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EC number: 204-889-8 | CAS number: 128-49-4
- 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 microorganisms
Administrative data
Link to relevant study record(s)
- Endpoint:
- activated sludge respiration inhibition testing
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 27 to 30 April 1993
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline compliant GLP study
- Justification for type of information:
- Data are read-across to a structurally analagous substance (docusate sodium)
- Reason / purpose for cross-reference:
- reference to same study
- Qualifier:
- according to guideline
- Guideline:
- DIN 38412-8 (Pseudomonas Zellvermehrungshemmtest)
- Deviations:
- no
- GLP compliance:
- yes
- Analytical monitoring:
- no
- Vehicle:
- no
- Test organisms (species):
- Pseudomonas putida
- Details on inoculum:
- - Laboratory culture: Pseudomonas putida MIGULA
- Method of cultivation: in a glass vial
- Preparation of inoculum for exposure: In the first experiment, the pre-culture had an optical density of 0.302. This pre-culture was adjusted to an optical density of 0.145. In the second experiment the optical density was adjusted from 0.285 to 0.138. The optical density as measured with a Zeiss-Photometer PM 6 and a 1 cm path length.
- Initial biomass concentration: not provided, but the inoculum was diluted 1:10. - Test type:
- static
- Water media type:
- freshwater
- Limit test:
- no
- Total exposure duration:
- 16.5 h
- Test temperature:
- 21.4°C for both experiments
- pH:
- See tables 2 and 3
- Duration:
- 16 h
- Dose descriptor:
- EC10
- Effect conc.:
- 122 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- act. ingr.
- Basis for effect:
- growth inhibition
- Duration:
- 16 h
- Dose descriptor:
- EC10
- Effect conc.:
- 190 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- growth inhibition
- Duration:
- 16 h
- Dose descriptor:
- EC50
- Effect conc.:
- 164 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- act. ingr.
- Basis for effect:
- growth inhibition
- Duration:
- 16 h
- Dose descriptor:
- EC50
- Effect conc.:
- 256 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- growth inhibition
- Details on results:
- - Effect concentrations exceeding solubility of substance in test medium: Since a 5 g/L stock solution was prepared and no insolubility was reported, it is likely that the test concentrations were below the solubility limit in the test medium
- Reported statistics and error estimates:
- Calculation of the mean optical density per test group and the percent inhibition were performed using the MULTIPLAN software "MIGULA". The ECx values and their corresponding probit values were calculated using the MULTIPLAN software "Programm ZZ". "Programm ZZ" calculates the ECx values by regression analysis of probit transformed % inhibition vs. log concentration.
- Validity criteria fulfilled:
- yes
- Conclusions:
- The EC50 as determeined in a Pseudomonas growth inhibition test according to DIN 38412 is 164 mg Docusate Sodium/L.
- Executive summary:
The growth inhibition of SERWET WH 170 (which contains 64.2% Docusate Sodium) to Pseudomonas putida MIGULA was determined in a 16 h static GLP Pseudomonas growth inhibition test. The test design was based on the DIN 38412.The nominal test concentrations were 0 (control), 40, 80, 160, 240, 320 and 400 mg SERWET WH 170/L, corresponding to 0 (control), 25.7, 51.4, 102.7, 154.1, 205.4 and 256.8 mg Docusate Sodium/L. Five control replicates and 3 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 436 nm. The optical density was determined at 0 hours in the control and about 16 hours after start of the exposure in the control and all test solutions. The EC10 and EC 50 values were calculated by regression of the log transformed concentration vs. probit transformed percent inhibition relative to the average control density. Two experiments were preformed. In the first experiment, the EC10 and EC50 were 121 and 164 mg Docusate Sodium/L, respectively. In the second experiment, the EC10 and EC50 were 123 and 164 mg Docusate Sodium/L, respectively. The mean values for the of the calculated EC10 and EC50 values of both experiments deviated at the maximum of less than 1 % from their mean values and hence, both experiments can be considered to be reliable. The 16 -hour EC10 is 122 mg Docusate Sodium/L and the EC50 is 164 mg Docusate Sodium/L.
This study is considered to be acceptable for the risk assessment.
- Endpoint:
- toxicity to microorganisms
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- disregarded due to major methodological deficiencies
- Study period:
- 27.01.1992
- Reliability:
- 3 (not reliable)
- Rationale for reliability incl. deficiencies:
- other: Basic data given: comparable to guidelines / standards, meets basic scientific principles, test substance purity not provided.
