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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Toxicological information

Carcinogenicity

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Administrative data

Description of key information

Under the Biocidal Products Regulation, the evaluating Member State formally requested the applicants for the Silver Containing Active Substances (SCAS) 'elemental silver', 'silver nitrate', 'Silver chloride', 'nano-silver absorbed on silicon dioxide' and 'Silver phosphate glass, silver borophosphate glass, silver phosphoborate glass' in April 2020 to perform a 2-year combined chronic toxicity/carcinogenicity study in line with OECD TG 453 to fill the existing data gap. Silver acetate has been selected to perform that test. The study is currently ongoing and the data need to be submitted under the BPR by September 2024. The REACH registrants of silver compounds, that are a member of the European Precious Metals Federation, have set-up a cooperation agreement with the BPR applicants of the above mentioned SCAS substances to jointly perform this test and generate the data requested under the BPR. The testing (in accordance with GLP and OECD TG 453) has been contracted at a CRO in September 2020. The 14-d palatability testing and the 90-d assay (in line with OECD TG408 - Lourens et al. 2021) has been finalised in 2021, and serves as dose-range finding study for the OECD 453 study that has been initiated in week 47 2021. The data will be included in the REACH dossiers once available. 

Key value for chemical safety assessment

Carcinogenicity: via oral route

Endpoint conclusion
Endpoint conclusion:
no study available

Carcinogenicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no study available

Carcinogenicity: via dermal route

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

Under the Biocidal Products Regulation, the evaluating Member State formally requested the applicants for the Silver Containing Active Substances (SCAS) 'elemental silver', 'silver nitrate', 'Silver chloride', 'nano-silver absorbed on silicon dioxide' and 'Silver phosphate glass, silver borophosphate glass, silver phosphoborate glass' in April 2020 to perform a 2-year combined chronic toxicity/carcinogenicity study in line with OECD TG 453 to fill the existing data gap. Silver acetate has been selected to perform that test. The study is currently ongoing and the data need to be submitted under the BPR by September 2024. The REACH registrants of silver compounds, that are a member of the European Precious Metals Federation, have set-up a cooperation agreement with the BPR applicants of the above mentioned SCAS substances to jointly perform this test and generate the data requested under the BPR. The testing (in accordance with GLP and OECD TG 453) has been contracted at a CRO in September 2020. The 14-d palatability testing and the 90-d assay (in line with OECD TG408 - Lourens et al. 2021) has been finalised in 2021, and serves as dose-range finding study for the OECD 453 study that has been initiated in week 47 2021. The data will be included in the REACH dossiers once available. 

Additional information

Justification for selection of carcinogenicity via inhalation route endpoint:
Waiving.

Justification for selection of carcinogenicity via dermal route endpoint:
Waiving.