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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:
31.1.2000 to 03.02.2000
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:
no
Specific details on test material used for the study:
SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: 99 Labor Mischung 1
- Expiration date of the lot/batch: 01/2005

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: room temperature
- Solubility of the test substance in the solvent/vehicle: insoluble
Analytical monitoring:
no
Details on sampling:
- Concentration for the range-finding test: 0.01 / 0.1 / 1.0 / 10 and 100 mg/l
- Concentrations for the definitive test: 4.3 / 9.4 / 21 / 45 and 100 mg test item /l.

Vehicle:
no
Test organisms (species):
Daphnia magna
Details on test organisms:
TEST ORGANISM
- Common name: Water Flea
- Strain: Daphnia magna Straus
- Method of breeding: Cultures of Daphnia magna are held in glass vessels containing approximately 3 litres of reconstituted water at 18 - 22 °C. The water is renewed partially three times per week. The daphnids are fed with a suspension of green algae (Scenedesmus subspicatus) supplemented by a Tetramine-extract in such quantities that the food is consumed within 24 h.

Pre-treatment:
24 h before the start of the exposure, reproductive daphnids were separated from the young daphnids by sieving all individuals through a 1000 µm sieve. For each test concentration 20 daphnids divided into two groups of 10 animals were used.
Test type:
static
Water media type:
freshwater
Limit test:
no
Total exposure duration:
48 h
Hardness:
152 mg CaCO2 /l
Test temperature:
19.4 - 21.0 °C
pH:
8.0
Nominal and measured concentrations:
Nominal concentrations: 4.3 / 9.4 / 21 / 45 and 100 mg test item /l.
Details on test conditions:
TEST SYSTEM
- Test vessel: 250 ml beakers containing 50 - 100 ml test medium.
- Material, size, headspace, fill volume: 3 litres of reconstituted water at 18 - 22 °C.
- Aeration: No aeration
- Renewal rate of test solution: The water is renewed partially three times per week.
- No. of organisms per vessel: 10 animals per beaker
- No. of vessels per concentration (replicates): All tests were run in duplicate.
- No. of vessels per control (replicates): Duplicate

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: Test medium prepared using bidistilled water. The test medium used the following composition: NaHCO3: 65 mg/l, MgSo4*7H2O: 123.3 mg/l, KCL: 5.8 mg/l, CaCl2*2H2O: 294 mg/l, Na2SiO3: 4.3 mg/l, NaNo3: 274 microgr/L, Kh2PO4: 143 microgr/L and K2HPO4: 184 microgr/L.
- Alkalinity: 0.8 mmol*l
- Ca/Mg ratio: 4:1
- Na/K ratio: 10:1
- Culture medium different from test medium: No

OTHER TEST CONDITIONS
- Photoperiod: 14 hours light and 10 hours dark.

TEST CONCENTRATIONS
- Spacing factor for test concentrations:>2
- Range finding study
- Test concentrations for range finding study: 0.01 / 0.1 / 1 / 10 and 100 mg/l
- Results used to determine the conditions for the definitive study: Yes
Reference substance (positive control):
yes
Remarks:
(Potassium dichromate is tested at least every 3 month)
Duration:
24 h
Dose descriptor:
EC0
Effect conc.:
100 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mobility
Remarks on result:
other: no confidence limits
Duration:
24 h
Dose descriptor:
EC50
Effect conc.:
> 100 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mobility
Remarks on result:
other: no confidence limits
Duration:
24 h
Dose descriptor:
EC100
Effect conc.:
> 100 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mobility
Remarks on result:
other: no confidence limits
Duration:
48 h
Dose descriptor:
EC0
Effect conc.:
9.4 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mobility
Duration:
48 h
Dose descriptor:
EC50
Effect conc.:
> 100 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mobility
Remarks on result:
other: No confidence limits
Duration:
48 h
Dose descriptor:
EC100
Effect conc.:
> 100 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mobility
Details on results:
No Daphnia were immobilised in the control and in the lower test concentration of 4.3 and 9.4 mg/l after an exposure period of 48 h. At a test concentration of 21 mg/l one daphnid was immobilised after 48 h. Four daphnids were immobilised at 45 mg/l and a total of seven daphnids were immobilised at a test concentration of a 100 mg/l following the 48 h test period.

