Registration Dossier

Administrative data

Endpoint:
repeated dose toxicity: oral, other
Remarks:
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:
RESHS 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:
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:
Germanium dioxide
EC Number:
215-180-8
EC Name:
Germanium dioxide
Cas Number:
1310-53-8
Molecular formula:
GeO2
IUPAC Name:
Germanium dioxide
Constituent 2
Chemical structure
Reference substance name:
Germanium
EC Number:
231-164-3
EC Name:
Germanium
Cas Number:
7440-56-4
Molecular formula:
Ge
IUPAC Name:
germanium (metallic form) equivalent
Constituent 3
Chemical structure
Reference substance name:
Silicon dioxide
EC Number:
231-545-4
EC Name:
Silicon dioxide
Cas Number:
7631-86-9
Molecular formula:
O2Si
IUPAC Name:
dioxosilane equivalent
Constituent 4
Chemical structure
Reference substance name:
Sodium chloride
EC Number:
231-598-3
EC Name:
Sodium chloride
Cas Number:
7647-14-5
Molecular formula:
ClNa
IUPAC Name:
sodium chloride
Constituent 5
Chemical structure
Reference substance name:
Aluminium oxide
EC Number:
215-691-6
EC Name:
Aluminium oxide
Cas Number:
1344-28-1
Molecular formula:
Al2O3
IUPAC Name:
Aluminium oxide equivalent
Constituent 6
Chemical structure
Reference substance name:
Calcium oxide
EC Number:
215-138-9
EC Name:
Calcium oxide
Cas Number:
1305-78-8
Molecular formula:
CaO
IUPAC Name:
Calcium oxide equivalent
Constituent 7
Chemical structure
Reference substance name:
Lead oxide
EC Number:
215-626-1
EC Name:
Lead oxide
Cas Number:
1335-25-7
Molecular formula:
PbO
IUPAC Name:
Lead oxide equivalent
Constituent 8
Chemical structure
Reference substance name:
Nickel monoxide
EC Number:
215-215-7
EC Name:
Nickel monoxide
Cas Number:
1313-99-1
Molecular formula:
NiO
IUPAC Name:
Nickel (II) oxide equivalent
Constituent 9
Chemical structure
Reference substance name:
Copper oxide
EC Number:
215-269-1
EC Name:
Copper oxide
Cas Number:
1317-38-0
Molecular formula:
CuO
IUPAC Name:
copper (II) oxide equivalent
Test material form:
solid

Results and discussion

Effect levels

Basis for effect level:
other: target organ toxicity
Remarks on result:
other: at least one component with animal studies with significant and/or severe toxic effects at moderate exposure concentration

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. 2 - H373.

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. 2.
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.