Dore

Respiratory sensitisation

Administrative data

Endpoint:

respiratory sensitisation

Remarks:

other:

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: calculation tool MeClas (www.meclas.eu) is usedcalculation tool MeClas (www.meclas.eu) is used

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:

2013

Materials and methods

Principles of method if other than guideline:

The C&L for respiratory sensitisation of Doré was determined by using the “Classification criteria for mixtures” of Regulation (EC) 1272/2006 section 3.4.3.3.1 “Classification of mixtures when data are available for all components or only for some components of the mixture”. For detailed information for classification strategy of UVCBs please refer to IUCLID section 13 (attachment “PMC Classification method”).

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

Gold and silver bullion

IUPAC Name:

Gold and silver bullion

Constituent 2

Reference substance name:

Dore

EC Number:

273-793-6

EC Name:

Dore

Cas Number:

69029-47-6

Molecular formula:

Not available

IUPAC Name:

dioxocopper antimony arsenic gold selenium silver tellurium λ²-plumbane

Test material form:

other: solid

Details on test material:

see "confidential details on test material"

Results and discussion

Any other information on results incl. tables

Doré refining is a complex metal containing UVCB substance with wide concentration ranges for each constituent. Each individual constituent of Doré refining may contribute (as 'relevant' component) to the UVCB toxicity. With knowledge of the composition, mineralogical information and knowledge of corresponding toxicity of the various chemical species, the respective mixture rules in accordance with Regulation (EC) 1272/2008 are used to calculate the C&L of Doré refining.

MeClas was used to automatically calculate the classification of the UVCB substance. The calculation tool is based on a database containing the human and environmental hazard information for each component relevant for classification. The information on the representative mineralogical composition (distribution pattern for each constituent of the UVCB substance) is incorporated into MeClas as well.

 

From the derived hazard category (output of MeClas) the corresponding human health (HH) toxicity value was deduced.

 

The following data were used as input of MeClas:

 

1. Classification from individual components according to Annex VI of the CLP regulation (Regulation (EC) 1272/2008) and the 2nd ATP to this regulation, unless additional information on self-classification was used.

 

2. Percentage of the components in the UVCB: individual total element concentrations (percentages based on total substance amount) were recalculated into percentage of the classified chemical species (i.e. substance), taking into account the distribution pattern of the respective element in its present various mineral forms if such information was available.

Applicant's summary and conclusion

Interpretation of results:

not sensitising

Conclusions:

Doré does not contain any constituent ≥ 0.1 % (w/w) that releases respiratory sensitisation. Hence, the substance must not be classified as respiratory sensitiser in accordance with Regulation (EC) 1272/2008.

Executive summary:

The described MeClas-based-calculation provides a conservative estimate of toxicological effects of Doré, derived on basis of the mixture C&L rules set forth in Regulation (EC) 1272/2008 using mineralogical information from a representative/worst case sample.