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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
Endpoint summary
Administrative data
Description of key information
No data are available on the reaction mass itself.
The reaction mass is a solution of two inorganic salts in water (68% of calcium chloride and 30% sodium chloride).
Calcium chloride dissociates into ions that are present physiologically in relatively high levels in vertebrates. In accordance with column 2 of REACH Annex VIII and IX, the repeated dose toxicity studies (required under section 8.6) are not needed where a substance undergoes immediate disintegration and there are sufficient data on the cleavage products. Therefore, repeated dose toxicity studies are considered (scientifically) not necessary for Calcium chloride and low toxicity is expected.
Three repeated toxicity studies are available on Sodium chloride. These studies have been performed in rats and Sodium chloride was administered in feed. Effects appeared at very high doses, between 1.3 and 2.5 gr/kg/day, depending on the studies.
Calcium chloride and sodium chloride have low repeated toxicity. Therefore the repeated toxicity of the reaction mass itself is also expected to be low. However, since body weight changes were noted in male rats at high dose in a 90 days study performed on sodium chloride, a DNEL was calculated for sodium chloride and use as a worst case for the risk assessment of the reaction mass.
Key value for chemical safety assessment
Repeated dose toxicity: via oral route - systemic effects
Link to relevant study records
- Endpoint:
- sub-chronic toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- 1951
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: The study was conducted before GLP compliance. The study contains sufficient amount of information for interpretation of the results.
- Qualifier:
- no guideline available
- Principles of method if other than guideline:
- Non-iodized sodium chloride, hereafter referred to as "salt" was fed to rats in their diets for periods of 90 days. A group of 40 Carworth Farms, Wistar
strain, albino rats was selected after a preliminary observation period. The animals were randomized among the 8 cages so that each cage contained 5 male or 5 female rats. The basic diet was the modified Food Research Laboratory Diet 2C which consisted of dried whole milk, ground whole wheat, inactivatedly yeast, U.S.P liver extract,and iodised salt. The iodized salt was present as 2% of the basic diet. The diets were continuously available in McCollum-type food cups. Groups of five males and 5 females received diets that contained 32, 8, 2, and 0% added salt respectively. In terms of total salt added plus that in the basic diet of these groups the percentages were 34, 10, 4, and 2%. - GLP compliance:
- not specified
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Carwoth Farms - Route of administration:
- oral: feed
- Vehicle:
- unchanged (no vehicle)
- Details on oral exposure:
- DIET PREPARATION
- Mixing appropriate amounts with (Type of food):The basfe diet was the modified Food Research Laboratory Diet 2C
which consisted of dried whole milk, ground whole wheat, inactivated yeast, U.S.P. liver extract,and iodised salt. The iodized salt was present as 2% of the basic diet. - Analytical verification of doses or concentrations:
- not specified
- Details on analytical verification of doses or concentrations:
- no data
- Duration of treatment / exposure:
- 90 days
- Frequency of treatment:
- daily
- Remarks:
- Doses / Concentrations:
0.00, 1.33, 5.73, 31.04 gms. added salt/kg/day
Basis:
nominal in diet - Remarks:
- Doses / Concentrations:
1.30, 2.67, 7.16, 32.92 gms total salt/kg/day
Basis:
actual ingested - No. of animals per sex per dose:
- 5 males and 5 females per dose.
- Control animals:
- yes, plain diet
- Details on study design:
- no data
- Positive control:
- no data
- Observations and examinations performed and frequency:
- CAGE SIDE OBSERVATIONS: No data
- Time schedule:no data
- Cage side observations checked in table [No.?] were included.: No data
DETAILED CLINICAL OBSERVATIONS: No data
- Time schedule:No data
BODY WEIGHT: Yes
FOOD CONSUMPTION AND COMPOUND INTAKE (if feeding study): - Sacrifice and pathology:
- GROSS PATHOLOGY: Yes
HISTOPATHOLOGY: Yes - Other examinations:
- None of the 40 rats used in this study died. At the end of 91 days of doses, the rats were weighed and sacrificed, Portions of kidney, liver, and lung were taken for histopathological examination, Livers and kidneys were weighed and the mean organ weight, expressed as percentage of body weight, calculated. These data, as well as those obtained on body weight gain and diet consumption were satatistically analysed for the sexes separately and combined.
