Scale (coating), copper

Genetic toxicity: in vitro

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-reference

Cross-reference 1

Reason / purpose for cross-reference:

reference to same study

Cross-reference 2

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

Test material information

Constituent 1

Reference substance name:

Scale (coating), copper

EC Number:

273-744-9

EC Name:

Scale (coating), copper

Cas Number:

69012-45-9

IUPAC Name:

scale (coating), copper

Details on test material:

Typical and max (across industry) as defined in 1.2 (taking into account fine portion of the material in all Grades);
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 “Germ cell mutagenicity: not classified”.

Applicant's summary and conclusion

Conclusions:

Interpretation of results (migrated information):
negative predictive

Result can be used to predict Germ cell mutagenic effect and to classify the UVCB substance as“ Germ Cell mutagenicity: not classified”.

Executive summary:

The study provided a conservative estimate of the Germ cell mutagenicity hazard, derived on basis of the Classification outcome (Mixture toxicity rules) from a Typical (and max for Ni and Pb) across industry as defined in IUCLID section 1.2/1.4/4.23.

The result is applicable to Grade 1, 2, 3 and 4 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 Germ cell mutagen species could be detected in representative samples (eg Ni sulphides) . Water solubility test furthermore confirmed that the UVCB has low solubility, except for Si, Na, K, Ca and Cu where these constituents solubilised (at high loading of 5g/100ml and after ca. 14 -16 days) -none of these constituents presenting mutagen species