Sodium hydrogen N-(1-oxotetradecyl)-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 19, 2016 to January 22, 2016

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 report is on page 4 of the attached report

Specific details on test material used for the study:

Batch no.: 3837 supplied by the sponsor
25.5% in water as active ingredient (water solution), purity 100%
Solubility: soluble in water
Storage condition of test material: room temperature (15 °C - 25 °C)
Stability and homogeneity of the test material in the vehicle/solvent under test conditions (e.g. in the exposure medium) and during storage: 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 (20 °C) = 6.22
More information can be found on the attached report

Analytical monitoring:

yes

Remarks:

Determination of analytical concentration of total organic carbon (TOC), see details on sampling for more information

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 test subst. 48h - TOC control 48h)/(TOC test subst. 0h - TOC control 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 mg/l), at t0 214.28, at t48h 215.64, % stability 101
Treated (195.31 mg/l), at t0 81.21, at t48h 83.21, % stability 102
Treated (76.29 mg/l), at t0 31.22, at t48h 30.67, % stability 98

Vehicle:

no

Details on test solutions:

Range finding test: 0.1 - 1000 mg/L of active ingredient
Definitive test: 500 mg/L and lower (active ingredient)

Test organisms (species):

Daphnia magna

Details on test organisms:

Age: 6 - 24 hours
Origine: Breeder in Eurofins Biolab Test Facility
Feeding: green alga
Number of animals: 20/group
Number of replications: 4/group

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

Hardness:

between 140 and 250 mg CaCO3/L

Test temperature:

20 +/- 2°C

pH:

Control: 7.80 - 7.84
Treated: 6.71 - 7.26
See table 3 of the attached report

Dissolved oxygen:

6.13 - 6.89 mg/L in different samples at the beginning and at the end of test (see table 2 of the attached report)

Nominal and measured concentrations:

Nominal concentrations of active matter 0, 76.29, 122.07, 195.31, 312.50 and 500.00 mg/L

Details on test conditions:

4 replications with tested concentrations have been prepared, afterwards Daphnie have been added to the vessels of the assay samples.
None lighting, aeration and feeding during test.
Control groups have been treated in the same way without adding the test item.
Immobilisation was evaluated after 24 and 48 h verifying that after light stirring organisms were not capable to move in the following 15 seconds.
pH, dissolved O2 and °C were evaluated at the beginning and at the end of the test.

Reference substance (positive control):

no

Key result

Duration:

48 h

Dose descriptor:

EC50

Effect conc.:

170.8 mg/L

Nominal / measured:

nominal

Conc. based on:

act. ingr.

Basis for effect:

mobility

Details on results:

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 312.50 mg/l active ingredient at 48 h Daphnie immobilised in the 4 replications were 4/5, 4/5 ,4/5, 3/5.
At 195.31 mg/l active ingredient at 48 h Daphnie immobilised in the 4 replications were 3/5 (all).
At 122.07 mg/l active ingredient at 48 h Daphnie immobilised in the 4 replications were 1/5, 1/5, 2/5, 1/5.
At 76.29 mg/l active ingredient at 48 h Daphnie immobilised in the 4 replications were 1/5, 1/5, 1/5, 0/5.

Results with reference substance (positive control):

-

Reported statistics and error estimates:

EC50 was evaluated using EPA Probit Analysis Program Version 1.5 (see Addenda 1 of the attached report)

VALIDITY CRITERIA

The immobilisation of controls animals must ot be higher than 10% at the end of the test. The concentration of dissolved oxygen in the vessels ought be higher than 3 mg/l during the assay. pH must not change more than 1.5 units. Samples stability must be between 80 and 120% of the value. All validity criteria have been satisfied (see tables 1,2,3,4 and 5 of the attached report)

Validity criteria fulfilled:

yes

Conclusions:

Under the study conditions, the 48 h EC50 of the substance in Daphnia magna was determined to be 170.8 mg a.i./L.

Executive summary:

A study was conducted to determine the short-term toxicity of the substance to Daphnia magna according to OECD Guideline 202, in compliance with GLP. Daphnia magna were exposed to a series of concentrations (0, 76.29, 122.07, 195.31, 312.5 and 500 mg/L) of the test substance for 48 h. Total organic carbon (TOC) concentrations were measured with a TOC analyser and the test substance was considered stable over the duration of the test. The number of immobilised Daphnia increased along the test substances. No immobilised animal was reported in the control group. However, the test substance treated groups showed concentration-related immobilisation of the treated daphnies. Under the study conditions, the 48 h EC50 of the substance in Daphnia magna was determined to be 170.8 mg a.i./L (Giarei, 2016).

Description of key information

EC50 (48h) = 170.8 mg/L (active ingredient) for Daphnia magna (OECD 202)

Key value for chemical safety assessment

Fresh water invertebrates

Fresh water invertebrates

Dose descriptor:

EC50

Effect concentration:

170.8 mg/L

Additional information

A study was conducted to determine the short-term toxicity of the substance to Daphnia magna according to OECD Guideline 202, in compliance with GLP. Daphnia magna were exposed to a series of concentrations (0, 76.29, 122.07, 195.31, 312.5 and 500 mg/L) of the test substance for 48 h. Total organic carbon (TOC) concentrations were measured with a TOC analyser and the test substance was considered stable over the duration of the test. The number of immobilised Daphnia increased along the test substances. No immobilised animal was reported in the control group. However, the test substance treated groups showed concentration-related immobilisation of the treated daphnids. Under the study conditions, the 48 h EC50 of the substance in Daphnia magna was determined to be 170.8 mg a.i./L (Giarei, 2016).