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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
Key value for chemical safety assessment
Effects on fertility
Description of key information
no data
Additional information
According annex IX of REACH, this test only need to be triggered in case that any reproductive or developmental alert was found in repeated toxicity test or developmental test. Existing repeated toxicity tests and developmental tests all gave no such concern. Therefore reproductive toxicity test can be omitted.
Short description of key information:
It can be concluded that the iodide is not reproductive toxicity.
Effects on developmental toxicity
Description of key information
It can be concluded that the iodide is not reproductive, embryonic or developmental toxicity.
Effect on developmental toxicity: via oral route
- Dose descriptor:
- NOAEL
- 50 mg/kg bw/day
Additional information
Iodide (KI) 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) of the diet.
There was no evidence suggesting that potassium iodide was embryotoxic. Litter size was significantly reduced, but birth weights and external morphology among those born alive were not significantly altered.
No change in thyroid
weight was observed indicating that these doses were not overtly
thyrotoxic. Thyroid hormones were not assessed, however, and it is
possible that thyroid function could have been altered in these animals.
Nevertheless, the data are consistent with a picture of impaired thyroid
function.
Several tests of post-weaning behaviour showed effects at the lowest
dose, 0.025 % potassium iodide. M-maze errors were increased at this
dose and rotorod performance decreased. However, because these effects
were not found at the higher doses it appears unlikely that they were
related to potassium iodide. At present, these effects can only
described as 'false positives'.
The only effect on post-weaning behaviour that appeared to be
consistently related to potassium iodide exposure was the reduction in
nocturnal running-wheel activity found among the tested females. It may
be that female cyclicity makes them more sensitive to the influence of
chronic moderate iodide exposure than males and this could explain the
contrast with the results of an acute test of activity and exploration,
the open-field test, on which no consistent iodide-related effects were
found.
According to REACH guidance “R 10.8 of Guidance on information requirements and chemical safety assessment Chapter R.10: Characterisation of dose [concentration]-response for environment” The NOAEL can be calculated with the equation R 10-7:NOAEL(mg/kg bw day) = NOEC (mg/kg food)/CONV
Where NOEC (mg/kg food) is 0.1, and CONV for Rattus norvegicus (> 6 weeks) is 20, and 10 for Rattus norvegicus (≤6 weeks). Therefore under this study the NOAEL for rats is 50 mg/kg bw day (developmental).
In another study, twenty-five thyroiditis-prone BB/W rats were prenatally and postnatally exposed to iodine in drinking-water at dosages equivalent to 0, 0.059, or 59 mg/kg body weight per day for about 12 weeks. An increase in the number of lysosomes and lipid droplets was observed in the treated animals, especially in the higher exposure group. However, the test organism is not healty, as well as not enough information in the study, the effects can not be considered to be dose related.
Additionally, old studies were conducted with rabbits hamsters, rats and swine (Arrington LR, et al., 1965) to determine the effects of excess iodine intake. Females were bred to normal males, potassium or sodium iodide were added to the diet during the latter portion of gestation and the females were permitted to litter normally. Observations were made for length of gestation, parturition time, lactation and survival of young.
250 to 1000 ppm iodide fed for 2 to 5 days caused increasing mortality of new born rabbits. Hamsters were not affected by 2500 ppm iodine except for slightly re duced feed intake and decreased weaning weight of the young. Gestation time for rats and hamsters was not affected by iodine. Female rats and rabbits re-bred after removal from dietary iodine produced and nursed litters normally. Swine were not affected by dietary levels of iodine which were toxic to rabbits and rats.
In conclusion, the iodide is not reproductive, embryonic toxicity, but the developmental toxicity was showed under concentration of 0.1% in diet, corresponding NOAEL as 50 mg/kg bw day (developmental).
Toxicity to reproduction: other studies
Additional information
no data
Justification for classification or non-classification
Based on this information, the iodide is not reproductive, embryonic toxicity, but the developmental toxicity was showed under concentration of 0.1% in diet, corresponding NOAEL as 50 mg/kg bw day (developmental). However, this value is much higher than the temporary most tolerated dose of 1.0 mg iodine/day, set by the FAO/WHO Joint Expert Meeting on Food Additive (the 30th Meeting of the Joint FAO/WHO Expert Committee on Food Additives,, 2±11 June 1986, 1987).
Therefore, the iodide can not meet the reproductive/developmental criteria under the Regulation (EC) No. 1272/2008 nor Directive 67/548/EEC.Additional information
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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