Scale (coating), copper

Respiratory sensitisation

Administrative data

Endpoint:

respiratory 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

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) for all Gradescopper scales from 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

Results:

The calculated classification via mixture toxicity rules resulted in “Respiratory sensitisation: not classified”

Any other information on results incl. tables

The UVCB substance is complex metal containing substance. Each individual (metal) constituent of this UVCB substance can release soluble ions that can contribute (as ‘relevant’ component) to the mixture toxicity. With knowledge of the elemental composition (IUCLID section 1.4 & 1.2) and mineralogical information on a representative sample (IUCLID Section 4.23), the mixture toxicity rules (EU CLP Guidance Annex I :3.4.3, and Cut-off table in Annex I: 3.4.3.1.) was used to calculate the Classification of the UVCB substance.   

The Arche CLP tool was used to automatically calculate the classification of the intermediate. The tool is based on a database containing the human and environmental classification for each component relevant for classification. The information on the representative mineralogical composition (distribution pattern for each constituent of the UVCB substance) is furthermore incorporated into the tool, so that the elemental composition (in % Total element) is automatically converted into % w/w of compounds that are relevant for applying the Sum/add formula.

 

Classification of mixtures for respiratory or skin sensitisation
Annex I: 3.4.3.3.1. The mixture shall be classified as a respiratory or skin sensitizer when at least one ingredient has been classified as a respiratory or skin sensitizer and is present at or above the appropriate generic concentration limit as shown in Table 3.4.3 below for solid/liquid and gas respectively.

3.4.3.3.2. Some substances that are classified as sensitizers may elicit a response, when present in a mixture in quantities below the concentrations established in Table 3.4.1, in individuals who are already sensitised to the substance or mixture (see Note 1 to Table 3.4.3).

Table 3.4.3

Generic concentration limits of ingredients of a mixture classified as either skin sensitizers or

respiratory sensitizers that trigger classification of the mixture

Ingredient classified as:	Concentration triggering classification of a mixture as:
	Skin Sensitizer	Respiratory Sensitizer
	All physical states	Solid/Liquid	Gas
Skin Sensitizer	≥0,1 % (Note 1)
	≥1,0 % (Note 2)
Respiratory Sensitizer		≥0,1 % (Note 1)	≥0,1 % (Note 1)
		≥1,0 % (Note 3)	≥0,2 % (Note 3)

Note 1

This concentration limit is generally used for the application of the special labelling requirements of Annex II section 2.8 to protect already sensitised individuals. A SDS is required for the mixture containing an ingredient above this concentration.

Note 2

This concentration limit is used to trigger classification of a mixture as a skin sensitizer.

Note 3

This concentration limit is used to trigger classification of a mixture as a respiratory sensitizer.

All sensitising components of the UVCB substance at or above their generic or specific concentration limit have been taken into consideration for the purpose of classification. Specific concentration limits did always take precedence over the generic concentration limits.

The additivity concept is not applicable for respiratory or skin sensitisation, i.e. if one single classified substance is present in the mixture above the generic concentration limit, the mixture must be classified for that hazard. If the mixture contains two substances each below the generic concentration limits, the mixture was not classified, as far as no SCL has been set.

Applicant's summary and conclusion

Interpretation of results:

not sensitising

Remarks:

predicted effect

Conclusions:

Study can be used to determine classification of the UVCB substance

Executive summary:

The study provides a conservative estimate of the Respiratory Sensitising classification (and effect), derived based on Mixture toxicity rules from Typical across industry as defined in IUCLID Section 1.2/1.4/4.23.

The result is applicable to Copper scales from all grades that fall under the defined concentration ranges (IUCLID Section 1.2)

The result is supported by (WoE) consideration from mineralogical information (IUCLID 4.23) showing that no significant amount Respiratory Sensitizer could be detected in representative samples, for neither Grade 1 nor Grade 2, " nor 4 (dross). Water solubility test furthermore confirmed that the UVCB has low solubility, except for Si, Na, K, Ca and Cu where these constituents/species solubilised (at high loading of 5g/100ml and after ca. 14 -16 days) -with pH observed remaining at ca 9 or ca 7 (ie not exceeding to extremes >2 or >11,5).