Registration Dossier

Ecotoxicological information

Short-term toxicity to aquatic invertebrates

Currently viewing:

Administrative data

Link to relevant study record(s)

Reference
Endpoint:
short-term toxicity to aquatic invertebrates
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to
Guideline:
OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)
GLP compliance:
yes (incl. certificate)
Analytical monitoring:
yes
Details on sampling:
The concentrations of the test item in the test medium were measured by DOC analysis at the beginning and after 24 and 48h of exposure.
Vehicle:
no
Details on test solutions:
Test solutions contained Daphnia medium with test item, two replicate for each concentrationBlank control contained pure Dpahnia medium, three replicateSince the test item is soluble, the test solutions were prepared by respective dilutions of a 100 mg/l stock solution (test item dissolved in Daphnia medium) with aerated Daphnia medium. The resulting solutions were used as test solutions in the toxicity test.
Test organisms (species):
Daphnia magna
Details on test organisms:
Test organismDaphnia magna (Straus, 1820), derived from a healthy stock and not first brood progenyBreedingParental and young Daphnia held in 4 l glass aquaria (3 l medium) at 20±2 °CIllumination16 h per dayMediumContinuously aerated Elendt M4 medium (Table 2 and Table 3); prepared with ultra-pure water (conductivity <1.5 µS/cm) FeedSuspension of Desmodesmus subspicatus in Elendt M4 medium with an optical density OD680 of about 15 unitsControl of sensitivityAcute reference test with potassium dichromate conducted twice a year
Test type:
static
Water media type:
freshwater
Limit test:
no
Total exposure duration:
48 h
Test temperature:
18-22°C, controlled at +/-1. The temperature slightly exceeded the required range (22-23°C)
pH:
6.9-7.5
Dissolved oxygen:
6.5-7.5 mg/l (required >= 3 mg/l)
Conductivity:
conductivity < 1.5 uS/cm
Nominal and measured concentrations:
nominal concentration: 1.94, 4.27, 9.39, 20.7, 45.5 and 100 mg/lgeometric means (0-48h): 1.58, 3.47, 7.16, 17.0, 32.9 and 81.6 mg/l
Details on test conditions:
Test vessel 100 ml beakers, all-glass, with 50 ml of test medium, covered with a glass plate to avoid evaporation and contamination of the test solutions with dustTest medium Elendt M4 medium (Table 2 and Table 3); prepared with ultra-pure water (conductivity <1.5 µS/cm)Number of Daphnia 40 individuals per test concentration, 20 per vesselAgeless than 24 hLight16 h photoperiod a day, supplied by overhead white fluorescent tubesFeedthe Daphnia are not fed during the test
Duration:
48 h
Dose descriptor:
EC50
Effect conc.:
ca. 3.17 mg/L
Nominal / measured:
meas. (geom. mean)
Conc. based on:
act. ingr.
Basis for effect:
mobility
Duration:
48 h
Dose descriptor:
EC10
Effect conc.:
ca. 2.01 mg/L
Nominal / measured:
meas. (geom. mean)
Conc. based on:
act. ingr.
Basis for effect:
mobility
Duration:
24 h
Dose descriptor:
EC50
Effect conc.:
ca. 14.9 mg/L
Nominal / measured:
meas. (geom. mean)
Conc. based on:
act. ingr.
Basis for effect:
mobility
Duration:
24 h
Dose descriptor:
EC10
Effect conc.:
ca. 10.7 mg/L
Nominal / measured:
meas. (geom. mean)
Conc. based on:
act. ingr.
Basis for effect:
mobility
Validity criteria fulfilled:
yes
Conclusions:
The substance was tested following OECD 202. Under the experimental conditions the EC50, 48h is equal to 3.17 mg/l (geometric mean of measured concentrations).
Executive summary:

The median effect concentration (EC50) and the no-effect concentration (NOEC) of test item to Daphnia magna were investigated under static exposure conditions over a period of 48 h, following guideline OECD 202.

Since the test item is well soluble, the media were prepared by respective dilutions of a stock solutiona.

The investigated nominal concentration were 100, 45.5, 20.7, 3.39, 4.27 and 1.94 mg/l.

40 individual Daphnia divided into 2 test vessels were exposed to each concentration of the test item, and 60Daphnia divided into 3 test vessels were used as blank controls.

The concentrations of test item in the test medium were measured by DOC analysis at the beginning and after 24 and 48 h of exposure. The analyses revealed that the test item was completely dissolved. However, the concentrations tended to decrease over the 48 h incubation period and did not remain within the 80-120% of the nominal concentration. Consequently, the effective concentrations (ECx) were assessed based on the geometric mean of the measured concentrations.

The 48 h EC50of test item toDaphnia magnais 3.17 mg/l (95% confidence interval: 3.41–4.63 mg/l). This result is based on measured concentrations.

All validity criteria were fulfilled.

Description of key information

EC50, 48h; Daphnia Magna, static test, OECD 202 = 3.17 mg/l

Key value for chemical safety assessment

Additional information

The substance was tested for short-term toxicity to aquatic invertebrates following OECD 202 (Ricci, 2016). Under the experimental conditions the EC50, 48h is equal to 3.17 mg/l.