Sodium hydrogen N-(1-oxododecyl)-L-glutamate

Short-term toxicity to aquatic invertebrates

Link to relevant study record(s)

Reference

Endpoint:

short-term toxicity to aquatic invertebrates

Type of information:

experimental study

Adequacy of study:

key study

Study period:

From January, 27 2021 to January 29, 2021

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)

Version / remarks:

2004

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Remarks:

Quality Assesment is on page 4 of the attached report

Specific details on test material used for the study:

Batch no.: y191119 supplied by the sponsor
Aspect: white powder
Purity: 97.3%
Solubility: soluble in water
Storage condition of test material: room temperature (15 °C - 25 °C), stable for at least 20 months
Stability and homogeneity of the test material in the vehicle/solvent under test conditions (e.g. in the exposure medium): stable for 12 months minimum
Solubility: soluble and stable in water
Reactivity of the test material with the incubation material used (e.g. plastic ware): not reactive
pH (sol. 5% 20 °C) = 5.10
More information can be found on the attached report

Analytical monitoring:

yes

Remarks:

Stability of test item was evaluated at the beginning and at the end of the test

Details on sampling:

Samples, properly diluted with deionised water with low TOC contents, have been analysed by means of an integrated sampling system directly from vials containing 40 ml volume. For each sample under test the corresponding blank is analysed.
CALCULATIONS
% stability: 100 x [(TOC substance 48h - TOC ctl 48h )/(TOC substance 0h - TOC ctl 0h )]
Samples are considered stable if the % stability is between 80 and 120% of the value.
STABILITY
The samples were stable throughout the test period.
Results that are summarized in table 5 of the attached report confirm stability.
Treated (500.00 mg/l), at t0 TOC 258.64, at t48h 242.81, % stability 94
Treated (103.30 mg/l), at t0 54.76, at t48h 57.79, % stability 106
Treated (21.34 mg/l), at t0 12.63, at t48h 14.36, % stability 114

Vehicle:

yes

Details on test solutions:

As dilution water, reconstituted water has been used.
It has been prepared dissolving the following salts in 1 l of deionised water obtaining the below solutions:
A: CaCl2 2H2O 11.76 g/l
B: MgSO4 7 H2O 4.93 g/l
C: NaHCO3 2.59 g/l
D: KCl 0.23 g/l
25 ml of solutions A,B,C and D have been taken to 1000 ml volume with deionised water.

Test organisms (species):

Daphnia magna

Details on test organisms:

Age: 6 - 24 hours
Origine: Breeder in Eurofins Biolab Test Facility
Feeding: green algae
Culture vessels: Glass becher 500 ml
Water change: 3 times per week
Temperature: 20 +/-2 °C
Lightning: photoperiod 16 hours of light, 8 hours of darkness
Water Hardness: 140-250 mg CaCO3

Test type:

static

Water media type:

other: deionized water + dissolved salts (CaCl2.H2O, MgSO4.7H2O, KCl, NaHCO3)

Limit test:

no

Total exposure duration:

48 h

Remarks on exposure duration:

Results at 24 h were also evaluated

Hardness:

Between 140 and 250 mg CaCO3/L

Test temperature:

20 +/- 2 °C (see table 4 of attached report)

pH:

The results of pH at the beginning and at the end of the test are reported in Table 3 of the attached report and satisfy the requirements of the regulation (pH in the control must not deviate by more than 1.5 units during the test).

Dissolved oxygen:

> 3 mg/l (see table 2 of the attached report)
None areation

Nominal and measured concentrations:

Range finding test: from 0.01 to 100 mg/L test item (nominal concentration)
Definitive test: 500.00, 227.27, 103.30, 46.96, 21.34 mg/L test item (nominal concentration)

Details on test conditions:

Range finding test
A solution at 100 mg/L of the test item has been prepared in culture medium. To better solubilize it the solution has been put on a magnetic stirrer for 15 minutes. Then 5 different concentrations have been prepared with ten-fold dilutions from 100 mg/L to 0.01 mg/L.
Tested concentrations have been 100.00 mg/L, 10.00 mg/L, 1.00 mg/L, 0.10 mg/L and 0.01 mg/L.
120 Daphnie have been used, 100 of them treated with the test item at different concentration and 20 used as control, kept in the same assay conditions without adding the test item.
At 24 and 48 hours, immobilisation of the organisms has been evaluated.
Definitive test
After the range finding test, the test item has been prepared at 500 mg/L in culture medium. To better solubilize it the solution has been put on a magnetic stirrer for 15 minutes.
120 Daphnie have been used, 100 of them treated with the test item at different concentration, and 20 used as control, kept in the same assay conditions without adding the test item, according to the design described in the table reported below in the paragraph any other information.
TREATMENT
4 replications with tested concentrations have been prepared, afterwards Daphnie have been added to the vessels of the assay sample.
The control group have been treated in the same conditions without adding the test item.
Daphnie have been kept withoutlight, aeration and feeding for the whole length of the assay.
Animals have been kept under observation for a period of 48 hours.

