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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

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).