2-Propenamide, N-[4-[[(4,6-dimethyl-2-pyrimidinyl)amino]sulfonyl]phenyl]-2-methyl-

Short-term toxicity to fish

Link to relevant study record(s)

Reference

Endpoint:

short-term toxicity to fish

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2017

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 203 (Fish, Acute Toxicity Test)

Version / remarks:

1992

Deviations:

no

GLP compliance:

yes

Analytical monitoring:

yes

Details on sampling:

Samples for possible analysis were taken from all test concentrations and the control according to the schedule below.
Frequency at t=0 h, t=24 h and t=72 h
Volume 3.0 mL
Storage Samples were stored in a freezer (≤-15°C) until analysis at the analytical laboratory of the Test Facility.
At the end of the exposure period, the replicates with algae were pooled at each concentration before sampling.
Compliance with the Quality criteria regarding maintenance of actual concentrations was checked by running a test vessel at the limit concentration but without algae and samples for analysis were taken at the start, after 24 hours of exposure and at the end of the test period.

Test samples were stored in the freezer (≤ -15°C). Storage stability of samples under these conditions was demonstrated in project 516986.

Vehicle:

no

Details on test solutions:

PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
The batch of V123109 tested was a white crystalline powder with a purity of >95% and completely soluble in test medium at the loading rates initially prepared. No correction was made for the purity/composition of the test item.
Preparation of test solutions started with a loading rate of 100 mg/L applying a 3-minutes treatment with ultrasonic waves followed by a 3-day period of magnetic stirring to ensure maximum dissolution of the test item in medium. Thereafter, the aqueous Saturated Solution (SS) was filtered through a 0.45 μm membrane filter (RC55, Whatman) and used as the highest test concentration. Lower test concentrations were prepared by subsequent dilutions of the SS in test medium. All test solutions were clear and colorless at the end of the preparation procedure.

Test organisms (species):

Cyprinus carpio

Details on test organisms:

TEST ORGANISM
- Common name: Carp
- Source: Zodiac, proefacc, "De Haar Vissen", Wageningen University and Research Centre, The Netherlands.
- Age at study initiation (mean and range, SD):
- Length at study initiation (length definition, mean, range and SD):
Range-finding test: 3.1 ± 0.3 cm
Limit test: 3.1 ± 0.1 cm
- Weight at study initiation (mean and range, SD):
Range-finding test: 0.37 ± 0.10 g
Limit test: 0.45 ± 0.03 g
- Method of breeding: F1 from a single parent-pair bred in UV-treated water.

ACCLIMATION
- Acclimation period: At least 12 days after delivery
- Acclimation conditions (same as test or not): Adjusted ISO medium, formulated using RO-water (tap-water purified by reverse osmosis; GEON Waterbehandeling, Berkel- Enschot, The Netherlands) with the following composition:
- Type and amount of food during acclimation: Daily with pelleted fish food (Essence (300-500 um), Coppens International bv, Helmond, The Netherlands)
- Health during acclimation (any mortality observed): In the batch of fish used for the test, mortality during the seven days prior to the start of the test was less than 5%.

FEEDING DURING TEST
No feeding from 24 hours prior to the test and during the total test period

Test type:

static

Water media type:

freshwater

Limit test:

yes

Total exposure duration:

96 h

Test temperature:

T: 20-24°C, constant within 2°C

pH:

pH: 6.0-8.5, constant within 1 unit

Dissolved oxygen:

Oxygen > 60% of air saturation (6.3 - 9.1 mg/L)

Nominal and measured concentrations:

Solution containing 100% of the saturated solution prepared at a loading rate of 100 mg/L.

Details on test conditions:

TEST SYSTEM
9 liters, all-glass, containing 8 liters of test solution
- Aeration: The test media were not aerated during the test
- No. of organisms per vessel: 7
- No. of vessels per concentration (replicates): 1
- No. of vessels per control (replicates): 1
- Biomass loading rate: 0.39 g fish/L, i.e. 7 fish per 8 liters of test medium


OTHER TEST CONDITIONS
- Adjustment of pH: no
- Photoperiod: 16 hours photoperiod daily

EFFECT PARAMETERS MEASURED (with observation intervals if applicable) :

TEST CONCENTRATIONS
- Justification for using less concentrations than requested by guideline: limit test
- Test concentrations: 2 (0 and 100 mg/l)

Reference substance (positive control):

yes

Remarks:

Pentachlorophenol (PCP)

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

> 73 mg/L

Nominal / measured:

meas. (initial)

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Details on results:

No mortality or other clinical effects were observed during this test in the limit concentration and the control, hence the test was considered valid.

Results with reference substance (positive control):

The 96h-LC50 for carp exposed to PCP was 0.32 mg/L (95 % confidence interval between 0.22 and 0.46 mg/L). This effect was already reached within 24 hours of exposure.

Validity criteria fulfilled:

yes

Conclusions:

The 96h-LC50 was beyond the range tested, i.e. exceeded a measured concentration of 73 mg/L being considered maximum soluble in test medium

Executive summary:

The objective of the study was to evaluate V123109 for its ability to generate acute toxic effects inCyprinus carpioduring an exposure period of 96 hours and, if possible, to determine the LC₅₀at all observation times.

The study procedure described in this report was based onthe OECD guideline No. 203, 1992.In addition, procedures were based on the test methods described in the OECD series on testing and assessment number 23, 2000.

The batch of V123109 tested was awhite crystalline powderwith a purity of>95%and not completely soluble in test medium at the loading rate initially prepared.No correction was made for the purity/composition of the test item.

A limit test was performed based on the results of a range-finding test. A Saturated Solution (SS) was prepared at a loading rate of 100 mg/L and used as the limit concentration.

 

Seven fish per group were exposed to an untreated control and to a limit concentration. The total exposure period was 96 hours and samples for analytical confirmation of exposure concentrations were taken at the start of the test and at the end of the test.

 

Samples taken from the limit concentration were analysed. The initially measured concentration in the undiluted saturated solution was 73 mg/L. This concentration remained stable during the exposure period (99% of initial at the end of the exposure). Therefore, the effect parameters were expressed in terms of measured concentrations.

 

The study met the acceptability criteria prescribed by the study plan and was considered valid.

In conclusion,the 96h-LC₅₀was beyond the range tested, i.e. exceeded a measured concentration of 73 mg/L being considered maximum soluble in test medium.

Key value for chemical safety assessment

Fresh water fish

Fresh water fish

Effect concentration:

73 mg/L