The EC0 value after 48 h was determined to be 9.4 mg/l.
The EC50 value after 48 h was determined as above 100 mg/l.
The EC100 value after 48 h is higher than 100 mg/l.

No remarkable observations were made concerning the appearance of the test media.
Results with reference substance (positive control):
For evaluation of the quality of the daphnids clone and the experimental conditions, potassium dichromate is tested every 3 months as a positive control.
The result of the latest positive control test in October 2006 is: EC50= 0.9 mg/l
Validity criteria fulfilled:
yes
Conclusions:
The EC50 of FAT 93503/A to Daphnia magna following an exposure priod of 48 h was determined to be >100 mg/l.
Executive summary:

The purpose of this acute toxicity study of FAT 93503/A to Daphnia magna Straus was to determine the EC50-value for acute toxicity to aquatic invertebrates (Concentration at which 50 % of the daphnids test population was immobilised). This study was performed according to the OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test). The test duration is 48 h in a static condition test. A range-finding test was done with the following test concentrations: 0.01, 0.1, 1.0, 10 and 100 mg/l. Immobilisation of daphnids occurred at a 100 mg/l, hence the test concentrations for the definitive test were chosen as: 4.3, 9.4, 21, 45 and 100 mg/l. For each test concentration 20 daphnids divided into two groups of 10 animals were used. All test were run in duplicate. Additionally, a blank control without test item was carried out test concentrations were prepared from a stock solution. No daphnids were immobilised in the control and in the lower test concentration of 4.3 and 9.4 mg/l after an exposure period of 48 h. At a test concentration of 21 mg/l one daphnid was immobilised after 48 hours. Four daphnids were immobilised at 45 mg/l and a total of seven daphnids were immobilised at a test concentration of a 100 mg/l following the 48 h test period. The EC0 value after 48 h was determined to be 9.4 mg/l. The EC50 value after 48 h was determined as above 100 mg/l. The EC100 value after 48 h is higher than 100 mg/l. In conclusion, the ecotoxicological classification of FAT 93503/A is "non-toxic" to Daphnia magna following an exposure period of 48 h.

Description of key information

The acute toxicity study of FAT 93503/A to Daphnia magna Straus is determined according to the OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test). The test duration is 48 hours under static test conditions. A range-finding test was done with the following test concentrations: 0.01, 0.1, 1.0, 10 and 100 mg/l. Immobilisation of daphnids occurred at a 100 mg/l, hence the test concentrations for the definitive test were chosen as: 4.3, 9.4, 21, 45 and 100 mg/l. For each test concentration 20 daphnids divided into two groups of 10 animals were used. All test were run in duplicate. Additionally, a blank control without test item was carried out. Test concentrations were prepared from a stock solution. No daphnids were immobilised in the control and in the lower test concentration of 4.3 and 9.4 mg/l after an exposure period of 48 h. At a test concentration of 21 mg/l one Daphnia was immobilised after 48 h. Four daphnids were immobilised at 45 mg/l and a total of seven daphnids were immobilised at a test concentration of a 100 mg/l following the 48 h test period.

-The EC0 value after 48 h was determined to be 9.4 mg/l.

-The EC50 value after 48 h was determined as above 100 mg/l.

-The EC100 value after 48 hours is higher than 100 mg/l.

In conclusion, the ecotoxicological classification of FAT 93503/A is "non-toxic" to Daphnia magna following an exposure period of 48 h.

Key value for chemical safety assessment

Fresh water invertebrates

Fresh water invertebrates
Effect concentration:
100 mg/L

Additional information