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Diss Factsheets
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EC number: 200-772-0 | CAS number: 72-17-3
- 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
![](https://poisoncentres.echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Repeated dose toxicity: oral
Administrative data
- Endpoint:
- short-term repeated dose toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- 1951
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- test procedure in accordance with national standard methods with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 951
- Report date:
- 1951
Materials and methods
Test guideline
- 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, inactivated yeast, U.S.P liver extract, and iodized 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:
- no
- Remarks:
- Study was conducted before GLP guidance was established
- Limit test:
- no
Test material
- Reference substance name:
- Sodium chloride
- EC Number:
- 231-598-3
- EC Name:
- Sodium chloride
- Cas Number:
- 7647-14-5
- Molecular formula:
- NaCl
- IUPAC Name:
- sodium chloride
Constituent 1
- Specific details on test material used for the study:
- - Name of test material (as cited in study report): Sodium Chloride
- Physical state: Salt
- Lot/batch No.: E 277
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Carwoth Farms
Administration / exposure
- 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
Doses / concentrationsopen allclose all
- Dose / conc.:
- 0 other: %
- Remarks:
- % in diet of added salt, equals 0 mg/kg/day
- Dose / conc.:
- 2 other: %
- Remarks:
- % in diet of added salt, equals 1.33 g/kg/day
- Dose / conc.:
- 8 other: %
- Remarks:
- % in diet of added salt, equals 5.73 g/kg/day
- Dose / conc.:
- 32 other: %
- Remarks:
- % in diet of added salt, equals 31.04 g/kg/day
- 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
Examinations
- Observations and examinations performed and frequency:
- CAGE SIDE OBSERVATIONS: No data
- Time schedule:no data
- Cage side observations checked in table 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 was 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:
- The experimental data were statistically evaluated.
Results and discussion
Results of examinations
- Clinical signs:
- no effects observed
- Description (incidence and severity):
- None of the 40 rats used in this study died. No adverse clinical signs of toxicity were reported.
- 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 g, +161.6 g, +217.6 g, and +236.8 for the 32, 8, 2, and 0% added salt groups). For females the weight gain was +70.6 g, +97.4 g, +95.0 g and 112.0 g 32, 8, 2, and 0% added salt groups.
- Food consumption and compound intake (if feeding study):
- not examined
- Description (incidence and severity):
- Whe
- Food efficiency:
- not examined
- Water consumption and compound intake (if drinking water study):
- not specified
- Ophthalmological findings:
- not specified
- Haematological findings:
- not specified
- Clinical biochemistry findings:
- not specified
- Endocrine findings:
- not examined
- Urinalysis findings:
- not specified
- Behaviour (functional findings):
- not specified
- Immunological findings:
- not examined
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Description (incidence and severity):
- The mean liver weights of the high dose group (combined) were statistically lower than the controls. The mean kidney weights of the high dose group were significantly higher in comparison to the control. Nevertheless, no pathological changes were seen by during histopathological examination.
- Gross pathological findings:
- no effects observed
- Neuropathological findings:
- not examined
- Histopathological findings: non-neoplastic:
- no effects observed
- Description (incidence and severity):
- The mean liver weights of the high dose group (combined) were statistically lower than the controls. The mean kidney weights of the high dose group were significantly higher in comparion to the control. Nevertheless, no pathological changes were seen by during histopathological examination.
- Histopathological findings: neoplastic:
- not specified
- Other effects:
- not examined
Effect levels
- Dose descriptor:
- NOAEL
- Effect level:
- 1 330 mg/kg diet
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- body weight and weight gain
Target system / organ toxicity
- Critical effects observed:
- not specified
Any other information on results incl. tables
Please refer to study results as attached.
Applicant's summary and conclusion
- Conclusions:
- In a sub-chronic repeated dose toxicity study the NOAEL for Sodium chloride was established to be < 1330 mg/kg/day.
- Executive summary:
In a sub-chronic repeated dose toxicity study, a group of 5 males and 5 female Wistar rats were fed with diets for 91 days, which contained additionally 32, 8, 2 and 0% Sodium chloride in excess of the 2% already present as a normal constituent of basic FRL-2C rat diet.
None of animals died during the study. 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 the body weight, calculated.
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 g, +161.6 g, +217.6 g, and +236.8 for the 32, 8, 2, and 0% added salt groups). For females the weight gain was +70.6 g, +97.4 g, +95.0 g and 112.0 g for the 32, 8, 2, and 0% added salt groups. The mean liver weights of the high dose group (combined) were statistically lower than the controls. The mean kidney weights of the high dose group were significantly higher in comparison to the control. Nevertheless, no pathological changes were seen during histopathological examination.
Based on the results, the NOAEL is considered to be less than 1330 mg Sodium chloride/kg/day.
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