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EC number: 233-332-1 | CAS number: 10124-37-5
- 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

Endpoint summary
Administrative data
Description of key information
A reliable study with calcium nitrate is not available. Based on an expert statement, a sub-chroning repeated dose toxicity study does not need to be conducted.
A OECD 407 study with the read-across substance Nitcal-K (potassium pentacaclium nitrate decahydrate) and an OECD 422 study with potassium nitrate did not show any adverse effects up to the highest dose level tested (1000 and 1500 mg/kg bw/day, respectively). The read-across rationale can be found in the document attached to the appropriate target record and is incorporated fully in the CSR (see Appendix A).
Key value for chemical safety assessment
Repeated dose toxicity: via oral route - systemic effects
Link to relevant study records
- Endpoint:
- short-term repeated dose toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
- Remarks:
- The study was performed with a substance analogue and the data are read across.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 407 (Repeated Dose 28-Day Oral Toxicity Study in Rodents)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.7 (Repeated Dose (28 Days) Toxicity (Oral))
- GLP compliance:
- yes
- Limit test:
- no
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River, Sulzfeld, Germany
- Age at study initiation: 6 weeks
- Weight at study initiation: males: 195-227 g; females: 154-181 g
- Fasting period before study: no
- Housing: group housing (5/sex) in Macrolon cages
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-23
- Humidity (%):31-73
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 9 February 2007 To: 9 March 2007 - Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on oral exposure:
- PREPARATION OF DOSING SOLUTIONS:
DIET PREPARATION
- Rate of preparation of diet (frequency): once
- Mixing appropriate amounts with (Type of food): not applicable
- Storage temperature of food: not indicated
VEHICLE
- Justification for use and choice of vehicle (if other than water): based on trial formulations
- Concentration in vehicle: 5, 10, 100 mg/ml
- Amount of vehicle (if gavage): 10 ml/kg body weight
- Lot/batch no. (if required): not applicable
- Purity: Water (Milli-U) (millipore Corporation, Bedford, USA - Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- homogeneity (high- and low dose) and concentration (all doses) were analysed
- Duration of treatment / exposure:
- 28 days
- Frequency of treatment:
- Daily
- Remarks:
- Doses / Concentrations:
50, 150, 1000 mg/kg bw
Basis:
actual ingested - No. of animals per sex per dose:
- 5
- Control animals:
- yes
- Details on study design:
- - Dose selection rationale: based on an 8-day dose range finding study (NOTOX project 482737)
- Positive control:
- no
- Observations and examinations performed and frequency:
- CAGE SIDE OBSERVATIONS: No
DETAILED CLINICAL OBSERVATIONS: Yes
- Time schedule: at least once daily
BODY WEIGHT: Yes
- Time schedule for examinations: weekly
FOOD CONSUMPTION:
- Food consumption for each animal determined and mean daily diet consumption calculated as g food/kg body weight/day: Yes
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: No
WATER CONSUMPTION AND COMPOUND INTAKE (if drinking water study): Yes
- Time schedule for examinations: not indicated (subjective appraisal)
OPHTHALMOSCOPIC EXAMINATION: No
HAEMATOLOGY: Yes
- Time schedule for collection of blood: day of necropsy
- Anaesthetic used for blood collection: Yes (iso-flurane)
- Animals fasted: Yes
- How many animals: all animals
- Parameters examined. standard parameters
CLINICAL CHEMISTRY: Yes
- Time schedule for collection of blood: day of necropsy
- Animals fasted: Yes
- How many animals: all animals
- Parameters checked in table [No.?] were examined.
URINALYSIS: No
NEUROBEHAVIOURAL EXAMINATION: Yes
- Time schedule for examinations: during treatment week 4
- Dose groups that were examined: all animals
- Battery of functions tested: hearing ability / grip strength / motor activity / righting reflex/ pupillary reflex: - Sacrifice and pathology:
- GROSS PATHOLOGY: Yes
HISTOPATHOLOGY: Yes, all selected tissues from control and high dose animals, gross lesions (all animals), stomach and spleen (all dose levels) - Other examinations:
- Organ weights
- Statistics:
- Yes
- Clinical signs:
- no effects observed
- Mortality:
- no mortality observed
- Body weight and weight changes:
- no effects observed
- Food consumption and compound intake (if feeding study):
- no effects observed
- Food efficiency:
- not specified
- Water consumption and compound intake (if drinking water study):
- not specified
- Ophthalmological findings:
- not examined
- Haematological findings:
- effects observed, treatment-related
- Clinical biochemistry findings:
- no effects observed
- Urinalysis findings:
- not examined
- Behaviour (functional findings):
- no effects observed
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Gross pathological findings:
- effects observed, treatment-related
- Histopathological findings: non-neoplastic:
- effects observed, treatment-related
- Histopathological findings: neoplastic:
- no effects observed
- Details on results:
- HAEMATOLOGY: high-dose males: reticulocytes and red cell distribution width slightly increased; high-dose females: red blood cell count and haematocrit slightly decreased. Reviewer: these changes are not consistent between males/females, are very slight, and three out of four appeared to be in the historical control range from this strain (based on NOTOX historical data) and this kind of study. Therefore, not considered adverse.
GROSS PATHOLOGY: thickened limiting ridge and/or foci in glandular mucosa in 2 and 3 high-dose males and females, respectively. This is a local effect and reversible.
