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EC number: 231-832-4 | CAS number: 7758-09-0
- 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
Repeated dose toxicity: oral
Administrative data
- Endpoint:
- sub-chronic toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- data from handbook or collection of data
- Justification for type of information:
- Data is from publication
Data source
Reference
- Reference Type:
- publication
- Title:
- EVALUATION OF THE ORAL TOXICITY OF POTASSIUM NITRITE IN A 13-WEEK DRINKING-WATER STUDY IN RATS
- Author:
- H. P. TIL, H. E. FALKE, C. F. KUPER and M. I. WILLEMS
- Year:
- 1 988
- Bibliographic source:
- Food and chemical toxicology
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: As mentioned below
- Principles of method if other than guideline:
- To determine Subchronic oral toxicity study of test chemical on Rats.
- GLP compliance:
- no
- Limit test:
- no
Test material
- Reference substance name:
- Potassium nitrite
- EC Number:
- 231-832-4
- EC Name:
- Potassium nitrite
- Cas Number:
- 7758-09-0
- Molecular formula:
- HNO2.K
- IUPAC Name:
- potassium nitrite
- Test material form:
- solid
- Details on test material:
- - Name of test material (IUPAC name): Potassium nitrite
- Molecular formula: KNO2
- Molecular weight: 85.103 g/mol
- Smiles notation: N(=O)[O-].[K+]
- InChl: 1S/K.HNO2/c;2-1-3/h;(H,2,3)/q+1;/p-1
- Substance type: Organic
- Physical state: Solid
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Details on species / strain selection:
- Weanling, Wistar derived SPF-bred rats (Bor; WlSW)
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Winkelmann (Institute for the Breeding of Laboratory Animals GmbH & Co. KG, Borchen, FRG).
- Females (if applicable) nulliparous and non-pregnant:yes
- Age at study initiation: 6 weeks old
- Weight at study initiation: NA
- Fasting period before study: NA
- Housing: The rats were housed under conventional conditions, in suspended stainless-steel cages fitted with a wire-mesh floor and front.
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 13 days
DETAILS OF FOOD AND WATER QUALITY: All rats were fed the Institute's grain-based open-formula diet (with a nitrite and nitrate content of 2 and 140mg/kg, respectively)
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 + 2°C
- Humidity (%): 40-70%
- Air changes (per hr): 10/hr
- Photoperiod (hrs dark / hrs light): 12hr light/dark cycles
IN-LIFE DATES: From: To:
Administration / exposure
- Route of administration:
- oral: drinking water
- Details on route of administration:
- The rats received potassium nitrite in the drinking-water (tap-water; nitrite and nitrate content <0.01 and 10mg/litre, respectively) at levels of 0 (negative control), 100, 300, 1000 and 3000mg/litre.
- Vehicle:
- water
- Details on oral exposure:
- PREPARATION OF DOSING SOLUTIONS:
DIET PREPARATION
- Rate of preparation of diet (frequency): Test solutions and tap-water were freshly supplied to the rats in glass bottles every day.
- Mixing appropriate amounts with (Type of food): Drinking water
- Storage temperature of food: NA
VEHICLE
- Justification for use and choice of vehicle (if other than water):
- Concentration in vehicle: nitrite and nitrate content <0.01 and 10mg/litre
- Amount of vehicle (if gavage): NA
- Lot/batch no. (if required): NA
- Purity:NA
Additional information: The potassium concentrations in the nitrite solutions were equalized by adding KCl up to the K+ level of the 3000 mg KNO2/litre solution.
