Butanedioic acid, sulfo-, C-[2-[(1-oxododecyl)amino]ethyl] ester, monosodium salt

Short-term toxicity to aquatic invertebrates

Link to relevant study record(s)

Reference

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.

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.