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reaction mass of: tetrasodium 4-amino-6-(5-(2,6-difluoropyrimidin-4-ylamino)-2-sulfonatophenylazo)-5-hydroxy-3-(4-(sulfatoethylsulfonyl)phenylazo)naphthalene-2,7-disulfonate;tetrasodium 4-amino-6-(5-(4,6-difluoropyrimidin-2-ylamino)-2-sulfonatophenylazo)-5-hydroxy-3-(4-(2-sulfatoethylsulfonyl)phenylazo)naphthalene-2,7-disulfonate
EC number: 431-830-5 | CAS number: -
- 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
Long-term toxicity to aquatic invertebrates
Administrative data
Link to relevant study record(s)
- Endpoint:
- long-term toxicity to aquatic invertebrates
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 21 March 2001 to 11 April 2001
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
- Remarks:
- The study was conducted in accordance with the OECD test guideline 211 (Daphnia magna reproduction test) in compliance with GLP. However, only three test concentrations were employed (guideline requirement: 5), the test concentrations were too low for identifying an NOEC and LOEC, and the measured test substance concentration fluctuated between 84 and 196 % of nominal over the 21 duration of the study. This does not invalidate the study, but only limits its reliability. The concentration fluctuations were addressed during preparation of this study summary by calculating the mean measured concentration.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 211 (Daphnia magna Reproduction Test)
- GLP compliance:
- yes
- Analytical monitoring:
- yes
- Details on sampling:
- - Concentrations: 1, 3.2 and 10 mg/L and blank control
- Sampling method: No data
- Sampling frequency: Stock solution - days 0, 2, 5, 7, 9, 12, 14, 16 and 19
- Sampling frequency: Control - days 0, 7, 16 in new media and 2, 9, 19 in old media
- Sampling frequency: test concentrations - days 0, 7, 16 in new media and 2, 9, 19 in old media
- Sample storage conditions before analysis: No data - Vehicle:
- no
- Test organisms (species):
- Daphnia magna
- Details on test organisms:
- Test organism:
- Common name: not stated
- Strain: Bundesgesundheitsamt Berlin
- Maintenance and acclimation: a population of parthenogenetic females of synchronised age structure were maintained for more than 15 years in the test facility.
- Weight at study initiation (mean and range, SD): No data
- Method of breeding: In M4 medium with weekly partly renewal, at 20 ± 1 °C, 16:8 h light/dark cycle, feeding with unicellular algae (Scenedesmus subspicatus CHODAT) ad libitum.
- Feeding during test: Scenedesmus subpicatus CHODAT, day 1-7: 0.1 mg/C/Daphnia/day and day 8-21: 0.2 mg C/Daphnia/day - Test type:
- semi-static
- Water media type:
- freshwater
- Limit test:
- no
- Total exposure duration:
- 21 d
- Post exposure observation period:
- Not conducted
- Hardness:
- Overall the hardness of the dilution water ranged from 14.9 -15.9 °dH (=266-283.8 mg/L CaCO3) during the test
Measured hardness for control: 14.9-15.8 °dH
Measured hardness for 1 mg/L nominal concentration: not stated
Measured hardness for 3.2 mg/L nominal concentration: not stated
Measured hardness for 10 mg/L nominal concentration: 14.9-15.9 °dH - Test temperature:
- Nominal: 18-22 °C, mean ± 1 °C
Measured temperature for control: 18.5-20.2 °C
Measured temperature for 1 mg/L nominal concentration: not stated
Measured temperature for 3.2 mg/L nominal concentration: not stated
Measured temperature for 10 mg/L nominal concentration: 18.6 -20.3 °C - pH:
- Measured pH for control: 7.6-7.9
Measured pH for 1 mg/L nominal concentration: not stated
Measured pH for 3.2 mg/L nominal concentration: not stated
Measured pH for 10 mg/L nominal concentration: 7.6-7.9 - Dissolved oxygen:
