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Additional toxicological data

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Administrative data

Endpoint:
additional toxicological information
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
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other: Non-GLP, follows a standard operating procedure, available as an unpublished report, reliable without restrictions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
Reference Type:
study report
Title:
Unnamed
Year:
2012
Report date:
2012

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: Standard Operating Procedure (SOP) prepared by Eurometaux on November 2010
Deviations:
no
Principles of method if other than guideline:
A bio-accessibility testing study has been designed to assay the metal release of Ruthenium compounds in gastric synthetic media. Metals or metallic compounds are subjected to a media that mimic gastric juice, in terms of pH and body temperature (pH 1.5 and 37 °C), for an exposure time of 1 hour with agitation. Then the compounds are incubated for another hour without agitation, before aliquots are taken, filtered and bio-accessible metal quantified by ICP-MS.
GLP compliance:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Ruthenium
EC Number:
231-127-1
EC Name:
Ruthenium
Cas Number:
7440-18-8
Molecular formula:
Ru
IUPAC Name:
ruthenium
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder
Details on test material:
- Name of test material (as cited in study report): Ruthenium powder
- Substance type: powder
- Physical state: solid
- Analytical purity: 99.95 % w/w
- Purity test date: 28/03/2012
- Lot/batch No.: 7470/00-10
- Other: Particle size distribution and specific surface area (BET analysis) values were taken from: Fraunhofer IKTS report N° 4198_4208_4214_4216 of 12.11.2012.
- d50 = 6.061 µm (50th percentile of the particle size cumulative distribution as measured by volume)
- d90 = 17.899 µm (90th percentile of the particle size cumulative distribution as measured by volume)
- BET = 0.44 m2/g

Results and discussion

Any other information on results incl. tables

Table 1.Ruthenium powder 2 hours bio-elution test in gastric mimetic fluid: Ruthenium 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 of incubation. The results are reported in µg/L and µg/g.

 

 

Gastric test parameters

Vessel 1

Vessel 2

Vessel 3

Ruthenium, µg/L

Ruthenium, µg/g

Blanks

Time, hr

Temp., °C

O2,mg/L

pH

R1

R2

R3

Mean, µg/L

St. Dev.

CV, %

Mean, µg/g

CV, %

 

Before

37.0

6.5

1.50

BDL

BDL

BDL

-

-

-

-

-

 

2

37.0

6.5

1.54

BDL

BDL

BDL

-

-

-

-

-

Ru powder

Time, hr

Temp., °C

O2,mg/L

pH

R1

R2

R3

Mean, µg/L

St. Dev.

CV, %

Mean, µg/g

CV, %

 

Before

37.0

6.5

1.50

BDL

BDL

BDL

-

-

-

-

-

 

2

37.0

6.5

1.49

BDL

BDL

BDL

-

-

-

-

-

CV: corresponds to the coefficient of variation between vessels (the ratio between the standard deviation and the mean of metal released).

BDL: Below detection limit.

 

Table 2. Summary of metals solubility from Ruthenium powder sample; submitted to bio-elution tests in synthetic gastric media. Metal release from the bio-elution tests is reported, as percentage of solubility, after 2 hours of incubation in gastric fluid. SD = Standard Deviation, calculated from the 3 measurements performed to the 3 replica vessels.

 

Sample

% solubility in gastric fluid

2h

SD

Ruthenium powder

BDL

BDL

BDL = Below Detection Limit

Table 3. Results of the metal release per surface area exposed to the medium. The ratio between metal released in the bio-elution test, expressed in µg/g, and the specific surface area in m2/g are presented for Ruthenium powder.

Sample

Metal release in gastric fluid [µg/m2]

2 h

Ruthenium powder

-

The control standards used to assure the quality of the measurements obtained with ICP-MS, demonstrated an adequate stability and accuracy of the instrument during the metal quantification of the bio-elution samples. All the QC samples showed metal concentration measurements in the range of 20% around the certified value of the standards; criterion used to assure the quality of the measurements.   

Applicant's summary and conclusion

Conclusions:
Solubility of ruthenium powder after 2 hours in gastric juice was below detection limit. After incubation in gastric juice, ruthenium released from samples after 2 hours was below detection limit.
Executive summary:

A study to estimate metal bio-accessibility for Ruthenium powder in synthetic gastric juice was performed following Standard Operating Procedure (SOP, Eurometaux, November 2010).

 

The test item was subjected to a media that mimic gastric juice, in terms of pH and body temperature (pH 1.5 and 37 °C), for an exposure time of 1 hour with agitation. Then the compounds are incubated for another hour without agitation, before aliquots are taken, filtered and bio-accessible metal quantified by ICP-MS.

Solubility of Ruthenium powder after 2 hours in gastric juice was below detection limit. After incubation in gastric juice, ruthenium released from samples after 2 hours was below detection limit.