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EC number: 231-679-3 | CAS number: 7681-82-5
- 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
Endpoint summary
Administrative data
Description of key information
Repeated dose toxicity: Oral
The subchronic study was conducted to evaluate the toxic effects of repeated administration of the test chemical to sprague-dawley rats by the oral (drinking water) route. Rats were treated with 0, 1, 3, 10, and 100 mg/l ( (0, 0.05, 0.15, 0.5 or 5 mg/Kg/day)) of the test chemical in the drinking water for 100 d. Treatment had no effect on body, brain, or heart weights in either sex, or on testes weights in male rats. Although differences in kidney and liver weights were noted, they did not appear to be treatment related. Thyroid weight in male rats was significantly increased with an increasing concentration of sodium iodide in the water. In contrast, thyroid weight decreased at the highest dose of sodium iodide in female rats. Hematocrit, hemoglobin, and blood urea nitrogen (BUN) values were relatively constant and did not vary with treatment. There were no significant differences in AST, ALT, cholesterol, and triglyceride values.Also there was a significant increase in T4/T3 ratios in female rats after 100 d of treatment with sodium iodide.The results of this study indicate that sodium iodide affect thyroid hormone status in substantially different ways. Based on the observations made, the the “ Lowest observed adverse effect level (LOAEL)” for repeated dose toxicity study was considered to be 100 mg/l (5 mg/Kg/day).
Repeated dose toxicity: Inhalation
According to column 2 of Annex VIII, exposure by inhalation route is negligible due to the very low vapour pressure of NaI (which is found to be 0.9 mm Hg as mentioned in the relevant end point) on account of high boiling points (as has been informed in the boiling point end point that is 1304 °C).
Repeated dose toxicity: Dermal
The acute dermal toxicity value for Sodium iodide (CAS no. 7681-82-5) (as provided in section 7.2.3) is >2000 mg/kg body weight. Considering this, the end point for repeated dermal toxicity is considered as waiver.
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:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- data from handbook or collection of data
- Justification for type of information:
- Data is from peer reviewed publication
- Qualifier:
- according to guideline
- Guideline:
- other: Refer below principle
- Principles of method if other than guideline:
- The subchronic study was conducted to evaluate the toxic effects of repeated administration of the test chemical to sprague-dawley rats by the oral (drinking water) route.
- GLP compliance:
- not specified
- Limit test:
- no
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source:Simonsen Laboratories(Gilroy, Calif.)
- Age at study initiation: 34-38 d
- Diet (e.g. ad libitum): Purina rodent chow ad lib.
- Water (e.g. ad libitum): ad libitum
- Housing: Animals were housed 3 per cage.
ENVIRONMENTAL CONDITIONS
- Photoperiod (hrs dark / hrs light): 12/12-h light/dark cycle - Route of administration:
- oral: drinking water
- Vehicle:
- water
- Analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- 100 days
- Remarks:
- Doses / Concentrations:
0, 1, 3, 10, and 100 mg/l (0, 0.05, 0.15, 0.5 or 5 mg/Kg/day)
Basis: - No. of animals per sex per dose:
- 120 Sprague-Dawley rats
Control group
0 mg/l : Twelve female and 12 male rats
Treatment group
1, 3, 10, and 100 mg/l : 6 males and 6 females - Control animals:
- yes, concurrent vehicle
- Details on study design:
- No data
- Positive control:
- No data
- Observations and examinations performed and frequency:
- BODY WEIGHT: Yes
HAEMATOLOGY: Yes
-Blood samples were taken from the tail vein (700 µl/animal, after warming under a heat lamp) at d 10 and from the inferior vena cava upon termination of the study (d 100).
-Following Hematological Parameters were examined :
Hematocrit
Total Hemoglobin
Blood Urea Nitrogen (BUN)
Triglycerides
Alanine Aminotransferase
Aspartate Aminotransferase
Total Cholesterol
CLINICAL CHEMISTRY: Yes
Plasma T3 and T4 levels were determined at d 10 as well as at d 100.
ORGAN WEIGHT: Yes
Thyroid, brain,liver, kidney, heart, and testes weights were determined. - Sacrifice and pathology:
- GROSS PATHOLOGY: Yes
HISTOPATHOLOGY: Yes - Statistics:
- The data were subjected to statistical analysis, using the 95% confidence level. The methods used included a one-way analysis of variance (ANOVA),Tukey's multiple range test for thyroid hormone levels and two-sample t-test for all others.
