Registration Dossier
Registration Dossier
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 231-131-3 | CAS number: 7440-22-4
Toxicological Summary
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.
