Registration Dossier

Diss Factsheets

Administrative data

acute toxicity: oral
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
Cross-referenceopen allclose all
Reason / purpose for cross-reference:
reference to same study
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:
Acute (oral) toxicity of the UVCB substance was determined by classifying based on Mixture rules from EU CLP (summation and/or additivity of classified components to derive Hazard class) and back calculation to the corresponding Acute (oral) Toxicity criteria
GLP compliance:
equivalent Quality assurance
Test type:
other: CLP calculation software

Test material

Constituent 1
Reference substance name:
sulfuric acid hydrate
EC Number:
sulfuric acid hydrate
Details on test material:
Worst case (maximum across industry) as in iu 1.2;
See IUCLID Section 1.4, for company specific elemental composition; and representative sample for mineralogical information (IUCLID Section 4.23 -Outotec report)
Representative copper speiss - randomly collected from production over long period, crushed and homogenised

Results and discussion

Effect levels
Dose descriptor:
Effect level:
> 300 - <= 2 000 other: ATE
Based on:
Remarks on result:
other: prediction

Any other information on results incl. tables

The calculated classification via Additivity method (lower Tier Arche CLP Tool) resulted in an "Acute Oral: Category 4", driven by Arsenic acid and its salts.

Based on this result, the related criteria provided the estimated value for acute (oral) toxicity: 300 < Acute Toxicity Estimate < or equal 2000 (or subsequently to an Acute Toxicity Point Estimate of 500)

Applicant's summary and conclusion

Interpretation of results:
Toxicity Category IV
Migrated information Criteria used for interpretation of results: EU
Result can be used to predict a ATE of the UVCB substance and to classify it (Note: constituents with unknown acute toxicity are < 1%).
Executive summary:

The study provided a conservative estimate of the Acute Oral toxicity, derived on basis of the Classification outcome (Mixture toxicity rules) from a worst case (max across industry) as defined in IUCLID section 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).