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Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation: in vitro / ex vivo
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:
Unnamed
Year:
2020

Materials and methods

Principles of method if other than guideline:
Skin irritation/corrosion 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.
GLP compliance:
no
Remarks:
other quality assurance was applied

Test material

Constituent 1
Reference substance name:
Lead alloy, base, Pb,Sn, dross
EC Number:
273-701-4
EC Name:
Lead alloy, base, Pb,Sn, dross
Cas Number:
69011-60-5
Molecular formula:
Molecular weight/formula concept not applicable to Inorganic UVCB (complex metal containing substance)
IUPAC Name:
Lead alloy, base, Pb,Sn, dross
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

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

Any other information on results incl. tables

According to MeClas, the General Grade is classified as Skin Irrit. 2.

Applicant's summary and conclusion

Interpretation of results:
Category 2 (irritant) based on GHS criteria
Remarks:
classification based on MeClas calculation
Conclusions:
Good quality study with result derived on basis of the classification outcome (mixture toxicity rules) from a conservative, worst-case, sample of the substance (using max. of max As, Cd, Pb, Ni and Sb and max. of typicals for other elements across industry as defined in IUCLID section 1.2/4.27). The analysed UVCB sample, General Grade, is classified Skin Irrit. 2.
Executive summary:

The study provided a conservative estimate, derived on basis of the classification outcome (mixture toxicity rules) from a worst-case sample of the General Grade 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.