Anode, copper

Basic toxicokinetics

Administrative data

Endpoint:

basic toxicokinetics in vitro / ex vivo

Type of information:

experimental study

Adequacy of study:

key study

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

Principles of method if other than guideline:

Metal release in human digestive system was estimated through in vitro bio-accessibility tests 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

Test material information

Constituent 1

Reference substance name:

copper

EC Number:

918-168-7

Molecular formula:

Not applicable, UVCB, inorganic

IUPAC Name:

copper

Details on test material:

The following samples were assessed:
Sample Code Sample size Description
5249 Less 500 μm Type I, primary blister
2775 Less 500 μm Type II, secondary blister


Sample collection made according to the B1-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 settling

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 was below Detection Limit (BDL) at 200 mg/L and above DLM at 2g/L. 

BDL = Below Detection Limit.

	Type I, primary blister - 09TT05249				Type II, secondary blister - 09TT02775
	Chemistry	Bio-elution - gastric fluid			Chemistry	Bio-elution - gastric fluid
		200 mg/L	2g/L			200 mg/L	2g/L
	(%)	(µg/L)	(µg/L)	%	(%)	(µg/L)	(µg/L)	%
Cu	99.8	3776		2.06	91.6	13488		6.8
Ni	0.27	15		1.36	0.55	36		6.7
As	0.08	63		10.5	0.3	87		54
Pb	0.09	BDL	2240	16	0.7	BDL

 

Applicant's summary and conclusion

Conclusions:

The study can be used to estimate the amounts of metals in anode, copper 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 and particle size of 500 µm (drilled samples). The influence of abrasion on bioaccessibility demonstrated that at the higher loading (2 g/L) abrasion of the particles occurred (relative releases at 2 g/L, much higher relative release at 200 mg/L).

The data at 200 mg/L were therefore considered as more reliable (see table in results). The relative release rate at 2 g/L for lead (16%) is thus to be considered as a worst-case release rate.