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

Short-term toxicity to fish

Link to relevant study record(s)

Reference

Endpoint:

short-term toxicity to fish

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:

96 h

Dose descriptor:

NOEC

Effect conc.:

>= 32 mg/L

Nominal / measured:

nominal

Conc. based on:

act. ingr.

Basis for effect:

mortality (fish)

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

> 32 mg/L

Nominal / measured:

nominal

Conc. based on:

act. ingr.

Basis for effect:

mortality (fish)

Details on results:

- Behavioural abnormalities: none reported
- Observations on body length and weight: NA
- Other biological observations: In the control and up to and including the highest test concentration 76 mg test item/L (32 mg solid content/L), all fish survived until the end of the test and no visible abnormalities were observed.
- 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: No remarkable observations were made concerning the appearance of the test media.
- Effect concentrations exceeding solubility of substance in test medium: no

Based on the structural similarity, the results can be considered as relevant also for the registered substance.

Reported statistics and error estimates:

The LC50 values at different observation times could not be calculated because up to the highest test concentration no mortality or any kind of symptoms were observed. The NOEC, LOEC, LC0 and LC100 were determined directly from the raw data.

Sublethal observations / clinical signs:

In the control and up to and including the highest test concentration 32 mg solid content/L, all fish survived until the end of the test and no visible abnormalities were observed.The 96 hour NOEC and LC₀of the test item to zebra fish were both determined to be 32 mg solid content/L. The 96 hour LC₅₀of the test item was determined to be > 32 mg solid content/L.

Based on the structural similarity, the results can be considered as relevant also for the registered substance.

Validity criteria fulfilled:

yes

Conclusions:

In the present study the LC50 (96 h) for Danio rerio is derived at > 32 mg/L

Executive summary:

In the Klimisch 1 GLP study from Kimmel (2013) the acute toxicity of Butanedioic acid, 2(or 3)-sulfo-, 4-[2-[(1-oxo(C12-C18(even numbered) and C18unsaturated)alkyl))amino]ethyl]esters, disodium salts to zebra fish (Danio rerio) was determined in a 96‑hour semi-static test with daily test medium renewal according to the EU Commission Directive 92/69/, Part C.1, the Commission Regulation (EC) No 440/2008, Part C.1 and the OECD Guideline for Testing of Chemicals No. 203 (1992). The following nominal concentrations of Butanedioic acid, 2(or 3)-sulfo-, 4-[2-[(1-oxo(C12-C18(even numbered) and C18unsaturated)alkyl))amino]ethyl]esters, disodium salts were tested: 0.76, 2.4, 7.6, 24 and 76 mg test item/L corresponding to 0.32, 1.0, 3.2, 10 and 32 mg solid content/L. Additionally, a control (test water without test item) was tested in parallel. The measured concentrations of the 32 mg solid content/L was within 94 and 101 % of the nominal concentrations. Consequently, the biological results are related to the nominal test item concentrations.

In the control and up to and including the highest test concentration 32 mg solid content/L, all fish survived until the end of the test and no visible abnormalities were observed. The 96 hour NOEC and LC₀ of Butanedioic acid, 2(or 3)-sulfo-, 4-[2-[(1-oxo(C12-C18(even numbered) and C18unsaturated)alkyl))amino]ethyl]esters, disodium salts to zebra fish were both determined to be 32 mg solid content/L. The 96 hour LC₅₀was determined to be > 32 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. As mentioned before, the physical chemical parameters 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 of this study 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

96 h LC50: 32 mg/L

Key value for chemical safety assessment

Fresh water fish

Fresh water fish

Effect concentration:

32 mg/L

Additional information

In the Klimisch 1 GLP study from Kimmel (2013) the acute toxicity of Butanedioic acid, 2(or 3)-sulfo-, 4-[2-[(1-oxo(C12-C18(even numbered) and C18unsaturated)alkyl))amino]ethyl]esters, disodium salts to zebra fish (Danio rerio) was determined in a 96‑hour semi-static test with daily test medium renewal according to the EU Commission Directive 92/69/, Part C.1, the Commission Regulation (EC) No 440/2008, Part C.1 and the OECD Guideline for Testing of Chemicals No. 203 (1992). The following nominal concentrations of Butanedioic acid, 2(or 3)-sulfo-, 4-[2-[(1-oxo(C12-C18(even numbered) and C18unsaturated)alkyl))amino]ethyl]esters, disodium salts were tested: 0.76, 2.4, 7.6, 24 and 76 mg test item/L corresponding to 0.32, 1.0, 3.2, 10 and 32 mg solid content/L. Additionally, a control (test water without test item) was tested in parallel. The measured concentrations of the 32 mg solid content/L was within 94 and 101 % of the nominal concentrations. Consequently, the biological results are related to the nominal test item concentrations.

In the control and up to and including the highest test concentration 32 mg solid content/L, all fish survived until the end of the test and no visible abnormalities were observed. The 96 hour NOEC and LC₀ of Butanedioic acid, 2(or 3)-sulfo-, 4-[2-[(1-oxo(C12-C18(even numbered) and C18unsaturated)alkyl))amino]ethyl]esters, disodium salts to zebra fish were both determined to be 32 mg solid content/L. The 96 hour LC₅₀was determined to be > 32 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. As mentioned before, the physical chemical parameters 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 of this study are considered relevant and reliable for the risk assessment.