Registration Dossier

Administrative data

Endpoint:
repeated dose toxicity: oral
Remarks:
other: prediction from hazard class
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 used
Cross-referenceopen allclose all
Reason / purpose:
reference to same study
Reason / purpose:
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 toxic to specific target organ after repeated dose application of Flue dust was determined by using the “Classification criteria for mixtures” of Regulation (EC) 1272/2006 section 3.9.3.4.1 “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

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
other: solid
Details on test material:
see "confidential details on test material"

Results and discussion

Target system / organ toxicity

Critical effects observed:
not specified

Any other information on results incl. tables

Flue dust, precious metal refining is a complex metal containing UVCB substance with wide concentration ranges for each constituent. Each individual constituent of Flue dust, precious metal 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 Flue dust, precious metal 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

Conclusions:
General note:
According to the self-classification of lead compounds the specific concentration limits (SCL) for STOT RE classification are as follows:
STOT RE 1; H372: C ≥ 0.5%
STOT RE 2; H373: 0.05% ≤ C < 0.5%

Therefore, the following C&L driver is identified for Flue dust, precious metal refining (Flue dust 1 - Flue dust 3) for the oral route:
(i):classification driver lead and lead compound (oral route, systemic effects)

Classification of UVCB substances as being toxic to specific target organs after repeated dose application is based on the presence of a constituent ≥ 1 % classified as STOT-RE 1 and/or on the presence of a constituent ≥ 10 % classified as STOT-RE 2, respectively. Since Flue dust, precious metal refining with the composition profiles 1 - 3 (Flue dust 1 - Flue dust 3) include lead/lead compounds with a content >=0.5%, Flue dust, precious metal refining (Flue dust 1 - Flue dust 3) must be classified as STOT-RE 1 (oral route) in accordance with Regulation (EC) 1272/2008.
Executive summary:

The described MeClas-based-calculation provides a conservative estimate of toxicological effects of Flue dust, precious metal refining, 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.