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:

The key study showed no evidence of skin sensitisation under the conditions of the test and this result was supported by a second study to a similar design with a 99.9 % pure electroformed material, AGC Galvanogold, also for dental restorations. In addition, previous testing of gold (Brouwers, 2012) has shown that any dissolution of the metal is below the limit of detection.


Migrated from Short description of key information:
A regulatory guideline guinea pig maximisation test (OECD 406) performed with a gold dental alloy with a purity of 98.2 %. This key study showed no evidence of skin sensitisation under the conditions of the test and was supported by negative results in a second study of similar design.

Justification for selection of skin sensitisation endpoint:
This study is a Klimisch 1 (Reliable without restrictions) Guinea pig maximisation study which, although not recognised as the most sensitive study design for this endpoint, was conducted according to GLP.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

According to the results of the two guinea pig maximisation tests, gold does not meet the current EU-CLP criteria for classification as a skin sensitiser. No risk phrase is required.

The respiratory sensitisation potential of gold was not evaluated. Hence, gold cannot be classified with respect to this endpoint.