N-phenyl-N'-[(phenylamino)sulfonyl]urea

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:

15.-18. March 2016

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2016

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)

Version / remarks:

2004

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

1-phenyl-3-(phenylsulfamoyl)urea

EC Number:

813-358-5

Cas Number:

4886-26-4

Molecular formula:

C13H13N3O3S

IUPAC Name:

1-phenyl-3-(phenylsulfamoyl)urea

Test material form:

solid: particulate/powder

Details on test material:

- State of aggregation:
- Particle size distribution:
- Mass median aerodynamic diameter (MMAD):
- Geometric standard deviation (GSD):
- Shape of particles:
- Surface area of particles:
- Crystal structure:
- Coating:
- Surface properties:
- Density:
- Moisture content:
- Residual solvent:
- Activation:
- Stabilisation:
- Other:

Sampling and analysis

Analytical monitoring:

yes

Details on sampling:

- Concentrations:
- Sampling method: sampling at 0 h, 24 h (before and after renewal of test solution), 48 h
- Sample storage conditions before analysis: <= 2 d

Test solutions

Vehicle:

no

Test organisms

Test organisms (species):

Daphnia magna

Details on test organisms:

TEST ORGANISM
- Common name: Daphnia magna
- Strain/clone: Straus
- Justification for species other than prescribed by test guideline: -
- Source: Federal Environment Agency, department IV 2.4, Berlin,
- Age of parental stock (mean and range, SD):
- Feeding during test
- Food type: Desmodesmus subspicatus algae
- Amount:0.1 mg C × daphnid-1 × day-1
- Frequency: on workdays

ACCLIMATION
- Acclimation period:
- Acclimation conditions (same as test or not):
- Type and amount of food:
- Feeding frequency:
- Health during acclimation (any mortality observed):

QUARANTINE (wild caught)
- Duration:
- Health/mortality:

METHOD FOR PREPARATION AND COLLECTION OF EARLY INSTARS OR OTHER LIFE STAGES:

Study design

Test type:

semi-static

Water media type:

freshwater

Limit test:

no

Total exposure duration:

48 h

Test conditions

Test temperature:

19.4 - 19.6 °C

pH:

7.0 - 7.6 in the control and 7.3 - 7.8 in the test concentrations

Dissolved oxygen:

7.8 - 8.0 mg/L in the control and 7.8 - 8.2 mg/L in the test concentrations

Nominal and measured concentrations:

nominal: 12.4, 24.8, 49.5, 99.0, 198 mg/L

Details on test conditions:

TEST SYSTEM
- Test vessel:
- Type (delete if not applicable): open / closed
- Material, size, headspace, fill volume: 250 mL
- Aeration:
- Type of flow-through (e.g. peristaltic or proportional diluter): -
- Renewal rate of test solution (frequency/flow rate): after 24 h
- No. of organisms per vessel: 5
- No. of vessels per concentration (replicates): 4
- No. of vessels per control (replicates): 4
- No. of vessels per vehicle control (replicates): -
- Biomass loading rate:

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: M4 standard medium
- Total organic carbon:
- Particulate matter:
- Metals:
- Pesticides:
- Chlorine:
- Alkalinity:
- Ca/mg ratio:
- Conductivity:
- Salinity:
- Culture medium different from test medium: no
- Intervals of water quality measurement:

OTHER TEST CONDITIONS
- Adjustment of pH:
- Photoperiod: 16 h / 8 h
- Light intensity:

EFFECT PARAMETERS MEASURED (with observation intervals if applicable) :

VEHICLE CONTROL PERFORMED: yes/no

RANGE-FINDING STUDY
- Test concentrations:
- Results used to determine the conditions for the definitive study:

Reference substance (positive control):

yes

Remarks:

potassium dichromate

Results and discussion

Effect concentrations

Effect concentrations 1

Key result

Duration:

48 h

Dose descriptor:

EC50

Effect conc.:

164.21 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mobility

Effect concentrations 2

Duration:

48 h

Dose descriptor:

EC10

Effect conc.:

109.83 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mobility

Effect concentrations 3

Duration:

48 h

Dose descriptor:

NOEC

Effect conc.:

99 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mobility

Results with reference substance (positive control):

EC50 (24h) = 1.30 mg/L (95%-confidence interval: 1.07 - 1.43 mg/L) and EC50 (48h) < 1.25 mg/L, which is in the declared range of 0.6 – 2.1 mg/L (24 h) according to OECD 202.

Applicant's summary and conclusion

Validity criteria fulfilled:

yes

Conclusions:

The test item shows a low acute toxicity to aquatic invertebrates. The effect value was calculated 164.2 mg/L (c.i. 138.35 - 197.56 mg/L).

Executive summary:

A semi-static D. magna acute immobilisation test was performed using a maximum concentrated stock solution (limit of solubility) with a loading rate of 200 mg/L test item. As the measured concentrations are within ± 20 % of the “nominal” concentrations, according to OECD 202, all results are given in relation to the “nominal” test item concentrations:

(Lowest/No Observed) Effect Concentration	“Nominal” test item concentration [mg/L] *
95 % Confidence Limits (CL)	24 h	48 h
EC50	n.d.	164.21
CL	n.d.	138.35 - 197.56
EC10	154.86	109.38
CL	n.d.	71.90 - 131.39
LOEC	> 198	198
NOEC	≥ 198	99.0

  * See section 6.4; n.d.: not determined due to mathematical reasons or inappropriate data

The test is valid according to OECD Test Guideline 202 (April 2004).

The measured test item concentration of the stock solution at the start of the test (0 h) is used as the highest “nominal” concentration and the lower “nominal” concentrations are calculated using the corresponding concentration factors. The measured test item concentrations in the test treatments were 97.8 - 108.3 % of the “nominal” test item concentrations and stable during the exposure period. The concentrations in the control were below the limit of quantification.