Registration Dossier

Administrative data

repeated dose toxicity: oral
other: calculated from CLP software
Type of information:
calculation (if not (Q)SAR)
Migrated phrase: estimated by calculation
Adequacy of study:
weight of evidence
2 (reliable with restrictions)
Cross-referenceopen allclose all
Reason / purpose:
reference to same study
Reason / purpose:
reference to other study

Data source

Reference Type:
other: software

Materials and methods

Principles of method if other than guideline:
The UVCB substance as complex substance is classified regarding STOT-RE by applying rules for classification of mixtures (EU CLP guidance section 3.9.1 pg 365ff). The classification criteria (as set out in EU CLP Guidance Annex I: pg 369) can be used to estimate effects derived from that classification/hazard.
GLP compliance:
other Quality assurance

Test material

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)

Administration / exposure

Route of administration:
oral: unspecified

Results and discussion

Target system / organ toxicity

Critical effects observed:
not specified

Any other information on results incl. tables

The calculated classification via mixture toxicity rules resulted in “STOT-RE: not classified”.

Applicant's summary and conclusion

Result can be used to establish STOT-RE potential of the UVCB substance, and to classify it.
Executive summary:

The study provided a conclusive estimate derived on basis of the Classification Mixture toxicity rules for a Worst case (as defined in IUCLID section 1.2). The result is applicable to all Sulphuric acid, waste gascooling and cleaning, copper smelting that fall under the therein defined concentration ranges.

The calculated classification via mixture toxicity rules resulted in “STOT-RE: not classified”.

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%