Registration Dossier
Registration Dossier
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EC number: 231-165-9 | CAS number: 7440-57-5
Endpoint summary
Administrative data
Link to relevant study record(s)
Description of key information
Generation of data for this endpoint was waived since the conduct of appropriate studies from which data would normally be extracted were waived.
Key value for chemical safety assessment
Additional information
Zero valent gold is considered inert and hence there will be a lack of transformation and dissolution into soluble forms within the mammalian body. This is supported by results from a bio-elution test in artificial gastric mimetic fluid which showed no metal release above the limit of detection (1 µg/L). Consequently, the conduct of any toxicity testing by the oral route of administration is waived. In addition, assessment of gold powder for particle size showed less than 10 % of the substance would pass through a 100 µm sieve and particle size cumulative distribution range for gold metal powder was measured at 83.88 to 308.06 µm hence the powder was unlikely to be significantly inhalable (as defined by criteria contained in EUR 20268 EN 2002). Consequently, studies by the inhalation route of administration were also waived. With regards to dermal exposure, there is a long history of the use of gold metal in jewellery, etc., with extensive skin contact. It is not therefore considered relevant to subject metallic gold to acute dermal toxicity testing. This decision is supported by the lack of dissolution observed in artificial sweat and the T/D testing of gold showed that the level of dissolution was below the level of detection. There were no tests conducted by either oral, inhalation or dermal routes of administration from which toxicokinetic data could be extracted. There is significant evidence from the cited references to confirm that there would be no systemic exposure in the mammalian system from exposure to gold via these routes.
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