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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Endpoint:
acute toxicity: inhalation
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:
Acute inhalation 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

Constituent 1
Reference substance name:
Automatically generated during migration to IUCLID 6, no data available
IUPAC Name:
Automatically generated during migration to IUCLID 6, no data available
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:
> 2 500 - <= 20 000 other: ppmV
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 toxicity inhalation Category 4; H332'. The key driver for acute toxicity (inhalation) 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 inhalation (Acute Toxicity Point Estimate) (see EU CLP Guidance Annex I Table 3.1.2): 4500 ppmV.

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) inhalation" of the UVCB substance. The derived classification result (via application of mixture toxicity rules) for both grades defined in section 1.2 is 'Acute toxicity inhalation Category 4; H332' resulting in an ATE of 4500 ppmV. The key driver for acute toxicity (inhalation) 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-inhalation 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-inhalation Category 4; H332"resulting in an ATE of 4500 ppmV. The key driver for acute toxicity (inhalation) 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-inhalation
  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 Inhalation Toxicity Estimate.