Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 269-225-1 | CAS number: 68201-55-8
- 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
- Endpoint:
- toxicity to aquatic algae and cyanobacteria
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2018-03-05 - 2018-03-08 (experimental phase)
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 018
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 201 (Freshwater Alga and Cyanobacteria, Growth Inhibition Test)
- Version / remarks:
- OECD Guideline for the Testing of Chemicals No. 201, adopted 23. Mar. 2006, Annex 5 corrected: 28 July 2011 “Freshwater Alga and Cyanobacteria, Growth Inhibition Test”
- Deviations:
- yes
- Remarks:
- not affecting the outcome or validity of the study
- Qualifier:
- according to guideline
- Guideline:
- EU Method C.3 (Algal Inhibition test)
- Version / remarks:
- Regulation EU No. 2016/266 amending Regulation EC No. 440/2008, Annex IV, Method C.3: “FRESHWATER ALGAE AND CYANOBACTERIA, GROWTH INHIBI-TION TEST,” adopted 07. December 2015
- Deviations:
- yes
- Remarks:
- not affecting the outcome or validity of the study
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Betaines, coco alkyldimethyl(3-sulfopropyl)
- EC Number:
- 269-225-1
- EC Name:
- Betaines, coco alkyldimethyl(3-sulfopropyl)
- Cas Number:
- 68201-55-8
- Molecular formula:
- C7H17NO3S·[CH2]6-16
- IUPAC Name:
- [3-(dodecyldimethylazaniumyl)propyl]trioxo-λ⁶-sulfanuide
- Reference substance name:
- Water
- EC Number:
- 231-791-2
- EC Name:
- Water
- Cas Number:
- 7732-18-5
- Molecular formula:
- H2O
- IUPAC Name:
- Water
- Test material form:
- liquid
- Remarks:
- Aqueous solution: clear, colourless to yellowish liquid
- Details on test material:
- - Storage: Room Temperature (20 ± 5°C)
Constituent 1
Constituent 2
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: sponsor
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: The test item was stored in a closed vessel dark and dry at room temperature (15.8 - 23.0°C).
Sampling and analysis
- Analytical monitoring:
- yes
- Details on sampling:
- - Concentrations: 0, 0.0032, 0.01, 0.032, 0.1, 0.32, 1 mg/l
Test solutions
- Vehicle:
- no
- Details on test solutions:
- PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
A stock solution containing 10.0 mg/L in algal medium (demineralised water enriched with minerals but without algae) was prepared. The lower treatments were prepared by dilution of this stock solution with algal medium.
- Evidence of undissolved material (e.g. precipitate, surface film, etc.): none stated
Test organisms
- Test organisms (species):
- Desmodesmus subspicatus (previous name: Scenedesmus subspicatus)
- Details on test organisms:
- TEST ORGANISM
- Common name: Unicellular freshwater green alga
Genus: Desmodesmus
Species: subspicatus
SAG Strain Number: 86.81
Taxonomic position: Chlorophyta - Chlorophyceae
- Source (laboratory, culture collection): The culture of Desmodesmus subspicatus was obtained in January 2016 by MBM Sciencebridge GmbH (Institut für Pflanzenphysiologie of Universität Göttingen).
- Method of cultivation: The algae are kept as stock culture on solid agar at 2 - 8 °C. From the stock culture, a permanent culture was prepared. From an aliquot of the permanent culture, the pre-culture was prepared.
Study design
- Test type:
- static
- Water media type:
- freshwater
- Limit test:
- no
- Total exposure duration:
- 72 h
- Post exposure observation period:
- none
Test conditions
- Test temperature:
- 20.9 – 24.0 °C
- pH:
- 7.6 - 7.7
- Nominal and measured concentrations:
- 0 / 0.0032 / 0.01 / 0.032 / 0.1 / 0.32 / 1 mg/L (nominal)
< LOQ / < LOQ / 0.00899 / 0.02912 / 0.09492 / 0.30532 / 0.90952 mg/l (measured, t=0h)
< LOQ / < LOQ / < LOQ / < LOQ / < LOQ / 0.21972 / 0.96893 mg/l (measured, t=72h) - Details on test conditions:
- TEST SYSTEM
- Test vessel: glass flasks total volume 65 mL
- Type (delete if not applicable): open
- Material, size, headspace, fill volume: 45 ±1 ml fill volume
- Renewal rate of test solution (frequency/flow rate): none
- Initial cells density: 2580 cells/ml
- Control end cells density: 95457 cells/ml
- No. of vessels per concentration (replicates): 3
- No. of vessels per control (replicates): 6
GROWTH MEDIUM
- Standard medium used: yes
OTHER TEST CONDITIONS
- Sterile test conditions: yes
- Adjustment of pH: no
- Photoperiod: continuous
- Light intensity and quality: 5000 lux
EFFECT PARAMETERS MEASURED (with observation intervals if applicable) :
- Determination of cell concentrations: electronic particle counter, every 24h
TEST CONCENTRATIONS
- Test concentrations: The concentrations to be tested are based on non-GLP pre-tests.
