Registration Dossier

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:
2010

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

Constituent 1
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)

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.