L-Threonine, N-coco acyl derivs., monosodium salts

Short-term toxicity to aquatic invertebrates

Administrative data

Endpoint:

short-term toxicity to aquatic invertebrates

Type of information:

experimental study

Adequacy of study:

key study

Study period:

January 11, 2018 to February 15, 2018

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2018

Report date:

2018

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)

Version / remarks:

2004

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method C.2 (Acute Toxicity for Daphnia)

Version / remarks:

2008

GLP compliance:

yes (incl. QA statement)

Remarks:

Fraunhofer-Institute for Molecular Biology and Applied Ecology (IME), Auf dem Aberg 1, 57392 Schmallenberg (Germany)

Test material

Test material information

Constituent 1

Reference substance name:

L-Threonine, N-coco acyl derivs., monosodium salts

Cas Number:

90583-79-2

Molecular formula:

n/a

IUPAC Name:

L-Threonine, N-coco acyl derivs., monosodium salts

Test material form:

solid

Specific details on test material used for the study:

SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: Ajinomoto Co., Inc., 15-1, Kyobashi 1-chome, Chou-ku, Tokyo, 104-8315, Japan//Batch/Lot number: 160325
- Expiration date of the lot/batch: 25.03.2020
- Purity test date: 09.06.2016

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: Store with necessary lighting and ventilation for storage and handling of dangerous goods. Store away from oxidants
- Stability under test conditions: Stable under normal conditions

Sampling and analysis

Analytical monitoring:

no

Test solutions

Vehicle:

no

Details on test solutions:

All test item solutions were prepared in Cu-reduced dilution water.
The highest test concentration was prepared by adding 100.0 mg of the test item to 1 L Cu-reduced dilution water, resulting in a concentration of 99.3 mg a.s./L. No solubilizer was used. The solution was stirred using a magnetic stirring bar for 1/2 hour at room temperature. The other test concentrations were prepared by dilution of the highest test concentration of 100 mg/L using a spacing factor of 2. The test solutions were freshly prepared prior to test start.

Test organisms

Test organisms (species):

Daphnia magna

Details on test organisms:

TEST ORGANISM
- Common name: Daphnia magna
- Source/Origin: German Federal Environment Agency, Institut für Wasser-, Boden- und Lufthygiene. Specimens used in the test were bred in the laboratora of the Fh-IME
- Age of parental stock (mean and range, SD): >=3 weeks old
- Feeding during test: no

ACCLIMATION: not necessary
- Acclimation conditions (same as test or not): Holding- and dilution water were the same
- Type and amount of food: Adult Daphnia were fed with Desmodesmus subspicatus
- Feeding frequency: daily
- Health during acclimation (any mortality observed): no mortality observed

Study design

Test type:

static

Water media type:

freshwater

Limit test:

no

Total exposure duration:

48 h

Test conditions

Hardness:

total hardness: 1.1 mmol/L (Ca-hardness: 0.8 mmol/L)

Test temperature:

18-22°C

pH:

8.0 - 8.5

Dissolved oxygen:

4.7 - 9.5 mg/L

Conductivity:

269 µS/cm

Nominal and measured concentrations:

nominal: 0 (control), 6.25, 12.5, 25.0, 50.0, and 100 mg/L test item
equivalent to
nominal: 0 (control), 6.21, 12.41, 24.83, 49.65, and 99.30 mg active substance/L

Details on test conditions:

TEST SYSTEM
- Test vessel: glass beaker
- Type (delete if not applicable): the beakers were covered with glass panes (gas exchange between medium and atmosphere and acess of light was possible)
- Material, size, headspace, fill volume: glass/50 mL/0/50 mL
- Aeration: no
- Type of flow-through (e.g. peristaltic or proportional diluter): not applicable (test conducted under static conditions)
- Renewal rate of test solution (frequency/flow rate): not applicable (test conducted under static conditions)
- 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: purified drinking water
- Chlorine: <0.02 mg/L
- Alkalinity: 1.6 mmol/L
- Conductivity: 269 µS/cm
- Culture medium different from test medium: no
- Intervals of water quality measurement: water quality data are reported regularly (intervals not reported)

OTHER TEST CONDITIONS
- Adjustment of pH: no
- Photoperiod: 16 h light/8 h dark
- Light intensity: 863-880 lx (corresponding to 11.5-11.7 µE/(m² x s)

EFFECT PARAMETERS MEASURED (with observation intervals if applicable): mobility (observation: daily)

VEHICLE CONTROL PERFORMED: no vehicle used

RANGE-FINDING STUDY: performed
- Test concentrations: 1, 10, 100 mg/L nominal
- Results used to determine the conditions for the definitive study: yes

Reference substance (positive control):

no

Remarks:

However, the sensitivity of the clone was checked twice a year

Results and discussion

Effect concentrations

Effect concentrations 1

Duration:

48 h

Dose descriptor:

NOEC

Effect conc.:

25 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mobility

Effect concentrations 2

Duration:

48 h

Dose descriptor:

LOEC

Effect conc.:

50 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mobility

Effect concentrations 3

Key result

Duration:

48 h

Dose descriptor:

LC50

Effect conc.:

> 136.9 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mobility

Remarks on result:

other: extrapolated value

Details on results:

- Behavioural abnormalities: no
- Other biological observations: not observed
- Mortality of control: no mortality
- Other adverse effects control: no
- Abnormal responses: no
- Any observations (e.g. precipitation) that might cause a difference between measured and nominal values: no
- Effect concentrations exceeding solubility of substance in test medium: no

Results with reference substance (positive control):

In November 2017 the following results were obtained using K2Cr2O7 as reference substance:
24 h EC50=1.435 mg/L (95% confidence limits: 1.23-1.75 mg/L)

Reported statistics and error estimates:

For immobilization, the NOEC and LOEC were determined. EC10, EC20, and EC50 values together with 95% confidence intervals (where possible) were calculated by Probit-analysis assuming log-normal distribution of the values. All statistical calculations were performed using the computer programme ToxRat®

Applicant's summary and conclusion

Validity criteria fulfilled:

yes

Conclusions:

The 48 h NOEC, LOEC, and LC50 values calculated based on measured data were 25, 50, and ca. 137 mg/L test item.

Executive summary:

The GLP study was performed according to OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test; 2004) and EU Method C.2 (Acute Toxicity for Daphnia; 2008). Nominal test item concentrations were 0 (control), 6.25, 12.5, 25, 50, and 100 mg/L test item containing 98.7% active ingredient. Per concentration step 20 daphnids were exposed to the various test item concentrations under static conditions for 48 h.

The study resulted in 48 h NOEC, LOEC, and LC50 values of 25, 50, and ca. 137 mg/L test item (values calculated based on measured data), respectively.