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Acute Toxicity: oral

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acute toxicity: oral
Type of information:
calculation (if not (Q)SAR)
Migrated phrase: estimated by calculation
Adequacy of study:
key study
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: calculation tool MeClas ( is used
Cross-referenceopen allclose all
Reason / purpose for cross-reference:
reference to same study
Reason / purpose for cross-reference:
reference to other study

Data source

Reference Type:
other: software

Materials and methods

Principles of method if other than guideline:
The C&L for acute oral toxicity of "Material for reclaim, precious metal with or without support" was determined by using the “acute toxicity range estimate (ATE)” and respective rules of Regulation (EC) 1272/2006 section “Classification of mixtures based on ingredients of the mixture”. For detailed information for classification strategy of UVCBs please refer to IUCLID section 13 (attachment “PMC Classification method”).
GLP compliance:

Test material

Constituent 1
Reference substance name:
Material for reclaim, precious metal with or without support
Material for reclaim, precious metal with or without support
Constituent 2
Reference substance name:
Waste solids, precious metal refining
EC Number:
EC Name:
Waste solids, precious metal refining
Cas Number:
Waste solids, precious metal refining
Test material form:
other: solid
Details on test material:
see "confidential details on test material"

Results and discussion

Effect levels
Dose descriptor:
other: Acute Toxicity Estimate (ATE)
Effect level:
> 300 - <= 2 000 mg/kg bw
Based on:
test mat.
Remarks on result:
other: calculation

Any other information on results incl. tables

"Material for reclaim, precious metal with or without support" is a complex metal containing UVCB substance with wide concentration ranges for each constituent. Each individual constituent of "Material for reclaim, precious metal with or without support" 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 "Material for reclaim, precious metal with or without support".

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:
Migrated information Criteria used for interpretation of results: EU
According to MeClas, "Material for reclaim, precious metal with or without support" (Reclaim 2 and Reclaim 3) should be classified as acute toxic via oral route Category 4 and labelled with H302 (harmful if swallowed) as defined in Regulation (EC) 1272/2008.

The converted acute toxicity point estimate value for acute toxicity, oral route in accordance with EU CLP Guidance Annex I Table 3.1.2 is 500 mg/kg bw. It is noted that this value is designed to be used in the calculation of the ATE for classification on a mixture based on its components and do not represent test results.
Executive summary:

The described MeClas-based-calculation provides a conservative estimate of toxicological effects of "Material for reclaim, precious metal with or without support", 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.

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