Registration Dossier

Administrative data

Endpoint:
toxicity to reproduction
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 considering reproduction toxicity (effects on male or female fertility) of "Slags, precious metal refining" was determined by using the “Classification criteria for mixtures” of Regulation (EC) 1272/2006 section 3.7.3.1 “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

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

Results and discussion

Overall reproductive toxicity

Reproductive effects observed:
not specified

Any other information on results incl. tables

"Slags, precious metal refining" is a complex metal containing UVCB substance with wide concentration ranges for each constituent. Each individual constituent of " Slags, 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 " Slags, 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:
"Slags, precious metal refining" contains lead and lead compounds ≥ 0.3 % that may possess reproduction toxicity (i.e., may damage the unborn child). Hence, "Slags, precious metal refining" meets classification criteria as being a reproductive toxicant Repr. 1A and requires labelling with H360 Df (May damage fertility or the unborn child).
Executive summary:

The described MeClas-based-calculation provides a conservative estimate of toxicological effects of "Slags, 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.