4-[(6-chloro-2-[(4-cyanophenyl)amino]-4-pyrimidinyl]oxy]-3,5-dimethylbenzonitrile

Short-term toxicity to aquatic invertebrates

Link to relevant study record(s)

Reference

Endpoint:

short-term toxicity to aquatic invertebrates

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2003-06-18 to 2003-07-25

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)

Deviations:

no

Remarks:

: There were no circumstances that may have affected the quality or integrity of the data.

Qualifier:

according to guideline

Guideline:

EU Method C.2 (Acute Toxicity for Daphnia)

Deviations:

no

Remarks:

: There were no circumstances that may have affected the quality or integrity of the data.

GLP compliance:

yes (incl. QA statement)

Specific details on test material used for the study:

SOURCE OF TEST MATERIAL
- Name of test material (as cited in study report): T002615
- Substance type: not applicable
- Physical state: solid white
- Analytical purity: > 98%
- Purity test date: no data
- Lot/batch No.: 00403487
- Expiration date of the lot/batch: December 2003 (retest date)

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Stability under test conditions: Determined in RCC study No. 847007
- Storage condition of test material: at room temperature at about 20 °C, away from direct sunlight
- Solubility in water: Determined in RCC study No. 846983

Analytical monitoring:

yes

Details on sampling:

- Concentrations: 100 mg/L (loading rate); 1.8 µg/L (average of all measurements). Just before test start: duplicate samples from the single test medium(without daphnids) and control (without daphnids). After 48 hours (stability samles): duplicate samples from the single test medium (without daphnids) and control (without daphnids).
- Sampling method: Sampling from test beakers with daphnids was not possible because the test media volumes (4x50mL) were too small for the analytical requirements.
- Sample storage conditions before analysis: The samples were analyzed immediatly after the sampling took place.

Vehicle:

no

Details on test solutions:

PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Method: A filtrate of a saturated dispersion of the test item was prepared. The undiluted filtrate was tested as the only test concentrations. Before the start of the test, a supersaturated dispersion with a loading rate of 100 mg/L was prepared by mixing 300.6 mg of the test item into 3000 mL of test water. The test item was mixed into the test water as homogeneously as possible using ultrasonic treatment for 15 minutes and by intense stirring for 24 hours at room temperature in the dark. No auxiliary solvent or emulsifier was used. the supersaturated dispersion of the test item was filtered through a membrane filter (Schleicher & Schuell, Type NC45, pore size 0.45 µm) just before the start of the test (= introduction of daphnids).
- Controls: yes
- Evidence of undissolved material (e.g. precipitate, surface film, etc): no remarkable observations, clear test substance solutions

Test organisms (species):

Daphnia magna

Details on test organisms:

TEST ORGANISM
- Common name: Water-flea
- Strain: Clones of Daphnia magna Straus, defined by supplier as 'clone 5'
- Source: University of Sheffield/UK, 1992. Since then the clone is bred in the laboratories of RCC in reconstit. water.
- Age at study initiation (mean and range, SD): 6-24 h old were not first brood progeny
- Method of breeding: no data
- Feeding during test: no
- Food type: not applicable
- Amount: not applicable
- Frequency: not applicable

ACCLIMATION
- Acclimation period: no data
- Acclimation conditions (same as test or not): yes
- Type and amount of food: not applicable
- Feeding frequency: not applicable
- Health during acclimation (any mortality observed): no mortalities observed

Test type:

static

Water media type:

freshwater

Limit test:

yes

Total exposure duration:

48 h

Post exposure observation period:

no data

Hardness:

2.5 mmol/L (250 mg/L as CaCO3

Test temperature:

20 °C

pH:

7.8

Dissolved oxygen:

8.7 mg/L

Salinity:

no data

Nominal and measured concentrations:

Nominal: 100 mg/L
Measured: 1.6 -1.9 µg/L (1.8 µg/L mean of measured concentrations)

Details on test conditions:

TEST SYSTEM
- Test vessel: 100 mL glass beakers
- Type (delete if not applicable): the vessels were covered with glass plates to reduce the loss of water and to avoid the entry of dust into the solutions
- Material, size, headspace, fill volume: 100 ml glass beakers filled with 50 mL of test medium
- Aeration: not aerated
- Type of flow-through (e.g. peristaltic or proportional diluter): not applicable
- Renewal rate of test solution (frequency/flow rate): not applicable
- No. of organisms per vessel: 20
- No. of vessels per concentration (replicates): 4
- No. of vessels per control (replicates): 20
- No. of vessels per vehicle control (replicates): 4
- Biomass loading rate: was less than one daphnid per 2 mL of test solution

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: reconstituent test water
- Total organic carbon: no data
- Particulate matter: no data
- Metals: no data
- Pesticides: no data
- Chlorine: no data
- Alkalinity:0.8 mmol/L
- Ca/mg ratio: 4.1 based on molarity
- Conductivity: no data
- Culture medium different from test medium: no
- Intervals of water quality measurement: 0, 24 and 48 h

OTHER TEST CONDITIONS
- Adjustment of pH: no
- Photoperiod: 16-h light and 8-h dark
- Light intensity: 460 and 670 Lux

EFFECT PARAMETERS MEASURED (with observation intervals if applicable) : mortality, mobility

TEST CONCENTRATIONS
- Spacing factor for test concentrations: not applicable since is a limit test
- Justification for using less concentrations than requested by guideline: the conclusions from the range finding study
- Range finding study: yes
- Test concentrations: no data
- Results used to determine the conditions for the definitive study: yes

Reference substance (positive control):

yes

Remarks:

potassium dichromate

Key result

Duration:

48 h

Dose descriptor:

EC50

Effect conc.:

>= 1.8 µg/L

Nominal / measured:

meas. (arithm. mean)

Conc. based on:

test mat.

Basis for effect:

mortality

Key result

Duration:

48 h

Dose descriptor:

EC50

Effect conc.:

>= 100 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality

Details on results:

- Behavioural abnormalities: no
- Mortality of control: no
- Other adverse effects control: no
- Abnormal responses: no
- Any observations (e.g. precipitation) that might cause a difference between measured and nominal values: The appearence of test solution during the test period was clear.

Results with reference substance (positive control):

no data

Reported statistics and error estimates:

no data

The 48-h EC50 and EC100 could not be determined due to the absence of toxicity of the substance T002615.

Conclusions:

The acute toxicity of T002615 to Daphnia maga was determined in a 48 hour static limit test according to OECD guideline 202. Based on nominal concentrations, the 48-h EC50 was determined to be >=100 mg/L (1.8 µg/L mean measured concentrations). The results of the test can be considered reliable without restriction.

Description of key information

The study of Seyfried (2003), investigating the acute toxicity of T002615 in Daphnia magna according to OECD guideline 202, was considered as the key study for endpoint coverage. An EC50 > 100 mg/L (based on nominal test concentrations) was found after an exposure of 48 hours in a static test in freshwater. Based on the results it can be concluded that T002615 is not harmful to aquatic invertebrates.