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Diss Factsheets

Administrative data

Endpoint:
fish life cycle toxicity
Type of information:
calculation (if not (Q)SAR)
Remarks:
Migrated phrase: estimated by calculation
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:
2013

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 EC10/NOEC range.

Test material

Constituent 1
Reference substance name:
Matte leaching residue 1, 2, 3
IUPAC Name:
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

Vehicle:
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

Hardness:
Not applicable
Test temperature:
Not applicable
pH:
Not applicable
Dissolved oxygen:
Not applicable
Salinity:
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
Duration:
28 d
Dose descriptor:
NOEC
Effect conc.:
<= 0.1 mg/L
Nominal / measured:
estimated
Conc. based on:
test mat.
Basis for effect:
other: most sensitive species
Details on results:
The substance is classified as aquatic chronic category 1 resulting in a EC10/NOEC < 0.01 mg/L (rapidly degradable UVCB) and < 0.1 mg/L (non-rapidly degradable UVCB). EC10/NOEC < 0.1 mg/L was selected since this covers both rapidly and non rapidly degradable UVCBs.
Results with reference substance (positive control):
Not applicable
Reported statistics and error estimates:
Not applicable

Any other information on results incl. tables

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

Applicant's summary and conclusion

Validity criteria fulfilled:
yes
Conclusions:
Good quality estimate of the EC10/NOEC of the UVCB substance.
The substance is classified as aquatic chronic category 1 resulting in an EC10/NOEC <= 0.1 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

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