Registration Dossier

Ecotoxicological information

Sediment toxicity

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Administrative data

Endpoint:
sediment toxicity: long-term
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2010
Report date:
2010

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 225 (Sediment-Water Lumbriculus Toxicity Test Using Spiked Sediment)
GLP compliance:
yes (incl. QA statement)

Test material

Constituent 1
Chemical structure
Reference substance name:
Calcium 3-hydroxy-4-[(4-methyl-2-sulphonatophenyl)azo]-2-naphthoate
EC Number:
226-109-5
EC Name:
Calcium 3-hydroxy-4-[(4-methyl-2-sulphonatophenyl)azo]-2-naphthoate
Cas Number:
5281-04-9
Molecular formula:
C18H14N2O6S.Ca
IUPAC Name:
calcium 3-hydroxy-4-[(4-methyl-2-sulfonatophenyl)diazenyl]-2-naphthoate
Test material form:
solid: nanoform
Details on test material:
Test materials used in this dossier are all considered to fall under the definition of nano-materials according to the European Commission Recommendation 2011/696/EU as the synthesis and manufacturing of this pigment always yields particulate material with a fine particle size distribution.
Specific details on test material used for the study:
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: Room temperature, protected from moisture

Sampling and analysis

Analytical monitoring:
no

Test substrate

Vehicle:
no
Details on sediment and application:
PREPARATION OF SPIKED SEDIMENT
- Method of mixing: the test item was mixed with quartz sand subsequently the quartz sand was mixed with artificial sediment.
- Equilibration time: 2 days

Test organisms

Test organisms (species):
Lumbriculus variegatus
Details on test organisms:
TEST ORGANISM
- Source: Bundesanstalt fuer Gewaesserkunde (BfG), Koblenz, Germany
- Feeding during test: yes
- Food type: Urtica dioica powder (Heinrich KlenK GmbH & co. KG, Schwebheim, Germany)
- Amount: 0.4 % of sediment dry weight
- Frequency: the plant powder was mixed with the sediment before test start.

Study design

Study type:
laboratory study
Test type:
static
Water media type:
freshwater
Type of sediment:
artificial sediment
Exposure duration
Duration:
28 d
Exposure phase:
total exposure duration

Test conditions

Hardness:
3.07 mmol/L
Test temperature:
19.4 - 21.5 °C
pH:
7.58 - 8.52
Dissolved oxygen:
6.2 mg/L
Nominal and measured concentrations:
- Nominal test substance concentration: 1000 mg test item/kg sediment dry weight (based on range-finding study)
Details on test conditions:
TEST SYSTEM
- Test container: glass-beakers (6 cm diameter, 250 mL)
- Sediment volume: 45 g, 3cm
- Overlying water volume: 150 mL
- Aeration: yes, slight
- Replacement of evaporated test water, if any: yes

EXPOSURE REGIME
- No. of organisms per container: 10
- No. of replicates per treatment group: 6
- No. of replicates per control / vehicle control: 6
- Type and preparation of food: food was mixed with sediment before test start

CHARACTERIZATION OF ARTIFICIAL SEDIMENT
- Composition: 5% peat, 20% kaolin, 75% quartz sand, 0.47% calcium carbonate
- Moisture: 1.68 %
- pH dry matter and/or whole sediment: 6.85

OTHER TEST CONDITIONS
- Photoperiod: 16:8 h day/night regime
- Light intensity: 100-500 lux

EFFECT PARAMETERS MEASURED: mortality and reproduction

TEST CONCENTRATIONS
- Based on a range-finding study
- Test concentrations: 10, 100, 1000 mg/kg sediment dw
- Results used to determine the conditions for the definitive study: no mortality observed
Reference substance (positive control):
yes
Remarks:
potassium chloride

Results and discussion

Effect concentrations
Key result
Duration:
28 d
Dose descriptor:
NOEC
Effect conc.:
>= 1 000 mg/kg sediment dw
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
other: mortality, behaviour, biomass, reproduction
Results with reference substance (positive control):
The 28-day NOEC was determined to be 2.0 mg/kg

Applicant's summary and conclusion

Validity criteria fulfilled:
yes