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EC number: 209-406-4 | CAS number: 577-11-7
- 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
Toxicity to aquatic algae and cyanobacteria
Administrative data
Link to relevant study record(s)
- Endpoint:
- toxicity to aquatic algae and cyanobacteria
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 10 to 13 November 1992
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
- Remarks:
- This GLP study is considered to be acceptable for the risk assessment despite the shortcomings in the reported documentation. Major criticism points are the lack of individual temperature measurement data and the lack of the calibration curve used to calculate the cell density.
- Qualifier:
- according to guideline
- Guideline:
- other: EWG 88/302
- Deviations:
- yes
- Remarks:
- lack of individual temperature measurement data and the lack of the calibration curve used to calculate the cell density.
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- EU Method C.3 (Algal Inhibition test)
- Deviations:
- yes
- Remarks:
- lack of individual temperature measurement data and the lack of the calibration curve used to calculate the cell density.
- GLP compliance:
- yes
- Analytical monitoring:
- no
- Vehicle:
- no
- Details on test solutions:
- PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Method: a stock solution with 1 g/L test material was prepared in deionized water
- Chemical name of vehicle (organic solvent, emulsifier or dispersant): not applicable
- Concentration of vehicle in test medium (stock solution and final test solution(s) including control(s)): not applicable - Test organisms (species):
- Desmodesmus subspicatus (previous name: Scenedesmus subspicatus)
- Details on test organisms:
- TEST ORGANISM
- Common name: Scenedesmus subspicatus (new name: Desmodesmus subspicatus)
- Strain: SAG 86.81
- Source (laboratory, culture collection): Institut für Wasser-, Boden- und Lufthygiene, Berlin, Germany, thereafter own culture.
- Age of inoculum (at test initiation): 3 days
- Method of cultivation: static - Test type:
- static
- Water media type:
- freshwater
- Limit test:
- no
- Total exposure duration:
- 72 h
- Hardness:
- not provided
- Test temperature:
- The temperature was 24 +/- 2°C, however, temperature readings for individual time intervals were not provided.
- pH:
- See table 2
- Nominal and measured concentrations:
- Nonimal concentrations: 0 (control), 10, 17, 30, 50, 90 and 150 mg SERWET WH 170/L corresponding to 0 (control), 6.42, 10.91, 19.26, 32.10, 57.78 and 96.30 mg Docusate Sodium/L
- Details on test conditions:
- TEST SYSTEM
- Test vessel: Erlenmeyer flasks
- Type (delete if not applicable): closed, but allowing air exchange under sterile conditions.
- Aeration: the stopper allowed air exchange
- Type of flow-through (e.g. peristaltic or proportional diluter): not applicable
- Renewal rate of test solution (frequency/flow rate): static test and hence no renewal
- Initial cells density: 20'000 cells/mL
- Control end cells density: 910'000 cells/mL
- No. of vessels per concentration (replicates): 5
- No. of vessels per control (replicates): 8
- No. of vessels per vehicle control (replicates): not applicable
GROWTH MEDIUM
- Standard medium used: yes (medium according to EWG 88/302)
TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: medium according to EWG 88/302
- Intervals of water quality measurement: the pH was measured at start and the end of the exposure.
OTHER TEST CONDITIONS
- Sterile test conditions: yes
- Adjustment of pH: no
- Photoperiod: not provided
- Light intensity and quality: about 8'000 lux, white
EFFECT PARAMETERS MEASURED (with observation intervals if applicable) :
- Determination of cell concentrations: spectrophotometer at 685 nm, the photometer readings were subsequently converted to cell density using an established calibration curve (not provided in the report), measurements were performed at 24, 48 and 72 hours
TEST CONCENTRATIONS
- Spacing factor for test concentrations: about 1.7 - Reference substance (positive control):
- no
- Duration:
- 72 h
- Dose descriptor:
- EC10
- Effect conc.:
- 12.4 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- act. ingr.
- Basis for effect:
- biomass
- Duration:
- 72 h
- Dose descriptor:
- EC10
- Effect conc.:
- 19.3 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- biomass
- Duration:
- 72 h
- Dose descriptor:
- EC50
- Effect conc.:
- 39.3 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- act. ingr.
- Basis for effect:
- biomass
- Duration:
- 72 h
- Dose descriptor:
- EC50
- Effect conc.:
- 61.2 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- biomass
- Key result
- Duration:
- 72 h
- Dose descriptor:
- EC10
- Effect conc.:
- 22 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- act. ingr.