- Statistics:
- No statistical differences were found in total diet eaten (or spilled). The mean weight gain of the combined sex groups dfffered significantly from the
controls only in the 3 s group. These rats gained 82 grams in 91 days while the controls gained 174 grams. However, the rats that received 8% and 2% added salt gained only 130 and 156 grams. The correlation between weight gain and salt content of the diet was -0.969, a significant finding that could occur only 5 times in 1000 by chance. When the body weigt data were examined separately by sex, each group of rats was found to have gained statistically significantly less weight than did the male controls (+92.6, +161.6, +217.6, and +238.8 for the 32, 8, 2, and 0% added salt groups ). The females differed only in the 32% groups. when the weight gain of each group was recalculated as grams gain per 100 grams basal diet eaten, the same statistical differences in growth data were found as when the weight data were calculated as grams weight gain. - Clinical signs:
- no effects observed
- Description (incidence and severity):
- None of the 40 rats used in this study died.
- Mortality:
- no mortality observed
- Description (incidence):
- None of the 40 rats used in this study died.
- Body weight and weight changes:
- effects observed, treatment-related
- Description (incidence and severity):
- When the body weight data were examined separately by sex, each group of male rats was found to have gained statistically significantly less weight than did the male controls (+92.6, +161.6, +217.6, and +238.8 for the 32, 8, 2, and 0% added salt groups )
- Food consumption and compound intake (if feeding study):
- effects observed, treatment-related
- Food efficiency:
- no effects observed
- Water consumption and compound intake (if drinking water study):
- not specified
- Ophthalmological findings:
- not specified
- Haematological findings:
- not specified
- Clinical biochemistry findings:
- not specified
- Urinalysis findings:
- not specified
- Behaviour (functional findings):
- not specified
- Organ weight findings including organ / body weight ratios:
- effects observed, treatment-related
- Description (incidence and severity):
- Livers and Kidneys were weighed and the mean organ weight, expressed as percentage of body weight, calculated.
- Gross pathological findings:
- effects observed, treatment-related
- Histopathological findings: non-neoplastic:
- effects observed, treatment-related
- Description (incidence and severity):
- Portion of kidney, liver and lung were taken for histopathological examination.
- Histopathological findings: neoplastic:
- not specified
- Details on results:
- CLINICAL SIGNS AND MORTALITY: No mortality was observed in all 40 rats
BODY WEIGHT AND WEIGHT GAIN: Weight gain observed and recorded
FOOD CONSUMPTION AND COMPOUND INTAKE (if feeding study): Food consumption and compound intake was recorded.
FOOD EFFICIENCY: increased
ORGAN WEIGHTS: Livers and kidneys were weighed
HISTOPATHOLOGY: Portions of kidney, liver and lung were taken for histopathological examination. - Key result
- Dose descriptor:
- LOAEL
- Effect level:
- 1.33 other: grams per kg/day
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- body weight and weight gain
- Remarks on result:
- other:
- Remarks:
- only in males and at high doses.
- Key result
- Critical effects observed:
- yes
- Lowest effective dose / conc.:
- 1.33 other: g/kg/day
- System:
- other: Body weight
- Organ:
- other: No organ affected. Only impact on body weight change.
- Treatment related:
- yes
- Dose response relationship:
- yes
- Relevant for humans:
- yes
- Conclusions:
- The LOAEL for 91 doses of salt in the diet of rats is 2%, 1.33 grams/kg/day of added salt in male rats only. Since this doses is high, no classification is required for repeated toxicity according to UN and EU GHS criteria.
- Executive summary:
In this study, a group of 5 males and 5 female rats were fed diets for 91 days that contained 32, 8, 2 and 0% salt in excess of the 2% already present as a normal constituent of basic FRL-2C rat diet.
The salt added to the dry diet in this study was Baker and Adamson crystal reagent Sodium Chloride, code 2232 from General Chemical Division of Allied Chemical and Dye Corp., New York, N.Y. It was identified as their lot E 277 and labeled as having passed A.C.S Specifications. This salt does not contain added potassium iodide as did the salt present as 2% of the basic diet.
Non-iodized sodium chloride, was fed to rats in their diets for periods of 90 days. A group of 40 Carworth Farms, Wistar strains, albino rats was selected after a preliminary observation period. The animals were randomized among the 8 cages so that each cage contained 5 male or 5 female rats. The basic diet was the modified Food Research Laboratory Diet 2C which consisted of dried whole milk, ground whole wheat, inactivated yeast, U.S.P. liver extract and iodized salt. The iodized salt was present as 2% of the basic diet. The diet were continuously available in McCollum-type food cups. Groups of five males and 5 females received diets that contained 32, 8, 2 and 0% added salt respectively. In terms of total salt added plus that in the basic diet of these groups the percentages were 34, 10, 4 and 2%.
None of the 40 rats used in the study died. At the end of 91 days of doses, the rats were weighed and sacrifice. Portions of kidney, liver, and lung were taken for histopathological examination. Livers and kidneys were weighed and the mean organ weight, expressed as percentage of the body weight, calculated. These data, as well as those obtained on body weight gain and diet consumption were statistically analyzed for the sexes separately and combined.
