Slimes and Sludges, battery scrap, antimony- and lead-rich

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

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-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:

2010

Materials and methods

Principles of method if other than guideline:

Acute oral toxicity potential of the UVCB substance was determined by classifying based on Mixture rules from EU CLP (additivity formula of classified components to derive hazard class) and back calculation to the corresponding acute toxicity point estimate (ATE).

GLP compliance:

no

Remarks:

equivalent quality assurance

Test material

Test material information

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

Effect levels

Dose descriptor:

other: Acute toxicity range estimate

Effect level:

> 300 - <= 2 000 mg/kg bw

Based on:

dissolved

Remarks on result:

other: prediction

Any other information on results incl. tables

The derived classification result (via application of mixture toxicity rules) for both grades defined in section 1.2 is 'Acute oral toxicity Category 4; H302'. The key driver for acute toxicity (oral) classification is Pb 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)).

Based on this result, the related criteria provided the estimated value for acute toxicity-oral (Acute Toxicity Point Estimate) (see EU CLP Guidance Annex I Table 3.1.2): 500 mg/kg bodyweight.

Applicant's summary and conclusion

Interpretation of results:

harmful

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Good quality "Acute Toxicity Estimate (ATE)-oral" of the UVCB substance. The derived classification result (via application of mixture toxicity rules) for both grades defined in section 1.2 is 'Acute oral toxicity Category 4; H302' resulting in an ATE of 500 mg/kg bodyweight. The key driver for acute toxicity (oral) classification is Pb 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 acute toxicity-oral 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 "Acute toxicity-oral Category 4; H302" resulting in an ATE of 500 mg/kg bodyweight. The key driver for acute toxicity (oral) classification is Pb 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)).

Validity of the model used:

1. Defined end points: Acute toxicity-oral
2. Unambiguous algorithm from EU CLP Guidance: additivity formula to determine classification, followed by back-calculation to related hazard criteria
3. Applicability domain: applicable to classify complex metal containing materials. Available input information: elemental composition and representative mineralogical information (no correction for bio availability)
4. Mechanistic interpretation - metal species:  the tool translates the elemental composition into a mineralogical composition relevant for classification (ie distribution pattern for each element/constituent of the UVCB substance). The classification is derived (by means of the Additivity formula) without taking into account any bio availability correction.   Adequacy of prediction: the substance falls within the applicability domain described above and, therefore, the predicted value can be considered as reliable. The prediction is moreover conservative since only elemental composition and mineralogy is known, no bio elution data is available. Same conclusions apply to the prediction of the Acute Oral Toxicity Estimate.