No. of animals per sex per dose:
- 5 females and 5 males per group
- Control animals:
- yes
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Toxic signs and mortality were observed at hourly intervals during the 4 h exposure period and at 1 hour post exposure on the day of exposure. Subsequently, rats were observed daily, twice a day for moribund state and mortality. The detailed clinical signs were recorded once a day.
- Necropsy of survivors performed: yes. Gross pathological examination.
- Other examinations performed: clinical signs, body weight,organ weights, histopathology, other: Observations included, but not limited to, evaluation of skin and fur, eyes and mucous membranes, respiratory and circulatory effects, autonomic and central nervous system effects, somatomotor activity and behaviours patter and observation of tremor, convulsions, salivation, diarrhea, lethargy, sleep and coma. Body weight was recorded individually, immediately prior to exposure, on day 7 and 14. - Statistics:
- As the study conducted was a limit test at the maximum achievable breathing zone concentration, no statistical analysis was required to calculate the LC50.
Results and discussion
- Preliminary study:
- At maximum achievable breathing zone concentration no mortality and lesion of pathological significance were observed in the treatment group as well as in the control group rats.
Effect levels
- Key result
- Sex:
- male/female
- Dose descriptor:
- LC50
- Effect level:
- > 0.527 mg/L air
- Exp. duration:
- 4 h
- Remarks on result:
- other: maximum achievable concentration
- Mortality:
- No mortality was observed in the control group as well as the treatment group rats.
- Clinical signs:
- other: No toxic signs were observed in the control group rats as well as in rats treated with 0.527 mg potassium nitrate/L air.
- Body weight:
- The per cent body weight change of rats from the treatment group were comparable to that of the control group at the end of the experiment.
- Gross pathology:
- External examination of the terminally sacrificed rats belonginf to both the control and treatment groups did not reveal any lesion of pathological significance.
Visceral examination of control and treatment group rats sacrificed during termination did not reveal any lesion of pathological significance except uuterine distension (rat no 19). Above noticed lesion is physiological/cyclical in nature and coould be considered as spontaneous finding, unrelated with the treatment. - Other findings:
- No other findings
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Remarks:
- Not classified according to Regulation (EC) 1272/2008
- Conclusions:
- No mortality, no lesion of pathological significance were observed at the maximum achievable breathing zone concentration (0.527 mg/L air). The acute median lethal concentration (LC50) of potassium nitrate was found to be greater than 0.527 mg/L air.
- Executive summary:
The study was performed to assess the acute inhalation toxicity (LC50) of potassium nitrate in Wistar rats. The method follow was as per the guidelines of OECD 403 (May 1981).
The study was conducted using inhalation equipment (head/nose only). Two groups of rats comprising of five males and five females each, were used for the study. The rats from Group I were exposed to air passed through inert bed material (iron grid) and served as control group. The rats from Group II were exposed to the maximum achievable breathing zone concentration (0.527 mg/L air) of potassium nitrate. Rats from either group were exposed for 4 hours followed by observation for a period of 14 days. No toxic signs and no mortality were observed in the rats of the control as well as rats treated with potassium nitrate. No effect on body weight was observed during the experiment in the rats from either the control or treated group.
The acute median lethal concentration (LC50) of potassium nitrate was found to be greater than 0.527 mg/L air.
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.