Matte, copper

Dermal absorption

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-reference

Cross-reference 1

Reason / purpose for cross-reference:

reference to same study

Cross-reference 2

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

Test material information

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