Lithium Nickel Cobalt Aluminium Oxide

Skin sensitisation

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

Test material information

Constituent 1

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

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

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

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.