Registration Dossier
Registration Dossier
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The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
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EC number: 920-632-9 | CAS number: -
Dermal absorption
Administrative data
- Endpoint:
- dermal absorption in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- June 2010
- 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
Materials and methods
- Principles of method if other than guideline:
- The solubility of Ni was assessed during an in-vitro bio-accessibility test in artificial sweat fluid in accordance with standardized test method (EN 1811). Results interpreted in the regulatory context of the EU Nickel Directive (94/27/EC ) which sets threshold for nickel release in artificial sweat of less than 0.5 µg Ni/cm2/week for products intended to come into direct and prolonged contact with the skin.
- GLP compliance:
- no
- Remarks:
- other quality assurance
Test material
- Reference substance name:
- Slag, nickel smelting
- IUPAC Name:
- Slag, nickel smelting
- Details on test material:
- Ni in metallic or compound form present at concentration above 0.1% in nickel slags ( see IUCLID 4.3).
The following sample was assessed:
4683( Ni content 0.15%)
Sample collection made according to the C2-sampling protocol (see IUCLID section 1.4)
Constituent 1
Administration / exposure
- Vehicle:
- water
- Duration of exposure:
- 68 hours
Results and discussion
Any other information on results incl. tables
The solubility of Ni was assessed during an in-vitro bio-accessibility test in artificial sweat fluid in accordance with standardized test method (EN 1811).
Results interpreted in the regulatory context of the EU Nickel Directive (94/27/EC ) which sets threshold for nickel release in artificial sweat of less than 0.5 µg Ni/cm2/week for products intended to come into direct and prolonged contact with the skin.
The amount of Ni released during the sweat tests of the nickel slag is below 1.3% or below 0.018 µg Ni/cm2/week.
Results are summarized below:
| Sample | % Nickel | Surface area, m2/g | Surface area, cm2/g | Sample ares, cm2 | Release, µg/g | Release µg/cm2/week |
| C2 4683 (0.05g/50ml) | 0.15 | 0.1 | 1000 | 50 | <20 | <0.018 |
| duplicate | 0.15 | 0.1 | 1000 | 50 | <20 | <0.018 |
| triplicate | 0.15 | 0.1 | 1000 | 50 | <20 | <0.018 |
Applicant's summary and conclusion
- Conclusions:
- Data on Ni release are critical for endpoint skin sensitization.
- Executive summary:
The solubility of Ni was assessed during an in-vitro bio-accessibility test in artificial sweat fluid in accordance with standardized test method (EN 1811).
Results interpreted in the regulatory context of the EU Nickel Directive which sets threshold for nickel release in artificial sweat (EN 1811) of less than 0.5 µg Ni/cm2/week (see section dermal absorption).
The amount of Ni released during the sweat tests of nickel slags is below 1.3% or below 0.018 µg Ni/cm2/week.
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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