An additional group received drinking-water supplemented with KCl only, to achieve the same K+ concentration as that found in the 3000 mg KNO2/litre solution. - Analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- 13 weeks (91 days)
- Frequency of treatment:
- Everyday
Doses / concentrationsopen allclose all
- Dose / conc.:
- 0 mg/L drinking water
- Remarks:
- Negative control
- Dose / conc.:
- 100 mg/L drinking water
- Dose / conc.:
- 300 mg/L drinking water
- Dose / conc.:
- 1 000 mg/L drinking water
- Dose / conc.:
- 3 000 mg/L drinking water
- No. of animals per sex per dose:
- ten rats of each sex/group (Five treatment groups )
- Control animals:
- yes, concurrent vehicle
Examinations
- Observations and examinations performed and frequency:
- DETAILED CLINICAL OBSERVATIONS: Yes / No / Not specified
- Time schedule:
BODY WEIGHT: Yes / No / Not specified
- Time schedule for examinations: The rats were weighed at weekly intervals and were observed daily for condition and behaviour
FOOD CONSUMPTION AND COMPOUND INTAKE (if feeding study):
- Food consumption for each animal determined and mean daily diet consumption calculated as g food/kg body weight/day: Yes / No / Not specified
- Compound intake calculated as time-weighted averages from the consumption and body weight gain data: Yes / No / Not specified
FOOD EFFICIENCY:
- Body weight gain in kg/food consumption in kg per unit time X 100 calculated as time-weighted averages from the consumption and body weight gain data: Yes / No / Not specified
WATER CONSUMPTION AND COMPOUND INTAKE (if drinking water study): Yes / No / Not specified
- Time schedule for examinations: Food and liquid intake were measured over weekly periods throughout the study
OPHTHALMOSCOPIC EXAMINATION: Yes / No / Not specified
- Time schedule for examinations: Ophthalmoscopic observations were made in all rats of the control and top-dose groups prior to the administration of the test substances and during wk 13.
- Dose groups that were examined:
URINALYSIS: Yes / No / Not specified
- Time schedule for collection of urine: In wk 9 of treatment urine was collected over a 24-hr period from all rats, except those receiving unsupplemented tap-water
- Metabolism cages used for collection of urine: Yes It was collected in calibrated tubes under cooling on dry ice. Its volume was determined and it was examined for
creatinine and nitrite and nitrate - Sacrifice and pathology:
- Early in wk 14, the rats were killed by exsanguination from the abdominal aorta whilst under light ether anaesthesia, and a thorough autopsy was performed.
- Statistics:
- Data on body weight were evaluated by a oneway analysis of covariance, followed by Dunnett's multiple comparison tests
Results and discussion
Results of examinations
- Clinical signs:
- not specified
- Mortality:
- no mortality observed
- Description (incidence):
- There were no deaths and the rats appeared to be healthy throughout the study
- Body weight and weight changes:
- effects observed, treatment-related
- Description (incidence and severity):
- Body weight was decreased at 3000 mg/l in males.
- Food consumption and compound intake (if feeding study):
- effects observed, treatment-related
- Description (incidence and severity):
- Growth and food intake were significantly decreased in the 3000-mg/litre group in males.
- Food efficiency:
- effects observed, treatment-related
- Description (incidence and severity):
- Food efficiency was decreased in the 3000-mg/litre group in males. (data not shown).
- Water consumption and compound intake (if drinking water study):
- effects observed, treatment-related
- Description (incidence and severity):
- Liquid intake was clearly diminished in the 3000- and the 1000-mg/litre groups of males and in the 3000-mg/litre group of females
- Ophthalmological findings:
- no effects observed
- Description (incidence and severity):
- Ophthalmoscopic examination did not reveal any differences between the test rats and controls that could be ascribed to treatment
- Haematological findings:
- effects observed, treatment-related
- Description (incidence and severity):
- Haemoglobin concentration, packed-cell volume and erythrocyte count were slightly decreased in the males receiving 1000 and 3000mg/litre, and in the females receiving 1000 mg/litre. In females, the erythrocyte count was also decreased with a dose of 3000 mg/litre which was accompanied by increases in mean corpuscular volume and mean corpuscular haemoglobin. Methaemoglobin concentration was significantly increased with 3000mg/litre in both sexes
- Clinical biochemistry findings:
- effects observed, treatment-related
- Description (incidence and severity):
- With the 3000-mg/litre treatment the plasma urea level was increased in males, while the plasma alkaline phosphatase activity was slightly decreased in both sexes, although the difference was statistically significant in females only (Table 3). There was a decrease in plasma aspartate aminotransferase in the females given 1000 and 3000 mg/litre in comparison to the KCI group, but not as compared with the controls receiving unsupplemented drinking-water
- Urinalysis findings:
- effects observed, treatment-related
- Description (incidence and severity):
- The volume of the urine produced during 24 hr decreased with increasing nitrite levels in the drinking-water, the differences from the controls being statistically significant in males treated with 3000 mg/litre and in females treated with 300 mg/litre and above . The urine concentration test revealed an increase in the density of the urine of the animals treated with 3000mg/litre in both sexes, accompanied by a decrease in urine production in males . Excretion levels of creatinine and
nitrate did not show treatment-related differences among the groups and nitrite was not found in the urine of any of the groups. There was no evidence of
increased mutagenic activity in the urine of rats receiving 3000 mg/litre, either in the presence or in the absence of S-9 mix and fl-glucuronidase. - Organ weight findings including organ / body weight ratios:
- effects observed, treatment-related
- Description (incidence and severity):
- The absolute and relative weights of the kidneys and spleen in females and the relative weight of the kidneys in males were increased in the group receiving 3000 mg/litre. The increase in the relative brain weight in males receiving 3000 mg/iitre is ascribed to the lower body weight in this group and the well-known inverse correlation between body weight and relative brain weight
- Gross pathological findings:
- not specified
- Neuropathological findings:
- not specified
- Histopathological findings: non-neoplastic:
- no effects observed
- Description (incidence and severity):
- Histopathological examination of all other organs was essentially negative.