- Justification for type of information:
- Data are read-across to a structurally analagous substance (docusate sodium)
- Qualifier:
- according to guideline
- Guideline:
- other: DIN 38412-3: Deutsches Einheitsverfahren zur Waser-, Abwasser und Schlammuntersuchung; Testverfahren mit Wasserorganismen (Gruppe L); Bestimmung der Toxizität von Abwässern und Abwasserinhaltsstoffen nach der Dehydrogenaseaktivität mittels 2,3,5- Tripheny
- Principles of method if other than guideline:
- Toxicity sreening conducted during the OECD 302 B - biodegradation test, Determination of the toxicity based on the dehydrogenase activity via 2,3,5 -triphenyltetrazolium chloride
- GLP compliance:
- not specified
- Analytical monitoring:
- no
- Vehicle:
- no
- Test organisms (species):
- activated sludge, domestic
- Details on inoculum:
- - Source of inoculum/activated sludge (e.g. location, sampling depth, contamination history, procedure): activated sludge was sampled from the municipal waste water treatment plant Bergisch Gladbach/Refrath (Germany)
- Laboratory culture: no
- Preparation of inoculum for exposure: activated sludge was centrifuged and washed twice and mixed with deionized water : tap water (1:3)
Dry weight= 8.0 g/L - Test type:
- static
- Water media type:
- freshwater
- Limit test:
- no
- Total exposure duration:
- 3 h
- Test temperature:
- 25 +/- 1°C
- Nominal and measured concentrations:
- nominal concentrations: 0 (Contol), 100; 200, 500, 1.000, 2.000, 4.000, 6.000 and 8.000 mg Rewopol SB DO 75/L corresponding to 0 (control) , 72, 144, 360, 720, 1.440, 2880, 4.320, 5.760 mg Docusate Sodium/L
- Details on test conditions:
- TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: deionized water : tap water (1:3)
OTHER TEST CONDITIONS
3 h in the dark at 25 +/- 1°C
TEST CONCENTRATIONS
- Spacing factor for test concentrations: 2 to 2.5 - Reference substance (positive control):
- no
- Duration:
- 3 h
- Dose descriptor:
- EC0
- Effect conc.:
- 144 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- act. ingr.
- Basis for effect:
- other: dehydrogenase activity
- Duration:
- 3 h
- Dose descriptor:
- EC0
- Effect conc.:
- 200 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- other: dehydrogenase activity
- Details on results:
- No further details were provided.
- Validity criteria fulfilled:
- yes
- Conclusions:
- EC0 (dehydrogenase inhibition) = 144 mg Docusate Sodium/L
- Executive summary:
The inhibition of the dehydrogenase of sewage treatment plant microorganisms originating from a domestic STP by Rewopol SB DO 75 (which contains equal or more than 72% Docusate Sodium) was determined in a 3 h static non-GLP dehydrogenase inhibition test. The test design was based on the Deutsches Einheitsverfahren (DEV) L 3.The nominal test concentrations were 0 (control), 100, 200, 500, 1000, 2000, 4000, 6000 and 8000 mg Rewopol SB DO 75/L, corresponding to 0 (control), 72, 144, 360, 720, 2880, 4320 and 5760 mg Docusate Sodium/L. Dose verification analysis was not performed. In order to determine the inhibition of the dehydrogenase activity, 2,3,5 -triphenylterazoliumchloride was added to the suspension. Dehydrogenase reduces 2,3,5 -triphenyltetrazoliumchloride to red formazan which is water unsoluble. After 3 hours incubation to test material and 2,3,5 -triphenyltetrazoiumchloride the formazan was extracted using ethanol and the optical density at 480 nm was measured in the supernatant after centrifugation. The EC0 was 144 mg Docusate Sodium/L. Inhibitory effects were observed at 360 mg Docusate Sodium/L and higher.
This study is considered to be acceptable with restrictions for the risk assessment.
