Nickel Cobalt Manganese Hydroxide

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:

2020

Materials and methods

Principles of method if other than guideline:

Developmental potential of pNMC hydroxide was determined by classifying based on Mixture rules from EU CLP (additivity formula of classified components to derive hazard classification). The classification criteria were used to estimate effects.

GLP compliance:

no

Remarks:

other quality assurance was applied

Test material

Test material information

1

Reference substance name:

Nickel Cobalt Manganese Hydroxide

EC Number:

839-353-8

Cas Number:

189139-63-7

Molecular formula:

Molecular formula: Ni1-x-yMnxCoy(OH)2, Stoechiometry of (Me = Ni + Co + Mn) equals 1, ranges of the elements approx. as: Ni/Me = 0.25 – 0.95 Mn/Me = 0.02 – 0.40 Co/Me = 0.02 – 0.40 OH = 2.00

IUPAC Name:

Nickel Cobalt Manganese Hydroxide

Constituent 1

Reference substance name:

Manganese dihydroxide

Cas Number:

18933-05-6

Molecular formula:

Mn(OH)2

IUPAC Name:

Manganese dihydroxide

Constituent 2

Reference substance name:

Cobalt dihydroxide

EC Number:

244-166-4

EC Name:

Cobalt dihydroxide

Cas Number:

21041-93-0

Molecular formula:

CoH2O2

IUPAC Name:

cobalt(2+) dihydroxide

Constituent 3

Reference substance name:

Nickel dihydroxide

EC Number:

235-008-5

EC Name:

Nickel dihydroxide

Cas Number:

12054-48-7

Molecular formula:

H2NiO2

IUPAC Name:

nickel(2+) dihydroxide

Test material form:

solid: particulate/powder

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

Any other information on results incl. tables

According to MeClas, the substance is classified as a Developmental Toxicant, Cat. 1B.

Applicant's summary and conclusion

Conclusions:

Good quality study with result derived on basis of the Classification outcome (Mixture toxicity rules) from the reasonable worst case sample of the substance (maximum of typicals across industry as defined in IUCLID section 1.2/4.23). The assessed generic pNMC hydroxide composition is classified for developmental toxicity, Cat. 1B.

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.