Glycine, N-coco acyl derivs., sodium salts

Short-term toxicity to aquatic invertebrates

Administrative data

Endpoint:

short-term toxicity to aquatic invertebrates

Type of information:

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

Adequacy of study:

supporting study

Study period:

04.12.2012 to 07.12.2012

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2013

Report date:

2013

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method C.2 (Acute Toxicity for Daphnia)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Remarks:

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

Test material

Test material information

Constituent 1

Reference substance name:

Fatty acids, coco derivs., reaction products with glycine, potassium salts

EC Number:

620-582-5

Cas Number:

301341-58-2

Molecular formula:

R-CO-NH-CH2-COOK (Note: "R-CO-" is a fatty acid residue)

IUPAC Name:

Fatty acids, coco derivs., reaction products with glycine, potassium salts

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, Chuo-Ku, Tokyo 104-8315 Japan/Lot/Batch No.: 110825
- Expiration date of the lot/batch: 25.08.2014
- Purity test date: 24.01.2012

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: dark and cool place, protected from light

TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing: no
- Preliminary purification step (if any): no
- Final dilution of a dissolved solid, for the definitive test stock liquid or gel: The final test concentrations were obtained by dilution of the stock solution
- Final preparation of a solid: For the definitive test a stock solution was prepared by weighing 200 mg of the test item and dissolving in 2 L of dilution water.

FORM AS APPLIED IN THE TEST (if different from that of starting material): aqueous solution

Sampling and analysis

Analytical monitoring:

no

Test solutions

Vehicle:

no

Details on test solutions:

PREPARATION AND APPLICATION OF TEST SOLUTION
- Method: stock solution was prepared in dilution water by weighing 200 mg of the test item, transferring it into a glass bottle and dissolving it in 2 L of dilution water. The solution was stirred for 2 h at about 300 rpm. The final test concentrations were obtained by dilution.

Test organisms

Test organisms (species):

Daphnia magna

Details on test organisms:

TEST ORGANISM
- Common name: Daphnia magna (water flea)
- Strain: STRAUS
- Source: German Federal Environment Agency, Institut für Wasser-, Boden- und Lufthygiene. Specimens used in the test were bred in the laboratory at Fraunhofer IME
- Age of parental stock (mean and range, SD): <24 h
- Method of breeding: Adult Daphnia, at least 3 weeks old, were separated from the stock population by sieving. Batches of 30 - 50 animals were held at room temperature in ca. 1.8 L of dilution water for one week. Algae growing in the log-phase were centrifuged and the pellet was re-suspended in a few mL of medium. Thirty millilitres of this suspension was given to 1 L of medium. The water was changed once per week.
- Feeding during test: no
- Food type: algal suspension (Desmodesmus subspicatus) and LiquizellR (HOBBY)
- Frequency: daily

ACCLIMATION
- Acclimation period: not necessary
- Acclimation conditions (same as test or not): same conditions
- Health during acclimation (any mortality observed): yes

Study design

Test type:

static

Water media type:

freshwater

Limit test:

no

Total exposure duration:

48 h

Test conditions

Test temperature:

20.3°C

pH:

7.85 – 8.40

Dissolved oxygen:

5.1 – 9.2 mg/L

Nominal and measured concentrations:

100.0, 50.0, 25.0, 12.5, 6.25 mg/L (nominal concentrations)

Details on test conditions:

TEST SYSTEM
- Test vessel: glass beaker
- Material, size, headspace, fill volume: glass/60 mL/-/50 mL
- Aeration: not during the test
- Type of flow-through (e.g. peristaltic or proportional diluter): test conducted under static conditions
- Renewal rate of test solution (frequency/flow rate): the test solution was not changed during the test
- 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 (filtration with activated charcoal, passage through a lime-stone column and aeration) was used according to guideline
- Alkalinity: 1.8 mmol/L
- Ca/Mg ratio: 4:1
- Conductivity: 206.4 µS/cm
- Culture medium different from test medium: no
- Intervals of water quality measurement: regularly (not further specified)

OTHER TEST CONDITIONS
- Adjustment of pH: no
- Photoperiod: 16/8 h light/dark cycle
- Light intensity: 499 – 509 lux

EFFECT PARAMETERS MEASURED (with observation intervals if applicable): Immobilisation and sublethal effects, determined after 24 and 48 h

VEHICLE CONTROL PERFORMED: no (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):

yes

Remarks:

potassium dichromate

Results and discussion

Effect concentrations

Effect concentrations 1

Key result

Duration:

48 h

Dose descriptor:

EC50

Effect conc.:

> 100 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mobility

Effect concentrations 2

Duration:

48 h

Dose descriptor:

NOEC

Effect conc.:

>= 100 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mobility

Results with reference substance (positive control):

24h-EC50 = 1.03 mg/L

Reported statistics and error estimates:

The NOEC and LOEC values were determined using statistical methods like ANOVA followed by Williams' Multiple Sequential t-Test. The computer program ToxRat(R)Professional was used for the statistical evaluations.

Any other information on results incl. tables

For the read-across substance GCK-11 -T, no statistically significant effects on immobilisation of Daphnia magna were observed up to the highest test concentration.

Applicant's summary and conclusion

Validity criteria fulfilled:

yes

Conclusions:

The acute toxicity of acylglycinate GCK-11 -T to Daphnia magna was determined in a study conducted according to guideline. In this static test the 48 h NOEC-, LOEC-, and EC50 -values were determined to be >=100 , >100, and >100 mg/L nominal, respectively.

Executive summary:

The acute toxicity of acylglycinate GCK-11 -T to Daphnia magna was investigated in a study conducted according to OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test) and EU Method C.2 (Acute Toxicity for Daphnia). In this static test, 20 daphnids per concentration were exposed to nominal concentrations of 0 (control), 6.25, 12.5, 25.0, 50.0, and 100.0 mg/L for 48 h. The 48 h NOEC-, LOEC-, and EC50 -values were determined to be >=100, >100, and >100 mg/L nominal, respectively.

This study is classified as reliable without restriction and satisfies the guideline requirements for an acute toxicity study with freshwater invertebrates.

Results Synopsis

Test organism: Daphnia magna (<24 h old)

Test type: static

48 h EC50>100 mg/L nominal

Endpoint(s) effected: immobilisation