Registration Dossier

Diss Factsheets

Administrative data

Endpoint:
skin sensitisation, other
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 with MeClas tool
Cross-reference
Reason / purpose for cross-reference:
reference to other study

Data source

Reference
Reference Type:
other: software
Title:
Unnamed
Year:
2019

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

Test material

Constituent 1
Reference substance name:
slag, copper smelting
EC Number:
266-968-3
Cas Number:
67711-92-6
IUPAC Name:
slag, copper 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

In vivo (LLNA)

Results
Remarks on result:
not measured/tested
Remarks:
calculated

Any other information on results incl. tables

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

Copper slag contains minor constituents classified as skin sensitisers but their actual levels are much 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) copper slag.

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

The result is applicable to all copper 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 below 1%) in representative samples and maximim levels across industry.

Ni in metallic or compound form present at concentration slightly above 0.1% in copper slags from secondary production ( see IUCLID section 1.2 and 4.3).

 

Therefore to further confirm the conclusionsthe 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 2 copper slags is in the ranges between 1.9 to 2.5% or between 0.021 and 0.036 µg Ni/cm2/week. This information thus provides further evidence that there is no need to classify the copper slag substance for skin sensitisation