In these pre-tests an inhibition of about 60 % at 0.01 mg/L could be observed. - Reference substance (positive control):
- yes
- Remarks:
- Potassium dichromate K2Cr2O7 (CAS No. 7778-50-9) was used as positive control in a separate reference test.
Results and discussion
Effect concentrationsopen allclose all
- Duration:
- 72 h
- Dose descriptor:
- EC50
- Remarks:
- test item
- Effect conc.:
- 66.68 µg/L
- Nominal / measured:
- meas. (geom. mean)
- Conc. based on:
- test mat.
- Remarks:
- aqueous solution
- Basis for effect:
- growth rate
- Remarks on result:
- other: 95%-confidence interval: 49.45 – 89.45 µg/L
- Key result
- Duration:
- 72 h
- Dose descriptor:
- EC50
- Remarks:
- solid content
- Effect conc.:
- 36.67 µg/L
- Nominal / measured:
- meas. (geom. mean)
- Conc. based on:
- act. ingr.
- Basis for effect:
- growth rate
- Duration:
- 72 h
- Dose descriptor:
- EC10
- Remarks:
- test item
- Effect conc.:
- 26.05 µg/L
- Nominal / measured:
- meas. (geom. mean)
- Conc. based on:
- test mat.
- Remarks:
- aqueous solution
- Basis for effect:
- growth rate
- Remarks on result:
- other: 95%-confidence interval: 20.16 – 33.66 µg/L
- Duration:
- 72 h
- Dose descriptor:
- EC10
- Remarks:
- solid content
- Effect conc.:
- 14.33 µg/L
- Nominal / measured:
- meas. (geom. mean)
- Conc. based on:
- act. ingr.
- Basis for effect:
- growth rate
- Duration:
- 72 h
- Dose descriptor:
- NOEC
- Remarks:
- test item
- Effect conc.:
- 9.4 µg/L
- Nominal / measured:
- meas. (geom. mean)
- Conc. based on:
- test mat.
- Remarks:
- aqueous solution
- Basis for effect:
- growth rate
- Duration:
- 72 h
- Dose descriptor:
- NOEC
- Remarks:
- solid content
- Effect conc.:
- 5.17 µg/L
- Nominal / measured:
- meas. (geom. mean)
- Conc. based on:
- act. ingr.
- Basis for effect:
- growth rate
- Duration:
- 72 h
- Dose descriptor:
- LOEC
- Remarks:
- test item
- Effect conc.:
- 30 µg/L
- Nominal / measured:
- meas. (geom. mean)
- Conc. based on:
- test mat.
- Remarks:
- aqueous solution
- Basis for effect:
- growth rate
- Duration:
- 72 h
- Dose descriptor:
- LOEC
- Remarks:
- solid content
- Effect conc.:
- 16.5 µg/L
- Nominal / measured:
- meas. (geom. mean)
- Conc. based on:
- act. ingr.
- Basis for effect:
- growth rate
- Duration:
- 72 h
- Dose descriptor:
- EC50
- Remarks:
- test item
- Effect conc.:
- 36.73 µg/L
- Nominal / measured:
- meas. (geom. mean)
- Conc. based on:
- test mat.
- Remarks:
- aqueous solution
- Basis for effect:
- biomass
- Remarks:
- yield
- Remarks on result:
- other: 95%-confidence interval: 19.74 – 66.81 µg/L
- Duration:
- 72 h
- Dose descriptor:
- EC50
- Remarks:
- solid content
- Effect conc.:
- 20.2 µg/L
- Nominal / measured:
- meas. (geom. mean)
- Conc. based on:
- act. ingr.
- Basis for effect:
- biomass
- Remarks:
- yield
- Duration:
- 72 h
- Dose descriptor:
- EC10
- Remarks:
- test item
- Effect conc.:
- 16.16 µg/L
- Nominal / measured:
- meas. (geom. mean)
- Conc. based on:
- test mat.
