Registration Dossier

Administrative data

Endpoint:
genetic toxicity in vitro
Remarks:
Type of genotoxicity: gene mutation
Type of information:
calculation (if not (Q)SAR)
Remarks:
Migrated phrase: estimated by calculation
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
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:
The UVCB substance as complex substance is classified regarding germ cell mutagenicity by applying rules for classification of mixtures (EU CLP guidance section 3.5.3 pg 293ff). The classification criteria (as set out in EU CLP Guidance Annex I: 3.5.2.2 pg 287) can be used to estimate effects derived from that classification/hazard.
GLP compliance:
no
Remarks:
other quality assurance
Type of assay:
other: calculation based on Classification

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Worst case (max across industry) as 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

Any other information on results incl. tables

The calculated classification via mixture toxicity rules resulted in “no classification for germ cell mutagenicity

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information):
negative predictive

study can be used to establish conclusion “NO Germ Cell mutagenicity” hazard of the UVCB substance
Executive summary:

The study provided a worst case estimate of the Germ cell mutagenicity, derived on basis of the Classification outcome (Mixture toxicity rules) from a worst case as defined in IUCLID section 1.4/4.23.

The result is applicable to all Sulphuric acid, waste gas cooling and cleaning, copper smelting that fall under the defined concentration ranges (IUCLID section 1.2).