Registration Dossier
Registration Dossier
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EC number: 918-168-7 | CAS number: -
Dermal absorption
Administrative data
- Endpoint:
- dermal absorption 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, other quality assurance
Cross-referenceopen allclose all
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to other study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 010
Materials and methods
- Principles of method if other than guideline:
- The solubility of Ni was assessed during an in-vitro test in accordance to a test method and regulatory framework defined in the EU Nickel Directive, which identifies a limit for nickel release in artificial sweat (EN 1811)
- GLP compliance:
- no
- Remarks:
- other quality assutance
Test material
- Reference substance name:
- copper
- EC Number:
- 918-168-7
- Molecular formula:
- Not applicable, UVCB, inorganic
- IUPAC Name:
- copper
- Details on test material:
- Type I, primary blister: 09TT05249
Type II, secondary blister: 09TT02775
Constituent 1
Administration / exposure
- Vehicle:
- water
- Duration of exposure:
- 6 & 8 hours
- Doses:
- equivalent to 1 ml per cm2
Results and discussion
Any other information on results incl. tables
The following amounts of nickel had leached from the samples after 168 hours:
- Sample 5249 (0.27% Ni, 0.05 m2/g): 89.5, 79.5 and 105 µg Ni/g
- Sample 2775 (0.55% Ni, 0.12 m2/g): 60.5,37.5,46.5 µg Ni/g
Applicant's summary and conclusion
- Conclusions:
- The data are critical to the endpoint skin sensitization - releases of Ni
The amount of Ni released during the sweat tests of 2 anode, copper samples ranges between 48 and 91 µg Ni/g, corresponding to 0.04 and 0.18 µg Ni/cm2.week. These values are below the recommended 0.5 µg Ni/cm2.week. - Executive summary:
The solubility of Ni was assessed during an in-vitro test in accordance to a test method and regulatory framework defined in the EU Nickel Directive, which identifies a limit for nickel release in artificial sweat (EN 1811) at 0.5 µg Ni/cm2.week.
The average solubilities observed are:
- sample 5249: 91 µg Ni/g sample (0.27% Ni, 0.05 m2/g)
- sample 2775: 48 µg Ni/g sample (0.55% Ni, 0.12 m2/g)
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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