Registration Dossier
Registration Dossier
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EC number: 267-291-6 | CAS number: 67828-72-2
Sediment toxicity
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:
- 2 010
- 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
- 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.
Constituent 1
- 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
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