Urea,N'-[3-[[[(dimethylamino)carbonyl]amino]methyl]-3,5,5-trimethylcyclohexyl]-N,N-dimethyl-

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:

03/2017 - 03/2017

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)

GLP compliance:

yes (incl. QA statement)

Specific details on test material used for the study:

Batch: 703709
Purity: 100 %
CoA: 2017-02-15

Analytical monitoring:

yes

Details on sampling:

Analytical data are required by the guidelines for verification of test item concentrations as well as
the stability of the test item over the entire test period. Analytical samples were taken from all test
item concentrations and control at test start and after 48 hours from aged solutions. For each
sampling also a retain sample was taken.
All samples were stored deep frozen until they were transferred to the analytical laboratory.

Vehicle:

no

Details on test solutions:

The following nominal concentrations were tested: 6.25, 12.5, 25.0, 50.0 and 100 mg/L and control.
The necessary amount of test item for preparing the stock solution S1 was weighed on a weighing
scoop and transferred to a volumetric flask. Test medium (see Appendix B) was added up to the
bench mark and the solution was homogenised by shaking and treated with 120 minutes of ultrasonication.
Afterwards the solution was clear and transparent and foam was visible. Lower test
solutions were prepared by dilution of the appropriate solution with test medium.

Test organisms (species):

Daphnia magna

Test type:

static

Water media type:

freshwater

Total exposure duration:

48 h

Hardness:

13°dH (232 mg/L CaCO3);

Test temperature:

19.1 – 22.0 °C

pH:

7.40 – 8.02

Dissolved oxygen:

≥ 8.0 mg/L

Reference substance (positive control):

yes

Remarks:

potassium dichromate; 1.00 mg/L, 2.00 mg/L

Key result

Duration:

48 h

Dose descriptor:

NOEC

Effect conc.:

ca. 100 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mobility

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

Key result

Duration:

24 h

Dose descriptor:

NOEC

Effect conc.:

ca. 100 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mobility

Key result

Duration:

24 h

Dose descriptor:

LC50

Effect conc.:

> 100 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mobility

Validity criteria fulfilled:

yes

Conclusions:

According to the results of the test, the EC50 (48 h) for immobilisation was determined to be > 100 mg/L (nominal). The corresponding NOEC (48 h) was 100 mg/L (nominal).

Executive summary:

Study Objective: The objectives of this study were to determine the immobilisation effect of the test item on the water flea Daphnia magna under worst-case exposure conditions, the no observed effect concentration (NOEC) and the effect median concentration (EC50).

Material and methods: Test item: IPDI-Uron, batch number: 703709, purity analysed: 100 % w/w.

Test species: Daphnia magna Straus, Clone V, max. 24 hours old.

Test design: Static dose-response test with twenty organisms per test concentration (4 replicates of 5 animals each) were used. The duration of the test was 48 hours.

Endpoints: Endpoints reported are the EC50 and the NOEC after 24 and 48 hours, where possible.

Test rates: A static main test with nominal concentrations of 100, 50.0, 25.0, 12.5, 6.25 mg/L and control was performed.

Test conditions: Temperature, pH-value and oxygen concentration of the test solutions measured after 0, 24 and 48 hours are reported. Hardness of the test water was measured on the day of application.

Samples analysed: Analytical samples taken at 0 hours (initial value) and 48 hours aged test solutions were analysed from control and 100 mg/L.

Statistics: The values for EC50 could not be determined since no immobilisation above the allowed control immobilisation occurred during the test. The NOEC was established based on the highest concentration at which the immobilisation is not higher than the allowed control immobilisation (≤ 10 % immobilisation).

Findings:

Validity criteria: Control immobilisation: The percentage of immobilisation should be ≤ 10 % In this study the control immobilisation was 0 %.

Oxygen concentration: The dissolved oxygen concentration at the end of the test should be ≥ 3 mg/L in all test units. In this test, the dissolved oxygen concentration at the end of the test was ≥ 8.0 mg/L.

Test conditions: The total hardness (as CaCO3) of the untreated control was determined to be 13°dH (232 mg/L CaCO3);

the mean pH-value of the untreated control was determined to be 7.54 ± 0.14 (Std. Dev.);

the mean temperature of the control and all test item concentrations was measured to be 20.0 ± 1.0 °C (Std. Dev.);

the mean oxygen concentration was determined to be 9.0 ± 0.3 mg/L (Std. Dev.).

Analytical Results: The measured content of IPDI-Uron was 111 % of nominal in the fresh sample. In the aged sample the measured content was 107 % of nominal.

Therefore toxicological endpoints were evaluated using the nominal concentrations of the test item.

Statistical Results: EC50 and NOEC-values of daphnids exposed to the test item evaluated using nominal concentrations

	Test item [mg/L] (nominal)
	24 h	48 h
NOEC	100	100
EC50	> 100	> 100
95 % confidence limit of EC50	-	-

- not applicalbe

Conclusions: According to the results of the test, the EC50 (48 h) was determined to be > 100 mg/L (nominal). The corresponding NOEC (48 h) was 100 mg/L (nominal).

Description of key information

According to the results of the test, the EC50 (48 h) for immobilisation was determined to be > 100 mg/L (nominal). The corresponding NOEC (48 h) was 100 mg/L (nominal).

Key value for chemical safety assessment

Fresh water invertebrates

Fresh water invertebrates

Dose descriptor:

EC50

Effect concentration:

> 100 mg/L