- Measured oxygen concentration (saturation) for control: 7.5-9.3 mg/L (84.7-102.2 %)
Measured oxygen concentration (saturation) for 1 mg/L nominal concentration: not stated
Measured oxygen concentration (saturation) for 3.2 mg/L nominal concentration: not stated
Measured oxygen concentration (saturation) for 10 mg/L nominal concentration: 7.5-9.1 mg/L (84.4- 100.8%) - Salinity:
- No stated
- Nominal and measured concentrations:
- Nominal concentration: 1, 3.2 and 10 mg/L
Measured concentration: 8.4-19.6 mg/L (based on 1mg/L TOC is equivalent to 2.8 mg/L of test substance)
Only the 10 mg/L concentration was measured due to the limit of detection
- Intervals of water quality measurement control and test vessels: measured on day 0, 7 and 19 for old media (after renewal) and 2, 9 and 19 for new media (before renewal) - Details on test conditions:
- TEST SYSTEM
- Material, size, headspace, fill volume: Glass beaker, 150 mL, containing 100 mL test medium
- Aeration: No
- Renewal rate of test solution: renewal of test media on Mondays, Wednesdays and Fridays
- No. of organisms per vessel: 1
- No. of vessels per concentration (replicates): 10
- No. of vessels per control (replicates): 10
TEST MEDIUM/WATER PARAMETERS
- Source/preparation of dilution water: Reconstituted water (M4 medium)
- Culture medium different from test medium: Same media used for maintenance of test animals, preparation of stock and test solutions
OTHER TEST CONDITIONS
- Adjustment of pH: No data
- Photoperiod: 16:8 h (L/D)
- Light intensity: not exceeding 800 lux
EFFECT PARAMETERS MEASURED
- mortality and reproduction - Reference substance (positive control):
- no
- Duration:
- 21 d
- Dose descriptor:
- EC50
- Effect conc.:
- > 14 mg/L
- Nominal / measured:
- meas. (not specified)
- Conc. based on:
- act. ingr.
- Basis for effect:
- reproduction
- Duration:
- 21 d
- Dose descriptor:
- NOEC
- Effect conc.:
- >= 14 mg/L
- Nominal / measured:
- meas. (not specified)
- Conc. based on:
- act. ingr.
- Basis for effect:
- reproduction
- Duration:
- 21 d
- Dose descriptor:
- NOEC
- Effect conc.:
- >= 14 mg/L
- Nominal / measured:
- meas. (not specified)
- Conc. based on:
- act. ingr.
- Basis for effect:
- mortality
- Duration:
- 21 d
- Dose descriptor:
- EC50
- Effect conc.:
- > 14 mg/L
- Nominal / measured:
- meas. (not specified)
- Conc. based on:
- act. ingr.
- Basis for effect:
- mortality
- Details on results:
- -The measured concentrations of test material varied between 84 and 196 % of the nominal concentration (based on the 10 mg/L nominal concentration)
- No mortality or immobilisation of parent Daphnia was recorded. - Reported statistics and error estimates:
- -Method: The NOEC (reproduction) and the NOEC (mortality) for parent Daphnia was determined using DUNNETT's test (1955, 1964), which is a multiple comparison procedure for comparing several treatments with a control.
- Result: The test showed no significant difference between the test solutions and the control. - Validity criteria fulfilled:
- yes
- Remarks:
- The validity of the test in terms of mortality rate of controls, living offspring of parents, DO concentration, pH and water hardness were fulfilled. The test material concentration varied dramatically over the duration of the exposure.
- Conclusions:
- Test organisms (Daphnia magna) were exposed to nominal test substance concentrations of 0, 1, 3.2 and 10 mg/L for 21 days. The 21 day EC50 values for mortality and reproduction were both > 14mg/L (mean measured concentration; variation by 84-196 % of the nominal over the study duration). The 21 day NOEC for reproduction and mortality were both ≥ 14 mg/L.
