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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: inhalation
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 (inhalation) toxicity of the UVCB was determined by classifying based on Mixture Toxicity rules from EU CLP (summation and/or additivity of classified components to derive hazard class), and back calculation to the corresponding Acute (inhalation) 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 (max across industry), as from IUCLID section 1.2, see IUCLID section 1.4 for company specific elemental composition, and representative samples for mineralogical information (+ section 4.23)

Results and discussion

Effect levels
Dose descriptor:
Effect level:
> 10 - <= 20 other: ATE (mg/l)
Based on:
Exp. duration:
4 h
Remarks on result:
other: prediction (vapours)

Any other information on results incl. tables

The calculated classification via Additivity method (lower Tier Arche CLP Tool) resulted in a classification "Acute (inhalation) Category 4 H332" (driven mainly by Arsenic) for the UVCB substance (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 (inhalation, vapours) toxicity: 10 < Acute Toxicity Estimate < or equal 20 (mg/l)

Applicant's summary and conclusion

Interpretation of results:
Toxicity Category IV
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 a conservative estimate of the Acute (inhalation) toxicity, derived on basis of the Classification outcome (Mixture toxicity rules, acute inhalation toxicity category 4) from a (worst case, max across industry) Sulfuric acid, waste gas cooling and cleaning, copper smelting 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).