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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:

Experiment start date - 07 February 2005; Experiment completion date - 06 Match 2005; Study completion date - 14 June 2005.

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

Qualifier:

according to guideline

Guideline:

EU Method C.2 (Acute Toxicity for Daphnia)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Specific details on test material used for the study:

Identity: FAT 40819/A
Description: Red brown powder
Batch number: Red ROE 420 BOP 01/04
Purity: approx. 77 %
Stability of test item: Stable under storage condition
Expiry date: 02 November 2009
Stability of test item dilution: Stable in PEG 300 for at least 7 days at room temperature
Storage conditions: At room temperature.

Analytical monitoring:

yes

Details on sampling:

For the determination of the actual test item concentrations, the following samples were taken:
- Just before the start of the test: duplicate samples from the test medium (without daphnids) and duplicate samples from the control (without daphnids)
- After 48 hours: duplicate samples from the test medium (stability samples) and duplicate samples from the control.
For the 48-hour stability samples, the contents of the respective replicates were combined.
All samples were deep-frozen (at about -20 °C) immediately after sampling. Based on pre-experiments for investigation of the storage stability (without GLP), the test item was found to be stable in the test water under these storage conditions.
The concentration of the test item was analyzed in both the medium samples from the sampling times at 0 and 48 hours. From the control samples only one of the duplicate samples was analyzed from the corresponding sampling times.

Vehicle:

no

Details on test solutions:

The test medium was prepared by dissolving 50.0 mg of test item completely in 500 mL of test water by intense stirring for 10 minutes at room temperature. The test medium was prepared just before introduction of the daphnids (= start of the test).

Test organisms (species):

Daphnia magna

Details on test organisms:

The study was performed with young daphnids of a clone of the species Daphnia magna Straus. A clone of this species was originally supplied by the University of Sheffield/UK in 1992, defined by the supplier as clone 5. Since that time, the clone has been bred in the laboratories of RCC in reconstituted water of the quality identical to the water quality used in the tests (in respect to pH, main ions, and total hardness) and under temperature and light conditions identical to those of the tests. At the start of the test, the organisms used in the test were 6-24 hours old and were not first brood progeny.

Test type:

static

Water media type:

freshwater

Limit test:

yes

Total exposure duration:

48 h

Hardness:

250 mg/L as CaCO3

Test temperature:

19-20 °C

pH:

7.9

Dissolved oxygen:

8.7-8.9 mg/L

Nominal and measured concentrations:

- Nominal: 100 mg/L.
- Measured: 91 % of nominal (at start and the end of the experiment).

Details on test conditions:

The test was performed in 100 mL glass beakers filled with 50 mL of test medium. The beakers were covered with glass plates to reduce the loss of water and to avoid the entry of dust into the solutions. The test vessels were labeled with the RCC study number and all necessary additional information to ensure unmistakable identification. At the test concentration and for the control, 20 daphnids were used divided into four replicates of five daphnids each. The daphnids were randomly distributed to the test vessels at initiation of the test. The loading rate was less than one daphnia per 5 mL of test solution. The fish were not fed during the experiment.
Light conditions: A 16-hour light to 8-hour dark photoperiod (with a 30 minute transition period). Light intensity during the light period was between approx. 570 and 740 Lux.

Reference substance (positive control):

yes

Remarks:

Potassium dichromate

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:

In the control and at the test concentration of 100 mg/L, no immobilized daphnids were observed during the test period of 48 hours At the test concentration of 100 mg/L, one daphnid was immobile at the observation after 48 hours. Therefore, the 48-hour NOEC (highest concentration tested without toxic effects after the exposure period of 48 hours) and the 48-hour EC0 of FAT 40819/A to Daphnia magna were determined to be at least 100 mg/L. The 48-hour NOEC and the 48-hour EC0 might even be higher but concentrations above 100 mg/L were not tested, according to the EU Commission Directive. The 48-hour EC50 and the 48-hour EC100 were clearly higher than 100 mg/L. These values could not be quantified due to the absence of toxicity of FAT 40819/A at the test concentration of 100 mg/L. No remarkable observations were made concerning the appearance of the test medium. The test medium was a clear solution colored red by the test item throughout the whole test duration.

Results with reference substance (positive control):

The latest result of the positive control test was obtained September 2004 (48-hour EC50: 0.83 mg/L, RCC Study No. 852355) showed that the toxic performance was valid.

Validity criteria fulfilled:

yes

Conclusions:

The 48-hour EC50 is >100 mg/L in Daphnia magna.

Executive summary:

In a GLP compliant study, performed according to OECD Guideline 202, the acute toxicity of the test substance to 20 Daphnia magna was determined in a 48 hours static test. The nominal concentration was 100 mg/L. At the beginning and at the end of the test, the test substance concentration was 91 % of the nominal value. Therefore, under test conditions the test article was sufficiently stable. No immobilization and abnormal behaviour of the Daphnia magna was observed. The EC50 value could not be calculated, but was clearly higher than 100 mg/L .

Description of key information

The 48-h EC50 value is >100 mg/L in Daphnia magna.	

Key value for chemical safety assessment

Fresh water invertebrates

Fresh water invertebrates

Effect concentration:

100 mg/L

Additional information

In a GLP-compliant study, performed according to OECD Guideline 202, the acute toxicity of the test substance to 20 Daphnia magna was determined in a 48 hours static test. The nominal concentration was 100 mg/L. At the beginning and at the end of the test, the test substance concentration was 91 % of the nominal value. Therefore, under test conditions the test article was sufficiently stable. No immobilization and abnormal behaviour of the Daphnia magna was observed. The EC50 value could not be calculated, but was clearly higher than 100 mg/L.