Registration Dossier

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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

skin sensitisation
other: calculation based on classification
Type of information:
calculation (if not (Q)SAR)
Migrated phrase: estimated by calculation
Adequacy of study:
key study
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: no GLP (but other Quality Assurance); software
Reason / purpose for cross-reference:
reference to other study

Data source

Reference Type:
other: software

Materials and methods

Principles of method if other than guideline:
The potential of the UVCB substance to be respiratory or skin sensitisation 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 Guidance Annex I: pg 269) 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 used to refine/confirm the hazard classification.
GLP compliance:
(CLP calculation software)
Type of study:
other: calculation

Test material

Constituent 1
Reference substance name:
Residues, copper speiss acid leaching
EC Number:
EC Name:
Residues, copper speiss acid leaching
Cas Number:
Residues, copper speiss acid leaching
Details on test material:
Typical across industry, as defined in IUCLID 1.2.

Results and discussion

Any other information on results incl. tables


The calculated classification via mixture toxicity rules is dependent on elemental composition and information from minerology.

Applicant's summary and conclusion

Interpretation of results:
other: Results dependent on elemental composition
Result can be used to predict skin sensitizing effect and to classify the UVCB substance. See Section 2 for potential resulting classifications.

Executive summary:

 The study provides a conservative estimate of the potential for skin sensitisation, derived on the basis of the Classification outcome (Mixture CLP rules).