Cobalt Lithium Manganese Nickel Oxide

Genetic toxicity: in vitro

Administrative data

Endpoint:

in vitro gene mutation study in bacteria

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:

Genetic toxicity potential of NMC (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.

Type of assay:

other: prediction from hazard class

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:

Manganese

EC Number:

231-105-1

EC Name:

Manganese

Cas Number:

7439-96-5

Molecular formula:

Mn

IUPAC Name:

Manganese

Constituent 4

Reference substance name:

Lithium

EC Number:

231-102-5

EC Name:

Lithium

Cas Number:

7439-93-2

Molecular formula:

Li

IUPAC Name:

lithium

Test material form:

solid: particulate/powder

Details on test material:

Composition represents the highest possible concentration of each individual constituent in NMC (estimated by Monte Carlo simulation, taking into account that the sum (stoechiometric) of Ni+Co+Mn = 1, Li =1-1.1, and O=2

Results and discussion

Remarks on result:

not measured/tested

Remarks:

Calculated with MeClas

Any other information on results incl. tables

According to MeClas, the substance is not classified as germ cell mutagen.

Applicant's summary and conclusion

Conclusions:

Interpretation of results (migrated information):
negative

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 1.2/4.23). The assessed generic NMC composition is not classified for germ cell mutagenicity.

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.