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EC number: 256-050-0 | CAS number: 43035-18-3
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Sediment toxicity
Administrative data
- Endpoint:
- sediment toxicity: long-term
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2008-05-26 - 2008-06-26
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline study compliant to GLP
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 009
- Report date:
- 2009
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: OECD 225: Sediment-Water Lumbriculus Toxicity Test Using Spiked Sediment (October 2007)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- according to German Chemikaliengesetz and Directive 88/320/EEC
Test material
- Reference substance name:
- Calcium bis[4-[[3-[[2-hydroxy-3-[[(4-methoxyphenyl)amino]carbonyl]-1-naphthyl]azo]-4-methylbenzoyl]amino]benzenesulphonate]
- EC Number:
- 256-050-0
- EC Name:
- Calcium bis[4-[[3-[[2-hydroxy-3-[[(4-methoxyphenyl)amino]carbonyl]-1-naphthyl]azo]-4-methylbenzoyl]amino]benzenesulphonate]
- Cas Number:
- 43035-18-3
- Molecular formula:
- C32H26N4O7S.1/2Ca
- IUPAC Name:
- calcium bis(4-{[3-({2-hydroxy-3-[(4-methoxyphenyl)carbamoyl]-1-naphthyl}diazenyl)-4-methylbenzoyl]amino}benzenesulfonate)
- Test material form:
- solid: nanoform, no surface treatment
Constituent 1
Sampling and analysis
- Analytical monitoring:
- no
Test substrate
- Vehicle:
- yes
- Details on sediment and application:
- PREPARATION OF SPIKED SEDIMENT
- Details of spiking: The test substance concentration was weighed out, dissolved in 15 mL acetone and mixed thoroughly with 60 g quartz sand (10 g sand per replicate) in a glass vessel. After complete evaporation of the solvent, the dry quartz sand was given to the sediment. Residues of the dry quartz sand sticking at the glass vessel were rinsed off with 50 mL demineralised water per treatment. Thereafter, the sediment was thoroughly mixed with a long handled blender for at least three minutes and filled into the test vessel.
- Equilibration time: 2 Days prior to insertion of test organisms
- Equilibration conditions: Same as test
- Controls: Controls with test sediment and quartz sand. Vehicle controls with test sediment and quartz sand treated with acetone.
- Chemical name of vehicle (organic solvent, emulsifier or dispersant): organic solvent acetone
- Concentration of vehicle in test medium (stock solution and final test solution): 15 mL per 60 g quartz sand (6 replicates)
- Evaporation of vehicle before use: Yes, complete evaporation
Test organisms
- Test organisms (species):
- Lumbriculus variegatus
- Details on test organisms:
- TEST ORGANISM
- Common name: Lumbriculus variegatus (Müller), Lumbriculidae, Oligochaeta
- Source: Bundesanstalt für Gewässerkunde (BfG), Am Mainzer Tor 1, 56068 Koblenz, Germany
- Age of parental stock (mean and range, SD): Synchronized from cultured organisms 13 days before test insertion
- Breeding conditions: 20 +/- 2 °C, diffuse light (100 - 1000 lx, 16 h photoperiod) dissolved oxygen concentration > 60 % of the air saturation value
- Handling of egg masses and larvae: 13 days before insertion into the test, the worms were synchronized. Therefore a sufficient amount of worms was taken from the breeding and cutted into half. After regeneration of heads, the worms were inserted into the test.
- Age of animals at beginning of exposure: 13 days after synchronization, completely regenerated head region. Synchronization was done to minimize uncontrolled regeneration and reproduction during the test.
- Feeding during test
- Food type: Powder of Urtica dioica (Heinrich Klein GmbH & Co KG, 97525 Schwebheim, Germany)
- Amount:0.5 % Urtica powder
- Frequency: Urtica powder was mixed into the sediment once at test start.
