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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
Repeated dose toxicity: oral
Administrative data
- 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.
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, 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
Test material
- Reference substance name:
- Sodium chloride
- EC Number:
- 231-598-3
- EC Name:
- Sodium chloride
- Cas Number:
- 7647-14-5
- Molecular formula:
- ClNa
- IUPAC Name:
- sodium chloride
- Reference substance name:
- 231-589-3
- IUPAC Name:
- 231-589-3
- Details on test material:
- - Name of test material (as cited in study report): Sodium Chloride
- Physical state: Salt
- Lot/batch No.: E 277
Constituent 1
Constituent 2
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
- 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
Examinations
- 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.
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.
- 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.
Effect levels
- 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.
Target system / organ toxicity
- 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
Any other information on results incl. tables
Table are attached in attached background material.
Applicant's summary and conclusion
- 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.
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