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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Endpoint:
skin sensitisation, 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:
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:
Skin sensitisation 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.

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 equivalent
Constituent 2
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 3
Chemical structure
Reference substance name:
Diiron trioxide
EC Number:
215-168-2
EC Name:
Diiron trioxide
Cas Number:
1309-37-1
Molecular formula:
Fe2O3
IUPAC Name:
diiron trioxide
Constituent 4
Chemical structure
Reference substance name:
Triiron tetraoxide
EC Number:
215-277-5
EC Name:
Triiron tetraoxide
Cas Number:
1317-61-9
Molecular formula:
Fe3O4
IUPAC Name:
Iron oxide
Constituent 5
Chemical structure
Reference substance name:
Calcium carbonate
EC Number:
207-439-9
EC Name:
Calcium carbonate
Cas Number:
471-34-1
Molecular formula:
CH2O3.Ca
IUPAC Name:
calcium carbonate
Constituent 6
Chemical structure
Reference substance name:
Magnesium carbonate
EC Number:
208-915-9
EC Name:
Magnesium carbonate
Cas Number:
546-93-0
Molecular formula:
CH2O3.Mg
IUPAC Name:
Magnesium carbonate equivalent
Constituent 7
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 equivalent
Constituent 8
Chemical structure
Reference substance name:
Calcium fluoride
EC Number:
232-188-7
EC Name:
Calcium fluoride
Cas Number:
7789-75-5
Molecular formula:
CaF2
IUPAC Name:
Calcium fluoride equivalent
Constituent 9
Chemical structure
Reference substance name:
Selenium
EC Number:
231-957-4
EC Name:
Selenium
Cas Number:
7782-49-2
Molecular formula:
Se
IUPAC Name:
Selenium equivalent
Constituent 10
Chemical structure
Reference substance name:
Chromium (III) oxide
EC Number:
215-160-9
EC Name:
Chromium (III) oxide
Cas Number:
1308-38-9
Molecular formula:
Cr2O3
IUPAC Name:
Chromium (III) oxide equivalent
Constituent 11
Chemical structure
Reference substance name:
Zinc oxide
EC Number:
215-222-5
EC Name:
Zinc oxide
Cas Number:
1314-13-2
Molecular formula:
OZn
IUPAC Name:
Zinc oxide equivalent
Constituent 12
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 13
Chemical structure
Reference substance name:
Diarsenic trioxide
EC Number:
215-481-4
EC Name:
Diarsenic trioxide
Cas Number:
1327-53-3
Molecular formula:
As2O3
IUPAC Name:
Diarsenic trioxide equivalent
Constituent 14
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 15
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
Constituent 16
Chemical structure
Reference substance name:
Tricobalt tetraoxide
EC Number:
215-157-2
EC Name:
Tricobalt tetraoxide
Cas Number:
1308-06-1
Molecular formula:
Co3O4
IUPAC Name:
Tricobalt tetraoxide equivalent
Constituent 17
Chemical structure
Reference substance name:
Disilver oxide
EC Number:
243-957-1
EC Name:
Disilver oxide
Cas Number:
20667-12-3
Molecular formula:
Ag2O
IUPAC Name:
Disilver oxide equivalent
Test material form:
solid: particulate/powder

Results and discussion

In vitro / in chemico

Results
Key result
Remarks on result:
no indication of skin sensitisation
Remarks:
Skin sensitisation 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.

Any other information on results incl. tables

According to MeClas, the substance is not classified as Skin sensitiser.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
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 sections 1.2/1.4). The analysed UVCB sample is not classified for skin sensitisation.
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.