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Diss Factsheets
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EC number: 918-168-7 | CAS number: -
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
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:
- 2 010
- 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
- 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)
Constituent 1
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.
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