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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 421-660-1 | CAS number: - Z-27
- 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 fish
Administrative data
- Endpoint:
- short-term toxicity to fish
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 14 June 1995 to 22 September 1995
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: The study was performed to a guideline and used GLP.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 996
- Report date:
- 1996
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 203 (Fish, Acute Toxicity Test)
- Version / remarks:
- 92/69/EEC, C1
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 203 (Fish, Acute Toxicity Test)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OTS 797.1400 (Fish Acute Toxicity Test)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Bis(dimethyl-(2-hydroxyethyl)ammonium) 1,2-ethanediyl-bis(2-hexadecenylsuccinate)
- EC Number:
- 421-660-1
- EC Name:
- Bis(dimethyl-(2-hydroxyethyl)ammonium) 1,2-ethanediyl-bis(2-hexadecenylsuccinate)
- Molecular formula:
- Hill formula: C50 H96 N2 O10 CAS formula: C42 H74 O8. 2(C4 H11 N O)
- IUPAC Name:
- bis((2-hydroxyethyl)dimethylazanium) (4E)-3-{[2-({3-carboxylato-3-[(2E)-hexadec-2-en-2-yl]propanoyl}oxy)ethoxy]carbonyl}-4-methyloctadec-4-enoate
- Reference substance name:
- BIS(DIMETHYL-(2-HYDROXYETHYL)AMMONIUM) 1,2-ETHANEDIYL-BIS (2-HEXADECENYLSUCCINATE)
- IUPAC Name:
- BIS(DIMETHYL-(2-HYDROXYETHYL)AMMONIUM) 1,2-ETHANEDIYL-BIS (2-HEXADECENYLSUCCINATE)
Constituent 1
Constituent 2
Sampling and analysis
- Analytical monitoring:
- yes
- Details on sampling:
- - Concentrations: The concentration and stability of the test material in the test solutions were verified by chemical analysis at 0, 24 and 96 hours.
- Sampling method: Water samples were taken from the solvent control and all surviving test groups (replicates pooled) for quantitative analysis.
- Sample storage conditions before analysis: NDA
Test solutions
- Vehicle:
- yes
- Details on test solutions:
- Identity and concentration of auxiliary solvent for dispersal: Dimethylformamide (50 microlites/litre)
PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Method: Amounts of test material were each separately dissolved in dimethylformamide and the volume adjusted to 25 mL to give 0.50, 0.90, 1.60, 2.80 and 5 g of test material/ 25 mL solvent stock solutions. They were freshly prepared each day prior to dosing.
- Eluate: N/A
- Differential loading: NDA
- Controls: A normal control (i.e. without the test material) and a solvent control were used and were maintained under identical test conditions to the test samples.
- Chemical name of vehicle (organic solvent, emulsifier or dispersant): Dimethylformamide
- Concentration of vehicle in test medium (stock solution and final test solution(s) including control(s)): NDA
- Evidence of undissolved material (e.g. precipitate, surface film, etc): NDA
Test organisms
- Test organisms (species):
- Oncorhynchus mykiss (previous name: Salmo gairdneri)
- Details on test organisms:
- TEST ORGANISM
- Common name: Rainbow trout
- Strain: Oncorhynchus mykiss
- Source: Parkwood Trout Farm, Wigmore, Kent, UK
- Age at study initiation (mean and range, SD): Juvenile
- Length: Mean standard length of 4.2 cm (s.d. = 0.2) at the end of the definitive study
- Weight: Mean weight of 0.59 g (s.d. = 0.14) at the end of the definitive study
- Method of breeding: NDA
- Feeding during test
- Food type: Commercial trout pellets
- Amount: NDA
- Frequency: Feeding was discontinued 48 hours prior to the start of the definitive study.
ACCLIMATION
- Acclimation period: 11 September 1995 to 18 Spetember 1995
- Acclimation conditions (same as test or not): Test conditions
- Type and amount of food: Commercial trout pellets. Amount not specified.
