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EC number: 853-587-8 | CAS number: 199387-97-8
- 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
Short-term toxicity to aquatic invertebrates
Administrative data
Link to relevant study record(s)
- Endpoint:
- short-term toxicity to aquatic invertebrates
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2022-02-16 to 2022-10-20
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study without detailed documentation
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)
- GLP compliance:
- yes (incl. QA statement)
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source (i.e. manufacturer or supplier) and lot/batch number of test material: Patheon Austria GmbH & Co KG; lot/batch number: LFND3B1003
- Purity, including information on contaminants, isomers, etc.: 100 % (according to certificate of analysis)
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: Room temperature. Store in a dry place, keep away from moisture. Protect from heat and direct sunlight.
TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing (e.g. warming, grinding): The test solution was prepared as Water accommodated fraction (WAF) with a loading rate of 100 mg/L in Elendt M4 test medium and shaking for 24 hours in an overhead shaker at 24.4 - 25.1°C. - Analytical monitoring:
- yes
- Details on sampling:
- - Concentrations: control and 100 mg/L after 0 h and 48 h of exposure
- Sampling method: 3 mL samples were transferred from the test vessels directly into 8 mL glass vials.
- Sample storage conditions before analysis: To each vial, 3 mL acetonitrile was added and samples were stored at ≤ -18 °C in the dark. - Vehicle:
- no
- Details on test solutions:
- PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Method: The test solution was prepared as Water accommodated fraction (WAF) with a loading rate of 100 mg/L in Elendt M4 test medium and shaking for 24 hours in an overhead shaker at 24.4 - 25.1°C.
- Controls: negative control with nutrition medium only
- Chemical name of vehicle (organic solvent, emulsifier or dispersant): none
- Test concentration separation factor: none since limit test - Test organisms (species):
- Daphnia magna
- Details on test organisms:
- TEST ORGANISM
- Common name: Daphnia magna Straus
- Age at study initiation (mean and range, SD): 1 - 22 h old
- Source: from the clone breeding of the Federal Environment Agency, department IV 2.4, Berlin, and has been cultivated at Hydrotox GmbH since October 2012.
- Feeding during test: none
METHOD FOR PREPARATION AND COLLECTION OF EARLY INSTARS OR OTHER LIFE STAGES, INCLUDING CULTURING CONDITIONS: The daphnids are cultured at 20 +/- 2 °C with 16 h light : 8 h dark and placed into fresh Elendt M4 medium twice a week. They are kept at approx. 10 animals / 200 mL and fed on workdays with Desmodesmus subspicatus algae corresponding to 0.1 mg C × daphnid-1 × day-1. - Test type:
- static
- Water media type:
- freshwater
- Limit test:
- yes
- Total exposure duration:
- 48 h
- Test temperature:
- 18.9 – 20.1 °C
- pH:
- 8.0 – 8.2 in the control and 6.4 – 7.4 in the test item treatments
- Dissolved oxygen:
- 8.2 – 8.3 mg/L in the control and in the test item
- Nominal and measured concentrations:
- nominal: 100 mg/L
mean measured: 98.1 mg/L after 0 h and 99.6 mg/L after 48 h - Details on test conditions:
- TEST SYSTEM
- Test vessel: Glass beakers 50 mL
- Material, size, headspace, fill volume: glass, 50 mL
- Volume of solution: 20 mL
- No. of organisms per vessel: 5
- No. of vessels per concentration (replicates): 4
- No. of vessels per control (replicates): 4
- Biomass loading rate: 4 mL/daphnia
TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: Elendt M4 medium according to OECD 202 (2004)
OTHER TEST CONDITIONS
- Photoperiod: 16 h light : 8 h dark
EFFECT PARAMETERS MEASURED (with observation intervals if applicable) : The swimming capability of the daphnids was determined after 24 h and 48 h exposure.
RANGE-FINDING STUDY
- Test concentrations: 6.8, 16 and 100 mg/L test item
- Results used to determine the conditions for the definitive study: Nominal concentrations of 6.8, 16 and 100 mg/L test item were tested and resulted in in 0 %, 0 % and 5 % immobility (48 h), respectively. - Reference substance (positive control):
- no
- Remarks:
- No positive control was used in this study. However, the recent quality testing was performed in November 2021 (GLP 1663) with EC50 (24h) = 2.02 mg/L, which is in the declared range of 0.6 – 2.1 mg/L (24 h) according to OECD 202.
- Key result
- Duration:
- 48 h
- Dose descriptor:
- EC50
- Effect conc.:
- > 100 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mobility
- Details on results:
- The measured test item concentrations in the test item treatments were 98.1 – 99.6 % of the nominal concentrations. As the measured test item concentration is within ± 20 % of the nominal concentration, according to OECD 202 (2004), the results are given in relation to the nominal test item concentration.
The immobilities of the test organisms in the control (NC) and the test item treatments are 0 % throughout the complete test duration of 48 h. - Results with reference substance (positive control):
- Quality assurance takes place at regular intervals by testing the sensitivity of the test organisms to the reference item potassium dichromate (Honeywell Speciality Chemicals Seelze GmbH, Seelze, Germany; Lot no.: H1030). The recent quality testing was performed in November 2021 (GLP 1663) with EC50 (24h) = 2.02 mg/L, which is in the declared range of 0.6 – 2.1 mg/L (24 h) according to OECD 202.
- Validity criteria fulfilled:
- yes
- Remarks:
- The test is valid according to OECD Test Guideline 202 (13 April 2004).
- Conclusions:
- The test item had no statistically significant effect on the immobilization of the daphnids at the nominal test concentration of 100 mg/L.
- Executive summary:
The OECD 202 Guideline study was performed to GLP standards and met validity criteria. The 48 h acute toxicity of N-[2-[bis(carboxymethyl)amino]ethyl]-N-(1-oxononyl)Glycine to Daphnia magna was studied under static conditions. Test species were exposed to the test chemical at a nominal concentration of 100 mg/L for 48 h. Immobilisation was recorded daily. The 48 h EC50 was > 100 mg/l test item.
This study is classified as acceptable and satisfies the guideline requirements for an acute toxicity study with freshwater invertebrates.
Results Synopsis
Test Organism: Daphnia magna (<24 h old)
Test Type: Static
EC50: > 100 mg/l (test item)
Endpoint(s) Effected: Mobility
Reference
Validity criteria:
Immobilisation of the test organisms in the control at the end of the test was 0 % and therefore ≤ 10 %.
Dissolved oxygen concentration in the control and the test item treatment at the end of the test was ≥ 8.2 mg/L and therefore ≥ 3 mg/L.
Description of key information
The 48 hours acute EC50 was >100 mg/L, tested in a limit test following OECD 202.
Key value for chemical safety assessment
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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