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Administrative data

repeated dose toxicity: inhalation
other: predicted from hazard class
Type of information:
calculation (if not (Q)SAR)
Migrated phrase: estimated by calculation
Adequacy of study:
key study
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Automatic calculation with MECLAS tool
Reason / purpose for cross-reference:
reference to same study

Data source

Reference Type:
other: software
MECLAS: Metals Classification Tool, version V5.0
ARCHE Consulting
Bibliographic source:
MECLAS webpage:
Report date:

Materials and methods

Principles of method if other than guideline:
Grade 1 and Grade 2
Repeated dose toxicity potential of the UVCB 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:
Tin, melting residues
EC Number:
EC Name:
Tin, melting residues
Cas Number:
Molecular formula:
Not applicable
Tin, melting residues
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 4.23.

Results and discussion

Effect levels

Dose descriptor:
other: target organ toxicity
Basis for effect level:
other: no evidence
Remarks on result:
not measured/tested
Effect level not specified (migrated information)

Target system / organ toxicity

Critical effects observed:
not specified

Any other information on results incl. tables

According to MeClas, the substance is not classified.

Applicant's summary and conclusion

Good quality study with result derived on basis of the Classification outcome (Mixture toxicity rules) from the reasinable worst case sample of the substance (maximum of typicals across industry as defined in IUCLID section 1.2/4.23). The analysed UVCB sample is classified for STOT-RE Cat. 1.
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.

Cross-reference to other study
IUCLID Section 1.4 Analytical information:
• for company specific elemental composition of the UVCB substance
• for details on the approach followed for Tiered classification (strategies for sample selection and testing).
IUCLID Section 4.8 Water solubility
IUCLID Section 4.5 Particle size distribution
IUCLID Section 4.23 Additional Phys-chem info: chemical & mineralogical info of representative sample