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Diss Factsheets

Administrative data

Endpoint:
repeated dose toxicity: oral
Remarks:
other: calculation
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: automatic calculation tool in development at Eurometaux
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
Reference Type:
other: software
Title:
Unnamed
Year:
2010

Materials and methods

Principles of method if other than guideline:
The UVCB substance as complex substance is classified regarding STOT-RE by applying rules for classification of mixtures (generic concentration limits EU CLP Guidance Annex I: Table 3.9.4). The classification criteria (as set out in EU CLP Guidance Annex I: 3.9.3) can be used to estimate effects derived from that classification/hazard.
GLP compliance:
no
Remarks:
equivalent quality assurance

Test material

Constituent 1
Reference substance name:
Slimes and Sludges, battery scrap, antimony- and lead-rich
EC Number:
310-061-8
EC Name:
Slimes and Sludges, battery scrap, antimony- and lead-rich
Cas Number:
102110-60-1
Molecular formula:
Molecular weigth/formula concept not applicable to Inorganic UVCB (comlex metal containing substance)
IUPAC Name:
Slimes and Sludges, battery scrap, antimony- and lead-rich
Details on test material:
Elemental composition of maximum of typicals across industry: IUCLID Section 1.2
Representative sample(s) for mineralogical information: IUCLID Section 4.23

Results and discussion

Target system / organ toxicity

Critical effects observed:
not specified

Any other information on results incl. tables

The derived classification result (via mixture toxicity rules) for Grade 1 and Grade 2 of Slimes and sludges battery scrap Sb, Pb rich is "Specific target organ toxicity-repeated exposure Category 2; H373" due to the presence of > = 0.5% lead compounds (maximum of typical used to derive the classification: 75.2% lead which is equal to ca. 66% lead compounds since 87.73% of lead is present in the compounds form and 12.27% in metal (powder) form (according to reference sample OR25, see section 4.23)).

Applicant's summary and conclusion

Conclusions:
Study can be used to establish the STOT RE effect of the UVCB substance. The derived classification result (via mixture toxicity rules) for Grade 1 and Grade 2 of Slimes and sludges battery scrap Sb, Pb rich is "Specific target organ toxicity-repeated exposure Category 2; H373" due to the presence of > = 0.5% lead compounds (maximum of typical used to derive the classification: 75.2% lead which is equal to ca. 66% lead compounds since 87.73% of lead is present in the compounds form and 12.27% in metal (powder) form (according to reference sample OR25, see section 4.23)).
Executive summary:

The study provided a conservative estimate of the STOT RE hazard, derived on the basis of the classification outcome (Mixture toxicity rules) from a reasonable worst case sample (maximum of typicals for every constituent) across industry for Slimes and Sludges battery scrap Sb, Pb rich Grade 1 and Grade 2 as defined in IUCLID section 1.2 and the mineralogical information from representative samples (IUCLID section 4.23). The classification result for both grades is "STOT RE Category 2; H373"

due to the presence of > = 0.5% lead compounds (maximum of typical used to derive the classification: 75.2% lead which is equal to ca. 66% lead compounds since 87.73% of lead is present in the compounds form and 12.27% in metal (powder) form (according to reference sample OR25, see section 4.23)).