Registration Dossier

Administrative data

Endpoint:
skin sensitisation
Remarks:
other: calculation based on classification
Type of information:
calculation (if not (Q)SAR)
Remarks:
Migrated phrase: estimated by calculation
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Cross-referenceopen allclose all
Reason / purpose:
reference to same study
Reason / purpose:
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 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: 3.4.2.1 pg 269) can be used to estimate effects derived from that classification/hazard.
GLP compliance:
no
Remarks:
other quality assurance
Type of study:
other: calculation

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Worst case (max across industry) as in iuclid 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 “skin sensitisation: not classified

Applicant's summary and conclusion

Interpretation of results:
sensitising
Remarks:
Migrated information skin sens. Category 1
Conclusions:
Study can be used to establish respiratory/skin sensitisation hazard of the UVCB substance, and to classify the UVCB.
Executive summary:

The study provided a conservative estimate of the skin sens toxicity, derived on basis of the Classification outcome (Mixture toxicity rules) from a worst case as defined in IUCLID section 1.2/1.4/4.23.

The result is applicable to all Sulphuric acid, waste gas cooling and cleaning, copper smelting that fall under the defined concentration ranges (IUCLID section 1.2).

Results from calculated classification (using mixture toxicity rules) are supported (WoE) by additional consideration from phys chem properties of the UVCB substance.

The UVCB is a complex metal containing substance , which major constituents are sulphuric acic and water. Sulphuric acid is a strong mineral acid that has high affinity to water. It dissociates in water to form sulphate and hydrogen (carbonium) ions. These are the relevant forms to determine hazard properties of the substance. Arsenic was the only constituent with concentration >0.1%