- Executive summary:
The 21-day-chronic toxicity of Reactive Navy FC 63805 to Daphnia magna was studied under semi-static conditions. Daphnids were exposed to control, and test chemical at nominal concentrations (measured concentrations) of 0, 1, 3.2, and 10 mg/L (mean measured: 14 mg/L). The 21 day EC50 based on mortality and reproduction effects was > 14 mg/L. The 21 day NOECs based on mortality and reproduction were both ≥ 14mg/L. No mortality or sublethal effects were recorded. Production of offspring in the treated groups indicated that the test chemical did not have an effect on the reproduction at concentrations of at least 14 mg/L.
This study is classified as acceptable and partly satisfies the guideline requirements for a chronic toxicity study with freshwater invertebrates. The number of test concentrations was less than prescribed by the guideline, and concentrations were not sufficiently high to induce effects, so no NOEC and LOEC could be identified. The test substance concentration fluctuated between 84 and 196 % of the nominal concentration, therefore the (unbounded) NOEC is given as the mean measured concentration of 14 mg/L
Results synopsis
Test type: Static Renewal
NOEC ≥ 14 mg/L (reproduction and mortality)
LOEC > 14 mg/L (reproduction and mortality)
Reference
Mean reproduction rate
Nominal concentration [mg/I] |
Mean measured concentration [mg/I) |
Mean reproduction rate |
SD |
CV [%] |
Control |
---- |
123.3 [n=10] |
18.8 |
15.3 |
1 |
---- |
133.5 [n=10] |
17.3 |
13 |
3.2 |
---- |
123.8 [n=10] |
18.4 |
14.9 |
10 |
14 |
112 [n=l0] |
19.5 |
17.4 |
Immobilisation /mortality rate and mean reproduction
Nominal concentration (mg/L) |
Mean measured concentration (mg/L) |
Immobilisation/mortality rate of parent Daphnia |
Mean reproduction rate of parent Daphnia |
||
Absolute |
% |
Absolute |
% |
||
Control |
|
0 |
0 |
123.3 (n=10) |
100 |
1 |
|
0 |
0 |
133.5 (n=10) |
108 |
3.2 |
|
0 |
0 |
123.8 (n=10) |
100 |
10 |
14 |
0 |
0 |
112 (n=10) |
91 |
Description of key information
Test organisms (Daphnia magna) were exposed to nominal test substance concentrations of 0, 1, 3.2 and 10 mg/L for 21 days. The 21 day EC50 values for mortality and reproduction were both > 14 mg/L (mean measured concentration; variation by 84-196 % of the nominal over the study duration). The 21 day NOEC for reproduction and mortality were both ≥ 14 mg/L.
Key value for chemical safety assessment
Fresh water invertebrates
Fresh water invertebrates
- Effect concentration:
- 14 mg/L
Additional information
The 21-day-chronic toxicity of Reactive navy FC 63805 to Daphnia magna was studied under semi-static conditions. Daphnids were exposed to control, and test chemical at nominal concentrations (measured concentrations) of 0, 1, 3.2, and 10 mg/L (mean measured: 14 mg/L). The 21 day EC50 based on mortality and reproduction effects was > 14 mg/L. The 21 day NOECs based on mortality and reproduction were both ≥ 14mg/L. No mortality or sublethal effects were recorded. Production of offspring in the treated groups indicated that the test chemical did not have an effect on the reproduction at concentrations of at least 14 mg/L.
This study is classified as acceptable and partly satisfies the guideline requirements for a chronic toxicity study with freshwater invertebrates. The number of test concentrations was less than prescribed by the guideline, and concentrations were not sufficiently high to induce effects, so no NOEC and LOEC could be identified. The test substance concentration fluctuated between 84 and 196 % of the nominal concentration, therefore the (unbounded) NOEC is given as the mean measured concentration of 14 mg/L.
Since the NOEC is unbounded it is not suitable as the key value for safety assessment. No relevant NOEC or EC10 for the chemical safety assessment can be derived.
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