- Basis for effect:
- growth rate
- Duration:
- 72 h
- Dose descriptor:
- EC10
- Effect conc.:
- 34.3 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- growth rate
- Key result
- Duration:
- 72 h
- Dose descriptor:
- EC50
- Effect conc.:
- 82.5 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- act. ingr.
- Basis for effect:
- growth rate
- Duration:
- 72 h
- Dose descriptor:
- EC50
- Effect conc.:
- 128.5 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- growth rate
- Details on results:
- - Exponential growth in the control (for algal test): yes
- Any stimulation of growth found in any treatment: no
- Any observations (e.g. precipitation) that might cause a difference between measured and nominal values: no information provided
- Effect concentrations exceeding solubility of substance in test medium: a stock solution was prepared with 1 g/L and no insolubility was reported. Therefore, it is highly likely that the test material was water soluble at the concentration levels tested. - Reported statistics and error estimates:
- The EC-values were calculated with probit transformed (%) inhibition values. These values were subsequently used for probit analysis according to Cavalli-Sforza (1972).
- Executive summary:
The growth inhibition of SERWET WH 170 (which contains 64.2% Docusate Sodium) to Scenedesmus subspicatius was determined in a 72 h static GLP algae growth inhibition test. The test design was based on the EWG 88/302 guideline which is similar to the EEC C.1 guideline. The nominal test concentrations were 0 (control), 10, 17, 30, 50, 90 and 150 mg SERWET WH 170/L, corresponding to 0 (control), 6.42, 10.91, 19.26, 32.10, 57.78 and 96.30 mg Docusate Sodium/L. Eight control replicates and 5 replicates from each test solution were set up. Dose verification analysis was not performed. In order to determine the growth of the cultures, the optical density was measured by photometry at 685 nm. The cell density was calculated using an calibration curve (not provided in the report). The cell density was determined at 0, 24, 48 and 72 hours. The growth of the control cultures fulfilled the validity criteria from OECD 201 (2006). The 72 -hour ErC10 and ErC50 are 22 and 82.5 mg Docusate Sodium/L based on the nominal concentration.
This study is considered to be acceptable for the risk assessment despite minor shortcomings in the reported documentation. Minor criticism points are the lack of individual temperature measurement data and the lack of the calibration curve used to calculate the cell density.
Reference
Table 2 pH-values at the start and end of the exposure
SERWET WH 170 | pH | pH |
mg/L | start of exposure | end of exposure |
0 | 8.9 | 9.5 |
10 | 8.8 | 9.6 |
17 | 8.8 | 9.5 |
30 | 8.7 | 9.4 |
50 | 8.5 | 9.2 |
90 | 8.5 | 9.3 |
150 | 8.6 | 7.8 |
Table 3 Cell densities in 10^4 cells/mL at the individual observation intervals (the test was started with 2*10^4 cells/mL)
SERWET WH 170 | replicate | 24 hours | 48 hours | 72 hours |
mg/L | ||||
0 | 1 | 7 | 28 | 94 |
2 | 7 | 28 | 101 | |
3 | 8 | 33 | 89 | |
4 | 8 | 31 | 91 | |
5 | 7 | 30 | 88 | |
6 | 7 | 30 | 90 | |
7 | 7 | 31 | 92 | |
8 | 7 | 28 | 85 | |
mean | 7.25 | 29.875 | 91.25 | |
SD | 0.46 | 1.81 | 4.77 | |
10 | 1 | 7 | 27 | 82 |
2 | 7 | 30 | 89 | |
3 | 7 | 30 | 87 | |
4 | 8 | 26 | 95 | |
5 | 7 | 27 | 89 | |
mean | 7.2 | 28 | 88.4 | |
SD | 0.45 | 1.87 | 4.67 | |
17 | 1 | 7 | 29 | 80 |
2 | 7 | 29 | 81 | |
3 | 7 | 30 | 84 | |
4 | 8 | 30 | 83 | |
5 | 7 | 29 | 86 | |
mean | 7.2 | 29.4 | 82.8 | |
SD | 0.45 | 0.55 | 2.39 | |
30 | 1 | 7 | 24 | 73 |
2 | 7 | 25 | 69 | |
3 | 8 | 28 | 68 | |
4 | 7 | 26 | 70 | |
5 | 7 | 26 | 74 | |
mean | 7.2 | 25.8 | 70.8 | |
SD | 0.45 | 1.48 | 2.59 | |
50 | 1 | 7 | 22 | 48 |
2 | 7 | 21 | 48 | |
3 | 7 | 19 | 45 | |
4 | 7 | 23 | 51 | |
5 | 7 | 24 | 57 | |
mean | 7 | 21.8 | 49.8 | |
SD | 0.00 | 1.92 | 4.55 | |
