Reaction mass of 2-hydroxyisopropyl 2-hydroxypropyl bicarbamate and 2-hydroxypropyl carbazate and propylene carbonate

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:

04 - 06 Jun 2002

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2002

Report date:

2002

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)

Version / remarks:

1984

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method C.2 (Acute Toxicity for Daphnia)

Version / remarks:

1992

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Remarks:

Niedersächsisches Umweltministerium, Hannover, Germany

Test material

Test material information

Constituent 1

Reference substance name:

Reaction mass of 2-hydroxyisopropyl 2-hydroxypropyl bicarbamate and 2-hydroxypropyl carbazate and propylene carbonate

EC Number:

906-521-8

Cas Number:

85391-60-2

Molecular formula:

C8H16N2O6

IUPAC Name:

Reaction mass of 2-hydroxyisopropyl 2-hydroxypropyl bicarbamate and 2-hydroxypropyl carbazate and propylene carbonate

Test material form:

liquid

Sampling and analysis

Analytical monitoring:

yes

Details on sampling:

- Concentrations: control and 100 mg/L (Limit concentration which can be achived by suitable preparation methods)

Test solutions

Vehicle:

no

Details on test solutions:

PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Method: A stock solution was prepared one day prior to application at a concentration of 100 mg/L. The stock solution was shaken with 20 rpm for 24 h. Undissolved particles were removed by centrifugation (20 min at 3000 rpm).
- Eluate: no
- Differential loading: no
- Controls: yes, test medium control

Test organisms

Test organisms (species):

Daphnia magna

Details on test organisms:

TEST ORGANISM
- Common name: water flea
- Source: Institut für Wasser-, Boden- und Lufthygiene des Bundesgesundheitsamt Berlin, Germany
- Feeding during test: none
- Culture: Daphnids were cultured in 2-3 L glass vessels with approx. 1.8 L culture medium (M4-medium) at 21 °C (20-25 °C); 16 h illumination (20 µmol*m-2*s-1); approx. 1200 lux. Daphnids were fed ad libitum with a mix of Scenedesmus subspicatus and Chlorella vulgaris with a cell density of >10E+06 cells/mL.
- Age at study inititation: 2-24 h; obtained by removing the mother animals twice within 22 h

ACCLIMATION
- Acclimation period: 2 h in dilution water

Study design

Test type:

static

Water media type:

freshwater

Limit test:

yes

Total exposure duration:

48 h

Test conditions

Hardness:

252 mg CaCO3/L (dilution water)

Test temperature:

21.2 - 21.9 °C

pH:

7.34 - 7.50

Dissolved oxygen:

7.80 - 8.06 mg/L

Conductivity:

668 µS/cm (dilution water)

Nominal and measured concentrations:

Nominal: control, saturated solution
measured DOC: please refer to "Any other information on results incl. tables"

Details on test conditions:

TEST SYSTEM
- Test vessel: Glass beakers (5 cm i.d. x 8 cm), volume: 50 mL, headspace: 30 mL, fill volume: 20 mL
- Aeration: no
- 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: according to EEC 92/69 L383A C.2
- Culture medium different from test medium: same as test

OTHER TEST CONDITIONS
- Adjustment of pH: no
- Photoperiod: 16 h light / 8 h dark
- Light intensity: approx. 1200 lux

EFFECT PARAMETERS MEASURED
- Immobilisation after 24 and 48 h

RANGE-FINDING STUDY
- Test concentrations:
- Results used to determine the conditions for the definitive study:

Reference substance (positive control):

yes

Results and discussion

Effect concentrations

Duration:

48 h

Dose descriptor:

EL50

Effect conc.:

> 100 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality

Remarks on result:

other: Reported as "saturated solution"

Details on results:

- Mortality of control: 0%

Results with reference substance (positive control):

- Results with reference substance valid? yes
- Dose-response test: yes, 0.58 - 5.8 mg/L
- ECx: EC50 (24 h): 1.5 mg/L (95% CI 1.3 - 1.7 mg/L)

Reported statistics and error estimates:

Effect concentrations were derived directly from the test results.

Any other information on results incl. tables

All validity criteria were met:

1.) pH did not vary by more than 1 unit

2.) No immobilisation was recorded in the control.

3.) EC50 value of the reference substance was between 1.0 - 2.5 mg/L.

4.) Dissolved O2 concentration was > 5.21 mg/L (60% of air saturation level)

Table 1: Results from DOC analysis

	DOC [mg/L]
	0 h (new without daphnids)	48 h (old without daphnids)	48 h (old media with daphnids)	Overall mean	Corrected vs. control
Saturated solution	43.9	43.37	51.65	46.31	41.16
Control	3.22	3.06	9.17	5.15	--

Applicant's summary and conclusion

Validity criteria fulfilled:

yes