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Diss Factsheets

Ecotoxicological information

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:
16.-18.03.2009
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP - Guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2009
Report date:
2009

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)
Qualifier:
according to guideline
Guideline:
EU Method C.2 (Acute Toxicity for Daphnia)
Qualifier:
according to guideline
Guideline:
ISO 6341 (Water quality - Determination of the Inhibition of the Mobility of Daphnia magna Straus (Cladocera, Crustacea))
Qualifier:
according to guideline
Guideline:
other: Guidance on aquatic toxicity testing of difficult substances and mixtures, OECD series on testing and assessment number 23 (2000)
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
N-(4-{[3-(dimethylamino)propyl]sulfamoyl}phenyl)-2-[(2-methoxy-4-nitrophenyl)diazenyl]-3-oxobutanamide
EC Number:
700-222-4
Cas Number:
1065519-44-9
Molecular formula:
C22H28N6O7S
IUPAC Name:
N-(4-{[3-(dimethylamino)propyl]sulfamoyl}phenyl)-2-[(2-methoxy-4-nitrophenyl)diazenyl]-3-oxobutanamide
Details on test material:
- Name of test material (as cited in study report): NO.408 YELLOW
- Physical state: powder
- Analytical purity: 98.6%
- Lot/batch No.: 081105-1
- Expiration date of the lot/batch: 04. November 2009
- Storage condition of test material: at room temperature in the dark
- Other: solubility in water: 0.38 mg/L

Sampling and analysis

Analytical monitoring:
yes

Test solutions

Vehicle:
no
Details on test solutions:
PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Method: Preparation of test solutions started with a stock solution prepared at a loading rate of 100 mg/L. A 15-minute treatment period with ultrasonic waves was followed by a magnetic stirring period of 45 h to accelerate the dissolving of the test substance in the test medium. This resulted in a solution that still ocntained some undissolved material, which was consequently removed by filtration through a 0.45 μm membrane filter (Whatman, RC55).
- Controls: Test medium without test substance or other additives.

Test organisms

Test organisms (species):
Daphnia magna
Details on test organisms:
TEST ORGANISM
- Common name: Daphnia magna
- Strain: Straus, 1820
- Source: In-house laboratory culture with a known history
- Age at study initiation (mean and range, SD): < 24 h
- Feeding during test: no

Study design

Test type:
static
Water media type:
freshwater
Limit test:
no
Total exposure duration:
48 h

Test conditions

Hardness:
180 mg CaCO3/L
Test temperature:
20.3 °C - 21.2 °C
pH:
see table below
Dissolved oxygen:
see table below
Nominal and measured concentrations:
Nominal concentrations: 1.0, 10 and 100% of a 0.45 μm filtered solution prepared at a loading rate of 100 mg/L
Measured concentrations: Analysis of the samples taken from the filtrate at the start of the combined limit/range-finding test showed a measure concentration of 0.256 mg/L. During the exposure period the measured concentration decreased to 0.113 mg/L. The average exposure concentration being the geometric mean was calculated to correspond to 0.17 mg/L. This concentration exceeded the maximum solubility that was limited to 19.8 μg/L.
Details on test conditions:
TEST SYSTEM
- Test vessel:
- Material, size, headspace, fill volume: 100 mL all-glass test vessels containing 80 mL of test solution
- Aeration: no
- No. of organisms per vessel: 5
- No. of vessels per concentration (replicates): 4 (highest concentration) and 2 (remaining concentrations)
- No. of vessels per control (replicates): 4


OTHER TEST CONDITIONS
- Photoperiod: 16 h light, 8 h dark


EFFECT PARAMETERS MEASURED (with observation intervals if applicable) : immobility was monitored daily


TEST CONCENTRATIONS
- Spacing factor for test concentrations: 10
- Justification for using less concentrations than requested by guideline: study is a combined limit/range-finding test
Reference substance (positive control):
yes
Remarks:
potassium dichromate

Results and discussion

Effect concentrations
Duration:
48 h
Dose descriptor:
EC50
Effect conc.:
> 0.17 mg/L
Nominal / measured:
meas. (geom. mean)
Conc. based on:
test mat.
Basis for effect:
mobility
Details on results:
- Mortality of control: 0%
- Effect concentrations exceeding solubility of substance in test medium: The average exposure concentration of 0.17 mg/L exceeded the maximum solubility that was limited to 19.8 μg/L.
Results with reference substance (positive control):
- EC50: 0.30 mg/L with a 95% confidence interval between 0.25 and 0.35 mg/L

Any other information on results incl. tables

Table 2: Acute immobilisation of daphnids after 24 and 48 hours in the combined limit/range-finding test

Test group NO.408 YELLOW
(% of filtrate)

Vessel number

Number of Daphnia
exposed

Response at 24 h

Response at
48 h

Number

Total %

Number

Total %

Control

A

B

C

D

5

5

5

5

0

0

0

0

0

0

0

0

0

0

1.0

A

B

5

5

0

0

0

0

0

0

10

A

B

5

5

0

0

0

0

0

0

100
(0.17 mg/L1)

A

B

C

D

5

5

5

5

0

0

0

0

0

1

1

1

1

20

1Average exposure concentration

Applicant's summary and conclusion