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Administrative data

Endpoint:
skin sensitisation: in vitro
Remarks:
prediction from hazard class
Type of information:
calculation (if not (Q)SAR)
Remarks:
estimated by calculation
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Automatic calculation with MeClas tool
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:
MECLAS: Metals Classification Tool, version V5.0
Author:
ARCHE Consulting
Year:
2018
Bibliographic source:
MECLAS webpage: www.meclas.eu
Report date:
2018

Materials and methods

Principles of method if other than guideline:
Skin sensitisation potential of the UVCB potential was determined by classifying based on Mixture rules from EU CLP (additivity formula of classified components to derive hazard class). The classification criteria were used to estimate effects.

Test material

Constituent 1
Reference substance name:
Slags, lead reverbatory smelting
EC Number:
273-800-2
EC Name:
Slags, lead reverbatory smelting
Cas Number:
69029-58-9
Molecular formula:
Molecular weight/formula concept not applicable to Inorganic UVCB (complex metal containing substance)
IUPAC Name:
Slags, lead reverbatory smelting
Details on test material:
Reasonable worst-case across industry, as reported in Section 1.2.
Representative sample for mineralogical information is provided in IUCLID Section 4.27.

Results and discussion

In vitro / in chemico

Results
Remarks on result:
other: classification based on MeClas calculation

Any other information on results incl. tables

According to MeClas, the substance does not meet the criteria for classification as a skin sensitiser.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Remarks:
classification based on MeClas calculation
Conclusions:
Good quality study with result derived on basis of the Classification outcome (Mixture toxicity rules) from the reasonable worst case sample of the substance (maximum of typicals across industry as defined in IUCLID section 1.2/4.27). The analysed UVCB sample does not meet the criteria for classification as a skin sensitiser.
Executive summary:

The study provided a conservative estimate, derived on basis of the classification outcome (mixture toxicity rules) from a reasonable worst-case sample of the substance using mineralogical information from the representative sample. 

 

Validity of the model used:

1. Defined endpoint: the endpoint is a REACH compliant defined endpoint

2. Unambiguous algorithm: EU CLP guidance based summation formula to determine classification, followed by back-calculation to related hazard criteria

3. Applicability domain: applicable to classify complex metal containing materials. 

4. Mechanistic interpretation - metal species: the tool translates the elemental composition into a mineralogical composition relevant for classification.

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