Registration Dossier

Administrative data

Description of key information

Key value for chemical safety assessment

Repeated dose toxicity: via oral route - systemic effects

Endpoint conclusion
Endpoint conclusion:
no study available

Repeated dose toxicity: inhalation - systemic effects

Endpoint conclusion
Endpoint conclusion:
no study available

Repeated dose toxicity: dermal - systemic effects

Endpoint conclusion
Endpoint conclusion:
no study available

Repeated dose toxicity: dermal - local effects

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

The conduct of repeat-dose toxicity studies by either the oral, inhalation or dermal routes of administration was waived based on the unlikely exposure to gold metal via these routes. Bio-elution tests using artificial gastric fluid and artificial sweat showed no metal release above the limit of detection (1 µg/L). In addition, the granulometry of gold powder showed that less than 10 % of the substance passed through a 100 µm sieve hence it was considered unlikely to be significantly inhalable.

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Justification for classification or non-classification

Through the conduct of bio-elution tests in artificial gastric fluid and sweat and the assessment of particle size, it was concluded that no meaningful studies could be conducted and that gold metal was not classifiable for this endpoint.