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)
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 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

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

Any other information on results incl. tables

 The mixture toxicity rules can be used to classify Germ cell mutagenicity

Applicant's summary and conclusion

Conclusions:
The tool can be used to predict Germ cell mutagenic effect and to classify the UVCB substances. In some cases no classification will be derived based on the estimates in the study. See Section 2 for potential resulting classifications.
Executive summary:

The study provides an estimate of the Germ cell mutagenicity hazard, derived on basis of the Classification outcome (Mixture toxicity rules) from a Typical industry as defined in IUCLID section 1.2/1.4. In some cases no classification will be derived based on the estimates in the study.