Registration Dossier

Administrative data

Description of key information

Reliable guideline-conform in-vivo studies are available for skin and eye irritation of silver (OECD guidelines 404 and 405). Based on these studies, silver is not irritating to skin or eyes when tested either in nanoform or not. Two acute inhalation toxicity studies failed to demonstrate any test-item related effects characteristic of respiratory irritation when tested either in nanoform or not. 

Key value for chemical safety assessment

Skin irritation / corrosion

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Eye irritation

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Additional information

Reliable guideline conform in-vivo studies are available for skin and eye irritation of silver (OECD guidelines 404 and 405). Based on these studies, silver is neither irritating to the skin and no irritating to eyes, regardless of whether the test material was in nanoform or not.

With regards to respiratory irritation, an acute inhalation toxicity study is available, which was extended with a satellite group of animals subject to detailed histopathology of the respiratory tract (Haferkorn, 2012). For technical reasons, a summary on this study is presented in the technical IUCLID dossier in section 7.9.3 (“Specific investigations: other studies”) and a tabular summary appears in the CSR in chapter 5.10.1.3. The mass median aerodynamic diameter of inhaled silver particlesas determined in the inhalation chamber during the study was MMAD = 2.3 µm. There were no clinical signs indicating respiratory irritation. Also, with respect to the results of the histopathological and macroscopic investigations on lung tissues, silver is not considered to represent a respiratory irritant. This conclusion is supported by findings by Sung et al. (2011) who reported an absence of statistically significant effects on lung function tests when the material was administered as nanomaterial.Asummary on this study by Sung et al. (2011) is presented in the technical IUCLID dossier in section 7.2.2 (“Acute toxicity: inhalation”) and a tabular summary appears in the CSR in chapter 5.2.1.2.

Justification for classification or non-classification

Reliable guideline-conform in-vivo studies are available for skin and eye irritation of silver (OECD guidelines 404 and 405). Based on these studies, silver is not irritating to skin or eyes when tested either in nanoform or not. Two acute inhalation toxicity studies failed to demonstrate any test-item related effects characteristic of respiratory irritation when tested either in nanoform or not. In consequence, no classification is required.