Registration Dossier

Administrative data

Description of key information

Key value for chemical safety assessment

Skin sensitisation

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:

Based on a weight-of-evidence assessment, it is concluded that silver substances do not elicit skin sensitising effects:

Human data:

Long term industrial experience does not raise any concern on skin sensitisation attributable to silver substances (personal communication, members of the Silver Work Group of the Precious Metals and Rhenium Consortium, 2010-07-27). Furthermore, a literature search has been conducted to check whether published literature is available which would provide further information on the potential occurrence or absence of skin sensitisation effects of silver substances, specifically in occupational settings. A report on this literature search is attached to the endpoint summary on sensitisation in the technical dossier. As a result, only a limited number of case reports dealing with skin sensitisation could initially be identified. However, upon close inspection, in several of these silver was not the potential cause. For example, one study investigated skin effects in workers with a range of precious metal compounds and found that silver compounds were not causing allergic skin reactions (Bruevich et al 1980). In other cases, “silver” was mentioned but not in the context of sensitisation by silver, but e. g. where thiourea contained in a silver polish was identified as a sensitiser (Dooms-Goossens, 1988).

Overall, very few publications are available and no specific concern for sensitising properties of silver (compounds) could be identified based on human data.

 

Animal data:

Two reliable studies on standard skin sensitisation tests are available with silver containing products/preparations:

Moore, G.E. (1999): Dermal sensitisation study (Buehler Method) in guinea pigs, with a biocidal product (aqueous solution) containing 2438 ppm Ag+ ions, besides other ingredients.

Prinsen, M.K. (1995): Sensitization study in guinea pigs (maximization test) with a liquid plant preservative preparation containing 18 g/L of silver thiosulfate in aqueous solution, besides other ingredients.

As a third source of information, the data published by Kim et al. (2012) on a guinea pig maximisation test are presented. Kim et al. studied the sensitising properties of a nano-silver product (in 1% citrate solution) in close agreement with OECD TG 406. Whereas this publication is of limited reliability since no test concentrations are stated and the use of a positive control is not reported, the clear negative outcome (no skin sensitisation) is in agreement with other information.

 

Conclusion:

Neither human nor animal data show any specific concern for skin sensitising properties of silver or silver substances. Based on a weight-of-evidence assessment it is concluded that classification for skin sensitisation is not required and that further experimental verification is not justified.


Migrated from Short description of key information:
Neither human nor animal data show any specific concern for skin sensitising properties of silver or silver substances. Based on this weight-of-evidence assessment, it is concluded that classification for skin sensitisation is not required and that further experimental verification is not justified (see discussion).

Justification for selection of skin sensitisation endpoint:
Weight-of-evidence assessment based on human and animal data.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

Neither human nor animal data show any specific concern for skin sensitising properties of silver or silver substances. Based on this weight-of-evidence assessment, it is concluded that classification for skin sensitisation is not required and that further experimental verification is not justified. In consequence, classification for skin sensitisation is not required for silver substances.

Similarly, based on a complete absence of any indication of respiratory sensitisation in the public domain, classification is not required.