- Feeding frequency: NDA
- Health during acclimation (any mortality observed): Less than 1 % mortality
QUARANTINE (wild caught)
- Duration: N/A
- Health/mortality: N/A
Study design
- Test type:
- flow-through
- Water media type:
- freshwater
- Limit test:
- no
- Total exposure duration:
- 96 h
- Post exposure observation period:
- N/A
Test conditions
- Hardness:
- 109 mg CaCO3/L
- Test temperature:
- Water temperature: 14 °C
- pH:
- 7.4
- Dissolved oxygen:
- Dissolved oxygen: greater than or equal to 9.8 mg O2/L
- Salinity:
- NDA
- Nominal and measured concentrations:
- Nominal test concentrations: 1.0, 1.8, 3.2, 5.6 and 10 mg/L
Mean measured concentrations: 1.047, 1.430, 3.014, 3.733, 5.868 mg/L - Details on test conditions:
- TEST SYSTEM
- Test vessel:
- Type (delete if not applicable): Closed
- Material, size, headspace, fill volume: 20 L glass exposure vessels were used
- Aeration: No auxiliary aeration was used; only the diluent supply was aerated.
- Type of flow-through: Peristaltic
- Renewal rate of test solution (frequency/flow rate): The diluent supply was pumped at a rate of 120 mL/minute with solvent stock solutions dosed at a rate of 0.36 mL/h to give the test series.
- No. of organisms per vessel: 10 fish
- No. of vessels per concentration (replicates): 2
- No. of vessels per control (replicates): 2
- No. of vessels per vehicle control (replicates): 2
- Biomass loading rate: NDA
TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: Dechlorinated laboratory tap water
- Total organic carbon: 2.0 mg C/L
- Particulate matter: 0.80 mg/L
- Metals: Various
- Pesticides: <0.08 µg/L
- Chlorine: 0.22 mg/L total chlorine, 0.17 mg/L free chlorine
- Alkalinity: pH 7.4
- Ca/mg ratio: 43 mg Ca/L, 7 mg Mg/L
- Conductivity: 382 M1CSM
- Culture medium different from test medium: The test water used for the studies was the same as that used to maintain the stock fish.
- Intervals of water quality measurement: Water temperature, pH and dissolved oxygen concentrations were measured daily.
OTHER TEST CONDITIONS
- Adjustment of pH: No
- Photoperiod: 16 hours light and 8 hours darkness
- Light intensity: NDA
EFFECT PARAMETERS MEASURED (with observation intervals if applicable) : Any mortalities and adverse reactions to exposure were recorded at 3, 6, 24, 48, 72 and 96 hours after the start of exposure. The criteria of death was taken to be the absence of both respiratory movement and response to physical stimulation.
TEST CONCENTRATIONS
- Spacing factor for test concentrations: NDA
- Justification for using less concentrations than requested by guideline: N/A
- Range finding study
- Test concentrations: Nominal concentrations 1.0, 10 and 100 mg/L
- Results used to determine the conditions for the definitive study: The results showed no mortalities at the test concentrations of 1.0 mg/L. However, mortalities were observed at 10 and 100 mg/L. Based on this information test concentrations of 1.0, 1.8, 3.2, 5.6 and 10 mg/L were selected for the definitive study. - Reference substance (positive control):
- no
Results and discussion
Effect concentrationsopen allclose all
- Duration:
- 24 h
- Dose descriptor:
- LC50
- Effect conc.:
- 2 mg/L
- Nominal / measured:
- meas. (not specified)
- Conc. based on:
- test mat.
- Basis for effect:
- mortality (fish)
- Remarks on result:
- other: 95 % CL: 1.9-2.3 mg/L
- Duration:
- 48 h
- Dose descriptor:
- LC50
- Effect conc.:
- 1.7 mg/L
- Nominal / measured:
- meas. (not specified)
- Conc. based on:
- test mat.
- Basis for effect:
- mortality (fish)
- Remarks on result:
- other: 95 % CL: 1.5-1.9 mg/L
- Duration:
- 72 h
- Dose descriptor:
- LC50
- Effect conc.:
- 1.2 mg/L
- Nominal / measured:
- meas. (not specified)
- Conc. based on:
- test mat.