No statistical differences were found in total diet eaten. The mean weight gain of the combined sex groups differed significantly from the controls only in the 32% group. These rats gained 82 grams in 91 days while the controls gained 174 grams. However, the rats that received 8% and 2% added salt gained only 130 and 156 grams. The correlation between weight gain and salt content of the diet was -0.969, a significant finding that could occur only 5 times in 1000 by chance. When the body weight data were examined separately by sex, each group of male rats was found to have gained statistically significantly less weight than did the male controls (+92.6, +161.6, +217.6 and +236.8 for the 32,8,2 and 0% added salt groups.). The females differed only in the 32% group. When the weight gain of each group was recalculated as grams gain per 100 grams basal diet eaten, the same statistical differences in growth data were found as when the weight data were calculated as grams weight gain.
The mean liver weights of the 32% group of male and female rats combined and of the females separately were statistically lower than those of their respective controls. The mean kidney weights of the 32% females were significantly higher than those of the controls.
However, no pathological changes were detected by microscopic examination of these organs.
The LOAEL for 91 days of salt in the diet of rats is 2%, 1.33 grams/kg/day of added salt for male rats body weight decrease.
- Endpoint:
- chronic toxicity: 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 oral 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:
- no
- Details on analytical verification of doses or concentrations:
- not applicable
- Duration of treatment / exposure:
- 2 years
- Frequency of treatment:
- daily
- 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. - Key result
- Dose descriptor:
- LOAEL
- Effect level:
- 4 other: percent in feed
- Based on:
- test mat.
- Remarks:
- 4% of sodium chloride in diet corresponds to 2533 mg/kg/day.
- Sex:
- male
- Basis for effect level:
- histopathology: non-neoplastic
- organ weights and organ / body weight ratios
- other:
- Remarks on result:
- other: The only dose tested.
- Key result
- Critical effects observed:
- yes
- Lowest effective dose / conc.:
- 2 533 mg/kg bw/day (nominal)
- System:
- other: liver, stomach and Kidney
- Organ:
- kidney
- liver
- stomach
- Treatment related:
- yes
- Dose response relationship:
- no
- Relevant for humans:
- yes
- Conclusions:
- Based on the results of the study, NaCl was not considered carcinogenic when administered through the diet to F344/Slc rats for a period of two years. For non-carcinogenic effect 4% of Sodium chloride (corresponding to 2533 mg/kg/day) induces nephrotic lesion with an increased incidence of gastritis and ulcerative lesions of the stomach. These effects occurred at very high dose of sodium chloride (2533 mg/kg/day). Therefore no classification is required according to UN and EU GHS criteria.
- 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.
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 tumors lesions did not indicate carcinogenic effect of KCl and NaCl. Among non-tumorous lesions, nephrotic lesion was predominant in all groups, especially in the 4% NaCl group, along with an increased incidence of gastritis and ulcerative lesions of the stomach. 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.
- Endpoint:
- chronic toxicity: oral
- Type of information:
- other: publication
- Adequacy of study:
- weight of evidence
- Study period:
- 1953
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: The study was conducted prior to GLP and guidelines and the report contains sufficient information to permit a meaningful evaluation of study results
- Qualifier:
- no guideline available
- Principles of method if other than guideline:
- The chronic adminsitration of sodium chloride throught the diet was administered to male rats and the effects on hypertension, renal and vascular lesions were evaluated
- GLP compliance:
- no
- Remarks:
- Study conducted prior to GLP
- Limit test:
- no
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: not specified in the publication
- Age at study initiation: not specified in the publication
- Weight at study initiation: not specified in the publication
- Fasting period before study: not specified in the publication
- Housing: housed in suspended steel wire cages
- Diet (e.g. ad libitum): not specified in the publication
- Water (e.g. ad libitum): demineralized or distilled waster was provided ad libitum
- Acclimation period: not specified in the publication
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 27
- Humidity (%): not specified in the publication
- 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 oral 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
To a basic purified diet, finely powdered sodium chloride was added to produce six additional rations as follows -
Diet I - 0.01% Sodium chloride (low NaCl)
Diet II - 0.15% Sodium chloride (control)
Diet III - 2.8% Sodium chloride
Diet IV - 5.6% Sodium chloride
Diet V - 7.0% Sodium chloride
Diet VI - 8.4% Sodium chloride
Diet VII - 9.8% Sodium chloride
The basic purified diet was made up of -
Cane sugar - 51.9%
Caesin, Vitamin-test - 25.0%
