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Diss Factsheets
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EC number: 208-047-0 | CAS number: 506-61-6
- 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
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:
- 0.078 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):
- 225
- Dose descriptor starting point:
- NOAEL
- Value:
- 10 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 17.6 mg/m³
- Explanation for the modification of the dose descriptor starting point:
Corrected inhalatory NOAEC:
oral NOAEL*1/sRVrat*ABSoral-rat/ABSinh-human*sRVhuman/wRVABS: Absorption; sRV: standard Respiratory Volume; wRV: worker Respiratory Volume
OR:
10 mg/kg/day divided by (0.38 m3.kg-1x 6.7 m3/10 m3) = 17.6 mg/m3
- AF for dose response relationship:
- 1
- Justification:
- As the starting point for the DNEL is a NOAEL this default factor is applied
- AF for differences in duration of exposure:
- 6
- Justification:
- Assumes long-term worker handling is to be expected, but in any case, short-term human exposure is normally assessed using long-term DNELs. In this case the extrapolation is from a subacute animal study to chronic human exposure.
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- Appropriate dose descriptor modification has been undertaken
- AF for other interspecies differences:
- 2.5
- Justification:
- In the absence of substance-specific toxicodynamic data to demonstrate interspecies differences this default factor is applied
- AF for intraspecies differences:
- 5
- Justification:
- As a standard procedure for threshold effects this default factor is applied for Worker populations based on the fact that this sub population does not cover the very young, the very old and the very ill.
- AF for the quality of the whole database:
- 3
- Justification:
- A complete data set in accordance with REACH regulations is not available since some of the study endpoints were waived on the basis of positive results in skin and eye damage tests.
- AF for remaining uncertainties:
- 1
- Justification:
- No other uncertainties
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- high hazard (no threshold derived)
- Most sensitive endpoint:
- skin irritation/corrosion
Acute/short term exposure
- Hazard assessment conclusion:
- high hazard (no threshold derived)
- Most sensitive endpoint:
- skin irritation/corrosion
DNEL related information
Workers - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.011 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):
- 900
- Dose descriptor starting point:
- NOAEL
- Value:
- 10 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
The oral to dermal extrapolation has a default Assessment Factor of 1 in the absence of any specific information on absorption by different routes, and is considered to be a systemic DNEL (the ‘internal dose’ that is expected to be non-hazardous).The relationship between the ‘external’ dose to the skin and the internal systemic dose is dependent on factors such as dermal absorption potential. The REACH guidance for dermal absorption has default values that can be used, or if specific information is available, then modified results are appropriate. The REACH default values are 10% or 100% (which are considered by HERAG not to be relevant for metals). Potassium dicyanoargentate was not subjected to bio-elution studies in dermal fluids, consequently there are no specific details on dermal absorption available. Also, no dermal data is available since the acute study was waived on the basis of the corrosivity displayed in the in vitro skin assay. Therefore, since the substance is also soluble in aqueous media, it is difficult to predict transdermal bioavailability. Pragmatically, therefore, it is considered reasonable to conduct the dermal risk assessment at the arbitrary absorption rate of 100% and no modification of the dose descriptor starting point is necessary in this regard.
- AF for dose response relationship:
- 1
- Justification:
- As the starting point for the DNEL is a NOAEL this default factor is applied.
- AF for differences in duration of exposure:
- 6
- Justification:
- Assumes long-term worker handling is to be expected, but in any case, short-term human exposure is normally assessed using long-term DNELs. In this case the extrapolation is from a subacute animal study to chronic human exposure.
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Default value for scaling from oral/dermal. Extrapolates doses according to an assumption that equitoxic doses (when expressed in mg/kg bw/day) scale with body weight to the power 0.75.
- AF for other interspecies differences:
- 2.5
- Justification:
- In the absence of substance-specific toxicodynamic data to demonstrate interspecies differences this default factor is applied.
- AF for intraspecies differences:
- 5
- Justification:
- As a standard procedure for threshold effects this default factor is applied for worker populations based on the fact that this sub population does not cover the very young, the very old and the very ill.
- AF for the quality of the whole database:
- 3
- Justification:
- A complete data set in accordance with REACH regulations is not available since some of the study endpoints were waived on the basis of positive results in skin and eye damage tests.
- AF for remaining uncertainties:
- 1
- Justification:
- No other uncertainties
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- high hazard (no threshold derived)
- Most sensitive endpoint:
- skin irritation/corrosion
Acute/short term exposure
- Hazard assessment conclusion:
- high hazard (no threshold derived)
- Most sensitive endpoint:
- skin irritation/corrosion
Workers - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- high hazard (no threshold derived)
Additional information - workers
The DNEL calculations were prepared following the ECHA Guidance on information requirements and chemical safety assessment, Chapter R.8: Characterisation of dose (concentration)-response for human health. No correction was made for silver content in the test substance.
The DNEL calculations have been conducted only for worker exposure (not consumer). Whilst consumers would be exposed to articles plated with silver as a consequence of using potassium dicyanoargentate during the plating process, the consumer would not actually be exposed to the test substance itself. Also as oral intake is not considered relevant for workers, only the values for dermal and inhalation have been presented using route to route extrapolation.
The DNELs have been derived for a threshold endpoint since the OECD TG422 study has provided some confirmation of this, albeit not to a particularly significant extent.
In the main, default assessment factors have been used to derive the DNELs. Under certain circumstances it may be possible to modify these based on knowledge of exposure conditions, human versus animal sensitivity, etc. and this was exercised in the quality of the database assessment. Many of the studies in the Annex VII and VIII assessment program were waived on the basis of positive results for corrosive potential in the in vitro skin and eye studies. Consequently, the toxicological data is derived from a curtailed data set.
In the in vitro studies potassium dicyanoargentate was found to be significantly corrosive to the skin (OECD431), category 1a, and also significantly damaging to the eye (OECD437), category 1. Consequently, a number of Annex VII and VIII studies were waived as being scientifically unjustifiable:
a) Acute studies by oral, dermal or inhalation routes of administration;
b) In vivo skin and eye irritation studies, and
c) The LLNA skin sensitisation assay.
Dermal DNELs were derived by route to route extrapolation from oral exposure. Generally speaking, a long-term DNEL is protective of acute exposure unless there are peak exposures significantly above the average daily exposure (determined from worker exposure studies), so acute DNELs for workers will not be required. The determination of the inhalation DNEL has been reassessed to take into consideration the Dustiness data for each of the two substances. These data indicated that the particle size and dosimetry would suggest only extremely marginal exposure to the respiratory airways. Consequently, it is considered that the corrected inhalatory NOAEC should remain unaltered.
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
The DNEL calculations have been conducted only for worker exposure (not consumer). Whilst consumers would be exposed to articles plated with silver as a consequence of using potassium dicyanoargentate during the plating process, the consumer would not actually be exposed to the test substance.
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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