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EC number: 232-019-7 | CAS number: 7783-66-6
- 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
The lowest LOAEL of 0.55 mg/kg bw/day was observed in the 2-year study with rats with potassium iodide in the drinking water.
Key value for chemical safety assessment
Repeated dose toxicity: via oral route - systemic effects
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- LOAEL
- 0.55 mg/kg bw/day
- Study duration:
- chronic
- Species:
- rat
- Quality of whole database:
- Data published in a peer-reviewed journal
Repeated dose toxicity: inhalation - systemic effects
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- NOAEC
- 0.72 mg/m³
- Study duration:
- subchronic
- Species:
- rat
- Quality of whole database:
- Proprietary study conducted according to GLP, and comparable to current guidelines.
Repeated dose toxicity: inhalation - local effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: dermal - systemic effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: dermal - local effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Due to the fact that the substance violently reacts with moisture and produces hydrofluoric and iodic acids, classification for toxicity is based on fluoride and iodide:
The repeated dose toxicity of fluoride was performed in 2 oral and 3 inhalation studies. In a 6 -month oral (drinking water) rat study, the effects of exposure to NaF were limited to reduced weight gain, dental fluorosis, thickening and ulceration of the gastric mucosa at the highest dose level of 300 ppm; gastric effects were also seen at 100 ppm. The fluoride content of plasma, bone and teeth increased with dose levels (NTP 1990). The NOEL for this study was 30 ppm, however these local effects are considered not to be relevant for the risk assessment. Therefore 100 ppm of NaF in the drinking water (5.2 and 6.4 mg/kg bw for male and female rats, respectively) was considered a NOAEL in this 6 -month rat study. In a 6 -month oral mouse study, mortality attributable to acute nephrosis was seen at the highest dose level of 600 ppm (NTP 1990). Skeletal effects were seen in males at 50 ppm and in both sexes at the higher dose levels. Therefore the LOAEL was determined to be 50 ppm (5.1 mg/kg bw). In a published study (Sadilova 1974), female rats were exposed to 1 mg/m3 HF 6 hours/day for 1 month. Effects were noted on the teeth, bones and respiratory tract. Two proprietary studies (Placke 1990, 1991) give over-all NOAEL for repeated inhalatory exposure in male and female rats of 0.72 mg/m3 (actual HF concentration) for a 6 hours per 5 days per week for 91 days exposure regimen (1991) and a NOAEL of 0.88 mg/m3 (actual HF concentration) for a 6 hours per 5 days per week for 2 weeks (1990). No adverse effects were noted at these concentrations. At higher concentrations death, tissue irritation, dental malformations, slight changes in haematological and clinical chemistry parameters, and changes in several organ weights were observed.
The repeated dose toxicity of iodide was examined In a chronic toxicity study (Takegawa 2000) in which male and female F344/DuCrj rats received potassium iodide (KI) in the drinking water at concentrations of 0, 10, 100 or 1000 ppm for 2 years. The average daily intakes (males - females) were 0, 0.55 - 0.66, 5.31 - 6.73. and 53.03 - 66.59 mg/kg bw/day. Survival rates of male rats were decreased in the100 and 1000 ppm groups. Body weights in the 1000 ppm groups of both sexes were decreased in the latter half of the treatment period. The incidence of thyroid follicular dilatation was increased in the 10, 100 and 1000 ppm groups of both sexes (the incidence of this non-neoplastic lesion did not decrease with decreasing dose levels). In the submandibular salivary gland of male adn female rats of the 1000 ppm group squamous cell carcinomas were observed, along with focal acinar atrophy and/or ductular proliferation, frequently accompanied by squamous metaplasia. No KI-related induction of any lesions was apparent in any other organ or tissue. The lowest dose level of 0.55 mg/kg bw/day was considered to be a LOAEL based on the non-neoplastic thyroid change.
Justification for selection of repeated dose toxicity via oral route - systemic effects endpoint:
Lowest LOAEL was observed in this study.
Justification for selection of repeated dose toxicity inhalation - systemic effects endpoint:
Lowest NOAEL was observed in this study.
Justification for classification or non-classification
Due to the fact that the substance violently reacts with moisture and produces hydrofluoric and iodic acids, classification for toxicity is based on fluoride and iodide. Based on the available studies, the substance needs to be classified as STOT Rep. Exp. Cat. 1; H372 (Causes damage to organs through prolonged or repeated exposure) according to EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008. According to the EU Directive 67/548/EEC the substance needs to be classified as T; R48/23/25 (Toxic: danger of serious damage to health by prolonged exposure through inhalation and if swallowed).
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