Scale (coating), copper

Skin sensitisation

Administrative data

Endpoint:

skin sensitisation

Remarks:

other: calculation based on classification

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 potential of the UVCB substance to be respiratory or skin sensitisation was established by classifying the complex metal substance according to rules for classification of mixtures for respiratory or skin sensitisation (EU CLP guidance section 3.4.3 pg 277ff). The classification criteria (as set out in EU CLP Guidance Annex I: 3.4.2.1 pg 269) can be used to estimate effects derived from that classification/hazard.

GLP compliance:

no

Remarks:

other quality assurance

Type of study:

other: calculation

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:

Typicals (and max) across industry for Grade 1 and Grade 2 and 4 respectively (max Ni<1%), as in IUCLID 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 “skin sensitisation: not classified ”

Applicant's summary and conclusion

Interpretation of results:

not sensitising

Remarks:

Migrated information predicted effect

Conclusions:

Study that can be used to determine Skin sensitisation hazard (classification) of the UVCB substance.

Executive summary:

The study provided a conservative estimate of the Skin sensitization toxicity, derived on basis of the Classification outcome (Mixture toxicity rules) for typicals (across industry) as defined in IUCLID section 1.2/1.4/4.23. The result is applicable to Copper scales Grade 1, 2 and 4 (with max Ni<1%)

that fall under the defined concentration ranges (IUCLID section 1.2).

The result is furthermore supported by (WoE) consideration from chemical & mineralogical information (IUCLID 4.23) showing that NO significant amount of Skin sensitizing species (such as Ni oxide for example) could be released from representative samples. Water solubility test furthermore confirmed that the UVCB has low solubility, except for Si, Na, K, Ca and Cu where these constituents/species solubilised but at high loading of 5g/100ml (and after ca. 14 -16 days)

Result can therefore been accepted as lower tier approach (no bio elution data available).