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Toxicological information

Skin sensitisation

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Administrative data

Endpoint:
skin sensitisation: in vivo (LLNA)
Type of information:
calculation (if not (Q)SAR)
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
accepted calculation method
Justification for type of information:
The assessment entity approach was used for the classification of NCA; this endpoint is assessed on the basis of the toxicological properties of the relevant constituents (= assessment entities) of the UVCB.
Cross-reference
Reason / purpose for cross-reference:
reference to same 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

Test guideline
Qualifier:
according to guideline
Guideline:
other: CLP Regulation 1272/2008 - Annex I (mixture rules)
Principles of method if other than guideline:
The skin sensitization potential of NCA (generic worst-case composition) was determined by classifying based on Mixture rules from EU CLP.
GLP compliance:
not specified

Test material

Constituent 1
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
Constituent 2
Chemical structure
Reference substance name:
Cobalt
EC Number:
231-158-0
EC Name:
Cobalt
Cas Number:
7440-48-4
Molecular formula:
Co
IUPAC Name:
cobalt(2+)
Constituent 3
Chemical structure
Reference substance name:
Lithium
EC Number:
231-102-5
EC Name:
Lithium
Cas Number:
7439-93-2
Molecular formula:
Li
IUPAC Name:
lithium
Constituent 4
Chemical structure
Reference substance name:
Aluminium
EC Number:
231-072-3
EC Name:
Aluminium
Cas Number:
7429-90-5
Molecular formula:
Al
IUPAC Name:
aluminum
Test material form:
solid: particulate/powder
Details on test material:
Composition represents the lowest and highest possible concentration of each individual constituent in NCA (estimated by Monte Carlo simulation, taking into account the following ranges of variability:
Sum of of Ni+Co+Al = approx. 1
Li =0.9-1.3
Ni: 0.75-0.99
Co: 0.01-0.2
Al: 0.01-0.2
A more detailed composition can be provided by the data holder, but is not defined in this record as this represents sensitive business information that cannot be shared with co-registrants. The composition, however, fits into the agrees Substance Identity Profile.

Results and discussion

In vivo (LLNA)

Results
Key result
Remarks on result:
other: A reliable assessment, based on the CLP mixture rules and using the MeClas Classification Tool, was conducted on a generic NCA sample. The assessed generic NCA composition is classified a Skin Sensitizer, Cat. 1.

Applicant's summary and conclusion

Interpretation of results:
Category 1 (skin sensitising) based on GHS criteria
Conclusions:
The assessment of the skin sensitizing properties of NCA is based on the skin sensitizing properties of its constituents (oxide forms of Al, Co, Li, Ni) (Assessment Entity Approach).
A reliable assessment, based on the CLP mixture rules and using the MeClas Classification Tool, was conducted on a generic NCA sample (composition based on worst-case concentrations for each constituent, as defined in IUCLID section 1.2). The assessed generic NCA composition is classified a Skin Sensitizer, Cat. 1.

Executive summary:

The study provides a conservative estimate of the effect concentration, 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.