Registration Dossier
Registration Dossier
Diss Factsheets
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EC number: 231-131-3 | CAS number: 7440-22-4
- 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:
- no hazard identified
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Workers - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
Workers - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- no hazard identified
Additional information - workers
The comparative in-vivo Toxicokinetic study demonstrates that silver metal (powder and massive) needs separate grouping from nanosilver and silver compounds. Based on TK evidence and other evidence like the presumed Mode of Action of silver, silver metal (massive and powder) remains unclassified for human health endpoints.
The previous DNELs calculated for silver metal massive and powder were based on the existing EU Indicative Occupational Exposure Limit (IOEL). This was deinfed in 1993 by Scientific Committee on Occupational Exposure Limits (SCOEL) using argyria as driving adverse effect for workers. In 2015, ECHA RAC-35, however, clarified that "argyria and other potential effects related to silver deposition appeared at doses above the classification thredholds and that it cannot be considered severe although irreversible", a conclusion that is in line with today's scientific consensus on the non-adverse character of argyria (e.g. recent review by Motal et al. 2021). According to ECHA Guidance (ECHA guidance on information requirements and chemical safety assessments Chapter R.8: Characterization of dose [concentration]- response for human health) "A registrant is allowed to use an IOEL as a DNEL for the same exposure route and duration, unless new scientific information that he has obstained in fulfilling his obligations under REACH does not support the use of the IOEL for this purpose."
Therefore, based on the ECHA RAC-35 evaluation of argyria as "non-adverse", the recent EPMF TK studies and today's scientific consensus on argyria, it has been concludes on "no adverse effects identified" for silver metal massive and powder and therefore, no DNELs needed to be calculated.
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
General Population - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
General Population - Hazard via oral route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
General Population - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- no hazard identified
Additional information - General Population
The comparative in-vivo Toxicokinetic study demonstrates that silver metal (powder and massive) needs separate grouping from nanosilver and silver compounds. Based on TK evidence and other evidence like the presumed Mode of Action of silver, silver metal (massive and powder) remains unclassified for human health endpoints.
The previous DNELs calculated for silver metal massive and powder were based on the existing EU Indicative Occupational Exposure Limit (IOEL). This was deinfed in 1993 by Scientific Committee on Occupational Exposure Limits (SCOEL) using argyria as driving adverse effect for workers. In 2015, ECHA RAC-35, however, clarified that "argyria and other potential effects related to silver deposition appeared at doses above the classification thredholds and that it cannot be considered severe although irreversible", a conclusion that is in line with today's scientific consensus on the non-adverse character of argyria (e.g. recent review by Motal et al. 2021). According to ECHA Guidance (ECHA guidance on information requirements and chemical safety assessments Chapter R.8: Characterization of dose [concentration]- response for human health) "A registrant is allowed to use an IOEL as a DNEL for the same exposure route and duration, unless new scientific information that he has obstained in fulfilling his obligations under REACH does not support the use of the IOEL for this purpose."
Therefore, based on the ECHA RAC-35 evaluation of argyria as "non-adverse", the recent EPMF TK studies and today's scientific consensus on argyria, it has been concludes on "no adverse effects identified" for silver metal massive and powder and therefore, no DNELs needed to be calculated.
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.

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