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EC number: 232-197-6 | CAS number: 7790-28-5
- 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
Oral
The subchronic (90 day) oral NOAEL in rats (female) was determined to be 3 mg/kg bw/day (potassium iodate)
Inhalation and Dermal
In accordance with REACH Annex VIII, section 8.6.1, a short-term toxicity study does not need to be conducted if a reliable sub-chronic (90 days) study is available. The oral route is considered to be the most appropriate route of administration and this endpoint has been addressed by a sub-chronic toxicity study in which the test material was administered via the drinking water. it is therefore considered justified to omit sub-acute testing via the inhalation and dermal routes.
In accordance with REACH Annex IX, section 8.6.2, a sub-chronic toxicity study (90 day), one species, rodent, male and female, most appropriate route of administration is required. The oral route is considered to be the most appropriate route of administration and data has therefore been provided to address this. As such, the registrant considers it justified to omit a sub-chronic toxicity study via the inhalation route.
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
- Study period:
- not reported
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- test procedure in accordance with generally accepted scientific standards and described in sufficient detail
- Remarks:
- The study was conducted on the read across substance, potassium iodate. Investigations on the gastric hydrolysis of the registration substance indicate a chemical reaction of periodate to iodate thereby confirming the validity of the read across.
- Reason / purpose for cross-reference:
- other: read across: target
- Principles of method if other than guideline:
- Groups of 10 female rats were administered test material, in drinking water, over a period of 13 weeks. At the end of the treatment period, after electroretinogram examination on selected rats, all animals were sacrificed. Haematology and clinical chemistry examinations were performed. Internal organs were weighed and examined histopathologically.
- GLP compliance:
- not specified
- Limit test:
- no
- Species:
- rat
- Strain:
- Wistar
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Age at study initiaion: Weanling
- Source: Hubei laboratory animal center (Hubei, China)
- Weight at study initiation: 50 - 60 g
- Acclimation period: 5 days - Route of administration:
- oral: drinking water
- Vehicle:
- unchanged (no vehicle)
- Analytical verification of doses or concentrations:
- no
- Duration of treatment / exposure:
- 90 days
- Frequency of treatment:
- daily
- Dose / conc.:
- 3 000 other: µg/L
- Dose / conc.:
- 6 000 other: µg/L
- Dose / conc.:
- 12 000 other: µg/L
- Dose / conc.:
- 24 000 other: µg/L
- Dose / conc.:
- 48 000 other: µg/L
- Dose / conc.:
- 96 000 other: µg/L
- Dose / conc.:
- 192 000 other: µg/L
- No. of animals per sex per dose:
- 10 females per dose
- Control animals:
- yes
- Details on study design:
- - Dose selection rationale: The dose which is 100 times the recommended nutrient intake (RNI) of iodine per adult per day was used in this experiment as the lowest dose, i.e.250 μg/kg. And the dose is 422 μg/kg if converted to KIO3. Daily water intake of rats were estimated to be 160~200 mL/kg. Thus, we can calculate that the lowest dose was 3000μg/L. Acute toxicity test which has been done in this experiment showed that the LD50 value of
KIO3 for female Wistar rats was 667 mg/kg, taking 1/20 of the LD50 value as the highest dose, i.e.33 mg/kg, and the drinking water concentration was 200 000 μg/L. Within the range of 3000~200 000 μg/L, total 7 dose groups were set up using two times the group interval.
- Rationale for animal assignment: the animals were divided into 8 groups according to their weight. - Observations and examinations performed and frequency:
- CAGE SIDE OBSERVATIONS: Yes
- Time schedule: General conditions were observed twice daily
BODY WEIGHT: Yes
- Time schedule for examinations: Weekly
FOOD CONSUMPTION: Yes
- Time schedule for examinations: Weekly
WATER CONSUMPTION : Yes
- Time schedule for examinations: Weekly
OPHTHALMOSCOPIC EXAMINATION: Yes
BLOOD COLLECTION: Yes
The bloods were collected from caudal veins of rats to determine the haematologic parameters (clinical microscopy method). All rats were sacrificed through heart blood collection, and serum was separated for testing the serum biochemical parameters (kits, determined by semiautomatic biochemistry analyser) and thyroid hormone (radioimmunoassay).