ACCLIMATION
- Acclimation period: 13 days (after synchronization)
- Acclimation conditions (same as test or not): Same as test
- Type and amount of food: Same as test
- Feeding frequency: Same as test (Once)
- Health during acclimation (any mortality observed): No mortality observed
Study design
- Study type:
- laboratory study
- Test type:
- static
- Water media type:
- freshwater
- Type of sediment:
- artificial sediment
- Limit test:
- yes
Exposure duration
- Duration:
- 28 d
- Exposure phase:
- total exposure duration
Test conditions
- Hardness:
- Day 0: Control: >356 mg/L CaCO3, Solvent control: 340 mg/L CaCO3, 1000 mg test substance/kg sediment DW: >356 mg/L CaCO3
Day 28: Control: >356 mg/L CaCO3, Solvent control: >356 mg/L CaCO3, 1000 mg test substance/kg sediment DW: >356 mg/L CaCO3 - Test temperature:
- Day Parameter Treatment
Control Solvent Control 1000 mg/kg sediment DW
0 Temperature [°C] 21.1 21.0 20.8
7 Temperature [°C] 21.9 21.2 21.4
14 Temperature [°C] 22.0 20.2 20.5
21 Temperature [°C] 21.8 21.8 21.9
28 Temperature [°C] 21.8 21.2 21.2 - pH:
- Day Parameter Treatment
Control Solvent Control 1000 mg/kg sediment DW
0 pH 7.74 7.82 7.86
7
pH 7.86 7.86 7.96
14
pH 7.76 7.79 7.91
21
pH 7.58 7.87 7.95
28
pH 8.22 8.27 8.28 - Dissolved oxygen:
- Day Parameter Treatment
Control Solvent Control 1000 mg/kg sediment DW
0 O2 [mg/L] 6.16 6.78 6.51
7
O2 [mg/L] 6.06 6.05 6.11
14
O2 [mg/L] 6.90 6.22 6.79
21
O2 [mg/L] 7.37 7.11 7.07
28
O2 [mg/L] 7.30 8.04 8.30 - Salinity:
- not measured, freshwater conditions
- Ammonia:
- Day Parameter Treatment
Control Solvent Control 1000 mg/kg sediment DW
0 NH4-N [mg/L] 0.803 0.622 0.810
2 NH4-N [mg/L] 0.114 < 0.02* 0.021
5 NH4-N [mg/L] 0.039 0.031 0.132
8 NH4-N [mg/L] 0.045 0.039 0.042
9 NH4-N [mg/L] 0.091 0.050 0.039
12 NH4-N [mg/L] 0.064 0.060 0.129
15 NH4-N [mg/L] 0.089 0.241 0.110
16 NH4-N [mg/L] 1.03 0.715 0.085
19 NH4-N [mg/L] > 2.5* > 2.5* > 2.5*
21 NH4-N [mg/L] 5.71 5.35 4.33
23 NH4-N [mg/L] 4.84 4.75 4.86
26 NH4-N [mg/L] 6.91 6.01 7.79
28 NH4-N [mg/L] 6.76 6.58 5.87
- Nominal and measured concentrations:
- 1000 mg test substance/kg sediment DW
- Details on test conditions:
- TEST SYSTEM
- Test container (material, size): 250 mL glass beakers, 6 cm in diameter
- Sediment volume: 45 g DW per vessel, ca. 2 cm from the ground
- Overlying water volume: 150 mL
- Depth of sediment and overlying water: sediment depth ca. 2 cm, water depth ca. 10 cm
- Aeration: yes
- Aeration frequency and intensity: Gentle aeration (2 bubbles per second)
- Replacement of evaporated test water, if any: Yes, once weekly
EXPOSURE REGIME
- No. of organisms per container (treatment): 10 per container (60 per treatment)
- No. of replicates per treatment group: 6 replicates per treatment group
- No. of replicates per control / vehicle control: 6 replicates per control/vehicle control
- Feeding regime: Once at test start
- Type and preparation of food: Powder of Urtica dioica mixed into the sediment before insertion of test organisms
- Amount of food: 0.5 %
OVERLYING WATER CHARACTERISTCS
- Type of water (e.g. deionized, ground water, sea water, Elendt medium acc. to OECD 219): Reconstituted water acc. to OECD 203
CHARACTERIZATION OF (ARTIFICIAL; delete if not applicable) SEDIMENT
- Composition (if artificial substrate): 5 % peat air dried and finely ground, 20 % kaolin, 75 % quartz sand, 0.33 % calcium carbonate
Table 1: Sediment Properties at Test Start
Total Organic Carbon [%] pH-value Moisture [%]
Sediment at test start 2.15 6.74 8.29
OTHER TEST CONDITIONS
Table 2: Environmental Conditions
Room temperature [°C] Photoperiod [h] Light intensity [lx]
Nominal 20 +/- 2 16 100 - 1000
Actual 18 ¿ 21 16 472 ± 47.2
EFFECT PARAMETERS MEASURED (with observation intervals if applicable) :
Mortality and behavioural changes (Day 0-28), reproduction and biomass at test end (28 d)
VEHICLE CONTROL PERFORMED: yes
TEST CONCENTRATIONS
1000 mg test substance/kg sediment DW
- Range finding study
- Test concentrations: 10 - 100 - 1000 mg/kg sediment DW