HISTOPATHOLOGY: NON-NEOPLASTIC: hyperplasia/hyperkeratosis of the limiting ridge of the stomach in 4 and 3 high dose males and females, respectively; increased severity of haemopoietic foci (erythroid) in the spleen at high dose. Reviewer: The effect in the stomach is a local effect and reversible. The effect in the spleen is limited to one male and one female with a moderate severity at the high dose. However, this is a symptom expected in young animals in such a study, in addition it is considered a reversible effect. This is based on expertise of experienced pathologist. - Key result
- Dose descriptor:
- NOAEL
- Effect level:
- >= 1 000 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: Author considered 150 mg/kg bw as a NOAEL, however no adverse effects at highest dose tested according to reviewer. See discussion.
- Critical effects observed:
- not specified
- Conclusions:
- Based on effects noted at high dose (1000 mg/kg body weight/day), the NOAEL of Nitcal/K was considered tobe 150 mg/kg body weight/day in a 28-day oral (gavage) study in rats
Reference
The treatment-related changes in hematology parameters and spleen morphology at high dose point a slightly increased red blood cell turnover
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEL
- 1 000 mg/kg bw/day
- Study duration:
- subacute
- Species:
- rat
- Quality of whole database:
- The study has been performed according to OECD and/or EC guidelines and according to GLP principles. However, since the study was performed with a substance analogue and the data are read across, the Klimisch score is 2.
Repeated dose toxicity: inhalation - systemic effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: inhalation - local effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: dermal - systemic effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: dermal - local effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Oral
No study with the substance itself is available.
A reliable 28 -day oral OECD 407, EU B.7 guideline study has been performed in rats (5 rats/sex/dose) via gavage, containing 50, 150 or 1000 mg/kg bw/day Nitcal-K (potassium pentacalcium nitrate decahydrate). There were no treatment-related deaths and no signs of overt clinical toxicity. There were no effects on body weight, food consumption, or food efficiency. Functional observational battery (FOB) and motor activity tests identified no treatment-related changes in behavior, function, or motor activity. In haematology high-dose males reticulocytes and red cell distribution width were slightly increased; in high-dose females red blood cell count and haematocrit was slightly decreased. Reviewer: these changes are not consistent between males/females, are very slight, and three out of four appeared to be in the historical control range from this strain (based on NOTOX historical data) and this kind of study. Therefore, these are not considered adverse. At gross pathology a thickened limiting ridge and/or foci in glandular mucosa in 2 and 3 high-dose males and females, respectively, were noted. This is a local effect and reversible. At histopathology some non-neoplastic effects were observed: hyperplasia/hyperkeratosis of the limiting ridge of the stomach in 4 and 3 high dose males and females, respectively. This is considered a local effect and reversible according to the reviewer. In addition an increased severity of haemopoietic foci (erythroid) in the spleen at high dose was noted. Reviewer: The effect in the spleen is limited to one male and one female with a moderate severity at the high dose. However, this is a symptom expected in young animals in such a study, in addition it is considered a reversible effect. This is based on expertise of an experienced pathologist. Therefore, it was concluded that the NOAEL is >=1000 mg/kg bw/day (highest dose tested).
In addition, a combined repeated dose toxicity study with a reproduction/ developmental toxicity screening performed according to OECD 422 guideline and GLP principles was performed with potassium nitrate. Male and female rats were exposed to 0, 250, 750 or 1500 mg/kg bw/ day. There were no treatment-related deaths and no signs of overt clinical toxicity. There were no effects on body weight, food consumption, or food efficiency, haematology, clinical chemistry. No effects on organ weights or upon macroscopic or microscopic examination were found. Based on these data, the NOAEL of potassium nitrate was found to be >=1,500 mg/kg/day for general toxicity.
No dermal and inhalation toxicity studies are available. Inhalation exposure seems to be an unlikely route of exposure as the vapour pressure is assumed to be very low and the particle size of the substance is high (in the case of calcium nitrate 2% < 100 µm, which is the inhalable fraction).
Based on an expert statement, no additional studies with Calcium nitrate are performed. In the 28-day study at the limit dose value of 1000 mg/kg bw/day no adverse toxicity is seen. In addition, in an OECD 422 study no toxicity is seen at the limit dose of 1500 mg/kg bw/day. Based on the assessment factors for exposure duration (see guidance IR CSA R.8) from subacute to semi-chronic a factor 3 is used, expecting a 3 times lower NOAEL. Assuming this factor would be applicable for this substance, this would still not result in a NOAEL showing a hazardous property. In addition, all supporting data, sub-chronic, chronic, carcinogenicity, included do not suggest any hazardous properties of the substsance. Calcium nitrate dissociates into Ca2+ and nitrate ions. Nitrates are regulated within the body. Ca2+ is a necessary element of which the accepted daily dose is 1-2.5 g/day (Dutch Voedingscentrum). Based on this weight of evidence, no sub-chronic study is considered required.
Justification for selection of repeated dose toxicity via oral route - systemic effects endpoint:
One 28-day study on the read-across substance Nitcal/K is available.
Justification for classification or non-classification
Based on the data available, calcium nitrate does not have to be classified according to the CLP Regulation for repeated dose toxicity.
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