2-(2-oxopyrrolidin-1-yl)butyramide

Short-term toxicity to fish

Administrative data

Endpoint:

short-term toxicity to fish

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2004

Report date:

2004

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 203 (Fish, Acute Toxicity Test)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method C.1 (Acute Toxicity for Fish)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test material

Reference

Name:

Unnamed

Type:

Constituent

Test material form:

solid: particulate/powder

Remarks:

migrated information: powder

Details on test material:

Batch: C02421 -1620
Purity: 98.6%

Sampling and analysis

Analytical monitoring:

yes

Test solutions

Vehicle:

no

Test organisms

Test organisms (species):

Danio rerio (previous name: Brachydanio rerio)

Details on test organisms:

The study was performed with zebra fish (Brachydanio rerio). The test fish were obtained from Zoohaus Schaub, CH-441OLiestal, Switzerland. In accordance with the test guidelines the fish were held in the laboratories of RCC for about five weeks without any medication. Prior to test start, they were acclimated for one week to the test water and temperature. During holding and acclimatization until one day before the start of the test the fish were fed with a commercial fish diet (Tetra Min Hauptfutter, supplied by TETRA-Werke, D-49304 Melle, Germany). During holding and acclimatization no fish died in the test fish batch and all fish were healthy.

From the acclimated test fish batch, 10 fish were measured at the start of the test: The mean body length of the fish was 3.3 +/- 0.2 cm (Mean +/- SD), the mean body wet weight was 0.36 +/- 0.09 g (Mean +/- SD).

Study design

Test type:

static

Water media type:

freshwater

Limit test:

yes

Total exposure duration:

96 h

Test conditions

Hardness:

2.5 mmol/L (= 250 mg/L) as CaCO3

Test temperature:

22°C

Dissolved oxygen:

The test water was aerated prior to the preparation of the test media until oxygen saturation was reached.

Nominal and measured concentrations:

Reconstituted water: analytical grade salts were dissolved in deionized water to obtain the following nominal concentrations:
CaCl2 x 2H20 : 2.0 mmol/L (= 294 mg/L)
MgSO4 X 7H20 : 0.5 mmol/L (= 123 mg/L)
NaHCO3 : 0.75 mmol/L (= 65 mg/L)
KCl : 0.075 mmol/L (= 5.8 mg/L)

Details on test conditions:

A 16-hour light to 8-hour dark photoperiod, with a 30-minute transition period (light intensity during the light period was approximately within the range of 280 to 500 Lux).

Results and discussion

Effect concentrations

Effect concentrations 1

Duration:

96 h

Dose descriptor:

NOEC

Effect conc.:

>= 100 mg/L

Nominal / measured:

nominal

Effect concentrations 2

Duration:

96 h

Dose descriptor:

LC0

Effect conc.:

>= 100 mg/L

Nominal / measured:

nominal

Any other information on results incl. tables

Sublethal observations / clinical signs:

In the control and in the test medium of 100 mg/L all fish survived until the end of the test and no visible abnormalities were observed at the test fish. Therefore, the 96-hour NOEC (highest concentration tested without toxic effects after the exposure period of 96 hours), and the 96-hour LC0 of ucb 6474 to zebra fish were determined to be at least 100 mg/L. The 96-hour NOEC and the 96-hour LC0 might even be higher than this concentration, but concentrations in excess of 100 mg/L have not been tested, according to the guidelines. The 96-hour LOEC (lowest concentration with toxic effects), the 96-hour LC50 and the 96-hour LC100 were clearly higher than 100 mg/L. These values could not be quantified due to the absence of toxicity of ucb 6474 at the tested concentration.

Applicant's summary and conclusion

Conclusions:

The 96-hour NOEC (highest concentration tested without toxic effects after the exposure period of 96 hours), and the 96-hour LCO of ucb 6474 to zebra fish were determined to be at least 100 mg/L.