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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 Co and Ni were 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:
Matte, copper
EC Number:
266-967-8
EC Name:
Matte, copper
Cas Number:
67711-91-5
IUPAC Name:
matte, copper
Details on test material:
Type III, blasting furnace matte: 10TT00139
sampling was performed acc. ECI Reach Copper Consortium sampling protocoll (iu 4.23)

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 cobalt had leached from the samples after 168 hours:

- Sample 0139 (0.76% Co, 0.05 m2/g): 19.0, 18.0 and 21.3 µg Co/g

- Sample 0139 (0.16%Ni, 0.05 m2/g): 39.5; 35.0 and 54.0 µgNi/g -respectively 0.004, 0.004 to 0.005 %Ni/g

Applicant's summary and conclusion

Conclusions:
The data are critical to the endpoint skin sensitization - releases of Co
The amount of Co released during the sweat tests of the copper matte sample ranges between 18 and 21.3 µg Co/g, corresponding to 2.74, 2.89 and 3.24 µg Co/cm2.week.This is equivalent to a 19.4% release from total Co content –this value is retained as a measurement for Co bioaccessibility for copper matte.
The amount of Nickel released during the sweat tests (168h) of the copper matte sample ranges between 39.5, 35.0 and 54.0 µg Ni/g, corresponding to 0.079, 0.070 and 0.108 µg Ni/cm2.week.This is equivalent to a 0.004% release from total Ni content –this value is retained as a measurement for Nickel bioaccessibility for copper matte (with surface area equal or above 0.05m2/g).
Executive summary:

The solubility of Co and Ni were assessed during an in-vitro test in accordance to a test method and regulatory framework defined in the EU Nickel Directive, .

The average solubilities observed are:

- sample 0139 (lab code 2170a and b): 2.96 µg Co/g sample and 42.83µgNi/g sample