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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 229-565-3 | CAS number: 6613-64-5
- 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:
- 2017-11-21 - 2017-11-24 (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
- Report date:
- 2018
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:
- but uncritical, see overall remarks
- 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 INHIBITION TEST,” adopted 07. December 201
- Deviations:
- yes
- Remarks:
- but uncritical, see overall remarks
- Qualifier:
- according to guideline
- Guideline:
- other: OECD guidance document no. 23, GUIDANCE DOCUMENT ON AQUATIC TOXICITY TESTING OF DIFFICULT SUBSTANCES AND MIXTURES, adopted 14. Dec. 2000
- Deviations:
- not specified
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- 1-(3-sulphonatopropyl)-2-vinylpyridinium
- EC Number:
- 229-565-3
- EC Name:
- 1-(3-sulphonatopropyl)-2-vinylpyridinium
- Cas Number:
- 6613-64-5
- Molecular formula:
- C10H13NO3S
- IUPAC Name:
- 3-(2-vinylpyridinium-1-yl)propane-1-sulfonate
- Test material form:
- solid: particulate/powder
- Remarks:
- light beige
Constituent 1
- 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 ± 20°C.
Sampling and analysis
- Analytical monitoring:
- yes
- Details on sampling:
- - Concentrations: 0, 100 mg/l
Test solutions
- Vehicle:
- yes
- Remarks:
- algal medium (demineralised water enriched with minerals but without algae)
- Details on test solutions:
- PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Method: A stock solution containing 100 mg/L test item in algal medium (demineralised water enriched with minerals but without algae) was prepared.
- Controls: yes, concurrent algal medium (negative control)
- 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
- Strain: Desmodesmus subspicatus, SAG Strain Number 86.81
- Source (laboratory, culture collection): The culture of Desmodesmus subspicatus was obtained in January 2016 by MBM Sciencebridge GmbH (Institut für Pflanzenphysiologie of Universität Göttingen). 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:
- yes
- Total exposure duration:
- 72 h
- Post exposure observation period:
- none
Test conditions
- Test temperature:
- 19.8 – 22.6 °C
- pH:
- 7.5 - 7.8
- Nominal and measured concentrations:
- Nominal: 0, 100 mg/l
Measured, at 0h: 0, 98 mg/l
Measured, at 72h: 0, 96 mg/ml
The concentrations to be tested are based on the result of a non-GLP pre-test, in which no inhibition of growth could be observed up to 100 mg/L. - Details on test conditions:
- TEST SYSTEM
- Type (delete if not applicable): open, covered with perforated plastic foil acting as a stopper
- Material, size, headspace, fill volume: glass flasks, total volume 65 mL, filled with 45 ± 1 mL of the respective test solution
- Initial cells density: 2.3 *10E3 cells/mL
- Control end cells density: 135360 cells/ml
- No. of vessels per concentration (replicates): 6
- 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
- Light intensity and quality: 5000 lux
EFFECT PARAMETERS MEASURED (with observation intervals if applicable) : cell numbers, light intensity every 24h, pH and appearance at 0 and 72 h
- Determination of cell concentrations: electronic particle counter
TEST CONCENTRATIONS
- Spacing factor for test concentrations: n/a, limit test
- Range finding study
The concentration to be tested is based on non-GLP pre-tests, in which no inhibition of growth could be observed up to 100 mg/L. - Reference substance (positive control):
- yes
- Remarks:
- potassium dichromate
Results and discussion
Effect concentrationsopen allclose all
- Key result
- Duration:
- 72 h
- Dose descriptor:
- EC50
- Effect conc.:
- > 100 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- growth rate
- Remarks:
- and yield
- Remarks on result:
- not determinable
- Remarks:
- No significant inhibition of algal growth was observed.
- Duration:
- 72 h
- Dose descriptor:
- NOEC
- Effect conc.:
- >= 100 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- growth rate
- Remarks:
- and yield
- Remarks on result:
- other: No significant inhibition of algal growth was observed.
- Duration:
- 72 h
- Dose descriptor:
- LOEC
- Effect conc.:
- > 100 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- growth rate
- Remarks:
- and yield
- Remarks on result:
- not determinable
- Remarks:
- No significant inhibition of algal growth was observed.
- Details on results:
- - Exponential growth in the control (for algal test): yes
- Observation of abnormalities (for algal test): Normal and Healthy Appearance of the Algae
- Any stimulation of growth found in any treatment: no
- Any observations (e.g. precipitation) that might cause a difference between measured and nominal values: none
- 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 = 0.94 mg/L (0.90 - 0.98 mg/L)
72h EyC50 = 0.42 mg/L (0.39 - 0.45 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 deviations from the guidelines, the validity criteria were met. Hence, the results can be considered as reliable to assess the toxicity of SPV towards algae.
The study was performed as a limit test at the concentration 100 mg/L. No significant inhibition of algal growth was observed.
The measured concentrations were 96 % and 98 % of the nominal concentration. Therefore, the determination of the results was based on the nominal concentration.
As no significant inhibition was observed at the limit dose of 100 mg/l, the EC50 for both growth rate and yield were >100 mg/l, and based on the results of this study, SPV does not need to be classified as hazardous to the environment, neither acute nor chronic. - Executive summary:
The study was conducted under GLP according to OECD guideline 201 and EU method C.3 on the registered substance itself.
One valid experiment was performed.
The study was performed as a limit test at the concentration 100 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.
No significant inhibition of algal growth was observed.
At the start and at the end of the test, the content of the test item in the test solutions was determined using HPLC.
The measured concentrations were 96 % and 98 % of the nominal concentration. Therefore, the determination of the results was based on the nominal concentration.
The 72h-EC50 values 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 1-(3-Sulfopropyl)-2-vinyl-pyridinumbetain (SPV) were determined:
Endpoint
NOEC
LOEC
EC50
Growth Rate
≥ 100 mg/L
> 100 mg/L
> 100 mg/L
Yield
≥ 100 mg/L
> 100 mg/L
> 100 mg/L
There is no statistically significant difference between control and 100 mg/L.
SPV does not need to be classified as hazardous to the environment, neither acute nor chronic.
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.