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EC number: 231-131-3
CAS number: 7440-22-4
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.
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