- Results used to determine the conditions for the definitive study:
Concentration Mortality Mean number of worms Mean dry weight
[mg test item/kg sediment DW] [%] [mg]
Control 0 13.5 14.7
Solv. Control 0 14.5 16.0
10 0 12.0 12.0
100 0 14.0 14.3
1000 0 13.0 12.9 - Reference substance (positive control):
- no
Results and discussion
Effect concentrationsopen allclose all
- 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:
- mortality
- 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:
- behaviour
- 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:
- biomass
- 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:
- reproduction
- Details on results:
- - Mortality of test animals at end of exposure period: No mortality
- Total mass of test animals at beginning of test: 10 worms were equal to ca. 45.8 mg wet mass
- Changes in body weigthH58 of live adults (% of initial weight) at end of exposure period:
Table 1: Worm Dry Biomass after 28 Days of Exposure
Nominal conc. [mg/kg sediment DW] Dry weight [mg]
Replicate per Repl. Significance* per worm
1 2 3 4 5 6 MV ¿ SD MV ¿ SD
Control 7.10 12.7 18.2 14.0 13.5 13.0 14.8 ± 3.27 - 0.65 ± 0.12
Solvent Control 15.5 20.3 14.9 15.7 16.7 16.0
1000 11.5 16.9 14.2 13.7 15.8 25.6 16.3 ± 4.93 No 0.69 ± 0.08
- No. of offspring produced:
Table 2: Reproduction after 28 days of Exposure
Nominal conc.
[mg/kg sediment DW] Number of incomplete worms
1 2 3 4 5 6 MV SD % Inhibition Significance*
Control 7 9 21 10 13 12 12.9 4.76 -
Solvent Control 11 22 15 16 9 10
1000 8 16 13 11 13 20 13.5 4.14 -4.52 No
- Morphological abnormalities: None
- Behavioural abnormalities: None - Reported statistics and error estimates:
- One Way Analysis of Variance (ANOVA, Dunnett¿s Method, Kruskal-Wallis) was carried out with worm numbers and biomass data for the determination of statistically significant differences compared to the pooled control. Prior to the ANOVA a normality test and an equal variance test were conducted. P-values for both normality and equal variance test were 0.05. The ¿-value (acceptable probability of incorrectly concluding that there is a difference) for ANOVA was ¿=0.05.
Any other information on results incl. tables
Mortality/Reproduction of worms:
After 28 days of exposure to the limit test item concentration the total number of worms did not differ significantly compared to the pooled control (Table 1). No significant mortality of complete worms was observed due to the exposure to the limit test item concentration of 1000 mg/kg sediment DW over a period of 28 days (Table 2). Also, the number of incomplete worms and thus the reproduction did not differ to the pooled control at test end (Table 3).
Table 1: Total Worm Number after 28 days of Exposure
Nominal conc. |
Total Number of Worms |
|||||||||
Day 28 |
||||||||||
[mg/kg sediment DW] |
1 |
2 |
3 |
4 |
5 |
6 |
MV |
SD |
% Inhibition |
Significance* |
Control |
17 |
19 |
31 |
20 |
23 |
22 |
22.9 |
4.76 |
- |
- |
Solvent Control |
21 |
32 |
25 |
26 |
19 |
20 |
||||
1000 |
17 |
26 |
23 |
21 |
23 |
30 |
23.3 |
4.41 |
-1.82 |
No |
Table 2: Mortality after 28 days of Exposure
Nominal conc. [mg/kg sediment DW] |
Total Number of Complete Worms |
|||||||||
1 |
2 |
3 |
4 |
5 |
6 |
MV |
SD |
% Mortality |
Significance* |
|
Control |
10 |
10 |
10 |
10 |
10 |
10 |
10 |
0 |
0 |
- |
Solvent Control |
10 |
10 |
10 |
10 |
10 |
10 |
||||
1000 |
9 |
10 |
10 |
10 |
10 |
10 |
9.8 |
0.41 |
2 |
No |
Table 3: Reproduction after 28 days of Exposure
Nominal conc. [mg/kg sediment DW] |
Number of incomplete worms |
|||||||||
1 |
2 |
3 |
4 |
5 |
6 |
MV |
SD |
% Inhibition |
Significance* |
|
Control |
7 |
9 |
21 |
10 |
13 |
12 |
12.9 |
4.76 |
- |
|
Solvent Control |
11 |
22 |
15 |
16 |
9 |
10 |
||||
1000 |
8 |
16 |
13 |
11 |
13 |
20 |
13.5 |
4.14 |
-4.52 |
No |
Behaviour and pathological symptoms
No difference in the worm behaviour was observed at the limit test item concentration of 1000 mg/kg sediment DW compared to the pooled control during the entire study (Table 4).
