Slags, nickel smelting

Skin sensitisation

Administrative data

Endpoint:

skin sensitisation

Remarks:

other: prediction from hazard class

Type of information:

calculation (if not (Q)SAR)

Remarks:

Migrated phrase: estimated by calculation

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Automatic calculation tool in development at Eurometaux

Cross-reference

Reason / purpose for cross-reference:

reference to other study

Data source

Reference

Reference Type:

other: software

Title:

Unnamed

Year:

2010

Materials and methods

Principles of method if other than guideline:

The potential of the UVCB substance as skin sensitiser was established by classifying the complex metal substance according to rules for classification of mixtures for respiratory or skin sensitisation (EU CLP guidance section 3.4.3 pg 277ff). The classification criteria (as set out in EU CLP Annex I: 3.4.3.3.1.) can be used to estimate effects derived from that classification/hazard.
In vitro solubility tests, mimicking sweat fluids in accordance to EN1811, were carried out. The results are further used to confirm the hazard classification

GLP compliance:

no

Remarks:

other quality assurance

Type of study:

other: calculation based on classification

Test material

Test material information

Constituent 1

Reference substance name:

Slag, nickel smelting

IUPAC Name:

Slag, nickel smelting

Details on test material:

Typical across industry as defined in IUCLID 1.2;
See IUCLID Section 1.4, for company specific elemental composition; and representative sample for mineralogical information (IUCLID Section 4.23 -Outotec report)

Results and discussion

Any other information on results incl. tables

The calculated classification via rules for mixtures resulted in “Skin sensitization: Not classified”

Nickel slag contains minor constituents classified as skin sensitisers ( Ni, Co) but their actual levels are lower than < 1% thus copper slag is not classified for skin sensitization.

Applicant's summary and conclusion

Interpretation of results:

not sensitising

Remarks:

Migrated information

Conclusions:

Study can be used to predict skin sensitizing effect and to classify the UVCB substance: Not classified.

Executive summary:

The study provided a conservative estimate of the skin sensitization effect,derived on basis of the Classification outcome by applying the rules for mixtures of a Typical (across industry) nickel slag.

It is concluded that slag, nickel smelting is not to be classified as skin sensitizer.

The result is applicable to all nickel slags that fall under the defined concentration ranges (IUCLID section 1.2).

Chemistry of the substance (see IUCLID section 4.23 chemical and mineralogical characterization) shows that no significant amounts of Skin Sensitizer species detected (eg Ni , Co below 1%) in representative samples and maximim levels across industry.

Ni in metallic form or sulhide form present at concentration slightly above 0.1% in typical nickel slags ( see IUCLID section 1.2 and 4.3). Co in metalic form present at concentration slightly above 0.1% in typical nickel slags

 

Therefore to further confirm the conclusions 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. (see section 7.1.2.Dermal absorption).

The amount of Ni released during the sweat tests of typical nickel slag is below 1.3% or below 0.018 µg Ni/cm2/week. This information thus provides further evidence that there is no need to classify the nickel slag substance for skin sensitisation