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EC number: 204-653-4 | CAS number: 123-81-9
- 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:
- 2021
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- EU Method C.3 (Algal Inhibition test)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 201 (Freshwater Alga and Cyanobacteria, Growth Inhibition Test)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Analytical monitoring:
- yes
- Details on sampling:
- The samples were taken from the biological phase of the study. Collecting, storage and handing over of the samples were the Study Director’s responsibility. The information concerning the samples was provided by the Study Director.
Duplicate samples from the freshly prepared test media (without algae) of all test concentrations and from the controls were taken at the start of the test.
For the determination of the stability of the test item under the test conditions and of the maintenance of the test item concentrations during the test period, duplicate samples from the test media of all test concentrations and the controls (containing algae) were taken after 24 and 48 hours test duration and at the end of the test (after the 72 hours test period by pouring together the contents of the test beakers of each treatment).
All samples were diluted by a factor of two with acetonitrile.
Additional samples of the untreated controls and of the sample dilution solvent were taken at each sampling without any sample treatment.
Storage of Test Samples:
All samples were stored in a freezer (≤ - 20 °C), protected from light until analysis was performed. Afterwards the samples were again stored deep frozen and will be kept stored up to the date of the final report.
Storage of Standard Solutions and Final Extracts:
All samples were analysed directly after sample preparation without further storage.
Analyses:
The concentrations of the test item GDMA were analysed in the duplicate test media samples from all test concentrations, in one replicate of the control samples and in the additional control and solvent samples from all sampling times (0, 24, 48 and 72 hours) - Vehicle:
- no
- Details on test solutions:
- Pre-Experiments:
Pre-experiments were performed to determine a suitable concentration range and to establish suitable methods to prepare the test solutions.
The pre-experiments were not performed in compliance with the GLP-Regulations and are excluded from the Statement of Compliance in the final report, but the raw data of these tests will be archived under the study number of the present study.
Test Concentrations:
10, 3.2, 1.0, 0.32, 0.1, 0.032 and 0.01 mg test item/L (spacing factor 3.16) and a control.
Control:
In the control, test water was used without addition of the test item.
Dosage of Test Item:
A stock solution of 10 mg test item/L was prepared by dissolving 10.6 mg test item into 1060 mL test water by intense stirring for 20 minutes. Adequate volumes of this stock solution were diluted with test water to prepare the test media of the desired test concentrations.
The test media were prepared just before introduction of the algae (= start of the test).
Appearance of the Test Item in Test Medium:
There were no remarkable observations - Test organisms (species):
- Raphidocelis subcapitata (previous names: Pseudokirchneriella subcapitata, Selenastrum capricornutum)
- Details on test organisms:
- Pseudokirchneriella subcapitata (KORSHIKOV), Strain No. 61.81 SAG, formerly known as Selenastrum capricornutum, and recently renamed as Raphidocelis subcapitata (KORSHIKOV).
The algae were originally supplied by the "Sammlung von Algenkulturen, Albrecht-von-Haller-Institut für Pflanzenwissenschaften, Universität Göttingen", 37073 Göttingen, Germany. - Test type:
- static
- Water media type:
- freshwater
- Limit test:
- no
- Total exposure duration:
- 72 h
- Hardness:
- Calculated water hardness of the test water: 0.24 mmol/L (= 24 mg/L) as CaCO3.
- Test temperature:
- In a range of 21 - 24 °C, controlled at ± 2 °C.
The temperature will be measured daily in an Erlenmeyer flask filled with water and incubated under the same conditions as the test flasks. - pH:
- The pH of the untreated test water should be pH 8.1 ± 0.1 at test start.
If necessary, the pH will be adjusted with e.g. 1 M HCl or 1 M NaOH. - Nominal and measured concentrations:
- nominal test concentrations: 10, 3.2, 1.0, 0.32, 0.1, 0.032 and 0.01 mg test item/L (spacing factor 3.16) and a control.
- Details on test conditions:
- Water Temperature:
The temperature was measured daily in an Erlenmeyer flask filled with water and incubated under the same conditions as the test flasks.
Water temperature was: 21.6 to 22.8 °C (see Table 10)
pH-Values:
The pH was measured in all test item concentrations and the control at the start and the end of the test.
pH value in the control at test start: 8.1,
pH value in the control at test end: 8.0
pH values in the test item treatments at test start: 7.8 to 8.1,
pH values in the test item treatments at test end: 7.9 to 8.0 (see Table 11).
