Registration Dossier

Administrative data

Endpoint:
acute toxicity: dermal
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 (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:
no
Remarks:
(equivalent Quality assurance)
Test type:
other: CLP calculation software

Test material

Reference
Name:
Unnamed
Type:
Constituent
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:
other:
Effect level:
>= 2 000 other: ATE (mg/kg bodyweigth)
Based on:
dissolved
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
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 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).