90 | 1 | 6 | 10 | 16 |
2 | 6 | 11 | 17 | |
3 | 6 | 11 | 18 | |
4 | 6 | 13 | 19 | |
5 | 6 | 12 | 19 | |
mean | 6 | 11.4 | 17.8 | |
SD | 0.00 | 1.14 | 1.30 | |
150 | 1 | 5 | 7 | 7 |
2 | 5 | 7 | 10 | |
3 | 4 | 7 | 8 | |
4 | 5 | 7 | 13 | |
5 | 5 | 8 | 24 | |
mean | 4.8 | 7.2 | 12.4 | |
SD | 0.45 | 0.45 | 6.88 |
Table 4 Areas under the growth curves (AUC), growth rates and corresponding % inhibition
SERWET WH 170 | AUC | % inhibition of AUC |
mg/L | ||
0 | 77.5 | - |
10 | 74.0 | 4.5 |
17 | 72.5 | 6.5 |
30 | 63.5 | 18.1 |
50 | 49.0 | 36.8 |
90 | 21 | 72.9 |
150 | 13 | 83.2 |
SERWET WH 170 | growth rate | % inhibition of growth rate |
mg/L | ||
0 | 1.273 | - |
10 | 1.3 | 0.9 |
17 | 1.2 | 2.4 |
30 | 1.2 | 6.5 |
50 | 1.1 | 15.7 |
90 | 0.732 | 42.5 |
150 | 0.597 | 53.1 |
Table 5 72-hour ECx-values based on SERWET WH 170 and Docusate Sodium
Parameter | based on SERWET WH 170 | based on Docusate Sodium |
mg/L | mg /L | |
AUC | ||
EbC10 | 19.3 | 12.4 |
EbC50 | 61.2 | 39.3 |
EbC90 | -* | -* |
Growth rate | ||
ErC10 | 34.3 | 22.0 |
ErC50 | 128 .5 | 82.5 |
ErC90 | -* | -* |
* the EbC90 and ErC90 are significantly higher than the highest tested concentration and were therefore not calculated
Description of key information
ErC10 freshwater algae = 22 mg Docusate Sodium/L
ErC50 freshwater algae = 82.5 mg Docusate Sodium/L
Key value for chemical safety assessment
- EC50 for freshwater algae:
- 82.5 mg/L
- EC10 or NOEC for freshwater algae:
- 22 mg/L
Additional information
For the data endpoint “Toxicity to aquatic algae and cyanobacteria” 2 experimental studies are available: 1 Klimisch 2 key-study and 1 disregarded Klimisch 3 study.
The study from Elementis (Scholz 1993) was classified as Klimisch 2 key study. In this study the growth inhibition of formulated product (which contains 64.2% Docusate Sodium) to Scenedesmus subspicatius was determined in a 72 h static GLP algae growth inhibition test. The test design was based on the EWG 88/302 guideline which is similar to the EEC C.1 guideline. The nominal test concentrations were 0 (control), 10, 17, 30, 50, 90 and 150 mg formulated product/L, corresponding to 0 (control), 6.42, 10.91, 19.26, 32.10, 57.78 and 96.30 mg Docusate Sodium/L. Eight control replicates and 5 replicates from each test solution were set up. Dose verification analysis was not performed. In order to determine the growth of the cultures, the optical density was measured by photometry at 685 nm. The cell density was calculated using a calibration curve (not provided in the report). The cell density was determined at 0, 24, 48 and 72 hours. The growth of the control cultures fulfilled the validity criteria from OECD 201 (2006). The 72 -hour ErC10 and ErC50 are 22 and 82.5 mg Docusate Sodium/L based on the nominal concentration. This study is considered to be acceptable for the risk assessment despite minor shortcomings in the reported documentation. Criticism points are the lack of individual temperature measurement data and the lack of the calibration curve used to calculate the cell density.
In addition to the Klimisch 2 study, there is one Klimisch 3 study for toxicity to aquatic algae and cyanobacteria available. Due to the poor reliability of this study, it is disregarded and not discussed here.
The ErC50 value of the key study from Elementis (Scholz 1993) is 82.5 mg Docusate Sodium/L. The ErC50 value of the disregarded study from Cognis (Rieche 1994), i. e., 127 mg Docusate Sodium/L, is considered to be less reliable since the validity criteria of the OECD 201 (2006) were not met. Furthermore, the results of the key study are more protective than the results from the disregarded study. The ErC10 and ErC50 of 22 and 82.5 mg Docusate Sodium/L, respectively, are considered to be reliable and will be used for the further risk assessment of Docusate Sodium.
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