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Administrative data

Endpoint:
short-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 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:
2014

Materials and methods

Principles of method if other than guideline:
Aquatic toxicity of NCA (generic sample) was determined by classifying based on Mixture rules from EU CLP ( Tier 2 = additivity of soluble components to derive Hazard class) and back calculation to the corresponding L(E)C50 range

Test material

Constituent 1
Chemical structure
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
Chemical structure
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
Chemical structure
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
Chemical structure
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.

Results and discussion

Effect concentrations
Key result
Duration:
96 h
Dose descriptor:
EC50
Effect conc.:
> 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

Sublethal observations / clinical signs:

According to MeClas, the substance is not classified to environment (acute).

Applicant's summary and conclusion

Validity criteria fulfilled:
yes
Conclusions:
Good quality estimate of the L/EC50 of NCA - generic composition.
The substance is not classified as acute Cat 1 to environment resulting in a L(E)C50 > 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 reasonable worst-case sample of the substance using dissolution data that were generated with an NCA-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.