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Toxicological information

Developmental toxicity / teratogenicity

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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-referenceopen allclose all
Reason / purpose for cross-reference:
reference to same study
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 oxide 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

impurity 1
Reference substance name:
Total unspecified impurities
IUPAC Name:
Total unspecified impurities
Constituent 1
Reference substance name:
Cobalt Nickel Manganese Oxide
Cas Number:
37348-84-8
Molecular formula:
Ni1-x-yMnxCoyOz with Me=Ni+Mn+Co=1 and Ni/Me= 0.45-0.98 Mn/Me= 0.01-0.35 Co/Me= 0.01-0.35 O/Me= 1.00-1.33
IUPAC Name:
Cobalt Nickel Manganese Oxide
Test material form:
solid

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 oxide 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.

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