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Ecotoxicological information

Short-term toxicity to aquatic invertebrates

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Administrative data

Endpoint:
short-term toxicity to aquatic invertebrates
Type of information:
experimental study
Adequacy of study:
key study
Study period:
31 January 2000 to 3 February 2000
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2000
Report Date:
2000

Materials and methods

Test guidelineopen allclose all
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:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Details on test material:
Disperse Red 302

Sampling and analysis

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.

Test solutions

Vehicle:
no

Test organisms

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 hours.

Pre-treatment :
24 hours 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.


Study design

Test type:
static
Water media type:
freshwater
Limit test:
no
Total exposure duration:
48 h

Test conditions

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.


EFFECT PARAMETERS MEASURED (with observation intervals if applicable) :

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)

Results and discussion

Effect concentrationsopen allclose all
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 48h. 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 hour test period.

The EC0 value after 48 hours was determined to be 9.4 mg/l.
The EC50 value after 48hours was determined as above 100 mg/l.
The EC100 value after 48 hours 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: EC 50= 0.9 mg/l

Applicant's summary and conclusion

Validity criteria fulfilled:
yes
Conclusions:
The 48-h EC50 to Daphnia magna was found to be >100 mg/L. The substance is not acutely toxic to aquatic invertebrates.
Executive summary:

The purpose of this acute toxicity study of FAT 93503/A to Daphnia magna Straus is to determine the EC 50 (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 hours 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 hour test period.

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

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

-The EC-100 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 hours.