Extract from the seeds of Trigonella foenum-graecum (Fabaceae) obtained by extraction with polar solvents

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:

30 September 2019 - 23 December 2019

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)

Deviations:

no

Qualifier:

according to guideline

Guideline:

EU Method C.2 (Acute Toxicity for Daphnia)

Deviations:

no

Qualifier:

according to guideline

Guideline:

ISO 6341 (Water quality - Determination of the Inhibition of the Mobility of Daphnia magna Straus (Cladocera, Crustacea))

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Specific details on test material used for the study:

Identification/Synonym FENUGREEK EXTRACT
Substance type UVCB substance
EC No. 950-727-0
Recommended storage Ambient (18-20°C) and protected from temperatures below 4°C; dry (< 70% rh);
conditions to be stored under dark conditions

Analytical monitoring:

yes

Details on sampling:

Samples for analysis were taken from the control and all test solutions at the start (t=0h), at t=24h (new and old solutions) and at the end of the test (t=48h). Concentration of dissolved organic material was checked by analysis of Total Organic Carbon (TOC) in the control medium and the WAFs. TOC analysis was not performed in compliance with the OECD GLP principles but was adapted to fit the specific parameters of the test item, in accordance with ISO 17025.

Vehicle:

no

Details on test solutions:

The loading rates of the test item were weighed on glass slides that afterwards were placed under the surface of the test water contained in the mixing vessels through fishing wire. Then the mixing vessels were closed immediately.

Test organisms (species):

Daphnia magna

Details on test organisms:

Daphnia magna (Straus)
Female
Age at test start < 24 hours old

Test type:

semi-static

Water media type:

freshwater

Limit test:

no

Total exposure duration:

48 h

Hardness:

250 mg.L-1 (as CaCO3).

Test temperature:

20°C ± 2 °C

pH:

6.0-9.0

Dissolved oxygen:

≥ 3 mg.L-1

Nominal and measured concentrations:

6.25, 12.5, 25.0, 50.0 and 100.0 mg.L-1

Details on test conditions:

TEST SYSTEM
- Test vessel: 60-mL glass flasks sealed with assembled screw cap with hole and PTFE/silicone septum.
- Type: closed
- Volume of solution: completely filled with test solution and stoppered without headspace
- Aeration: no
- Renewal rate of test solution: Semi-static (24h renewals),
- 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: Reconstituted water (Elendt M4 medium),
- Total organic carbon: ± 20%

OTHER TEST CONDITIONS
- Light regime 16h light : 8h dark

RANGE-FINDING STUDY
- Test concentrations: 6.25, 12.5, 25.0, 50.0 and 100.0 mg.L-1.

Reference substance (positive control):

yes

Remarks:

Potassium dichromate

Key result

Duration:

48 h

Dose descriptor:

EL50

Effect conc.:

74.733 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat. (dissolved fraction)

Basis for effect:

mobility

Key result

Duration:

48 h

Dose descriptor:

NOELR

Effect conc.:

25 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat. (dissolved fraction)

Basis for effect:

mobility

Details on results:

Thus, the highest loading rate without effect (NOELR) was 25.0 mg.L-1. Under experimental conditions, and based upon nominal loading rates, the 48-hour EL50 value was estimated to be 74.733 mg.L-1.

Results with reference substance (positive control):

On November 7, 2019 (KD19-003; most recent test), the 24h-EC50 was 1.243 mg.L-1. Hence, the sensitivity of the clone of Daphnia magna was in agreement with OECD 202 (1) (expected 24h-EC50: 0.6 mg.L-1 to 2.1 mg.L-1) at this time.

Reported statistics and error estimates:

Probit analysis using linear max. likelihood regression
Step-down Cochran-Armitage test

Validity criteria fulfilled:

yes

Conclusions:

The toxic effect of test item to the freshwater invertebrate Daphnia magna was investigated in a closed semi-static test using Water Accommodated Fractions. Under experimental conditions, and based upon nominal loading rates, the 48-hour EL50 value was estimated to be 74.733 mg.L-1.

Description of key information

EL50 = 74.733 mg.L-1

NOELR = 25.0 mg.L-1

Key value for chemical safety assessment

Fresh water invertebrates

Fresh water invertebrates

Effect concentration:

74.733 mg/L