URINALYSIS: Yes
For the determination of urine iodine level, acid digestion arsenic cerium catalytic spectrophotometric method was adopted. At the end of the 13th week, 5 rats were randomly selected from the control group and high dose groups, respectively for the ERG examination according to literature methods. - Sacrifice and pathology:
- GROSS PATHOLOGY: Yes
Liver, kidney and spleen were taken and weighed, organ coefficients were calculated and the organs of each group were examined by pathological section (HE staining). - Statistics:
- SPSS 12.0 software package was used for data analysis.
- Clinical signs:
- no effects observed
- Description (incidence and severity):
- During the experiment, animals of each group showed no obvious toxic reactions.
- Mortality:
- no mortality observed
- Body weight and weight changes:
- effects observed, treatment-related
- Description (incidence and severity):
- The weights of rats dosed at concentrations of 3000 and 6000 µg/L increased faster than animals dosed at 48 000 µg/L and above, but there was no significant difference (P > 0.05) when compared to the control group.
- Food consumption and compound intake (if feeding study):
- no effects observed
- Description (incidence and severity):
- The average daily food intake of rats was not affected by KIO3. The first month’s food utilisation of rats in each group also showed no obvious change trends.
- Food efficiency:
- not examined
- Water consumption and compound intake (if drinking water study):
- effects observed, treatment-related
- Description (incidence and severity):
- Results show that high doses of KIO3 can affect the water intake of rats. The daily water intake of rats dosed at 48 000 µg/L and above decreased. Rats dosed at 48 000, 96 000 and 192 000 µg/L showed significant differences (P<0.05 or P<0.01) when compared with animals in the control group.
- Ophthalmological findings:
- effects observed, treatment-related
- Description (incidence and severity):
- - ERG: The mechanism of KIO3’s damage to retina was not clear and possibly related to its own oxidation. The appropriate amount, and high doses, of potassium iodide and KIO3 were administered to iodine deficient rats for 22 weeks. The antioxidant capacity of the normal iodine group was better than that of the 2 high iodine groups, and the total retina antioxidant capacity of rats in potassium iodide group was higher than that of the KIO3 group. Therefore, the doses and dosage forms of iodine all have significant effects on the retina antioxidant capacity of iodine deficient rats.
To test the theory that the retina toxicity of iodate is related to its interference on the metabolism of amino acid inside retina and damage of the blood retinal barrier, the ERG method was used in this study. The method found that the amplitude of a and b waves of ERG both decreased significantly in the highest dose group rats, but there was no obvious abnormity in retina pathological sections, which means high KIO3 doses can possibly damage the functions of retina at first. - Haematological findings:
- effects observed, treatment-related
- Description (incidence and severity):
- Blood of rats in each group was tested at the end of the experiment, the leukocytes amount of rats dosed at 6000 µg/L and above increased (P<0.01) while that of other groups was within normal ranges, and there was no significant difference (P>0.05) observed for other indexes among the groups.
- Clinical biochemistry findings:
- effects observed, treatment-related
- Description (incidence and severity):
- The test results of blood biochemical index at the end of the experiment suggested that KIO3 has an effect on the metabolism of sugar, lipid and protein, especially TC. The results of variance analysis showed that TC values of animals dosed at 6000 µg/L and above were all higher than that of control group, and the differences were significant (P<0.05) except for the group dosed at 96 000 µg/L. TC values tended to increase at first and then decreased, and the values of the 96 000 and 192 000 µg/L dose groups were the lowest. TP values of the two groups also declined and significant differences (P<0.05) were observed when compared to the controls. Glucose (Glu) values were also increased first and then decreased, but there was no significant difference among the groups. Other blood biochemical indexes were not significantly affected by KIO3.
- Changes of serum thyroid hormone level: The levels of serum TT4, TT3 and rT3 went up with increasing doses of KIO3 .
- ERG: The results of ERG examination suggested that the amplitude of a (18.8 ± 4.4 μv) and b (79.7 ± 18.2 μv) waves of ERG were significantly lower (P < 0.05) in rats dosed at 192 000 µg/L compared to that of other groups. - Urinalysis findings:
- effects observed, treatment-related
- Description (incidence and severity):
- - Terminal urine iodine: The urine iodine levels of each dose group were significantly different (P < 0.01) compared with the control group. The higher the dose of KIO3, the higher the level of urine iodine.
