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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

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.

Diss Factsheets

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:
2010

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

Constituent 1
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

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)