Registration Dossier

Administrative data

Endpoint:
long-term toxicity to fish
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:
reference to same study
Reason / purpose:
reference to other study

Data source

Reference
Reference Type:
other: software
Title:
Unnamed
Year:
2019

Materials and methods

Principles of method if other than guideline:
Aquatic toxicity of NMC (typical composition) was determined by classifying based on Mixture rules from EU CLP (Tier 2 = additivity of soluble components (T/Dp data) to derive Hazard class) and back calculation to the corresponding EC10/NOEC range

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Type:
Constituent
Type:
Constituent
Test material form:
solid: particulate/powder
Details on test material:
Composition represents a typical concentration of each individual consituent in NMC; oiy should be noted that the composition of actual NMC always meets the following stoechiometric criteria: Ni+Co+Mn = 1, Li =1-1.1, and O=2

Results and discussion

Effect concentrations
Duration:
28 d
Dose descriptor:
NOEC
Effect conc.:
> 0.1 - <= 1 mg/L
Nominal / measured:
estimated
Conc. based on:
test mat.
Basis for effect:
other: most sensitive species

Any other information on results incl. tables

According to MeClas, the substance is classified as Aq.Chronic Cat.3 to the environment.

Applicant's summary and conclusion

Validity criteria fulfilled:
yes
Conclusions:
Good quality estimate of the EC10/NOEC of NMC - typical composition.
The substance is classified as Aq.Chronic Cat.3 to the environment resulting in a EC10/NOEC <= 1 mg/L.
Executive summary:

The study provided a conservative estimate of the effect concentration, derived on basis of the classification outcome (mixture toxicity rules) from a typical NMC sample of the substance using dissolution data that were generated with an NMC-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 soluble composition relevant for classification.