Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
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 for cross-reference:
reference to same study
Reason / purpose for cross-reference:
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 (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.
The classification criteria (as set out in EU CLP Guidance) were used to estimate effects.
GLP compliance:
no
Remarks:
no (CLP calculation software)
Test type:
other: CLP calculation software

Test material

Constituent 1
Reference substance name:
Residues, copper speiss acid leaching
EC Number:
309-643-4
EC Name:
Residues, copper speiss acid leaching
Cas Number:
100656-54-0
IUPAC Name:
copper(2+) lambda2-lead(2+) antimony tetraarsenic hexacopper lead dinickel decasulfur disulfanediide
Details on test material:
Typical across industry as defined in IUCLID 1.2.

Results and discussion

Effect levels
Remarks on result:
other: Results determined based on elemental composition and T/D tests
Mortality:
The Higher Tier Arche Tool CLP was run using available data from elemental composition (each as Total % constituent) and information from Transformation/Dissolution (i.e. applying bioavailability correction)



Applicant's summary and conclusion

Interpretation of results:
other: dependent on composition
Remarks:
Criteria used for interpretation of results: EU
Conclusions:
The study provides a conservative estimate of the Acute Oral toxicity. See Section 2 for potential resulting classifications.
Executive summary:

The study provides a conservative estimate of the Acute Oral toxicity, derived on basis of the Classification outcome (Mixture toxicity rules) from a typical (across industry) concentration as defined in IUCLID section 1.2/1.4.

The result is applicable to all intermediates that fall under the defined concentration ranges (IUCLID section 1.2).