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EC number: 913-635-1 | CAS number: -
- 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
Carcinogenicity
Administrative data
Description of key information
No data are available on the reaction mass itself. However, a carcinogenic study performed according to the OECD guideline 453 showed that sodium chloride (one component of the reaction mass) has no carcinogenic effect on rats. There is no carcinogenic study on calcium chloride (the second component of the reaction mass). However, both calcium and chloride ions are essential human nutrients with recommended daily uptake of 1000 mg/day for each ion and no carcinogenic effects are not expected for the both ions.
Key value for chemical safety assessment
Carcinogenicity: via oral route
Link to relevant study records
- Endpoint:
- carcinogenicity
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- other:
- Endpoint:
- carcinogenicity: oral
- Type of information:
- other: publication
- Adequacy of study:
- weight of evidence
- Study period:
- 1986
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: The publication contains sufficient information to permit a meaningful evaluation of study results
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 453 (Combined Chronic Toxicity / Carcinogenicity Studies)
- Principles of method if other than guideline:
- not applicable
- GLP compliance:
- not specified
- Species:
- rat
- Strain:
- Fischer 344
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Shizuka Experimental Cooperative
- Age at study initiation: 4 weeks on receipt of animals
- Weight at study initiation: not specified in the publication
- Fasting period before study: not specified in the publication
- Housing: 2 rats/cage
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 1 week
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 23 ± 2°C
- Humidity (%): 40%
- Air changes (per hr): not specified in the publication
- Photoperiod (hrs dark / hrs light): not specified in the publication - Route of administration:
- oral: feed
- Vehicle:
- unchanged (no vehicle)
- Details on exposure:
- DIET PREPARATION
- Rate of preparation of diet (frequency): not specified in the publication
- Mixing appropriate amounts with (Type of food): not specified in the publication
- Storage temperature of food: not specified in the publication
- The administration was performed by mixing with the feed. MF powdered feed (oriental Kobo Co.) was used as the basal diet and appropriate amounts of either sodium chloride were added to the basal diet. - Analytical verification of doses or concentrations:
- not specified
- Details on analytical verification of doses or concentrations:
- not specified in the publication
- Duration of treatment / exposure:
- 2 years
- Frequency of treatment:
- daily
- Post exposure period:
- not applicable
- Remarks:
- Doses / Concentrations:
0.25% KCl, 1% KCl, 4% KCl, 4% NaCl and 2% KCl+2% NaCl
Basis:
nominal in diet - No. of animals per sex per dose:
- 50 rats/group
- Control animals:
- yes, plain diet
- Details on study design:
- - Dose selection rationale: not specified in the publication
- Rationale for animal assignment: not specified in the publication - Positive control:
- not applicable
- Observations and examinations performed and frequency:
- CAGE SIDE OBSERVATIONS: Yes
- Time schedule: daily
DETAILED CLINICAL OBSERVATIONS: No data
BODY WEIGHT: Yes
- Time schedule for examinations: not specified in the publication
FOOD CONSUMPTION: Yes
- Time schedule for examinations: not specified in the publication
HAEMATOLOGY: Yes
- Time schedule for collection of blood: at termination
- Anaesthetic used for blood collection: No data
- Animals fasted: data
- How many animals: all surviving animals
- Parameters examined: Red blood and white blood cell counts, hemoglobin, hematocrit, MCV, MCH, MCHC and platelets
CLINICAL CHEMISTRY: Yes
- Time schedule for collection of blood: at termination
- Animals fasted: No data
- How many animals: all surviving animals
- Parameters examined: GOT, GPT, ALP, LDH, CH-E, Na, K, Ca, NU, Clu, TP and Glu
URINALYSIS: Yes
- Time schedule for collection of urine: at termination
- Metabolism cages used for collection of urine: No data
- Animals fasted: No data
- Parameters examined: protein, glucose, ketone, bilirubin, urobilinogen, pH, occult blood and specific gravity
NEUROBEHAVIOURAL EXAMINATION: No - Sacrifice and pathology:
- GROSS PATHOLOGY: Yes
HISTOPATHOLOGY: Yes - Other examinations:
- Blood pressure measurements were performed 3 times, at 1 year, 1.5 year and 2 years.
- Statistics:
- Standard descriptive statistics were used.
- 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 examined
- Water consumption and compound intake (if drinking water study):
- not examined
- Ophthalmological findings:
- not examined
- Haematological findings:
- no effects observed
- Clinical biochemistry findings:
- no effects observed
- Urinalysis findings:
- no effects observed
- Behaviour (functional findings):
- not examined
- Organ weight findings including organ / body weight ratios:
- effects observed, treatment-related
- Description (incidence and severity):
- In the organ weight ratios, an increase in the liver weight was seen in the 4% NaCl group
- Gross pathological findings:
- no effects observed
- Histopathological findings: non-neoplastic:
- effects observed, treatment-related
- Description (incidence and severity):
- Among non-tumorous lesions, nephrotic lesion was predominant in all groups, especially in the 4% NaCl group along with increased gastritis and ulcerative lesions of the stomach.
- Histopathological findings: neoplastic:
- no effects observed
- Details on results:
- At the end of the 2-year experimental period, the survival rates were 64%, 58%, 84%, 60%, 52% and 48% in 0.25% KCl, 1% KCl, 4% KCl, 4% NaCl, 2% KCl+2% NaCl and control groups. In regard to blood pressure, the level of 4% NaCl group was higher than that of the control group. Pathological non-tumorous and tumors lesions did not indicate a toxic or carcinogenic effect of KCl and NaCl. Among non-tumorous lesions, nephrotic lesion was predominant in all groups, especially in the 4% NaCl group.
Chronic gastritis and ulcer were found more in the experimental groups than in the control group. In tumorous lesions, testicular tumor developed with a high incidence in all groups and the incidence of pheochromocytoma in the adrenals was moderately high in all the groups. However, the incidence and type of tumor in experimental and control groups were comparable to those of spontaneous tumors in F344/Slc rats. Therefore, the tumors observed in the study were considered to be spontaneous in origin. - Dose descriptor:
- NOAEL
- Effect level:
- > 4 other: per cent in the diet
- Based on:
- test mat.
- Sex:
- male
- Basis for effect level:
- histopathology: neoplastic
- Remarks on result:
- other:
- Remarks:
- The incidence and type of tumor seen in experimental and control groups were comparable to those of spontaneous tumors in F344/Slc rats. Therefore the tumors observed in this study are not considered to be related to the substance.
- Conclusions:
- Based on the results of the study, NaCl was not considered carcinogenic when administered thorugh the diet to F344/Slc rats for a period of two years.
- Executive summary:
Chronic toxicity tests of KCl and NaCl were carried out in male F344/Slc rats for two years. Each group consisted of 50 rats and each group was fed with 0.25% KCl, 1% KCl, 4% KCl, 4% NaCl, 2% KCl+2% NaCl.
Referenceopen allclose all
none
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
Justification for classification or non-classification
No data are available on the reaction mass itself. However, a carcinogenic study performed according to the OECD guideline 453 showed that sodium chloride (one component of the reaction mass) has no carcinogenic effect on rats. There is no carcinogenic study on calcium chloride (the second component of the reaction mass). However, both calcium and chloride ions are essential human nutrients with recommended daily uptake of 1000 mg/day for each ion and no carcinogenic effects are expected for the both ions. The two components of the reaction mass do not induce carcinogenic effect. Therefore the reaction mass is not considered to be carcinogenic and no classification is required for this effect.
Additional information
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.
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