reaction product of diphenylmethanediisocyanate, octylamine, 4-ethoxyaniline and ethylenediamine (1:0,37:1,53:0,05)

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:

1998-11-26 to 1999-02-15

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

EU Method C.2 (Acute Toxicity for Daphnia)

Deviations:

no

Qualifier:

according to guideline

Guideline:

OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Analytical monitoring:

no

Vehicle:

no

Details on test solutions:

PREPARATION AND APPLICATION OF TEST SOLUTION
- Method: No concentrations in excess of the water solubility limit of the test substance were tested. Due to the low solubility of the test substance in test water the following dosage was chosen: A supersaturated stock suspension of the test substance with a nominal concentration of 100 mg/L was prepared by weighing an adequate amount of the test substance into test water. No auxiliary solvent or emulsifier was used. The test substance was mixed into the test water as homogeneously as possible by ultrasonic treatment for 15 minutes and intense stirring. The supersaturated stock suspension was stirred on a magnetic stirrer at room temperature in the dark over 27 hours. Due to the results of a pre-experiment no differences of dissolved amount of test substance in test water were determined after stirring periods between 2 and 48 hours. The stock suspension of the test substance was filtered through a cellulose-nitrate filter with a defined pore size of 0.2 µm just before the start of the test.

Test organisms (species):

Daphnia magna

Details on test organisms:

TEST ORGANISM
- Common name: water flea
- Source: supplied 1997 by the Umweltbundesamt, Institut für Wasser-, Boden- und Lufthygiene, Berlin, Germany.
- Age at study initiation: 6 - 22 hours old
- Method of breeding: The Daphnia are bred in the laboratories of IBACON under similar temperature and light conditions as in the test, and in reconstituted water of a similar quality regarding to pH, components of the main ions and total hardness as the test water used in the test. The test organisms were not first brood progeny.

ACCLIMATION
- Acclimation period: for 6 hours
- Acclimation conditions: test conditions

Test type:

static

Water media type:

freshwater

Limit test:

yes

Total exposure duration:

48 h

Post exposure observation period:

No

Hardness:

Not specified

Test temperature:

20 °C

pH:

7.7 to 8.0

Dissolved oxygen:

at least 7.9 mg/L

Salinity:

Not applicable

Conductivity:

Not specified

Nominal and measured concentrations:

100 mg/L (nominal concentration)

Details on test conditions:

TEST SYSTEM
- Test vessel: Glass beakers of 100 mL volume with 50 m L test medium
- No. of organisms per vessel: 10 animals per vessel
- No. of vessels per concentration: two replicates
- No. of vessels per control: two replicates

TEST MEDIUM / WATER PARAMETERS
- in accordance to the guideline

OTHER TEST CONDITIONS
- Adjustment of pH: no
- Photoperiod: 16 h light: 8 h dark
- Light intensity: 1120 lux

EFFECT PARAMETERS MEASURED:
The immobility or mortality of the Daphnia was determined by visual controls after 24 and 48 hours.

Reference substance (positive control):

no

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

Duration:

48 h

Dose descriptor:

EC0

Effect conc.:

>= 100 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mobility

Duration:

48 h

Dose descriptor:

NOEC

Effect conc.:

>= 100 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mobility

Details on results:

After 24 and 48 hours in the control and in the undiluted filtrate of the supersaturated stock suspension no mortality or immobilization of the test animals was observed.

Reported statistics and error estimates:

Not applicable (limit test).

Validity criteria fulfilled:

yes

Conclusions:

The test item shows no toxic effects up to a nominal concentration of 100 mg/L after 48 hours of exposure.

Executive summary:

A limit test was performed to demonstrate that the test substance has no toxic effect on Daphnia up to the solubility limit of the test substance in the used test water. After 24 and 48 hours in the control and in the undiluted filtrate of the supersaturated stock suspension no mortality or immobilization of the test animals was observed. Therefore, the 48-hour NOEC, respectively the 48-hour EC 0 of UREA 4 to Daphnia magna were determined to be at least up to the solubility limit of the test substance in test water. The NOEC and the EC 0 might even be higher than the solubility limit, but concentrations in excess of the solubility limit have not been tested. The 48- hour EC 50 was clearly higher than the solubility limit of the test substance in the used test water. This value could not be quantified due to the absence of toxicity of UREA 4 up to the tested concentration.

Description of key information

The acute toxicity to aquatic invertebrates was assessed with Daphnids exposed under static conditions to a nominal concentration of 100 mg/L. The LC50 was calculated to be > 100 mg/L (limit concentration).

The NOEC was greater or equal 100 mg/L.

Key value for chemical safety assessment

Fresh water invertebrates

Fresh water invertebrates

Effect concentration:

100 mg/L

Additional information

A limit test was performed according to EU-method C.2 and OECD guideline 202 to demonstrate that the test substance has no toxic effect on Daphnia up to the solubility limit of the test substance in the used test water. After 24 and 48 hours in the control and in the undiluted filtrate of the supersaturated stock suspension no mortality or immobilization of the test animals was observed. Therefore, the 48-hour NOEC, respectively the 48-hour EC 0 of UREA 4 to Daphnia magna were determined to be at least up to the solubility limit of the test substance in test water. The NOEC and the EC 0 might even be higher than the solubility limit, but concentrations in excess of the solubility limit have not been tested. The 48- hour EC 50 was clearly higher than the solubility limit of the test substance in the used test water. This value could not be quantified due to the absence of toxicity of UREA 4 up to the tested concentration.