N,N'-(2-chloro-1,4-phenylene)bis(3-oxobutaneamide)

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:

2000-01-06 to 2000-03-06

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2000

Report date:

2000

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 203 (Fish, Acute Toxicity Test)

Deviations:

yes

Remarks:

Test chambers were aerated from 24 hours after study start, since the maintenance of an oxygen content of at least 60 % of the saturation value was not ensured. Aeration was carried out using a glass capillary with a bubble-frequency of 1 - 3 per second.

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

-

EC Number:

443-010-4

EC Name:

-

Cas Number:

53641-10-4

Molecular formula:

C14H15ClN2O4

IUPAC Name:

N-[3-chloro-4-(3-oxobutanamido)phenyl]-3-oxobutanamide

Test material form:

solid

Sampling and analysis

Analytical monitoring:

yes

Details on sampling:

In order to determine the substance concentration, water samples were taken from the middle of the test chamber by pipetting approx. 20 mL into a screw-neck glass bottle at study start, and after 48 and 96 hours.

Test solutions

Vehicle:

yes

Remarks:

Reconstituted water, composition according to ISO/DIS 7346/1 was used as water for dilution. Preparation was carried out in a unit consisting of two Hostalen®- lined steel vessels with a capacity of 1000 litres each. The dilution water was prepared as des

Details on test solutions:

A solubilizer was not used. The test substance was weighed
into a beaker, water for dilution was added and was
homogenized using an Ultra-Turrax.

Test organisms

Test organisms (species):

Danio rerio (previous name: Brachydanio rerio)

Details on test organisms:

Species Danio rerio (HAMILTON-BUCHANAN)
Origin : Aventis Pharma Deutschland GmbH
ProTox
Date of hatching February, 11 1999
Delivery date April, 14 1999
The fish were kept for 14 days before the start of the study in water for dilution (see section 6.3) under the following conditions:
Temperature : 22 ± 1 °C
Oxygen content : 80 % of the saturation value
Duration of light period : 12 hours daily
Fish density 1 g fish / L water
Feeding : twice daily ad libitum
Food : Tetra Min, Tetra Werke, Melle (Germany)

Study design

Test type:

static

Water media type:

freshwater

Limit test:

no

Total exposure duration:

96 h

Test conditions

Hardness:

The total hardness of the dilution water was determined weekly and was at 2.1 mmol Ca2+ + Mg2+ / L during the study.

Test temperature:

21.5-22.1 °C

pH:

7.5-8.2

Dissolved oxygen:

6.1-9.4 mg/L

Nominal and measured concentrations:

Nominal: 100 mg/L
Measured: 93 mg/L

Reference substance (positive control):

no

Results and discussion

Effect concentrations

Effect concentrations 1

Duration:

24 h

Dose descriptor:

LC50

Effect conc.:

> 100 mg/L

Basis for effect:

mortality (fish)

Effect concentrations 2

Duration:

48 h

Dose descriptor:

LC50

Effect conc.:

> 100 mg/L

Basis for effect:

mortality (fish)

Effect concentrations 3

Duration:

72 h

Dose descriptor:

LC50

Effect conc.:

> 100 mg/L

Basis for effect:

mortality (fish)

Effect concentrations 4

Key result

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

> 100 mg/L

Basis for effect:

mortality (fish)

Effect concentrations 5

Duration:

96 h

Dose descriptor:

NOEC

Effect conc.:

100 mg/L

Details on results:

The 100 mg/L group showed no effect in comparison with the control. In the control group and in the 100 mg/L group no mortality was observed.
In this 96-hour acute toxicity study of CL-DAEP in zebra fish (Danio rerio) no mortality occurred in the 100 mg/L group (nominal concentration) and in the control group.

Applicant's summary and conclusion

Validity criteria fulfilled:

yes

Remarks:

Aeration was started from 24 h into to the test, measured concentration of 6.1-9.4 mg/L do not indicate reasons for concern regarding the validity of the results.

Conclusions:

Under the conditions of this test the LC50 of CL-DAEP after 96 hours was >100 mg/L.

Executive summary:

CL-DAEP was tested in zebra fish (Danio rerio) for 96 hours in a static system. The concentration tested was 100 mg/L and a negative control (0 mg/L).
The chamber contents were stirred for approximately 24 hours with a KPG-stirrer and a glass rod to ensure that the limit of solubility of the test substance in water was reached.
The tested concentration was visually present as clear solution. The test batch was homogeneous. No particulate matter was observed.
The substance concentration was determined in the 100 mg/L group. The values determined were in a range of ± 10 % of the theoretical value.
In this 96-hour acute toxicity study of CL-DAEP the following mortality values were determined:

LC0 (24, 48, 72, 96 h) = 100 mg/L

LC50 (24, 48, 72, 96 h) > 100 mg/L

LC100 (24, 48, 72, 96 h) > 100 mg/L

The 100 mg/L group showed no effect in comparison with the control. In the control group no effects were observed.