Reference substance (positive control):

no

Key result

Duration:

48 h

Dose descriptor:

EC50

Effect conc.:

120.949 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mobility

Details on results:

After 24 hours from the beginning of the test and at the end of the test (48 hours) the immobilisation of  the Daphnie have been evaluated verifying if the organisms, afterlight stirring of the vessels, were not capable to move in the following 15 seconds.
pH and dissolved oxygen have been measured at the beginning and at the end of the test (after 48
hours) in the highest concentration in the treated group and in control. Temperature of the assay
environment has been measured at the beginning and at the end of the test (after 48 hours).The number of immobilised Daphnia was increasing along with the test substance dose. No immobilsed animals were reported in the control group at 24 and 48 hours in the 4 replications.
At 500 mg/l active ingredient at 48 h all Daphnie were immobilised in all 4 replications (5/5)
At 227.27 mg/l active ingredient at 48 h Daphnie immobilised in the 4 replications were all 5/5.
At 103.30 mg/l active ingredient at 48 h Daphnie immobilised in the 4 replications were 1/5, 2/5, 2/5 and 0/5.
At 46.96 mg/l active ingredient at 48 h Daphnie immobilised in the 4 replications were 1/5, 0/5, 0/5, 0/5.
At 21.34 mg/l active ingredient at 48 h none Daphnia was immobilised in the 4 replications.

Reported statistics and error estimates:

EC50 has been evaluated using Karber Spearman method.

The immobilization of control animals must not be higher than 10% at the end ofthe test.
The concentration of dissolved oxygen in the vessels used in the assay should be higher than 3 mg/L during the assay. However, in any case, the concentration of dissolved oxygen must not be lower than 2 mg/L.

Validity criteria have been satisfied in range finding and in the definitive test.
% of immobilized Daphnie in control: 0.
During the definitive test at the 500.00 mg/L treated tested concentrations a deposit has been observed at the bottom of each vessel after 24 hours. All data used for validity assesment are on the attached report.

Validity criteria fulfilled:

yes

Conclusions:

EC50 (48 h) of the test item “SODIUM HYDROGEN N-(1-OXODODECYL)-L-GLUTAMATE” (nominal concentration) = 120.949 mg/L (OECD 202)

Executive summary:

The aim of the study is to determine the ecotoxicological effects of the test item “SODIUM HYDROGEN N-(1-OXODODECYL)-L-GLUTAMATE” on biotic systems: in particular on aquatic organism Daphnia magnain order to calculate the ECso value, according to OECD guideline N. 202.
After a range finding test, the organisms have been exposed to 5 different dilutions of the test item for a total period of 48 hours.
Daphnie have been kept under observations for a period of 48 hours and the number of immobilised organisms and/or possible abnormal behaviours both in control and in treatment group vessel have been observed.
At the beginning and at the end of the test (48 hours) dissolved oxygen and pH have been measured in the highest concentration and in control group. Temperatures of the assay environment have been recorded at the beginning and at the end ofthe test.
Stability of the test item in the definitive test has been performed using TOC analyser. Organic carbon concentration has been measured at the beginning and at the end of the test in a pool derived from vessels at the higher, intermediate and lower tested concentration according to the Sponsor.
The obtained results, in compliance with test acceptability criteria, of the nominal concentration of the test item can be summarised as follow:
EC50 (48 h) of the test item “SODIUM HYDROGEN N-(1-OXODODECYL)-L-GLUTAMATE” (nominal concentration) = 120.949 mg/L

Description of key information

EC50 (48h) = 120.949 mg/L (nominal) for Daphnia magna (OECD 202)

Key value for chemical safety assessment

Fresh water invertebrates

Fresh water invertebrates

Dose descriptor:

EC50

Effect concentration:

120.949 mg/L

Additional information

The aim of the study is to determine the ecotoxicological effects of the test item “SODIUM HYDROGEN N-(1-OXODODECYL)-L-GLUTAMATE” on biotic systems: in particular on aquatic organism Daphnia magnain order to calculate the ECso value, according to OECD guideline N. 202.
After a range finding test, the organisms have been exposed to 5 different dilutions of the test item for a total period of 48 hours.
Daphnie have been kept under observations for a period of 48 hours and the number of immobilised organisms and/or possible abnormal behaviours both in control and in treatment group vessel have been observed.
At the beginning and at the end of the test (48 hours) dissolved oxygen and pH have been measured in the highest concentration and in control group. Temperatures of the assay environment have been recorded at the beginning and at the end ofthe test.
Stability of the test item in the definitive test has been performed using TOC analyser. Organic carbon concentration has been measured at the beginning and at the end of the test in a pool derived from vessels at the higher, intermediate and lower tested concentration according to the Sponsor.
The obtained results, in compliance with test acceptability criteria, of the nominal concentration of the test item can be summarised as follow:
EC50 (48 h) of the test item “SODIUM HYDROGEN N-(1-OXODODECYL)-L-GLUTAMATE” (nominal concentration) = 120.949 mg/L