Lead, dross, copper-rich

Genetic toxicity: in vitro

Administrative data

Endpoint:

in vitro gene mutation study in bacteria

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-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:

2020

Materials and methods

Principles of method if other than guideline:

Genetic toxicity 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.

Type of assay:

other: prediction from hazard class

Test material

Test material information

Constituent 1

Reference substance name:

Lead, dross, copper-rich

EC Number:

273-925-2

EC Name:

Lead, dross, copper-rich

Cas Number:

69227-11-8

Molecular formula:

Molecular weigth/formula concept not applicable to Inorganic UVCB (comlex metal containing substance)

IUPAC Name:

Lead, dross, copper-rich

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

Remarks on result:

other: classifcation based on MeClas calculation

Any other information on results incl. tables

According to MeClas, the General Grade of the substance are classified as germ cell mutagen Category 2 - H341.

Applicant's summary and conclusion

Conclusions:

Interpretation of results: Cat. 2 H341 predicted by MeClas.

Good quality study with result derived on basis of the classification outcome (mixture toxicity rules) from a conservative, worst-case sample of the substance (max. of max for As, Cd, Co, Cr, Pb, Ni, Sb, and max. of typicals for other elements) across industry as defined in IUCLID section 1.2/4.27.
According to MeClas, the analysed UVCB sample is not classified for germ cell mutagenicity.

Executive summary:

Good quality study with result derived on basis of the classification outcome (mixture toxicity rules) from a conservative, worst-case sample of the substance (max. of max for As, Cd, Co, Cr, Pb, Ni, Sb, and max. of typicals for other elements) across industry as defined in IUCLID section 1.2/4.27.

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