Registration Dossier

Toxicological information

Carcinogenicity

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Description of key information

In accordance with Regulation (EC) No 1907/2006 ("REACH"), Annex X, 8.9.1, column 2, a carcinogenicity study for silver substances is NOT proposed by the registrant (see discussion).

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

Additional information

A carcinogenicity study for silver substances is not proposed by the registrant. Silver or inorganic silver substances are not classified for mutagenicity, nor are there any indications of hyperplasia and/or pre-neoplastic lesions in the available toxicological studies involving repeated exposure of experimental animals (i. e. the conditions cited in accordance with Regulation (EC) No 1907/2006 ("REACH"), Annex X, 8.9.1, column 2). In addition, despite a long history of use of silver and silver substances, there is no reliable human data indicating any concern for carcinogenicity. Animal toxicity and human occupational studies using normal routes of exposure (i. e. excluding implantation studies) have not provided evidence of carcinogenicity, and silver is not expected to pose a carcinogenic hazard to humans.


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

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

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

Justification for classification or non-classification

Silver or inorganic silver substances are not classified for mutagenicity, nor are there any indications of hyperplasia and/or pre-neoplastic lesions in the available toxicological studies involving repeated exposure of experimental animals (i. e. the conditions cited in accordance with Regulation (EC) No 1907/2006 ("REACH"), Annex X, 8.9.1, column 2). In addition, despite a long history of use of silver and silver substances, there is no reliable human data indicating any concern for carcinogenicity. Animal toxicity and human occupational studies using normal routes of exposure (i. e. excluding implantation studies) have not provided evidence of carcinogenicity, and silver is not expected to pose a carcinogenic hazard to humans.

In consequence, hazard classification for carcinogenicity is NOT required, based on the criteria of Regulation (EC) No. 1272/2008 ("CLP"), Annex I, Part 3.6.