- Remarks:
- aqueous solution
- Basis for effect:
- biomass
- Remarks:
- yield
- Remarks on result:
- other: 95%-confidence interval: 9.87 – 26.48 µg/L
- Duration:
- 72 h
- Dose descriptor:
- EC10
- Remarks:
- solid content
- Effect conc.:
- 8.89 µg/L
- Nominal / measured:
- meas. (geom. mean)
- Conc. based on:
- act. ingr.
- Basis for effect:
- biomass
- Remarks:
- yield
- Duration:
- 72 h
- Dose descriptor:
- NOEC
- Remarks:
- test item
- Effect conc.:
- 30 µg/L
- Nominal / measured:
- meas. (geom. mean)
- Conc. based on:
- test mat.
- Remarks:
- aqueous solution
- Basis for effect:
- biomass
- Remarks:
- yield
- Duration:
- 72 h
- Dose descriptor:
- NOEC
- Remarks:
- solid content
- Effect conc.:
- 16.5 µg/L
- Nominal / measured:
- meas. (geom. mean)
- Conc. based on:
- act. ingr.
- Basis for effect:
- biomass
- Remarks:
- yield
- Duration:
- 72 h
- Dose descriptor:
- LOEC
- Remarks:
- test item
- Effect conc.:
- 93.9 µg/L
- Nominal / measured:
- meas. (geom. mean)
- Conc. based on:
- test mat.
- Remarks:
- aqueous solution
- Basis for effect:
- biomass
- Remarks:
- yield
- Duration:
- 72 h
- Dose descriptor:
- LOEC
- Remarks:
- solid content
- Effect conc.:
- 51.65 µg/L
- Nominal / measured:
- meas. (geom. mean)
- Conc. based on:
- act. ingr.
- Basis for effect:
- biomass
- Remarks:
- yield
- Details on results:
- - Exponential growth in the control (for algal test): yes
- Observation of abnormalities (for algal test): no
- Unusual cell shape: no
- Any stimulation of growth found in any treatment: lowest test item concentration
- Any observations (e.g. precipitation) that might cause a difference between measured and nominal values: no precipitation noted
- Effect concentrations exceeding solubility of substance in test medium: none - Results with reference substance (positive control):
- - Results with reference substance valid? yes
- EC50:
72h ErC50 = 0.90 mg/L (0.77 – 1.06 mg/L)
72h EyC50 = 0.42 mg/L (0.35 - 0.51 mg/L)
Any other information on results incl. tables
Results Pre-Test: In this pre-test a clear inhibition of algal growth could be observed at 0.01 mg/L.
Applicant's summary and conclusion
- Validity criteria fulfilled:
- yes
- Conclusions:
- The study was conducted under GLP according to OECD guideline 201 and EU method C.3 on the registered substance itself. The method is to be considered scientifically reasonable with no deficiencies in documentation or relevant deviations from the guidelines, the validity criteria were met. Hence, the results can be considered as reliable to assess the toxicity of the test item resp. Sulfobetaines, coco alkyldimethyl(3-sulfopropyl) towards algae.
One valid experiment was performed.
The study was performed using 6 concentrations ranging from 0.0032 to 1 mg/L. Incubation time (test system Desmodesmus subspicatus) was 72 hours. The cell concentration of each replicate was determined by measuring the cell numbers every 24 hours with an electronic particle counter. Growth rate µ and the yield were determined from the cell number at the respective observation times.
Significant inhibition of algal growth was observed at the following concentrations:
0.1 / 0.32 / 1 mg/L (0.032 mg/L only for growth rate)
At the start and at the end of the test, the content of the test item in the test solutions was determined using LC-MS-MS.
At the lowest concentrated treatment, the measured concentration was lower than the LOQ. In the other treatments the measured concentrations lay between 90 % and 95 % of the nominal concentrations at the beginning of the test. At the end of the test, test item was detectable only in the two highest concentrated treatments (69 % and 97 % of the nominal concentration).
That means at the end of the test, the measurable test item concentration was biased by the presence of the test organism (most likely adsorption or ingestion onto the algae cells). Test item was present but partly not measurable in the test solutions.
Photolysis of the test item is less likely, as all test item solutions were equally exposed to 5000 lux. Due to the magnitude of the test item concentration, which could not be detected any more, adsorption onto the glass vessel can also be excluded. So adsorption or ingestion onto the algae cells is the most likely explanation, especially considering the fact that in the highest concentrated treatments no algal cells were visible which could have absorbed the test material.