- Clinical signs:
- not examined
- Mortality:
- not examined
- Body weight and weight changes:
- no effects observed
- Description (incidence and severity):
- No effects observed on body weights.
- Food consumption and compound intake (if feeding study):
- not examined
- Food efficiency:
- not examined
- Water consumption and compound intake (if drinking water study):
- not examined
- Ophthalmological findings:
- not examined
- Haematological findings:
- no effects observed
- Description (incidence and severity):
- Hematocrit, hemoglobin, and blood urea nitrogen (BUN) values were relatively constant and did not vary with treatment. There were no significant differences in AST, ALT, cholesterol, and triglyceride values.
- Clinical biochemistry findings:
- effects observed, treatment-related
- Description (incidence and severity):
- Significant increase in T4/T3 ratios in female rats after 100 d of treatment with sodium iodide was observed. There were variations in AST, ALT, cholesterol, and triglyceride values between treatment groups, but there are no consistent treatment-related effects.
- Urinalysis findings:
- not examined
- Behaviour (functional findings):
- not examined
- Immunological findings:
- not specified
- Organ weight findings including organ / body weight ratios:
- effects observed, treatment-related
- Description (incidence and severity):
- Treatment had no effect on kideneys, liver, brain, or heart weights in either sex, or on testes weights in male rats. In male Sprague-Dawley rats thyroid weights increased with an increasing concentration of test chemical in the drinking water. The increase was statistically significant using a one-way ANOVA (p < .05 with a one-tailed test). When thyroid weights were corrected for body weight, this ratio was significantly increased at the 10 and 100 ppm levels in male rats. In contrast, thyroid weight was
decreased in female rats at the highest dose of iodide treatment. - Gross pathological findings:
- not specified
- Neuropathological findings:
- not specified
- Histopathological findings: non-neoplastic:
- no effects observed
- Description (incidence and severity):
- Histological exmination of the thyroid sections stained revealed no pathological alterations that were treatment related
- Histopathological findings: neoplastic:
- not specified
- Other effects:
- not specified
- Dose descriptor:
- LOAEL
- Effect level:
- 100 mg/L drinking water
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: Effects were observed on modifications of thyroid function.
- Critical effects observed:
- not specified
- Conclusions:
- The repeated dose toxicity of the test chemical to rats by the oral route was observed at a dose concentration of 100 mg/l (5 mg/Kg/day) in a 100 days study period. Effects were observed on modifications of thyroid functions. Therefore the “ Lowest observed adverse effect level (LOAEL)” for repeated dose toxicity study was considered to be 100 mg/l (5 mg/Kg/day).
- Executive summary:
The subchronic study was conducted to evaluate the toxic effects of repeated administration of the test chemical to sprague-dawley rats by the oral (drinking water) route. Rats were treated with 0, 1, 3, 10, and 100 mg/l ( (0, 0.05, 0.15, 0.5 or 5 mg/Kg/day)) of the test chemical in the drinking water for 100 d. Treatment had no effect on body, brain, or heart weights in either sex, or on testes weights in male rats. Although differences in kidney and liver weights were noted, they did not appear to be treatment related. Thyroid weight in male rats was significantly increased with an increasing concentration of sodium iodide in the water. In contrast, thyroid weight decreased at the highest dose of sodium iodide in female rats. Hematocrit, hemoglobin, and blood urea nitrogen (BUN) values were relatively constant and did not vary with treatment. There were no significant differences in AST, ALT, cholesterol, and triglyceride values.Also there was a significant increase in T4/T3 ratios in female rats after 100 d of treatment with sodium iodide.The results of this study indicate that sodium iodide affect thyroid hormone status in substantially different ways. Based on the observations made, the the “ Lowest observed adverse effect level (LOAEL)” for repeated dose toxicity study was considered to be 100 mg/l (5 mg/Kg/day).