Table 4: Worm Behaviour during 28 Days of Exposure
Nominal conc. [mg/kg sediment DW] |
Effect |
Days after insertion (pooled replicates) |
||||||||||||
0 |
2 |
5 |
7 |
9 |
12 |
14 |
16 |
19 |
21 |
23 |
26 |
28 |
||
Control |
s) |
60 |
60 |
60 |
60 |
60 |
60 |
60 |
60 |
60 |
60 |
60 |
60 |
60 |
Solvent Control |
s) |
60 |
60 |
58 |
60 |
60 |
60 |
60 |
59 |
60 |
60 |
60 |
60 |
60 |
a) |
0 |
0 |
2 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
|
1000 |
s) |
60 |
60 |
58 |
60 |
60 |
60 |
60 |
60 |
60 |
60 |
60 |
60 |
59 |
a) |
0 |
0 |
2 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
t) |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
conc. = concentration DW = Dry Weight
s) = worm burrowing in sediment a) = worm on sediment surface t) = dead
Dry biomass of the worms
The dry biomass of the worms at the limit test item concentration of 1000 mg/kg sediment DW did not differ significantly to the pooled control (Table 5).
Table 5: Worm Dry Biomass after 28 Days of Exposure
Nominal conc. [mg/kg sediment DW] |
Dry weight [mg] |
||||||||
Replicate |
per Repl. |
Significance* |
per worm |
||||||
1 |
2 |
3 |
4 |
5 |
6 |
MV ± SD |
MV ± SD |
||
Control |
7.10 |
12.7 |
18.2 |
14.0 |
13.5 |
13.0 |
14.8 ± 3.27 |
- |
0.65 ± 0.12 |
Solvent Control |
15.5 |
20.3 |
14.9 |
15.7 |
16.7 |
16.0 |
|||
1000 |
11.5 |
16.9 |
14.2 |
13.7 |
15.8 |
25.6 |
16.3 ± 4.93 |
No |
0.69 ± 0.08 |
Applicant's summary and conclusion
- Validity criteria fulfilled:
- yes
- Conclusions:
- In this study the submission substance caused no significant effects on mortality, behaviour, biomass and reproduction at the limit test item concentration of 1000 mg/kg sediment DW. Thus, the NOEC was determined to be ¿ 1000 mg/kg sediment DW.
- Executive summary:
The effects of the submission substance on the oligochaete Lumbriculus variegatus in a water-sediment system were determined at Dr.U.Noack-Laboratorien, Sarstedt, Germany, from May 26th to June 26th, 2008. The study was carried out according to OECD Guideline 225 (2007). Test duration was 28 days after insertion of the test organisms. A limit test with the nominal test concentration of 1000 mg/kg sediment dry weight (DW) was performed by spiking the test item into the sediment. Six replicates per control, vehicle control and limit test item concentration with ten worms per replicate were set up. Water quality parameters as temperature, pH-value, O2-concentration, ammonia and total hardness were determined.
Due to the chemical properties of the test item the fraction of the pigment in the overlying water
as well as in the pore water can be neglected. Thus, no analytical verification of the test item
was performed.
After 28 days no significant mortality or behavioural changes of L. variegatus were observed at the limit test item concentration of 1000 mg/kg sediment DW. Also, the biomass was not significantly reduced compared to the pooled control after 28 days of exposure to the test item. L. variegatus reproduced without any significant differences between the pooled control and the limit test item concentration of 1000 mg/kg sediment DW (Table 1).
Table 1: Summary of all Significant Effects
Effects
Submission substance
Significance of effects
[mg/kg sediment DW]
Mortality
> 1000
Behaviour
> 1000
Biomass
> 1000
Reproduction
> 1000
NOEC
(mortality, behaviour, biomass, reproduction)
¿ 1000
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