Registration Dossier

Diss Factsheets

Administrative data

short-term toxicity to fish
Type of information:
calculation (if not (Q)SAR)
Migrated phrase: estimated by calculation
Adequacy of study:
key study
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 Type:
other: software

Materials and methods

Principles of method if other than guideline:
Aquatic toxicity of the UVCB substance was determined by classifying based on mixture rules from EU CLP (Tier 1: summation of classified components or Tier 2: additivity of soluble components to derive Hazard class) and back calculation to the corresponding L(E)C50 range.

Test material

Constituent 1
Reference substance name:
Matte leaching residue 1, 2, 3
Matte leaching residue 1, 2, 3
Details on test material:
Reasonable worst-case across industry, as reported in Section 1.2.
Representative sample for mineralogical information is provided in IUCLID Section 4.23.
Specific details on test material used for the study:
Details on properties of test surrogate or analogue material (migrated information):
Not applicable

Sampling and analysis

Analytical monitoring:
not required
Details on sampling:
Not applicable

Test solutions

not specified
Details on test solutions:
Not applicable

Test organisms

Test organisms (species):
no data
Details on test organisms:
Not applicable

Study design

Test type:
not specified
Water media type:
not specified
Post exposure observation period:
Not applicable

Test conditions

Not applicable
Test temperature:
Not applicable
Not applicable
Dissolved oxygen:
Not applicable
Not applicable
Nominal and measured concentrations:
Not applicable
Details on test conditions:
Not applicable
Reference substance (positive control):
not required

Results and discussion

Effect concentrations
96 h
Dose descriptor:
Effect conc.:
<= 1 mg/L
Nominal / measured:
Conc. based on:
test mat.
Basis for effect:
other: most sensitive species
Details on results:
Not applicable
Results with reference substance (positive control):
Not applicable
Reported statistics and error estimates:
Not applicable

Any other information on results incl. tables

Sublethal observations / clinical signs:

According to MeClas, the substance is classified as aquatic acute 1 under CLP.

Applicant's summary and conclusion

Validity criteria fulfilled:
Good quality estimate of the L/EC50 of the UVCB substance.
The substance is classified as aquatic acute category 1 under CLP, resulting in an 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 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