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Short-term toxicity to aquatic invertebrates

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Reference
Endpoint:
short-term toxicity to aquatic invertebrates
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2006-01-23 to 2006-05-04
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to
Guideline:
OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)
Deviations:
no
Qualifier:
according to
Guideline:
EU Method C.2 (Acute Toxicity for Daphnia)
Deviations:
no
GLP compliance:
yes (incl. certificate)
Specific details on test material used for the study:
Identity: TIC2782 (T002907)
Batch No.: 00467090 (= charge 05C0836)
Expiration date: May 04, 2006
Purity: 99.9%
Solubility in water: 32 g/L
Aggregate state/physical form
at room temperature: Solid
Color: White
Storage conditions: At room temperature at about 20 °C, away from
direct sunlight
Analytical monitoring:
yes
Details on sampling:
- Sampling method: duplicate samples from each test medium and from the control were taken just before the start of the test and after 48 hours.
- Sample storage conditions before analysis: deep frozen (~-20°C)
Vehicle:
no
Details on test solutions:
PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Method: the test medium of the highest nominal concentration of 100 mg/L was prepared by dissolving 100.2 mg of the test item completely in 1000 mL test water using ultrasonic treatment for 10 minutes and intense stirring for 10 minutes at room temperature. adequate volumes of this tes medium were diluted with test water to prepare the test media with the lower test item concentrations.
- Controls: yes
- Evidence of undissolved material (e.g. precipitate, surface film, etc): No remarkable observations were made concerning the appearance of the test media. All test media were clear solutions throughout the entire test duration.
Test organisms (species):
Daphnia magna
Details on test organisms:
TEST ORGANISM
- Common name: water-flea
- Source: originally supplied by the University of Sheffield/UK in 1992 (clone 5)
- Age at study initiation (mean and range, SD): 6-24 hours old
- Method of breeding: the clone has been bred in the RCC laboratories in reconstituted water of the quality identical to the water quality used in the tests and under the same temperature and light conditions
- Feeding during test: none

ACCLIMATION
- Acclimation period: no data
- Acclimation conditions (same as test or not): same as the test
- Health during acclimation (any mortality observed): not stated

Test type:
static
Water media type:
freshwater
Limit test:
no
Total exposure duration:
48 h
Hardness:
250 mg CaCO3/L
Test temperature:
20°c
pH:
7.7 - 7.8
Dissolved oxygen:
8.5-8.8 mg/L
Salinity:
not applicable
Nominal and measured concentrations:
nominal test concentrations: control, 4.6, 10, 22, 46 and 100 mg/L.
mean measured concentration at t = 0-h (nominal 46 mg/L): 38 mg/L
mean measured concentration at t= 48-h (nominal 100 mg/L): 77 mg/L
Details on test conditions:
TEST SYSTEM
- Test vessel: glass beakers
- Type (delete if not applicable): beakers were closed with glass plates
- Material, size, headspace, fill volume: 100 mL glass beakers filled with 50 mL of test medium
- Aeration: aerated prior the start of the study until oxygen saturation
- No. of organisms per vessel: 5
- No. of vessels per concentration (replicates): 4
- No. of vessels per control (replicates): 4

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: reconstituted test water
- Alkalinity: 0.8 mmol/L
- Ca/mg ratio: 4:1 (based on molarity)
- Culture medium different from test medium: no
- Intervals of water quality measurement: daily

OTHER TEST CONDITIONS
- Adjustment of pH: no pH adjustment
- Photoperiod: 8-hour dark/16-hour light with 30 minute transition period
- Light intensity: 570-740 lux

TEST CONCENTRATIONS
- Spacing factor for test concentrations: 2
- Range finding study
- Test concentrations: not reported
- Results used to determine the conditions for the definitive study: yes, test concentrations were based on the results of a range-findin test and on results of a pre-experiment to determine the solubility of the test item in test water (without GLP)
Reference substance (positive control):
yes
Remarks:
Potassium dichromate
Duration:
48 h
Dose descriptor:
EC50
Effect conc.:
> 77 mg/L
Nominal / measured:
meas. (geom. mean)
Conc. based on:
test mat.
Basis for effect:
mobility
Details on results:
- Behavioural abnormalities: not stated
- Mortality of control: no
- 48-h NOEC = 38 mg/L.
Results with reference substance (positive control):
- Results with reference substance valid? not reported
- Mortality: not stated
- EC50/LC50: no data
Validity criteria fulfilled:
yes
Conclusions:
The acute toxicity of T002907 to Daphnia magna was determined in a 48-hour static test according to the OECD guideline 202.
No effects were observed up to and including the highest nominal test concentration of 100 mg/L (corresponding to a mean measured 48-h EC50 of > 77 mg/L and calculated as the geometric mean of the start and final concentrations). The results of the test can be considered reliable without restriction.

Description of key information

The study of Peither (2006), investigating the acute toxicity of T002907 in Daphnia magna according to OECD guideline 202, was considered as the key study for endpoint coverage. An EC50 > 77 mg/L (based on

geometric mean of the start and final concentrations

) was found after an exposure of 48 hours in a static test in freshwater. Based on the results it can be concluded that T002907 is not harmful to aquatic invertebrates.

Key value for chemical safety assessment

Additional information