Reference
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- LOAEL
- 5 mg/kg bw/day
- Study duration:
- subchronic
- Species:
- rat
- Quality of whole database:
- Data is from peer reviewed publication
Repeated dose toxicity: inhalation - systemic effects
Link to relevant study records
- Endpoint:
- repeated dose toxicity: inhalation
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- other:
- Critical effects observed:
- not specified
Reference
Endpoint conclusion
- Endpoint conclusion:
- no study available
- Quality of whole database:
- Waiver
Repeated dose toxicity: inhalation - local effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: dermal - systemic effects
Link to relevant study records
- Endpoint:
- repeated dose toxicity: dermal
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- other:
- Critical effects observed:
- not specified
Reference
Endpoint conclusion
- Endpoint conclusion:
- no study available
- Quality of whole database:
- Waiver
Repeated dose toxicity: dermal - local effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Data available for the target chemical was reviewed to determine the toxic nature of the test chemical upon repeated exposure. The studies are as mentioned below:
Repeated dose toxicity: Oral
The subchronic study was conducted to evaluate the toxic effects of repeated administration of the test chemical to sprague-dawley rats by the oral (drinking water) route. Rats were treated with 0, 1, 3, 10, and 100 mg/l ( (0, 0.05, 0.15, 0.5 or 5 mg/Kg/day)) of the test chemical in the drinking water for 100 d. Treatment had no effect on body, brain, or heart weights in either sex, or on testes weights in male rats. Although differences in kidney and liver weights were noted, they did not appear to be treatment related. Thyroid weight in male rats was significantly increased with an increasing concentration of sodium iodide in the water. In contrast, thyroid weight decreased at the highest dose of sodium iodide in female rats. Hematocrit, hemoglobin, and blood urea nitrogen (BUN) values were relatively constant and did not vary with treatment. There were no significant differences in AST, ALT, cholesterol, and triglyceride values.Also there was a significant increase in T4/T3 ratios in female rats after 100 d of treatment with sodium iodide.The results of this study indicate that sodium iodide affect thyroid hormone status in substantially different ways. Based on the observations made, the the “ Lowest observed adverse effect level (LOAEL) for repeated dose toxicity study was considered to be 100 mg/l (5 mg/Kg/day).
Another subacute study was conducted to evaluate the toxic effects of repeated administration of the test chemical to wistar rats by the oral route. Thirty six rats were given the test chemical by oral route on a daily basis for 21 days. Body weight of the TPTX rats were decreased , the intake of I with the drink increased I concentrations in plasma (+ 114%), kidney (+ 100%), liver (+50%), and heart (+ 200%), but there was no increase in the brain. Levels of thyroxine were decreased in the plasma of TPTX rats. The concentrations of I were much higher in plasma than in the other tissues.whereas TPTX did not induce any change in the concentration of I in the tissues tested. Based on the observations made, the low observed adverse effect level (LOAEL) for repeated dose toxicity study is therefore considered to be 0.5 µmol/kg/d.
In yet another study, subchronic study was conducted to evaluate the toxic effects of repeated administration of the test chemical to Walter Reed strain albino rats by the oral route. Fifty four rats were given 0, 500 mg/kg bw and 4000 mg/kg bw sodium iodide by oral (feed) route for 28 days. Submaxillary gland sialadenitis has been produced in rats on diets containing 500 mg/kg bw and 4000 mg/kg bw. This inflammatory and metaplastic process selectively involves distal ductular structures and is modified by concomitant administration of 2000 mg/kg bw sulfaguanidine. Based on the observations made, the low observed adverse effect level (LOAEL) for repeated dose toxicity study is therefore considered to be 500 mg/kg
Repeated dose toxicity: Inhalation
According to column 2 of Annex VIII, exposure by inhalation route is negligible due to the very low vapour pressure of NaI (which is found to be 0.9 mm Hg as mentioned in the relevant end point) on account of high boiling points (as has been informed in the boiling point end point that is 1304 °C).
Repeated dose toxicity: Dermal
The acute dermal toxicity value for Sodium iodide (CAS no. 7681-82-5) (as provided in section 7.2.3) is >2000 mg/kg body weight. Considering this, the end point for repeated dermal toxicity is considered as waiver.
Based on the data available, the test chemical is likely to be toxic upon repeated exposure by oral route and hence it can be categorized as STOT RE 1.
Justification for classification or non-classification
Based on the data available, the test chemical is likely to be toxic upon repeated exposure by oral route and hence it can be categorized as STOT RE 1.
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