Because of the growing biomass such effects are inevitable and also described in the OECD guideline in chapter 40 on page 6.
The only possibility to verify that the test material is still present in the test system (not in solution but in the cells), would be a lysis of the cells and an analytical determination of the test item in complete test system. However, the concentrations to be determined would be very low, and the organic material would create a background overlying the test item signal in the LC-MS-MS system. So, the analytical verification of the test material in those concentration ranges is not possible in the presence of algal cells, and the following approach has to be followed:
Since the lower concentrations were prepared by dilution of the stock solution, the real concentrations were calculated on the basis of the geometric mean of the measured concentration in the highest concentrated treatment and the respective dilution factor.
The 72h-EC50s of potassium dichromate were determined in a separate reference test. For the estimation of the 72h-EC50s of the positive control, the fits showed sufficient statistical correspondence of the data with the dose-response-equation. The values were within the range of the laboratory.
The pH of the blank control should not fluctuate by more than 1.5 units. The change was 0.1 units in the blank control.
All validity criteria were met.
No observations were made which might cause doubts concerning the validity of the study outcome. The result of the test can be considered valid.
The 72h ECr50 of the test item was determined to be 66.68 µg/l, which corresponds to a 72h ECr50 = 36.67 µg/L of the registered substance, Sulfobetaines, coco alkyldimethyl(3-sulfopropyl). Based on the obtained results, Sulfobetaines, coco alkyldimethyl(3-sulfopropyl) must be classified as acutely toxic to the environment (limit value for classification as acutely toxic: 1 mg/l) according to Regulation 1272/2008 and amendments. Further, as it is not biodegradable it should be classified as hazardous to the aquatic environment Cat. 1 (chronic), too. - Executive summary:
The study was conducted under GLP according to OECD guideline 201 and EU method C.3 on an aqueous solution of the registered substance Sulfobetaines, coco alkyldimethyl(3-sulfopropyl).
One valid experiment was performed.
The study was performed using 6 concentrations ranging from 0.0032 to 1 mg/L. Incubation time (test system Desmodesmus subspicatus) was 72 hours. The cell concentration of each replicate was determined by measuring the cell numbers every 24 hours with an electronic particle counter. Growth rate µ and the yield were determined from the cell number at the respective observation times.
Significant inhibition of algal growth was observed at the following concentrations:
0.1 / 0.32 / 1 mg/L (0.032 mg/L only for growth rate)
At the start and at the end of the test, the content of the test item in the test solutions was determined using LC-MS-MS.
At the lowest concentrated treatment, the measured concentration was lower than the LOQ. In the other treatments the measured concentrations lay between 90 % and 95 % of the nominal concentrations at the beginning of the test. At the end of the test, test item was detectable only in the two highest concentrated treatments (69 % and 97 % of the nominal concentration).
That means at the end of the test, the measurable test item concentration was biased by the presence of the test organism (most likely adsorption or ingestion onto the algae cells). Test item was present but partly not measurable in the test solutions.
Since the lower concentrations were prepared by dilution of the stock solution, the real concentrations were calculated on the basis of the geometric mean of the measured concentration in the highest concentrated treatment and the respective dilution factor.
The 72h-EC50s of potassium dichromate (K2Cr2O7, CAS No. 7778-50-9) were determined in a separate reference test. The values lay within the range of the laboratory (growth rate 0.73 - 1.10 mg/L, yield 0.21 – 0.66 mg/L).
The following results for the test item Sulfobetaines, coco alkyldimethyl(3-sulfopropyl), aqueous solution were determined:
Table Results of the test item and Sulfobetaines, coco alkyldimethyl(3-sulfopropyl)
Endpoint
NOEC
LOEC
EC10
EC50
Test item
Growth Rate
9.40 µg/L
30.00 µg/L
26.05 µg/L
66.68 µg/L
Yield
30.00 µg/L
93.90 µg/L
16.16 µg/L
36.73 µg/L
Sulfobetaines, coco alkyldimethyl(3-sulfopropyl)
Growth Rate
5.17 µg/L
16.50 µg/L
14.33 µg/L
36.67 µg/L
Yield
16.5 µg/L
51.65 µg/L
8.89 µg/L
20.20 µg/L
Sulfobetaines, coco alkyldimethyl(3-sulfopropyl) is classified as hazardous to the aquatic environment Cat. 1 (acute and chronic) according to Regulation 1272/2008 and amendments.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.