Registration Dossier

Administrative data

Workers - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

Workers - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified

Workers - Hazard for the eyes

Local effects

Hazard assessment conclusion:
low hazard (no threshold derived)

Additional information - workers

General Population - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

General Population - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified

General Population - Hazard via oral route

Systemic effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

General Population - Hazard for the eyes

Local effects

Hazard assessment conclusion:
low hazard (no threshold derived)

Additional information - General Population

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) (Rodriguez, 2012). Consequently, the conduct of any toxicity testing by the oral route of administration is waived. In addition, gold powder was subject to particle size screening by Harlan Laboratories (Tremain and Atwal 2011). Less than 10 % of the substance passed through a 100 µm sieve, and hence a full particle size distribution assessment was not required since the powder was unlikely to be significantly inhalable (as defined by criteria contained in EUR 20268 EN 2002). However, these data were supported by a particle size distribution assessment (Rodriguez, 2012) in which the 50th and 90th percentiles of the particle size cumulative distribution for gold metal powder were 83.88 and 308.06 µm respectively. Consequently, with 50% of particles actually measured at 83.88 um the substance was confirmed as being unlikely to be significantly inhalable and 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 (Liden C et al. 1998). The Transformation/Dissolution testing of gold (Brouwers, 2012) showed that the level of dissolution was below the level of detection. Liden et al. (1998) investigated the release of gold metal from 13 different gold-containing jewellery materials stored for several weeks in artificial sweat. No release of gold was detected using ICP and atomic absorption. Consequently, it is considered that no hazard is presented to either workers or the general public via these routes of exposure to gold powder.