Registration Dossier

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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

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.