Referenceopen allclose all
Table 2 pH-values at the start and end of the exposure of the first experiment
SERWET WH 170 | pH | pH |
mg/L | start of exposure | end of exposure |
0 | not provided | not provided |
40 | 6.2 | 6.8 |
80 | 6.2 | 6.8 |
160 | 6.3 | 6.8 |
240 | 6.4 | 6.8 |
320 | 6.6 | 6.8 |
400 | 7.3 | 6.6 |
Table 3 pH-values at the start and end of the exposure of the second experiment
SERWET WH 170 | pH | pH |
mg/L | start of exposure | end of exposure |
0 | not provided | not provided |
40 | 5.8 | 6.8 |
80 | 5.8 | 6.8 |
160 | 5.9 | 6.8 |
240 | 6.1 | 6.8 |
320 | 6.6 | 6.8 |
400 | 7.1 | 6.7 |
Table 4 Optical density (OD) at 436 nm (1cm path length) in the first and second experiment
Note: % inhibition was calculated as: 100*(mean increase of control OD - (mean OD of test culture-initial control OD)/(mean increase of control OD) )
SERWET WH 170 | replicate | Experiment 1 | Experiment 2 |
mg/L | initial optical density controls 0.017 | initial optical density controls 0.016 | |
0 | 1 | 1.705 | 1.806 |
2 | 1.784 | 0.706* | |
3 | 1.806 | 1.796 | |
4 | 1.709 | 1.776 | |
5 | 1.745 | 1.821 | |
mean | 1.750 | 1.800 | |
increase of optical density | 1.733 | 1.784 | |
40 | 1 | 1.781 | 1.833 |
2 | 1.786 | 1.838 | |
3 | 1.806 | 1.813 | |
mean | 1.791 | 1.828 | |
% inhibition | -2.4 | -1.5 | |
80 | 1 | 1.792 | 1.833 |
2 | 1.806 | 1.828 | |
3 | 1.803 | 1.821 | |
mean | 1.800 | 1.827 | |
% inhibition | -2.9 | -1.5 | |
160 | 1 | 1.703 | 1.779 |
2 | 1.681 | 1.767 | |
3 | 1.797 | 1.775 | |
mean | 1.727 | 1.774 | |
% inhibition | 1.3 | 1.5 | |
240 | 1 | 1.194 | 1.329 |
2 | 1.030 | 1.358 | |
3 | 1.254 | 1.280 | |
mean | 1.159 | 1.322 | |
% inhibition | 34.1 | 26.8 | |
320 | 1 | 0.183 | 0.180 |
2 | 0.218 | 0.183 | |
3 | 0.224 | 0.188 | |
mean | 0.208 | 0.184 | |
% inhibition | 89.0 | 90.7 | |
400 | 1 | 0.082 | 0.076 |
2 | 0.075 | 0.075 | |
3 | 0.077 | 0.085 | |
mean | 0.078 | 0.079 | |
% inhibition | 96.5 | 96.5 |
* not used for calculations
Table 5 ECx-values based on SERWET WH 170 and Docusate Sodium
Experiment | Effect parameter | based on SERWET WH 170 | based on Docusate Sodium |
mg/L | mg /L | ||
Experiment 1 | EC10 | 189 | 121 |
Experiment 2 | EC10 | 191 | 123 |
Mean | EC10 | 190 | 122 |
Experiment 1 | EC50 | 255 | 164 |
Experiment 2 | EC50 | 256 | 164 |
Mean | EC50 | 256 | 164 |
Table 1: Inhibition of dehydrogenase activity:
Nominal concentration [mg Rewopol SB DO 75 /L] |
Inhibition [%] |
Control |
- |
100 |
+ 35 |
200 |
0 |
500 |
20 |
1000 |
30 |
2000 |
65 |
4000 |
85 |
6000 |
100 |
8000 |
100 |
Description of key information
No data are available for the registered substance, however data are available for the corresponding sodium salt of the substance, docusate sodium (CAS 577-11-7). These data are used for read-across to the registered substance calcium docusate (CAS 128 -49 -4). The presence of either of the counterions sodium or calcium is not considered to have an impact on the toxicity. It is therefore considered justified to use the data of the sodium salt for read across to the calcium salt of docusate.
EC10 = 122 mg Docusate Sodium/L
Key value for chemical safety assessment
- EC50 for microorganisms:
- 164 mg/L
- EC10 or NOEC for microorganisms:
- 122 mg/L
Additional information
For the data endpoint “Toxicity to microorganisms” in total 2 experimental studies are available: 1 key-study and 1 disregarded study.
The study from Elementis (Schöberl 1993) was classified as Klimisch 1 key study. In this study the growth inhibition of formulated product (which contains 64.2% Docusate Sodium) to Pseudomonas putida MIGULA was determined in a 16 h static GLP Pseudomonas growth inhibition test. The test design was based on the DIN 38412.The nominal test concentrations were 0 (control), 40, 80, 160, 240, 320 and 400 mg formulated product/L, corresponding to 0 (control), 25.7, 51.4, 102.7, 154.1, 205.4 and 256.8 mg Docusate Sodium/L. Five control replicates and 3 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 436 nm. The optical density was determined at 0 hours in the control and about 16 hours after start of the exposure in the control and all test solutions. The EC10 and EC 50 values were calculated by regression of the log transformed concentration vs. probit transformed percent inhibition relative to the average control density. Two experiments were preformed. In the first experiment, the EC10 and EC50 were 121 and 164 mg Docusate Sodium/L, respectively. In the second experiment, the EC10 and EC50 were 123 and 164 mg Docusate Sodium/L, respectively. The mean values for the of the calculated EC10 and EC50 values of both experiments deviated at the maximum of less than 1 % from their mean values and hence, both experiments can be considered to be reliable. The 16 -hour EC10 is 122 mg Docusate Sodium/L and the EC50 is 164 mg Docusate Sodium/L. This study is considered to be acceptable for the risk assessment.
In addition to the Klimisch 1 study, there is one Klimisch 3 study for toxicity to microorganisms available. Due to the poor reliability of this study, it is disregarded and not discussed here.
Therefore, the EC10 (122 mg Docusate Sodium/L) and EC50 (164 mg Docusate Sodium/L) reported by Elementis (Schöberl 1993) (Klimisch 1 key study) will be used for the risk assessment.
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