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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Administrative data

genetic toxicity in vitro
Type of genotoxicity: gene mutation
Type of information:
calculation (if not (Q)SAR)
Migrated phrase: estimated by calculation
Adequacy of study:
key study
2 (reliable with restrictions)
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 Type:
other: software

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: pg 287) can be used to estimate effects derived from that classification/hazard.
GLP compliance:
other quality assurance
Type of assay:
other: calculation based on Classification

Test material

Constituent 1
Reference substance name:
sulfuric acid hydrate
EC Number:
sulfuric acid hydrate
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

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).