Urea, reaction products with formaldehyde

Short-term toxicity to aquatic invertebrates

Administrative data

Endpoint:

short-term toxicity to aquatic invertebrates

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2008-09-15 - 2008-10-03

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: The GLP study was conducted according to an internationally accepted guideline. All study parameters are based on the specific guideline.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2008

Report date:

2008

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

Urea, reaction products with formaldehyde

EC Number:

271-898-1

EC Name:

Urea, reaction products with formaldehyde

Cas Number:

68611-64-3

Molecular formula:

not available

IUPAC Name:

Urea, reaction products with formaldehyde

Test material form:

other: liquid

Sampling and analysis

Analytical monitoring:

yes

Test solutions

Vehicle:

yes

Details on test solutions:

Standard dilution water was prepared just before the test by admixing 2.5 mL of stored solutions A, B, C and D into 1000 mL of distilled water.

A. 117.6 g CaCl2-2H20 in 1 L of distilled water

B. 49.3 g MgS04-7H20 in 1 L of distilled water

C. 25.9 g NaHC03 in 1 L of distilled water

D. 2.3 g KC1 in 1 L of distilled water

The dilution water should be of pH 7.8 ± 0.2. The sum of Ca + Mg ions should be approx. 2.5 mmol/L.
The stock solution of the test substance was prepared in the dilution water. 100 mg of the test substance was weighed into 1000 mL of the dilution water for preliminary test and 200 mg of the test substance was weighed into 1000 mL of the dilution water for limit test. The concentrations of solutions used in the preliminary and the limit test were obtained by dilution of the stock solution with dilution water.

Test organisms

Test organisms (species):

Daphnia magna

Details on test organisms:

Daphnia magna Straus were obtained by aperiodic parthenogenesis from own laboratory breeding. Daphnia were fed by a mixture of algae. The sensitivity of test species is periodically monitored by testing with the reference substance, potassium dichromate. The grow-up gravid females are separated into dilution water. Young daphnia born in 24 hours are segregated to the handling container from which they entered the experiment. At handling a care should be taken of not to penetrate the air under animal's shell.

Study design

Test type:

static

Water media type:

freshwater

Limit test:

yes

Total exposure duration:

48 h

Test conditions

Test temperature:

20±2°C

pH:

7.8 - 8.0

Dissolved oxygen:

8.4 - 8.5 mg/l

Reference substance (positive control):

yes

Remarks:

potassium dichromate

Results and discussion

Effect concentrations

Effect concentrations 1

Duration:

48 h

Dose descriptor:

EC50

Effect conc.:

> 150 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.:

150 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mobility

Effect concentrations 3

Duration:

48 h

Dose descriptor:

EC100

Effect conc.:

> 150 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mobility

Applicant's summary and conclusion

Validity criteria fulfilled:

yes

Conclusions:

No immobilisation was observed in limit test. Therefore, exact values of EC5o could not be calculated and the values of EC are given in the form of a range. The NOEC and EC100 values are identified by direct observation.

Test results
24-hour EC5o > 150 mg/L
48-hour EC5o > 150 ing/L

24-hour NOEC - 150 mg/L
48-hour NOEC - 150 mg/L

24-hour EC100 > 150 mg/L
48-hour EC100 > 150 mg/L

Executive summary:

The test substance, Weikoform (Urea, reaction products with formaldehyde), was tested in acute immobilisation test on Daphnia magna. The test was performed according to EU method C.2 - Daphnia sp. Acute Immobilisation Test, Council Regulation (EC) No. 440/2008, published in O.J.L 142, 2008. The preliminary test was performed in range of test substance nominal concentrations 1-100 mg-L"'. Based on the no toxicity of the test substance found in preliminary test, the limit test was performed in appropriate concentration range. The analytical results showed that the test substance Weikoform (Urea, reaction products with formaldehyde) was stable in dilution water in conditions of the test. With regard to stability of the test substance the static test design was chosen. The limit test was performed in range of test substance nominal concentrations 61 - 150 mg/L. The nominal concentrations of the test substance were used for all evaluations and results.

Test results

24-hour EC5o > 150 mg/L

48-hour EC5o > 150 mg/L

24-hour NOEC - 150 mg/L

48-hour NOEC - 150 mg/L

24-hour EC100 > 150 mg/L

48-hour EC100 > 150 mg/L