- Basis for effect:
- mortality (fish)
- Remarks on result:
- other: 95 % CL: 1.0-1.4 mg/L (resulting in 0 and 100 % mortalities, respectively)
- Duration:
- 96 h
- Dose descriptor:
- LC50
- Effect conc.:
- 1.2 mg/L
- Nominal / measured:
- meas. (not specified)
- Conc. based on:
- test mat.
- Basis for effect:
- mortality (fish)
- Remarks on result:
- other: 95 % CL: 1.0-1.4 mg/L (resulting in 0 and 100 % mortalities, respectively)
- Duration:
- 96 h
- Dose descriptor:
- LC100
- Effect conc.:
- 1.4 mg/L
- Nominal / measured:
- meas. (not specified)
- Conc. based on:
- test mat.
- Basis for effect:
- mortality (fish)
- Duration:
- 96 h
- Dose descriptor:
- NOEC
- Effect conc.:
- 1 mg/L
- Nominal / measured:
- meas. (not specified)
- Conc. based on:
- test mat.
- Basis for effect:
- other: Zero mortalities and the absence of any behavioural responses to exposure
- Details on results:
- - Behavioural abnormalities: Behavioural resposnes to exposure (other than death) were observed at test concentrations of > 1.0 mg/L. These responses were swimming at the surface, swimming at the bottom of test vessels, loss of equilibrium and the presence of moribund fish.
- Observations on body length and weight: NDA
- Other biological observations: None
- Mortality of control: 0 %
- Other adverse effects control: None
- Abnormal responses: NDA
- Any observations (e.g. precipitation) that might cause a difference between measured and nominal values: No
- Effect concentrations exceeding solubility of substance in test medium: No - Results with reference substance (positive control):
- Not applicable
- Reported statistics and error estimates:
- The LC50 values and associated confidence limits were calculated by the moving average method of Thompson (1947).
Any other information on results incl. tables
- Sublethal observations / clinical signs:
Temperature was maintained at 14 ± 1 °C throughout the study, while there were no treatment related differences for oxygen concentration or pH.
Analysis of the test preparations showed the measured concentrations to range between 52 -116 % of nominal. The low and variable results obtained are considered to be due to deficiencies in the analytical method and not due to losses during dosing.
Table 1 Cumulative mortality data in the definitive study
Nominal concentration (mg/L)
Cumulative mortality (initial population = 10)
% mortality
3 h
6 h
24 h
48 h
72 h
96 h
96 h
Control
R1
R2
0
0
0
0
0
0
0
0
0
0
0
0
0
0
Solvent control
R1
R2
0
0
0
0
0
0
0
0
0
0
0
0
0
0
1.0
R1
R2
0
0
0
0
0
0
0
0
0
0
0
0
0
0
1.8
R1
R2
0
0
0
0
0
0
5
7
10
10
10
10
100
100
3.2
R1
R2
0
0
0
0
9
6
10
10
10
10
10
10
100
100
5.6
R1
R2
0
0
0
0
10
10
10
10
10
10
10
10
100
100
10
R1
R2
2
5
9
10
10
10
10
10
10
10
10
10
100
100
R1 and R2 = replicates 1 and 2
Applicant's summary and conclusion
- Validity criteria fulfilled:
- yes
- Conclusions:
- The 96 h LD50 value for OS 114451A was 1.2 mg/L (95 % confidence limits 1.0-1.4 mg/L) based on mean measured test concentrations. The NOEC was 1.0 mg/L.
- Executive summary:
In a 96-h acute toxicity study, Rainbow Trout (Oncorhyncus mykiss)were exposed to OS 114451A at nominal concentrations of 1.0, 1.8, 3.2, 5.6 and 10 mg a.i./L in dimethylformamide under flow through conditions. The 96-h LC50was 1.3 mg a.i./L (nominal) and 1.2 mg a.i./L (measured concentration). The NOEC value, based on sublethal effects, was 1.0 mg a.i./L. Sublethal effects of swimming at the surface, swimming at the bottom of the test vessels, loss of equilibrium and the presence of moribund fish were observed in the groups exposed to concentrations of greater than 1 mg/L of OS 114451A. Based on the results of this study, OS 114451A would be classified as toxic to aquatic organisms, may cause long-term adverse effects in the aquatic environment, in accordance with Annex III of Directive 67/548/EEC.
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.