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Ecotoxicological information

Long-term toxicity to aquatic invertebrates

Administrative data

Endpoint:
long-term toxicity to aquatic invertebrates
Type of information:
experimental study
Adequacy of study:
key study
Study period:
March, 2003
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP study performed according to OECD TG 211 for a surrogate chemical with a very high similarity to the target chemical, CCP-V-1.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2003
Report Date:
2003

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 211 (Daphnia magna Reproduction Test)
Deviations:
no
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder
Specific details on test material used for the study:
Details on properties of test surrogate or analogue material (migrated information):
Batch: K30246697
Purity: 99.7% (HPLC)
Molecular Weight: 328.38 g/mol
Colour: off white
Solubility in water. <0.08 mg/L
Sum formula: C 18H23F302

Sampling and analysis

Analytical monitoring:
no

Test solutions

Vehicle:
no
Details on test solutions:
Pre-experiments were performed to determine the solubility of the test item in test water and to select suitable methods for the preparation of a stock solution and the dosage of the test item into the test media.

Pre-experiments:
Method: HPLC-method
Apparatus: LaChrom Merck Hitachi
Column: Purospher RP 18 Mobile Phase: 100 % acetonitrile


The test concentration was based on the results of a range-finding test.
The test item is not well soluble in test water. To avoid physical effects of undissolved test item on Daphnia no concentrations above the solubility limit of the test item in test water were tested. Since no significant toxic response was indicated in the range finding test at the highest concentration of test item which could be dissolved in test water, only this concentration and a control were tested (Limit-test).

A concentrated stock suspension of nominal 100 mg test itemlL was prepared at each treatment by mixing 100 mg test item into 1000 mL test water by intense stirring for about 24 hours to dissolve as much test item as possible. The undissolved test item was separated by filtration through a cellulose-nitrate filter (pore size 0.45 µm). The filtrates were prepared just before each test medium renewal.

Test organisms

Test organisms (species):
Daphnia magna
Details on test organisms:
TEST ORGANISM
- Common name: Daphnia magna (Straus)
- Strain/clone: clone 5
- Justification for species other than prescribed by test guideline: According to guideline
- Source: supplied 1997 by the "Umweltbundesamt, Institut fair Wasser-, Boden- and Lufthygiene", Berlin, Germany.
- Age of parental stock (mean and range, SD): 4.5 - 21.5
- Feeding during test : yes
- Food type: freshly grown green algae (Desmodesmus subspicatus)
- Amount: based on the concentration of total organic carbon (TOC),
day 0/1/5: 0.1 mg TOC/Daphnia, day 2: 0.3 mg TOC/Dapnia, day 6-8/12/13: 0.15 mg TOC/Dapnia, day 9/16: 0.4 mg TOC/Daphnia, day 14/15/19/20: 0.2 mg TOC / Daphnia
- Frequency: on each working day

ACCLIMATION
- Acclimation conditions (same as test or not): same

Study design

Test type:
semi-static
Water media type:
freshwater
Limit test:
yes
Total exposure duration:
21 d

Test conditions

Hardness:
250 mg/L CaCO3
Test temperature:
20 - 21 °C
pH:
7.7 - 8.2
Dissolved oxygen:
7.3 - 9.6 mg/L
Nominal and measured concentrations:
100 mg/L (analytically determined water solubility = 0.08 mg/L)
Details on test conditions:
TEST SYSTEM
- Test vessel: 100 mL containing 80 mL test solution
- Type (delete if not applicable): open
- Type of flow-through (e.g. peristaltic or proportional diluter): semi static
- Renewal rate of test solution (frequency/flow rate): test media were renewed on days 2, 5, 7, 9, 12, 14, 16 and 19
- No. of organisms per vessel: 10
- No. of vessels per concentration (replicates): 10
- No. of vessels per control (replicates): 10


OTHER TEST CONDITIONS
- Adjustment of pH: 7.7-8.2
- Photoperiod: 16 hours light / 8 hours dark
- Light intensity: 510 - 630 lux

EFFECT PARAMETERS MEASURED (with observation intervals if applicable) :

- Mortality of Adults and Number of Young:
The mortality of the test animals and the number of young were recorded each working day. Offspring were removed at the same times.

- Measurements of pH, Dissolved Oxygen and Water Temperature:
The pH-values and dissolved oxygen concentrations in the control and the only test concentration were measured at the start and end of each treatment period. The water temperature was measured in one control beaker at the start and end of each treatment period.

- Behaviour of the Test Item in Test Water:
The behaviour of the test item in test water was determined at each test medium renewal period in the freshly prepared and old test media of the only test concentration.
Reference substance (positive control):
not required

Results and discussion

Effect concentrationsopen allclose all
Duration:
21 d
Dose descriptor:
NOEC
Effect conc.:
> 100 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Duration:
21 d
Dose descriptor:
LOEC
Effect conc.:
> 100 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Details on results:
- Mortality of parent animals:
In the control and in the only test concentration (a filtrate of a supersaturated stock suspension of nominal 100 mg/L) all Daphnia survived until the end of the test

- No. of offspring produced per female:
control: 105.1 + 16.2 (mean ± SD) alive off-spring per adult
test solution: 111.5 ± 12.9 (mean ± SD) alive off-spring per adult
- Type and number of morphological abnormalities: 0
- Type and number of behavioural abnormalities: 0
- Time to first brood release or time to hatch
The first young Daphnia released from their parent animals were recorded in the control and in the test solution on day 8

No particular signs of intoxication were observed at the test animals during the test

Applicant's summary and conclusion

Validity criteria fulfilled:
yes
Conclusions:
The 21-days LOEC and the 21 days NOEC are clearly higher than the solubility limit of the test material in test water (e.g. 100 mg/L nominal corresponds to 0.08 mg/L limit of solubility).
Executive summary:

Study Design

This study was performed with a surrogate test item (see details on test analogue material).

The toxic effects of the test item on the survival and reproduction rate of Daphnia magna were determined during an exposure period of 21 days. The Daphnia were exposed in a semi static test to an aqueous test medium containing the test item at the highest concentration, which could be dissolved in test water. The mortality rate, the reproduction rate and symptoms of intoxication were compared with corresponding parameters in the control.
The GLP compliant study was performed according to OECD TG 211.

Results

In the control and in the test solution (a filtrate of a supersaturated stock suspension of nominal 100 mg/L) all Daphnia survived until the end of the test.
The first young Daphnia released from their parent animals were recorded in the control and in the only test concentration at the observation on day 8.
The mean reproduction rate of those Daphnia in the control was 105.1 + 16.2 (mean ± SD) alive off-spring per adult. In the test solution, the mean reproduction rate was 111.5 ± 12.9 (mean ± SD) alive off-spring per adult. Thus, no significant toxic effect of the test item on the mean reproduction rate was determined.

Conclusion

Taking into account the survival rates and the reproduction rates of the test animals, the test material showed no toxic effects up to its solubility limit after the exposure period of 21 days. Therefore, the 21-days NOEC was determined to be at least up to the solubility limit of the test substance in test water. The NOEC might even be higher than the solubility limit of the test item in test water. The 21-days LOEC is clearly higher than the solubility limit of the test material in water.