Registration Dossier

Administrative data

additional toxicological information
Type of information:
experimental study
Adequacy of study:
key study
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Non-GLP, follows a standard operating procedure, available as an unpublished report, reliable without restrictions

Data source

Reference Type:
study report
Report date:

Materials and methods

Test guideline
according to guideline
other: Standard Operating Procedure (SOP) prepared by Eurometaux on November 2010
GLP compliance:

Test material

Test material form:
solid: particulate/powder
migrated information: powder
Details on test material:
BET surface area information was taken from Fraunhofer IKTS report 64-814-12-09 of 2012-03-14. Particle size distribution information was taken from ECTX - Consult report number X01-061 of 2012-02-03.

Sample: Gold
Metal: Au
% w/w: 99.9
d50, µm: 83.88
d90, µm: 308.06
BET, m2/g: 0.042-0.051

Results and discussion

Any other information on results incl. tables

The results of the gastric bio-elution test of Gold powder are presented in table 3. The Gold released from blanks and samples at pH 1.5 (200 mg/L mass loading) were recorded before the sample was added and after 2 hours incubation at 37°C. The measurements of the metal released are reported in µg/L and µg/g for the blanks (top half of the table) and sample values (bottom half of the table).

The results from the bio-elution study with gold powder in gastric mimetic fluid

  Gastric test parameters Vessels Gold
  Time (hr) Temp (°C) O2 (mg/L) pH R1 R2 R3 Mean (µg/L) Stan. Dev. CV (%) Mean (µg/g) CV (%)
Blanks Before 37 7.48 1.51 BDL BDL BDL - - - - -
2 37 6.93 1.53 BDL BDL BDL - - - - -
Au powder Before 30 7.48 1.51 BDL BDL BDL - - - - -
2 30 6.93 1.51 BDL BDL BDL -
- - - -

CV: Coefficient of variation between vessels (the ratio between the standard deviation and mean of the metal released)

BDL: Below detection limit

No metal release was detected for Gold above the method detection limit (1 µg/L). The control standards for the ICP-MS demonstrated an adequate stability and accuracy of the instrument during the metal quantification of the bio-elution samples.

Applicant's summary and conclusion

The results of the bio-elution study confirm that under the conditions of the test, no metal release was detected for Gold above the method detection limit of 1 µg/L.
Executive summary:

The results obtained at the CIMM laboratory (2012) showed no release of Gold to the synthetic gastric medium above the method detection limit for the metal (1 µg/L). The results of the bio-elution study confirm the inert behaviour of Gold under simulated gastric fluid conditions, and together with the published data on the lack of solubility in artificial sweat, indicate that no oral or dermal toxicity testing is required for the registration of Gold metal.