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EC number: 942-401-1 | 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
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- Endpoint summary
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- Environmental data
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- 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
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- Endocrine disrupter testing in aquatic vertebrates – in vivo
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- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
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- Repeated dose toxicity
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- Additional toxicological data

Repeated dose toxicity: oral
Administrative data
- Endpoint:
- sub-chronic toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1991
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
Data source
Reference
- Reference Type:
- publication
- Title:
- Comparison of toxicity induced by iodine and iodide in male and female rats
- Author:
- Sherer TT, Thrall KD, Bull RJ
- Year:
- 1 991
- Bibliographic source:
- J. Toxicol. Environ. Health: Curr. Iss. 32, 89
Materials and methods
- Principles of method if other than guideline:
- The subchronic study was conducted to evaluate the toxic effects of repeated administration of sodium iodide to Sprague-Dawley rats by the oral (drinking water) route.
- GLP compliance:
- not specified
- Limit test:
- no
Test material
- Reference substance name:
- Sodium iodide
- EC Number:
- 231-679-3
- EC Name:
- Sodium iodide
- Cas Number:
- 7681-82-5
- Molecular formula:
- INa
- IUPAC Name:
- sodium iodide
- Test material form:
- solid
Constituent 1
Test animals
- 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 days
- Housing: 3 per cage
- Diet (e.g. ad libitum): Purina rodent chow, ad lib.
- Water (e.g. ad libitum): ad libitum
ENVIRONMENTAL CONDITIONS
- Photoperiod (hrs dark / hrs light): 12/12
I
Administration / exposure
- Route of administration:
- oral: drinking water
- Analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- 100 days
- Frequency of treatment:
- Daily
Doses / concentrationsopen allclose all
- Dose / conc.:
- 0 mg/L drinking water
- Remarks:
- Vehicle controls
- Dose / conc.:
- 1 mg/L drinking water
- Dose / conc.:
- 3 mg/L drinking water
- Dose / conc.:
- 10 mg/L drinking water
- Dose / conc.:
- 100 mg/L drinking water
- No. of animals per sex per dose:
- Controls: 12/sex/dose
Test groups: 6/sex/dose - Control animals:
- yes, concurrent vehicle
Examinations
- Observations and examinations performed and frequency:
- BODY WEIGHT: Yes
HAEMATOLOGY: Yes
- Time schedule for collection of blood: day 10 and day 100, from tail vein (700 µL/animal, after warming under a heat lamp)
- Anaesthetic used for blood collection: Not specified
The following parameters were examined: hematocrit, total hemoglobin, blood urea nitrogen, triglycerides, alanine aminotransferase, aspartate aminotransferase, total cholesterol
CLINICAL CHEMISTRY: Yes
- Time schedule for collection of blood: day 10 and day 100
- Animals fasted: Not specified
The following parameters were examined: plasma T3 and T4 levels
OTHER: the following organ weights were determined: thyroid, brain, liver, kidney, heart, testes - 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.
Results and discussion
Results of examinations
- Clinical signs:
- not specified
- Mortality:
- not specified
- Body weight and weight changes:
- no effects observed
- 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.
- Urinalysis findings:
- not examined
- Behaviour (functional findings):
- not examined
- Immunological findings:
- not examined
- Organ weight findings including organ / body weight ratios:
- effects observed, treatment-related
- Description (incidence and severity):
- 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.
- Gross pathological findings:
- not specified
- Neuropathological findings:
- not examined
- Histopathological findings: non-neoplastic:
- not specified
- Histopathological findings: neoplastic:
- not specified
- Other effects:
- not specified
Effect levels
open allclose all
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- 10 mg/L drinking water
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- clinical biochemistry
- Key result
- Dose descriptor:
- LOAEL
- Effect level:
- 100 mg/L drinking water
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- clinical biochemistry
Target system / organ toxicity
- Key result
- Critical effects observed:
- yes
- Lowest effective dose / conc.:
- 100 mg/L drinking water
- System:
- endocrine system
- Organ:
- thyroid gland
- Treatment related:
- yes
- Dose response relationship:
- not specified
- Relevant for humans:
- yes
Any other information on results incl. tables
The study was performed with young rats, estimated average weight = 100 g. Based on an average water consumption of 18 ml/day[1](water consumption = 0.11 * (0.1)0.7872), the intake of the 10 mg/L group is estimated to correlate to appr. 0.18 mg sodium iodide. Thus, the intake for rats of 100 g is estimated at 1.8 mg/kg bw/ day NaI, which correlates to appr. 1.53 mg I-/ kg bw/ day.
[1]Calculation based on defaults reported in TNO report V98.390 (1998)
Applicant's summary and conclusion
- Conclusions:
- In the drinking water study with the test substance sodium iodide, following 100 days exposure, a significant increase of T4/T3 ratio was noted in female rats at the highest dose level of 100 mg/L drinking water. 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. Therefore the LOAEL for repeated dose toxicity study was considered to be 100 mg/L. The NOAEL was 10 mg/L drinking water, which was calculated to correspond to ca. 1.8 mg NaI/kg bw/day.
- Executive summary:
The subchronic study was conducted to evaluate the toxic effects of repeated administration of sodium iodide to Sprague-Dawley rats by the oral (drinking water) route. Rats were treated with 0, 1, 3, 10, and 100 mg/l of sodium iodide in the drinking water for 100 days.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 day of treatment with sodium iodide.The results of this study indicate that sodium iodide affect thyroid hormone status in substantially different ways. The highest concentration level of 100 mg/L was considered to be a LOAEL based on the results of the study. The NOAEL was set at 10 mg/L, which was calculated to correspond to ca. 1.8 mg NaI/kg bw/day.
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