- 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):
- The kidney/weight value of rats dosed at 192 000 µg/L and the spleen/weight value of rats dosed at 24 000, 96 000 and 192 000 µg/L increased and showed significant differences (P<0.05) compared to animals in the control group. The other organ coefficients (including ovary/weight, liver/weight and lung/weight) were not apparently affected by KIO3.
- Gross pathological findings:
- no effects observed
- Neuropathological findings:
- not examined
- Histopathological findings: non-neoplastic:
- no effects observed
- Description (incidence and severity):
- Pathological sections of each organ (thyroid, retina, liver, kidney, gastrointestinal, spleen, lung and ovary) were observed by microscopy, and there were no significant pathologic changes.
- Histopathological findings: neoplastic:
- not specified
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- 3 000 other: µg/L
- Based on:
- test mat.
- Sex:
- female
- Basis for effect level:
- clinical biochemistry
- ophthalmological examination
- Key result
- Critical effects observed:
- yes
- Lowest effective dose / conc.:
- 6 000 other: µg/L
- System:
- endocrine system
- Organ:
- thyroid gland
- Treatment related:
- yes
- Dose response relationship:
- not specified
- Relevant for humans:
- not specified
- Conclusions:
- Under the conditions of the study KIO3 was found to result in lower thyroxine in serum, lipid metabolism disorder and retina dysfunction in rats. The NOAEL of KIO3 in rats was determined to be 3000 μg/L. Serum TC level was found to be a sensitive contacting biomarker of excessive iodine.
- Executive summary:
The repeated dose toxicity of the test material was investigated in a study in which groups of 10 female rats were administered test material, in drinking water, over a period of 13 weeks. Animals were dosed at 3000, 6000, 12 000, 24 000, 48 000, 96 000 and 192 000 µg/L, a concurrent control group was administered with plain drinking water. At the end of the treatment period, after electroretinogram examination on selected rats, all animals were sacrificed. Haematology and clinical chemistry examinations were performed. Internal organs were weighed and examined histopathologically.
The levels of serum TT4, TT3 and rT3 increased with increasing doses of KIO3, while total cholesterol (TC), triglyetide (TG) in serum and white blood cell (WBC) rose significantly in animals dosed at 6000 μg/L and above (P < 0.05). In addition, the amplitude of a and b waves of ERG were significantly lower in the highest KIO3 group rats compared to the control rats (P < 0.05).
Under the conditions of the study, KIO3 was found to result in lower thyroxine in serum, lipid metabolism disorder and retina dysfunction in rats. The NOAEL of KIO3 in rats was determined to be 3000 μg/L. Serum TC level was found to be a sensitive contacting biomarker of excessive iodine.
Reference
Effects of KIO3 on the serum thyroid hormone level of rats
KIO3 doses of 48 000 μg/L and above can decrease the serum thyroid hormone level of rats. In the study, values of TT4, TT3 and rT3 all decreased with increasing KIO3 doses, which means that high dose of KIO3 may result in hypothyroidism of rats. There were, however, no colloid goiter of rats observed in any dose group.
Effects of KIO3 on the lipid metabolism of rats
Higher doses of KIO3 can increase the serum TC level. Indeed, during the study, as the KIO3 dose increased, the serum TC first increased and then decreased; serum TC was the most sensitive to high iodine. In this experiment, lipid disorder of rats was likely to be related to high iodine and hypothyroidism.
The study revealed that the TC values of groups dosed at 6000 μg/L and above were significantly higher than that of the control group. Meanwhile, the study also showed that serum TC level was more sensitive than crowd goiter rate when used as the contacting biomarker of excessive iodine.
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- NOAEL
- 3 mg/kg bw/day
- Study duration:
- subchronic
- Species:
- rat
- Quality of whole database:
- The study was performed to sound scientific principles with a sufficient level of detail to assess the quality of the relevant results. The study was conducted with the read across substance, potassium iodate. Investigations on the gastric hydrolysis of the registration substance indicate a chemical reaction of periodate to iodate thereby confirming the validity of read across from potassium iodate. The study was assigned a reliability score of 2 according to the criteria of Klimisch (1997) and findings from the study were considered suitable for assessment as an accurate reflection of the registered substance.