Shortening, All-vegetable - 20.0%
Mineral mixture - 2.9%
Vitamins - 0.2% - Analytical verification of doses or concentrations:
- no
- Details on analytical verification of doses or concentrations:
- not applicable
- Duration of treatment / exposure:
- nine months
- Frequency of treatment:
- continuous through the diet
- Remarks:
- Doses / Concentrations:
0.01% Sodium chloride (low), 0.15% Sodium chloride (control), 2.8% Sodium chloride, 5.6% Sodium chloride, 7.0% Sodium chloride, 8.4% Sodium chloride, 9.8% Sodium chloride
Basis:
nominal in diet - No. of animals per sex per dose:
- thirty male 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
- Rationale for selecting satellite groups: not applicable
- Post-exposure recovery period in satellite groups: not applicable
- Section schedule rationale : not applicable - Positive control:
- not applicable
- Observations and examinations performed and frequency:
- CAGE SIDE OBSERVATIONS: No data
DETAILED CLINICAL OBSERVATIONS: No data
BODY WEIGHT: Yes
FOOD CONSUMPTION: Yes
WATER CONSUMPTION: Yes
OPHTHALMOSCOPIC EXAMINATION: No
HAEMATOLOGY: No
CLINICAL CHEMISTRY: Yes
- Time schedule for collection of blood: not specified in the publication
URINALYSIS:No
NEUROBEHAVIOURAL EXAMINATION: No - Sacrifice and pathology:
- GROSS PATHOLOGY: Yes
HISTOPATHOLOGY: Yes - Other examinations:
- not applicable
- Statistics:
- not specified in the publication
- Clinical signs:
- effects observed, treatment-related
- Mortality:
- mortality observed, treatment-related
- Body weight and weight changes:
- effects observed, treatment-related
- Food consumption and compound intake (if feeding study):
- effects observed, treatment-related
- Food efficiency:
- not examined
- Water consumption and compound intake (if drinking water study):
- effects observed, treatment-related
- Ophthalmological findings:
- not examined
- Haematological findings:
- not examined
- Clinical biochemistry findings:
- effects observed, treatment-related
- Urinalysis findings:
- not examined
- Behaviour (functional findings):
- not examined
- Organ weight findings including organ / body weight ratios:
- not examined
- Gross pathological findings:
- no effects observed
- Histopathological findings: non-neoplastic:
- effects observed, treatment-related
- Histopathological findings: neoplastic:
- not examined
- Details on results:
- Edema, hypertension, anemia, lipemia, hypoproteinemia and azotemia were observed in 18 percent of the rats exposed from 7.0 to 9.8% sodium chloride in the diet. The plasma was grossly lipemic and the blood protein levels were low. All animals has significantly increased arterial blood pressure. Gross pathologic changes although were not evident, histopathological changes were noted in kidney and the vascular system and these changes resembled human hypertension.
- Dose descriptor:
- NOAEL
- Remarks on result:
- not determinable
- Remarks:
- no NOAEL identified
- Critical effects observed:
- not specified
- Conclusions:
- The results indicated that adminsitration of sodium chloride ranging from 0.01 - 9.8% via the diet to male rats over a period of approximately 9 months induced changes in growth with associated changes in water consumption. Edema was observed in 18% of the animals exposed to ranges from 7.0 to 9.8%. Pathologic changes were noted in the kidney and to a lesser extent in various other tissues consuming high levels of sodium chloride. Sustanined arterial hypertension was observed in all the rats exposed to high levels of sodium chloride.
- Executive summary:
The chronic adminsitration of sodium chloride throught the diet was administered to male rats and the effects on hypertension, renal and vascular lesions were evaluated. The results indicated that adminsitration of sodium chloride ranging from 0.01 - 9.8% via the diet to male rats over a period of approximately 9 months induced changes in growth with associated changes in water consumption. Edema was observed in 18% of the animals exposed to ranges from 7.0 to 9.8%. Pathologic changes were noted in the kidney and to a lesser extent in various other tissues consuming high levels of sodium chloride. Sustanined arterial hypertension was observed in all the rats exposed to high levels of sodium chloride.
Referenceopen allclose all
Table are attached in attached background material.
none
not applicable
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- LOAEL
- 1 330 mg/kg bw/day
- Study duration:
- subchronic
- Species:
- rat
- System:
- other: Body weight and body weight gain only in males observed at high dose.
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
Justification for classification or non-classification
Calcium chloride, one component of the reaction mass dissociates into ions that are present physiologically in relatively high levels in vertebrates. Therefore, Calcium chloride has low toxicity after repeated exposure. Experimental data on rats showed that Sodium chloride (the second component of the reaction mass) induced effects at high doses. Since the two components, calcium chloride and sodium chloride have low repeated toxicity, it is considered that the reaction mass itself has low repeated toxicity. Therefore according to UN and EU GHS criteria no classification is required.
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