Registration Dossier

Administrative data

Endpoint:
acute toxicity: inhalation
Type of information:
calculation (if not (Q)SAR)
Remarks:
Migrated phrase: estimated by calculation
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: no GLP (but other Quality Assurance); software
Cross-referenceopen allclose all
Reason / purpose:
reference to same study
Reason / purpose:
reference to other study

Data source

Reference
Reference Type:
other: software
Title:
Unnamed
Year:
2010

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:
no
Remarks:
equivalent Quality Assurance
Test type:
other: CLP calculation software

Test material

Reference
Name:
Unnamed
Type:
Constituent
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:
other:
Effect level:
> 10 - <= 20 other: ATE (mg/l)
Based on:
dissolved
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
Remarks:
Migrated information Criteria used for interpretation of results: other: EU CLP mixture toxicity rules
Conclusions:
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).