Supporting information is available in the form of a combined repeated dose toxicity / developmental toxicity study, reported by Vorhees et al. (1984). The study was performed to sound scientific principles with a sufficient level of detail to assess the quality of the relevant results. However, as the study was conducted on the read-across substance, potassium iodide, it has been assigned a reliability score of 2.
Overall, the quality of the database is good. - System:
- endocrine system
- Organ:
- thyroid gland
Repeated dose toxicity: inhalation - systemic effects
Link to relevant study records
- Endpoint:
- short-term repeated dose toxicity: inhalation
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- a short-term toxicity study does not need to be conducted because a reliable sub-chronic (90 days) or chronic toxicity study is available, conducted with an appropriate species, dosage, solvent and route of administration
- Critical effects observed:
- not specified
Reference
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: inhalation - local effects
Link to relevant study records
- Endpoint:
- short-term repeated dose toxicity: inhalation
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- a short-term toxicity study does not need to be conducted because a reliable sub-chronic (90 days) or chronic toxicity study is available, conducted with an appropriate species, dosage, solvent and route of administration
- Critical effects observed:
- not specified
Reference
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: dermal - systemic effects
Link to relevant study records
- Endpoint:
- short-term repeated dose toxicity: dermal
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- a short-term toxicity study does not need to be conducted because a reliable sub-chronic (90 days) or chronic toxicity study is available, conducted with an appropriate species, dosage, solvent and route of administration
- Critical effects observed:
- not specified
Reference
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: dermal - local effects
Link to relevant study records
- Endpoint:
- short-term repeated dose toxicity: dermal
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- a short-term toxicity study does not need to be conducted because a reliable sub-chronic (90 days) or chronic toxicity study is available, conducted with an appropriate species, dosage, solvent and route of administration
- Critical effects observed:
- not specified
Reference
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Oral
In the key study (Guo et. al, 2005), the repeated dose toxicity of the read across substance, potassium iodate, was investigated. During the study groups of 10 female rats were administered potassium iodate, in drinking water, over a period of 13 weeks. Animals were dosed at 3000, 6000, 12 000, 24 000, 48 000, 96 000 and 192 000 µg/L, a concurrent control group was administered with plain drinking water. At the end of the treatment period, after electroretinogram examination on selected rats, all animals were sacrificed. Haematology and clinical chemistry examinations were performed. Internal organs were weighed and examined histopathologically.
The levels of serum TT4, TT3 and rT3 increased with increasing doses of KIO3, while total cholesterol (TC), triglyetide (TG) in serum and white blood cell (WBC) rose significantly in animals dosed at 6000 μg/L and above (P < 0.05). In addition, the amplitude of a and b waves of ERG were significantly lower in the highest KIO3 group rats compared to the control rats (P < 0.05).
Under the conditions of the study, KIO3 was found to result in lower thyroxine in serum, lipid metabolism disorder and retina dysfunction in rats. The NOAEL of KIO3 in rats was determined to be 3000 μg/L. Serum TC level was found to be a sensitive contacting biomarker of excessive iodine.
Supporting information is available in the form of a combined repeated dose toxicity / developmental toxicity study, reported by Vorhees et al. (1984). During the study, potassium iodide was fed to male and female rats before and during breeding, to females only during gestation and lactation, and to their offspring after weaning (day 21 after birth) through to day 90, at levels of 0, 0.025, 0.05 or 0.1 % (w/w) in the diet. To investigate the repeated dose toxicity of the test material to parental animals, body weights and food consumption was measured; animals were also checked regularly for mortality.
Under the conditions of the study, dietary doses of up to 0.1 % w/w test material in the diet, equivalent to approximately 90 mg/kg/day, produced only minor effects on parental weight gain and food consumption, and no significant effects on parental mortality. The NOAEL for parental toxicity was therefore determined to be 90 mg/kg/day.
Justification for classification or non-classification
In accordance with the criteria for classification as defined in Annex I, Regulation 1272/2008, the test material requires classification for specific organ toxicity, repeated dose, Category 1 (H372: Causes damage to organs through prolonged or repeated exposure). The effects observed in the main study are considered to be toxicologically significant and indicate signs of organ dysfunction.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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