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Toxicological information

Basic toxicokinetics

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Administrative data

Endpoint:
basic toxicokinetics in vitro / ex vivo
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: No GLP but other quality assurance
Cross-reference
Reason / purpose for cross-reference:
reference to same study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2010
Report date:
2010

Materials and methods

Objective of study:
other: determine bio accessibility of metals in gastric fluids
Principles of method if other than guideline:
Metal release in human digestive system was estimated through in vitro bio-accessibility test in extraction solvent that resembles gastric fluid (using HCl 0.07N at pH 1.5) in accordance with the ASTM D 5517-07 standard. Metal released to the medium were determined after 1 hour of agitation at 171 rpm and another hour to allow the sample to settle at 37°C.
GLP compliance:
no
Remarks:
other quality assurance

Test material

Constituent 1
Reference substance name:
Matte, copper
EC Number:
266-967-8
EC Name:
Matte, copper
Cas Number:
67711-91-5
IUPAC Name:
matte, copper
Details on test material:
The following samples were assessed:
Sample Code Sample size Description
0139 Less 500 μm Type III, matte from blasting furnace
Sample collection made according to the B2-sampling protocol (see IUCLID section 1.4)

Administration / exposure

Vehicle:
other: HCl 0.07N, pH 1.5
Duration and frequency of treatment / exposure:
1 hour agitation and 1 hour to allow the sample to settle

Results and discussion

Any other information on results incl. tables

Table 1: Chemistry and metal concentrations obtained after bio-elution tests, mimicking gastric bio-elution (200 mg/L). The results at 2g/L are also provided if the metal level at 200mg/L was below Detection Limit (BDL) and above DLM at 2g/L. BDL = Below Detection Limit.

 

Sample

Metal

Bio-elution new SOP            (200 mg/L), µg/L

Mean               %CV

Bio-elution new SOP             (2 g/L), µg/L

Mean               %CV

 

 

 

 

0139

Cu

           47#                     21

        7973                     33

Blasting Furnace (B2)

Ni

           26                       13

          428                     11

 

As

         BDL                       -

          329                      5

 

Pb

        4420                      18

        62712                   14

 

Zn

         144                       5

         1120                     8

 

Cd

         BDL                       -

          BDL                     -

 

Mo

         BDL                       -

          BDL                     -

 

Co

       505.79                     6

         6879                     9

 

 

 

 

  #Thesample was measured again (only copper), non significantive difference was found

Applicant's summary and conclusion

Conclusions:
The study can be used to estimate the amounts of metals in copper matte that are readily available for absorption and support conclusions on hazard classification.
Executive summary:

Rodriguez et al, 2010 assessed the relative release/dissolution of metal ions from Type 1 and Type 2 anode, copper materials in biological fluids, simulating oral exposure. The in vitro test used by Rodriguez et al, 2010, follows the ASTMD 5517 – 07 protocol, using HCl 0.07N (pH 1.5) as a gastric mimetic fluid. The result from this test is a conservative measure of bio-accessibility because only solubility in the gastric fluid (pH 1.5) is assessed and the homeostatic mechanisms at the level of the intestine and liver are ignored. The results are expressed as % soluble metal relative to the total metal that can be solubilised. The tests were carried out at 2 g/L and 200 mg/L (crushed and grinded test item).

Lead : For both samples tested, the relative lead concentrations released amounts to 33.1% of the total amount of lead that could potentially be released. This value is retained as a conservative measurement for lead bioaccessability from copper matte.

Copper: for both samples tested, the relative lead concentrations released amounts to 0.04% of the total amount of Cu that could potentially be released. This value is retained as a conservative measurement for Cu bioaccessability from copper matte

Cobalt: for both samples tested, the relative lead concentrations released amounts to 33.3% of the total amount of Co that could potentially be released. This value is retained as a conservative measurement for Co bioaccessability from copper matte

Nickel: for both samples tested, the relative lead concentrations released amounts to 8.1% of the total amount of Ni that could potentially be released. This value is retained as a conservative measurement for Ni bioaccessability from copper matte