N,N'-ethylenebis[N-acetylacetamide]

Short-term toxicity to fish

Administrative data

Endpoint:

short-term toxicity to fish

Type of information:

experimental study

Adequacy of study:

key study

Study period:

21.01.1985 - 25.01.1985

Reliability:

other: reliable with restrictions (2), the Danio rerio study was choosen as key because the highest tested concentration of 500 mg/l with no effect was considerably higher than the highest tested conc. of 127 mg/L with no effects in the Oncorhynchus mykiss study

Rationale for reliability incl. deficiencies:

other: The present study was carried out before 1990, i. e. at a time when GLP was not implemented. However, regarding the methodologies applied and the carefulness for executing the experimental work, the study adhered GLP comparable quality conditions.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1985

Report date:

1985

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 203 (Fish, Acute Toxicity Test)

Deviations:

yes

Remarks:

, the concentration of the test item in the test media was not measured

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

N,N'-ethylenebis[N-acetylacetamide]

EC Number:

234-123-8

EC Name:

N,N'-ethylenebis[N-acetylacetamide]

Cas Number:

10543-57-4

Molecular formula:

C10H16N2O4

IUPAC Name:

N,N'-ethylenebis[N-acetylacetamide]

Details on test material:

TAED > 99 %
appearance: white powder

Sampling and analysis

Analytical monitoring:

no

Details on sampling:

not applicable

Test solutions

Vehicle:

no

Details on test solutions:

Preparation of test solution: 5000 mg was added to the test medium and dispersed via ultra sonic. Afterwards the test item was given to the test vessel and thoroughly mixed for 2 hours. In general 5000 mg test item was given to 10 L test medium.

Test organisms

Test organisms (species):

Danio rerio (previous name: Brachydanio rerio)

Details on test organisms:

TEST ORGANISM
- Common name: Zebra fish
- Source: not applicable
- Age at study initiation (mean and range, SD): not applicable
- Length at study initiation (length definition, mean, range and SD): 2.8 - 3.4
- Feeding during test: not applicable

Study design

Test type:

static

Water media type:

freshwater

Limit test:

yes

Total exposure duration:

96 h

Post exposure observation period:

none

Test conditions

Hardness:

not applicable

Test temperature:

water temperature: 22 ± 1 °C

pH:

7.3 - 8.0

Dissolved oxygen:

Control: 6.7 - 8.7 mg/L
TAED: 3.9 - 8.7 mg/L

Salinity:

not applicable

Nominal and measured concentrations:

not applicable

Details on test conditions:

TEST SYSTEM
- Test vessel:
- Material, size, headspace, fill volume: glass tanks
- Aeration: yes
- No. of organisms per vessel: 10
- No. of vessels per concentration (replicates): 1
- No. of vessels per control (replicates): 1


TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: reconstituted water according to Nusch, no further information provided


EFFECT PARAMETERS MEASURED (with observation intervals if applicable) : mortality, behaviour

Reference substance (positive control):

not specified

Results and discussion

Effect concentrations

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

> 500 mg/L

Any other information on results incl. tables

Sublethal observations / clinical signs:

During the experimental time the test item in the test media was soluble, but deposits was observed at the surface.

Surviving fish in the test item treated group exhibited effects such as hyperactivity and hyperreflexia. Despite of these clinical observation no mortality was observed. The LC50 after 96 hour was determined to be higher than 500 mg/L, the highest rate tested.

Applicant's summary and conclusion

Validity criteria fulfilled:

yes

Executive summary:

The acute toxicity of the test item TAED to zebra fish (Danio rerio) was determined in a 96-hour static test. A limit test was performed in accordance with the guideline to demonstrate that the test item has no toxic effect on the test organisms at the nominal concentration of 500 mg/L.

There were no effects of TAED on zebra fish observed at 500 mg/L, the only rate tested. The NOEC was therefore determined to be 500 mg/L. The LC50 could not be calculated due to the absence of toxicity of the test item up to 500 mg/L, but was estimated to be > 500 mg/L.