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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 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
Repeated dose toxicity: oral
Administrative data
- 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.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 007
- Report date:
- 2007
Materials and methods
Test guidelineopen allclose all
- 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
Test material
- Reference substance name:
- Potassium
- EC Number:
- 231-119-8
- EC Name:
- Potassium
- Cas Number:
- 7440-09-7
- Molecular formula:
- K
- IUPAC Name:
- potassium
- Reference substance name:
- Calcium
- EC Number:
- 231-179-5
- EC Name:
- Calcium
- Cas Number:
- 7440-70-2
- Molecular formula:
- Ca
- IUPAC Name:
- calcium
- Reference substance name:
- Ammonium nitrogen
- IUPAC Name:
- Ammonium nitrogen
- Reference substance name:
- Nitrate nitrogen
- IUPAC Name:
- Nitrate nitrogen
- Test material form:
- solid: granular
- Details on test material:
- - Name of test material (as cited in study report): Nitcal/K
- Physical appearance: White granules
- Storage conditions: at room temperature in the dark
Constituent 1
Constituent 2
Constituent 3
Constituent 4
Test animals
- 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
Administration / exposure
- 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
Doses / concentrations
- 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
Examinations
- 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
Results and discussion
Results of examinations
- 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.
Effect levels
- 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.
Target system / organ toxicity
- Critical effects observed:
- not specified
Any other information on results incl. tables
The treatment-related changes in hematology parameters and spleen morphology at high dose point a slightly increased red blood cell turnover
Applicant's summary and conclusion
- 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
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.