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EC number: 939-648-2 | CAS number: 75081-73-1
- 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:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Justification for type of information:
- see read across justification
- Reason / purpose for cross-reference:
- read-across source
- Duration:
- 48 h
- Dose descriptor:
- EC50
- Effect conc.:
- 19 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- act. ingr.
- Basis for effect:
- other: Immobilization
- Remarks on result:
- other: 95% C.I.: 55 - 83 mg as/L
- Details on results:
- - Behavioural abnormalities: not reported
- Other biological observations: none
- Mortality of control: none
- Other adverse effects control: none
- Abnormal responses: none
- Any observations (e.g. precipitation) that might cause a difference between measured and nominal values: none. analytics confirmed the correct dosage and the stability of the test item under test conditions
- Effect concentrations exceeding solubility of substance in test medium: none
Based on the structural similarity, the results can be considered as relevant also for the registered substance. - Results with reference substance (positive control):
- - Results with reference substance valid?: yes
- Mortality: as expected
- EC50/LC50: 0.94 mg/L
- Other: For evaluation of the quality of the daphnia clone and the experimental conditions, potassium dichromate is tested as a positive control twice a year. The result of the latest positive control test in September 2012 (48-hour EC50: 0.94 mg/L, Harlan Laboratories Study D64333) showed that the sensitivity of the test organisms was within the internal historical range (48-hour EC50 from 2000 to 2012: 0.43 1.1 mg/L). - Reported statistics and error estimates:
- The NOEC, EC0 and EC100 were determined directly from the raw data. The 24- and 48-hour EC50 and the 95% confidence limits were calculated by Weibull Analysis.
- Validity criteria fulfilled:
- yes
- Conclusions:
- In the present study the EC 50 (48 h) for Daphnia m. is derived at 19 mg/mL
- Executive summary:
In the Klimisch 1 GLP study from Kimmel (2013) the acute toxicity of item Butanedioic acid, 2(or 3)-sulfo-, 4-[2-[(1-oxo(C12-C18(even numbered) and C18unsaturated)alkyl))amino]ethyl]esters, disodium salts on Daphnia magna was determined in an 48 hour static test according to OECD 202 and EU method C.2. The test was performed with concentrations of 6.25, 12.5, 25, 50 and 100 mg test item/L(referring to 2.6, 5.2, 10.4, 20.8 and 41.5 mg solid content/L) and a blank control. Four replicates with 5 daphnids each were set up. After 48 hours 0, 0, 0. 0, 65 and 100 % immobilization was observed in the control and at test concentrations of 2.6, 5.2, 10.4, 20.8 and 41.5 mg solid content/L, respectively. Analytical measurements confirmed that the test solutions were correctly dosed and stable throughout the exposure period. Therefore the data were evaluated based on nominal concentrations. The EC50 is 19 mg solid content/L, the NOEC is 10.4 mg solid content/L.
For C12 -MEA (Butanedioic acid, 2(or 3)-sulfo-, 4 -[2 -[(1 -oxododecyl)amino]ethyl] ester, disodium salt) read across was made from the source chemical C12 -C18/C18'-MEA (Butanedioic acid, 2(or 3)-sulfo-, 4 -[2 -[(1-oxo(C12-C18(even numbered) and C18 unsaturated)alkyl))amino]ethyl]esters, disodium salts). Both substances have the same main C-Chain length of C12 (C12 -MEA 75 -90% C12, C12 -C18/C18'-MEA 45 -55%) . In C12 -MEA the C14 alkyl rest is represented with < 10% while in C12 -C18/C18'-MEA C14 comprises to 15 -20%. This difference is considered small. It can be argued that C12 -MEA is already part of C12 -C18/C18'-MEA. The physical chemical parameters of both substances are similar. Within the N2 subgroup, the toxicity does not show a clear C-Chain dependency, i.e., the EC50/LC50 data for all members of this group are similar. Therefore, read across from C12 -C18/C18'-MEA (source) to C12 -MEA is considered as being justified.
Based on the data set and the supporting evidence for read across including the similarity of the C-Chain distribution, no further risk assessment factor is needed. The results are considered relevant and reliable for the risk assessment.
Based on the structural similarity, the results can be considered as relevant also for the registered substance.
Reference
Description of key information
48 h EC50: 19 mg/L
Key value for chemical safety assessment
Fresh water invertebrates
Fresh water invertebrates
- Effect concentration:
- 19 mg/L
Additional information
In the Klimisch 1 GLP study from Kimmel (2013) the acute toxicity of item Butanedioic acid, 2(or 3)-sulfo-, 4-[2-[(1-oxo(C12-C18(even numbered) and C18unsaturated)alkyl))amino]ethyl]esters, disodium salts on Daphnia magna was determined in an 48 hour static test according to OECD 202 and EU method C.2. The test was performed with concentrations of 6.25, 12.5, 25, 50 and 100 mg test item/L(referring to 2.6, 5.2, 10.4, 20.8 and 41.5 mg solid content/L) and a blank control. Four replicates with 5 daphnids each were set up. After 48 hours 0, 0, 0. 0, 65 and 100 % immobilization was observed in the control and at test concentrations of 2.6, 5.2, 10.4, 20.8 and 41.5 mg solid content/L, respectively. Analytical measurements confirmed that the test solutions were correctly dosed and stable throughout the exposure period. Therefore the data were evaluated based on nominal concentrations. The EC50 is 19 mg solid content/L, the NOEC is 10.4 mg solid content/L.
For C12 -MEA (Butanedioic acid, 2(or 3)-sulfo-, 4 -[2 -[(1 -oxododecyl)amino]ethyl] ester, disodium salt) read across was made from the source chemical C12 -C18/C18'-MEA (Butanedioic acid, 2(or 3)-sulfo-, 4 -[2 -[(1-oxo(C12-C18(even numbered) and C18 unsaturated)alkyl))amino]ethyl]esters, disodium salts). Both substances have the same main C-Chain length of C12 (C12 -MEA 75 -90% C12, C12 -C18/C18'-MEA 45 -55%) . In C12 -MEA the C14 alkyl rest is represented with < 10% while in C12 -C18/C18'-MEA C14 comprises to 15 -20%. This difference is considered small. It can be argued that C12 -MEA is already part of C12 -C18/C18'-MEA. The physical chemical parameters of both substances are similar. Within the N2 subgroup, the toxicity does not show a clear C-Chain dependency, i.e., the EC50/LC50 data for all members of this group are similar. Therefore, read across from C12-C18/C18'-MEA (source) to C12-MEA is considered as being justified.
Based on the data set and the supporting evidence for read across including the similarity of the C-Chain distribution, no further risk assessment factor is needed.The results are considered relevant and reliable for the risk assessment.
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