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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Toxicological information

Repeated dose toxicity: oral

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Administrative data

Endpoint:
repeated dose toxicity: oral
Remarks:
other: calculated from CLP software
Type of information:
calculation (if not (Q)SAR)
Remarks:
Migrated phrase: estimated by calculation
Adequacy of study:
weight of evidence
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:
The UVCB substance as complex substance is classified regarding STOT-RE by applying rules for classification of mixtures (EU CLP guidance section 3.9.1 pg 365ff). The classification criteria (as set out in EU CLP Guidance Annex I: 3.9.2.9.7 pg 369) can be used to estimate effects derived from that classification/hazard.
GLP compliance:
no
Remarks:
other Quality assurance

Test material

Constituent 1
Reference substance name:
Automatically generated during migration to IUCLID 6, no data available
IUPAC Name:
Automatically generated during migration to IUCLID 6, no data available
Details on test material:
max across industry for Grade 1 as defined in IUCLID section 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

Target system / organ toxicity

Critical effects observed:
not specified

Any other information on results incl. tables

The calculated classification via mixture toxicity rules resulted in “STOT-RE: not classified”.

Applicant's summary and conclusion

Conclusions:
result can be used to predict STOT-RE effect level and classify the UVCB substance.
Executive summary:

The study provided a conservative estimate of the STOT-RE hazard, derived on basis of the Classification outcome (Mixture toxicity rules) from a typical and Worst case (max conc. on Ni, across industry) as defined in IUCLID section 1.2/1.4/4.23.

The result is applicable to Grade 1 and Grade 2 Copper scales that fall under the defined concentration ranges (IUCLID section 1.2).

The result is supported by (WoE) consideration from chemical & mineralogical information (IUCLID 4.23) showing that NO significant amount of STOT-RE Toxicant are present in representative samples or in max across industry (eg Ni species STOT Re cat 1 as Total Ni across industry below 1%; or Pb powder/compounds STOT-RE cat 2 species as Total Pb across industry is below 10% (ie in Grade 2, the Pb powder STOT Re cat 2 species are below 1%).