L-Glutamic acid, N-coco acyl derivs., disodium salts

Short-term toxicity to aquatic invertebrates

Link to relevant study record(s)

Reference

Reference 1

Endpoint:

short-term toxicity to aquatic invertebrates

Type of information:

experimental study

Adequacy of study:

supporting study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: GLP guideline study with acceptable restrictions (temperature slightly higher (0.3 °C) then recommended in guideline: as no significant immobility occurred this deviation is considered as uncritical)

Qualifier:

according to guideline

Guideline:

OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)

GLP compliance:

yes (incl. QA statement)

Analytical monitoring:

yes

Details on sampling:

- Concentrations: Samples were taken from the control and each test concentration after 0, 24 and 48 h.

Vehicle:

no

Details on test solutions:

PREPARATION AND APPLICATION OF TEST SOLUTION
- Method: A stock solution containing 100 mg test substance/L was prepraed in water. The stock solution was then diluted to prepare the concentrations to be tested.

Test organisms (species):

Daphnia magna

Details on test organisms:

TEST ORGANISM
- Common name: water flea
- Strain: Berlin
- Source: Umweltbundesamt Berlin
- Age at study initiation: < 24 h
- Method of breeding: similar to the method described in ISO guideline 6341
- Feeding during test: none

ACCLIMATION
- Acclimation period: 24 hours
- Acclimation conditions: same as test
- Type and amount of food: unicellular green algae
- Feeding frequency: twice a week

Test type:

semi-static

Water media type:

freshwater

Limit test:

no

Total exposure duration:

48 h

Hardness:

250 mg/L as CaCO3

Test temperature:

21.2 - 22.0 °C

pH:

7.4 - 7.9

Dissolved oxygen:

8.1 - 8.8 mg/L

Nominal and measured concentrations:

Nominal concentrations: 2.2, 4.6, 10, 22, 46 and 100 mg/L
Measured concentrations (geom. mean): 1.7, 3.9, 9.1, 18.7, 37 and 77.1 mg/L

Details on test conditions:

TEST SYSTEM
- Test vessel: beaker
- Material: glass; Size: 50 mL; Fill volume: 20 mL
- Renewal rate of test solution (frequency/flow rate): every 24 h
- No. of organisms per vessel: 5
- No. of vessels per concentration (replicates): 4
- No. of vessels per control (replicates): 4

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: deionized water
- TOC content: < 2 mg/L
- Particulates: < 20 mg/L
- Culture medium different from test medium: no (Elendt M4)
- Intervals of water quality measurement: The pH and dissolved oxygen concentration were measured at the beginning and at the end of the test and at every medium renewal in the old and the new test solution.

EFFECT PARAMETERS MEASURED: Immobilization was recorded after 24 and 48 h test duration.

Reference substance (positive control):

yes

Remarks:

potassium dichromate

Key result

Duration:

48 h

Dose descriptor:

EC50

Effect conc.:

49 mg/L

Nominal / measured:

meas. (geom. mean)

Conc. based on:

test mat.

Basis for effect:

mobility

Duration:

48 h

Dose descriptor:

EC100

Effect conc.:

77 mg/L

Nominal / measured:

meas. (geom. mean)

Conc. based on:

test mat.

Basis for effect:

mobility

Details on results:

In the control, none of the daphnia died or showed any signs of abnormal behaviour throughout the test.

Results with reference substance (positive control):

- Results with reference substance valid? yes
- EC50 (24h) = 1.4 mg/L
- Other: The EC50 (24h) for the reference substance was determined to be in the accepted range of 0.6 - 1.7 mg/L.

Analytical determination:

The concentration of the test item was calculated through measured DOC divided by the content of organic carbon (60%) of the test item. The measured concentrations showed good correlation with the nominal concentrations. The geometric means of the measured concentrations were in a range of 77 - 91 % of the nominal concentrations. Therefore, the geometric mean of the measured concentrations was used for the determination of the results. The measured DOC values in the control and in the lowest concentrated treatment were in a similar range. The measured DOC concentration in the control at t = 0 h was unexpectedly high. This might be caused by a contaminated test vessel.

Validity criteria fulfilled:

yes

Reference 2

Endpoint:

short-term toxicity to aquatic invertebrates

Type of information:

read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

supporting study

Reason / purpose for cross-reference:

read-across source

Key result

Duration:

48 h

Dose descriptor:

EC50

Effect conc.:

49 mg/L

Nominal / measured:

meas. (geom. mean)

Conc. based on:

test mat.

Basis for effect:

mobility

Description of key information

In a final decision on a compliance check ECHA requested the registrant to conduct a long-term toxicity testing on aquatic invertebrates with CAS 68187-30-4. According to the decision, to Annex VII, Section 9.1.1, Column 2 of REACH and to prevent unnecessary animal testing, a short-term toxicity study on aquatic invertebrates does not need to be provided.

 

 

Additional information

No studies investigating the short-term toxicity of l-Glutamic acid, N-coco acyl derivs., disodium salts (CAS No. 68187-30-4) to aquatic invertebrates are available. Thus, available data for the source substance l-Glutamic acid, N-coco acyl derivs., monosodium salts (CAS No. 68187-32-6) was used in a read across approach. The read across is considered valid as both substances are structurally identical (solely differing in the degree of deprotonation being di- and monosodium salts, respectively), which assume very similar physico-chemical properties resulting in identical environmental behavior and ecotoxicity.

The read across key study was performed according to GLP and OECD guideline 202 using Daphnia magna as test organism (Laus, 2011). Nominal concentrations between 2.2 and 100 mg/L were tested over a period of 48 h. Thus, a 48h-EC50 is determined to be 49 mg/L based on the measured test concentration. Due to the very high structural similarity, this result can also be considered for l-Glutamic acid, N-coco acyl derivs., disodium salts (CAS No. 68187-30-4).

 

In a final decision on a compliance check ECHA requested the registrant to conduct a long-term toxicity testing on aquatic invertebrates with CAS 68187-30-4. According to the decision, to Annex VII, Section 9.1.1, Column 2 of REACH and to prevent unnecessary animal testing, a short-term toxicity study on aquatic invertebrates does not need to be provided.