Registration Dossier

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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

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