- Histopathological findings: neoplastic:
- not specified
- Other effects:
- not specified
Effect levels
open allclose all
- Key result
- Dose descriptor:
- NOEL
- Effect level:
- < 100 mg/L drinking water
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- body weight and weight gain
- clinical biochemistry
- food consumption and compound intake
- food efficiency
- haematology
- ophthalmological examination
- organ weights and organ / body weight ratios
- urinalysis
- water consumption and compound intake
- Dose descriptor:
- NOAEL
- Effect level:
- 300 mg/L drinking water
- Based on:
- test mat.
- Sex:
- female
- Basis for effect level:
- body weight and weight gain
- food consumption and compound intake
- mortality
- Dose descriptor:
- LOAEL
- Effect level:
- 1 000 mg/L drinking water
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- body weight and weight gain
- food consumption and compound intake
- mortality
Target system / organ toxicity
- Critical effects observed:
- no
Applicant's summary and conclusion
- Conclusions:
- A subchronic oral toxicity study with test chemical was carried out in groups of ten male and ten female 6-wk-old rats. No mortality observed and the rats appeared to be healthy throughout the study. Effects were observed in food and water consumption, opthalological and haematological effects were observed. It was concluded that in the study reported here the NOEL is lower than I00 mg /litre in the drinking-water, which is equivalent to a level lower than 10 mg /kg body weight/day and a NOAEL of 300 mg/L drnking water was observed.
- Executive summary:
A subchronic oral toxicity study with test chemical was carried out in Wistar derieved SPF Bred rats. Groups of ten male and ten female 6-wk-old rats received test chemical in the drinking-water (tap-water) at levels of 0, 100, 300, 1000 and 3000mg/litre for a period of 13 week. The potassium concentration in the nitrite solutions was equalized by adding potassium chloride (KCL) up to the potassium level of the 3000 mg /litre solution. An additional group of ten males and ten females received drinking-water supplemented with KCI only, at an amount resulting in a potassium concentration equivalent to that of the 3000 mg /litre solution. No mortality observed and the rats appeared to be healthy throughout the study. Ophthalmoscopic examination did not reveal any differences between the test rats and controls that could be ascribed to treatment. Body weight, food intake and food efficiency were decreased at 3000-mg/litre level in males, while liquid intake was decreased in males given 1000 and 3000 mg/litre and in females given 3000 mg/litre. There was a significant increase in the methaemoglobin concentration in animals given 3000 mg/litre, while slight decreases in red blood cell variables occurred at the 1000 and 3000 mg/litre dose. No impaired renal function was observed in any of the test groups, although the relative weight of the kidneys and the plasma urea nitrogen level was increased at 3000 mg/litre. There was a slight decrease in plasma alkaline phosphatase activity at 3000 mg/litre. A small amount of nitrite was present in the saliva of the rats receiving 3000 mg/litre but there was no evidence of increased mutagenic activity in the urine of these rats. Interestingly, hypertrophy of the adrenal zone glomerulosa was observed in all test groups, the incidence and degree being dose related. It was concluded that in the study reported here the NOEL is lower than I00 mg /litre in the drinking-water, which is equivalent to a level lower than 10 mg /kg body weight/day and a NOAEL of 300 mg/L drnking water was observed.
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