Light Regime:
Continuous illumination
Light Intensity:
The light intensity was measured once during the test at 6 positions distributed over the experimental area at the surface of the test media.
Mean light intensity: 5047 lux (range: 4500 to 5330 lux)
Recording:
Test conditions were recorded with suitable instruments and documented in the raw data.
Reconstituted Water (OECD Medium):
Analytical grade salts were added at the following nominal concentrations in deionised water:
Macro-nutrients:
NaHCO3 50.0 mg/L CaCl2 × 2 H2O 18.0 mg/L NH4Cl 15.0 mg/L MgSO4 × 7 H2O 15.0 mg/L MgCl2 × 6 H2O 12.0 mg/L KH2PO4 1.6 mg/L
Trace Elements:
Na2EDTA × 2 H2O 100.0 μg/L FeCl3 × 6 H2O 64.0 μg/L MnCl2 × 4 H2O 415.0 μg/L H3BO3 185.0 μg/L Na2MoO4 × 2 H2O 7.0 μg/L ZnCl2 3.0 μg/L CoCl2 × 6 H2O 1.5 μg/L CuCl2 × 2 H2O 0.01 μg/L - Reference substance (positive control):
- no
- Duration:
- 72 h
- Dose descriptor:
- LOEC
- Effect conc.:
- 1 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- growth rate
- Duration:
- 72 h
- Dose descriptor:
- NOEC
- Effect conc.:
- 0.32 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.:
- 2.77 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- growth rate
- Details on results:
- The 72-hour EyC50 was calculated to be 0.853 mg test item/L and the ErC50 2.77 mg test item/L. The 72-hour EyC10 was calculated to be 0.266 mg test item/L and the ErC10 0.408 mg test item/L. The 72-hour NOEyC was determined to be 0.032 mg test item/L and the associated 72-hour LOEyC of 0.1 mg test item/L. The 72-hour NOErC was determined to be 0.32 mg test item/L and the associated 72-hour LOErC is 1.0 mg test item/L. For further details ses Table 2.
- Reported statistics and error estimates:
- Cell Density Increase in Control Cultures:
31.5-fold increase within 72 hours and thus, the validity criterion was met.
Coefficient of Variation of Sectional (Daily) Growth Rates in Control Cultures:
14.9 % and thus, the validity criterion was met.
Coefficient of Variation of Average Growth between Control Replicates:
2.1 % and thus, the validity criterion was met. - Validity criteria fulfilled:
- yes
- Conclusions:
- The influence of GDMA on the growth of the freshwater green algae Pseudokirchneriella subcapitata was assessed in a static concentration-response test. The 72-hour EyC50 was calculated to be 0.853 mg test item/L, and the 72-hour ErC50 value was calculated to be 2.77 mg test item/L. The 72-hour NOEyC was determined to be 0.032 mg test item/L and the associated 72-hour LOEyC was 0.1 mg test item/L. The 72-hour NOErC was determined to be 0.32 mg test item/L and the associated 72-hour LOErC was 1 mg test item/L.
The initial concentrations and the maintenance of the exposure concentrations during the test were examined in the analytical part. All reported results refer to nominal concentrations.
Reference
Table 2. Influence of GDMA on the Growth of Pseudokirchneriella subcapitata Parameter | Yield [mg test item/L] | Growth rate [mg test item/L] |
72-hour EC50 | 0.853 | 02.77 |
95 % conf. interval | 0.730 - 0.993 | 2.52 - 3.04 |
72-hour EC20 | 0.409 | 0.827 |
95 % conf. interval | 0.297 - 0.504 | 0.702 - 0.951 |
72-hour EC10 | 0.266 | 0.408 |
95 % conf. interval | 0.169 - 0.353 | 0.323 - 0.496 |
72-hour NOEC | 0.032 | 0.32 |
72-hour LOEC | 0.1 | 1.0 |
Values refer to nominal test concentrations |
Description of key information
The estimated EC50 of GDMA against algae is 6.7 mg/L
Key value for chemical safety assessment
- EC50 for freshwater algae:
- 2.77 mg/L
- EC10 or NOEC for freshwater algae:
- 0.32 mg/L
Additional information
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.
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