Lithium Nickel Cobalt Aluminium Oxide

Developmental toxicity / teratogenicity

Administrative data

Endpoint:

developmental toxicity

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-reference

Cross-reference 1

Reason / purpose for cross-reference:

reference to same study

Cross-reference 2

Reason / purpose for cross-reference:

reference to other study

Data source

Reference

Reference Type:

other: software

Title:

Unnamed

Year:

2014

Materials and methods

Principles of method if other than guideline:

Developmental potential of NCA (generic composition) 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.

GLP compliance:

no

Remarks:

other quality assurance was applied

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.

Test animals

Species:

other: Calculated with MeClas

Results and discussion

Results: maternal animals

Effect levels (maternal animals)

Remarks on result:

not measured/tested

Remarks:

Calculated with MeClas

Results (fetuses)

Effect levels (fetuses)

Remarks on result:

not measured/tested

Remarks:

Calculated with MeClas

Fetal abnormalities

Abnormalities:

not specified

Overall developmental toxicity

Developmental effects observed:

not specified

Applicant's summary and conclusion

Conclusions:

The assessment of the developmental toxicity properties of NCA is based on the development toxicity 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). According to MeClas, the assessed generic NCA composition is classified for the developmental endpoint (Cat.1). This classification is determined by the presence of CoO

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.