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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

acute toxicity: dermal
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 (dermal) 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)

Results and discussion

Effect levels
Dose descriptor:
Effect level:
>= 2 000 other: ATE (mg/kg bodyweigth)
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 a Classification "Acute (dermal): not classified" for the UVCB substance Copper Slime (toxicity of all metal constituents > 1% w/w is known, from 1st ATP CLP + all assessed metals).

Based on this result, the related criteria provided the estimated value for acute (dermal) toxicity: Acute Toxicity Estimate >2000 mg/kg bodyweight.

Applicant's summary and conclusion

Interpretation of results:
not classified
Migrated information Criteria used for interpretation of results: other: EU CLP mixture toxicity rules
Good quality study that can be used to predict a ATE of the UVCB substance. Note: toxicities of constituents/species as of 1st ATP CLP + assessed metals
Executive summary:

The study provided an estimate of the Acute (dermal) toxicity, derived on basis of the Classification outcome (Mixture toxicity rules, no acute dermal toxicity = no dermal toxicity) from the UVCB (max across industry) as defined in IUCLID section 1.2/1.4/4.23. The result is applicable to all sulfuric acid, waste gas cooling and cleaning, copper smelting that fall under the defined concentration ranges (IUCLID section 1.2).