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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:
Slags, copper smelting
EC Number:
266-968-3
EC Name:
Slags, copper smelting
Cas Number:
67711-92-6
IUPAC Name:
slag, copper smelting
Details on test material:
Ni in metallic or compound form present at concentration slightly above 0.1% in copper slags from secondary production : Sample Type II, Secondary granules ( see IUCLID 4.3).

The following samples were thus assessed:
09TT03177 ( Ni content 0.21%) and 09TT03181 ( Ni content 0.116%)

Sample collection made according to the C1-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 2 copper slags is in the ranges between 1.9 to 2.5% or 0.021 to 0.036 µg Ni/cm2/week.

Results are summarized below:

Sample % Nickel Surface area, m2/g Surface area, cm2/g Sample area, cm2 Release, µg/g Release µg/cm2/week  

C1 3177   

 (0.05g/50ml)

0.21 0.11 1100 55 39 0.035  
duplicate 0.21 0.11 1100 55 40 0.036  
triplicate 0.21 0.11 1100 55 40 0.036  

C1 3181 

(0.02g/50ml)

0.198 0.24 2400 48 50 0.021  
duplicate 0.198 0.24 2400 48 50 0.021  
triplicate 0.198 0.24 2400 48 50 0.021  

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 0.2 µg Ni/cm2/week (see section dermal absorption).

The amount of Ni released during the sweat tests of 2 copper slags is in the ranges between 1.9 to 2.5% or between 0.021 to 0.036 µg Ni/cm2/week.