Registration Dossier

Administrative data

Key value for chemical safety assessment

Effects on fertility

Effect on fertility: via oral route
Endpoint conclusion:
no study available
Effect on fertility: via inhalation route
Endpoint conclusion:
no study available
Effect on fertility: via dermal route
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.

Effects on developmental toxicity

Effect on developmental toxicity: via oral route
Endpoint conclusion:
no study available
Effect on developmental toxicity: via inhalation route
Endpoint conclusion:
no study available
Effect on developmental toxicity: via dermal route
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.

Justification for classification or non-classification

Since there are no specific studies conducted for this endpoint, gold metal cannot be classified for the endpoint.

Additional information