Registration Dossier

Administrative data

Endpoint:
repeated dose toxicity: oral
Remarks:
other: prediction from hazard class
Type of information:
calculation (if not (Q)SAR)
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 V5.2) classification for Slimes and sludges, electrolytic tin refining
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:
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
Chemical structure
Reference substance name:
Tin
EC Number:
231-141-8
EC Name:
Tin
Cas Number:
7440-31-5
Molecular formula:
Sn
IUPAC Name:
tin
Constituent 2
Chemical structure
Reference substance name:
Silver
EC Number:
231-131-3
EC Name:
Silver
Cas Number:
7440-22-4
Molecular formula:
Ag
IUPAC Name:
Silver
Constituent 3
Chemical structure
Reference substance name:
Antimony
EC Number:
231-146-5
EC Name:
Antimony
Cas Number:
7440-36-0
Molecular formula:
Sb
IUPAC Name:
antimony(3+)
Constituent 4
Chemical structure
Reference substance name:
Fluorine
EC Number:
231-954-8
EC Name:
Fluorine
Cas Number:
7782-41-4
Molecular formula:
F2
IUPAC Name:
fluorine
Constituent 5
Chemical structure
Reference substance name:
Lead
EC Number:
231-100-4
EC Name:
Lead
Cas Number:
7439-92-1
Molecular formula:
Pb
IUPAC Name:
lead
Constituent 6
Chemical structure
Reference substance name:
Arsenic
EC Number:
231-148-6
EC Name:
Arsenic
Cas Number:
7440-38-2
Molecular formula:
As
IUPAC Name:
arsenic
Constituent 7
Chemical structure
Reference substance name:
Nickel
EC Number:
231-111-4
EC Name:
Nickel
Cas Number:
7440-02-0
Molecular formula:
Ni
IUPAC Name:
nickel(2+)
Constituent 8
Chemical structure
Reference substance name:
Copper
EC Number:
231-159-6
EC Name:
Copper
Cas Number:
7440-50-8
Molecular formula:
Cu
IUPAC Name:
copper
Test material form:
solid: particulate/powder

Results and discussion

Effect levels

Dose descriptor:
other: target organ toxicity
Effect level:
other: at least one component has reliable and good quality evidence from human cases or epidemiological studies or animal studies with significant and/or severe toxic effects at low exposure concentrations
Basis for effect level:
other: not specified
Remarks on result:
other: calculations with MeClass-tool

Target system / organ toxicity

Critical effects observed:
not specified

Any other information on results incl. tables

According to MeClas, the substance is classified as STOT-RE Cat. 1 - H372.

Applicant's summary and conclusion

Conclusions:
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 1.2/1.4). 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.