Registration Dossier

Administrative data

Endpoint:
respiratory 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:
reference to other study

Data source

Reference
Reference Type:
other: software
Title:
Unnamed

Materials and methods

Principles of method if other than guideline:
The potential of the UVCB substance as respirsatory 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.
GLP compliance:
no
Remarks:
other quality assurance

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Typical (across industry) copper slag as defined in section 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 mixture toxicity rules resulted in “Respiratory sensitization: Not classified

Nickel slag contains minor constituents classified as respiratory sensitisers ( Co) but their actual levels are much lower than < 1% thus the mixture is not classified for respiratory sensitization.

Applicant's summary and conclusion

Interpretation of results:
not sensitising
Remarks:
predicted effect
Conclusions:
Result can be used to predict respiratory sensitizing effect and to classify the UVCB substance
Executive summary:

The study provided a conservative estimate of the Respiratory 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 respiratory 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 Respiratory Sensitizer species detected in representative samples and maximim across industry.