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Diss Factsheets
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EC number: 231-442-4 | CAS number: 7553-56-2
- 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
Toxicological Summary
- Administrative data
- Workers - Hazard via inhalation route
- Workers - Hazard via dermal route
- Workers - Hazard for the eyes
- Additional information - workers
- General Population - Hazard via inhalation route
- General Population - Hazard via dermal route
- General Population - Hazard via oral route
- General Population - Hazard for the eyes
- Additional information - General Population
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.07 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 1
- Dose descriptor starting point:
- NOAEL
- Value:
- 0.01 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 0.07 mg/m³
- Explanation for the modification of the dose descriptor starting point:
A chronic NOAEL in humans has been set at 0.01 mg/kg bw/day and is the dose descriptor starting point.
Inhalation correction starting point: Inhalation NOAEL = Oral NOAEL x Standard worker human body weight (70 kg)/ Breathing volume for workers in 8 hours assuming light activity (10 m3). Inhalation NOAEL = 0.07 mg/m3.
Interspecies differences: 1 (NOAEL is based on a human study); Intraspecies differences: 1 (The NOAEL was obtained from a children study, already considered a sensitive subpopulation, ATSDR indicates that the NOAEL would also applicable to elderly who may represent another sensitive subpopulation); Differences in duration of exposure: 1 (Study on chronic effects); Issue related to dose-response: 1 (Starting point NOAEL); Quality of whole database: 1 (A large set of information is available for the substance).
- AF for dose response relationship:
- 1
- AF for differences in duration of exposure:
- 1
- AF for interspecies differences (allometric scaling):
- 1
- AF for other interspecies differences:
- 1
- AF for intraspecies differences:
- 1
- AF for the quality of the whole database:
- 1
- AF for remaining uncertainties:
- 1
Acute/short term exposure
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
DNEL related information
- Explanation for the modification of the dose descriptor starting point:
The short-term DNEL for local effects is considered sufficiently protective for short-term systems effects based on precedence of hazards.
Irritation is likely to occur at lower concentrations than systemic effects.
Local effects
Long term exposure
- Hazard assessment conclusion:
- insufficient hazard data available (further information necessary)
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 1 mg/m³
- Most sensitive endpoint:
- irritation (respiratory tract)
DNEL related information
Workers - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.01 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 1
- Dose descriptor starting point:
- NOAEL
- Value:
- 0.01 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 0.01 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
A chronic NOAEL in humans has been set at 0.01 mg/kg bw/day and is the dose descriptor starting point.
Dermal correcting starting point: Dermal NOAEL = Oral NOAEL x No default factor (1). Dermal NOAEL = 0.01 mg/kg bw/day. The factor of 1 is provided on page 25 of Chapter R8 as dermal absorption is not higher than oral absorption, and that no factor should be introduced when performing oral-to-dermal extrapolation.
Overall assessment factors: Interspecies differences: 1 (NOAEL is based on a human study); Intraspecies differences: 1 (The NOAEL was obtained from a children study, already considered a sensitive subpopulation, ATSDR indicates that the NOAEL would also applicable to elderly who may represent another sensitive subpopulation); Differences in duration of exposure: 1 (Study on chronic effects); Issue related to dose-response: 1 (Starting point NOAEL); Quality of whole database: 1 (A large set of information is available for the substance)
No oral-to-dermal extrapolation has been applied even though an assumed absorption rate of 1% in humans is available. As it is difficult to apply an exact figure for dermal absorption, a further adjustment compared to oral absorption is difficult to apply. Therefore, a very precautinary approach has been applied in the derivation of DNEL for systemic effects via dermal route of exposure. Further, the irritative properties of Iodine could at higher exposure levels affect dermal absorption, making adjustment of absorption figure very problematic.
- AF for dose response relationship:
- 1
- AF for differences in duration of exposure:
- 1
- AF for interspecies differences (allometric scaling):
- 1
- AF for other interspecies differences:
- 1
- AF for intraspecies differences:
- 1
- AF for the quality of the whole database:
- 1
- AF for remaining uncertainties:
- 1
Acute/short term exposure
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
Acute/short term exposure
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
Workers - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
Additional information - workers
Acute Exposure
The information available is inappropriate to derive an acute Derived No Effect Level (DNEL) for systemic and local effects. There is no information of thresholds at which sub-lethal toxicity occurs from studies. The in vitro skin irritation study does not yield any information that can be used to derive a DNEL for the observed skin irritation effects (local irritation). There is also insufficient information available from the acute dermal toxicity study to determine a DNEL for skin irritation.
With respect to setting a systemic DNEL for acute dermal exposure, the same value as the DNEL for long term exposure has been set. This is based on ECHA Guidance on chemical safety assessment (Chapter R8) which recommends that in the first tier, that acute dermal exposures should be compared against the corresponding long term DNEL.
Similarly for eye irritation, a DNEL cannot be derived as this classification has been determined from the in vitro skin irritation data and published data. Therefore a qualitative risk assessment has been conducted to determine appropriate risk mitigation measures to cover this effect.It is noted that there are workplace exposure limits available for iodine in European member states that report short term exposure limits (STELs) and Time Weighted Averages (TWAs) of 0.1 ppm (equivalent to 1 mg/m3). According to the American Conference of Industrial Hygienists (ACGIH) humans can work at an air iodine concentration of 0.1 part per million; work is impossible at 0.3 part per million; and concentrations of 1 part per million were highly irritating.
Therefore, 1 mg/m3is set as a short term DNEL for inhalation effects. This DNEL covers both local and systemic effects via acute inhalation exposure, as respiratory irritation is likely to occur at lower concentrations than systemic effects.
Repeated exposure
In a work environment, the dermal and inhalation routes are the relevant exposure pathways. As a suitable dose descriptor was not available via these routes for long term exposure, the NOAEL (oral) has been adjusted to a correct starting point for the dermal and inhalation routes. The calculations used to determine the correct starting point are provided below.
Dermal Correct Starting Point:
Dermal NOAEL = Oral NOAEL x No default factor (1)
Dermal NOAEL = 0.01 mg/kg bw/day
The factor of 1 is provided on page 25 of Chapter R8 as dermal absorption is not higher than oral absorption, and that no factor should be introduced when performing oral-to-dermal extrapolation.
Inhalation Correct Starting Point:
Inhalation NOAEL = Oral NOAEL x Standard worker human body weight (70 kg)/ Breathing volume for workers in 8 hours assuming light activity (10 m3).
Inhalation NOAEL = 0.07 mg/m3
These values when divided by an overall AF of 1 result in a long term dermal DNEL of 0.01 mg/kg bw/day and a long term inhalation DNEL of 0.07 mg/m3.
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
Acute/short term exposure
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
Acute/short term exposure
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
DNEL related information
General Population - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
Acute/short term exposure
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
Acute/short term exposure
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
General Population - Hazard via oral route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
Acute/short term exposure
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
DNEL related information
General Population - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
Additional information - General Population
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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