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Ecotoxicological information

Short-term toxicity to aquatic invertebrates

Administrative data

Endpoint:
short-term toxicity to aquatic invertebrates
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Report Date:
2014

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)
Deviations:
no
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder
Details on test material:
- Name of test material (as cited in study report): BI 10773 Fluoride
- Physical state: solid
- Analytical purity: 98.9 %
- Impurities (identity and concentrations): PD 731 0.55% / PD 729 0.10 % / PD178 0.43 % / PD 728/PD 800 < 0.06 % / IN 75548 < 0.06%
- Lot/batch No.: 0002
- Expiration date of the lot/batch: 31 December 2014
- Storage condition of test material: room temperature (15 to 25 °C), in a well closed container

Test solutions

Details on test solutions:
The water solubility of the test item in medium was tested in a pre-experiment. Due to the observed low water solubility a stock dispersion was prepared by stirring 100 mg test item/L test medium (see 4.4) at room temperature in the dark for 48 hours to dissolve a maximum amount of the test
item. A stock solution was withdrawn from the middle of the preparation vessel by suction. Transfer of undissolved test item was avoided as far as
possible. Adequate aliquots of the withdrawn phase were diluted with test medium to prepare the test solutions with the lower test item
concentrations. The preparation of the stock dispersion was based on the OECD Guidance Document No. 23 on Aquatic Toxicity Testing of
Difficult Substances and Mixtures (2000). The solubility of the test item in test medium was very low, flocculation at the
surface and the bottom of the beakers during the test period was observed in the stock solution and a dilution of 1:3.2. The test item concentrations were selected based on the results of a non-GLP range-finding test. The large spacing factor of approximately 3.2 was selected since a flat dose response relationship was observed in the range finding test. The test solution volume was 50 mL per test vessel.

Test organisms

Test organisms (species):
Daphnia magna
Details on test organisms:
TEST ORGANISM
- Common name: daphnia magna
- Strain: Daphnia magna STRAUS, Clone V
- Source: German Federal Environment Agency (UBA).
- Age at study initiation (mean and range, SD): max. 24 h
- Method of breeding: Daphnia magna was bred as single culture (one daphnid per 100 mL) in Elendt
M4 medium. The pH-value of the aerated water was within a range of 6.0 – 9.0.
The dissolved oxygen was above 60 % saturation and the total hardness 140 -
250 mg/L (as CaCO3).
- Feeding during test: The animals were fed with single cell green algae
(Desmodesmus subspicatus, formerly Scenedesmus subspicatus) at least three
times a week.

Study design

Test type:
static
Water media type:
not specified
Limit test:
yes
Total exposure duration:
48 h

Test conditions

Hardness:
250 mg/L as CaCO3).
Test temperature:
19.0 - 19.9 °C
pH:
7.7. - 7.93
Dissolved oxygen:
96%
Nominal and measured concentrations:
1.00 - 100 mg/L
Details on test conditions:
TEST SYSTEM
- Test vessel: baker
- Material, size, headspace, fill volume: glass, 100 mL, 50 mL
- Aeration: none
- No. of organisms per vessel:5
- No. of vessels per concentration (replicates): 4
- No. of vessels per control (replicates): 4
- No. of vessels per vehicle control (replicates): 4

OTHER TEST CONDITIONS
- Photoperiod:16 hours photoperiod daily

TEST CONCENTRATIONS
- Spacing factor for test concentrations: 3.2
- Justification for using less concentrations than requested by guideline: A flat dose response relationship was observed in the range finding test.
- Test concentrations: 1.0 - 100 mg/L

Results and discussion

Effect concentrationsopen allclose all
Duration:
48 h
Dose descriptor:
EC0
Effect conc.:
< 0.071 mg/L
Duration:
48 h
Dose descriptor:
LL100
Effect conc.:
9.2 mg/L
Duration:
48 h
Dose descriptor:
EC50
Effect conc.:
0.216 mg/L
Results with reference substance (positive control):
The results indicate an EC50 (24 h) of the reference item potassium dichromate of 2.0 mg/L. Since the results fall within the historical data generated with the reference item at the testing facility and are within the range of 0.6 – 2.1 mg/Lrecommended by the test guideline OECD 202, the daphnids were suitable for the determination of the toxicological effects of the test item.

Applicant's summary and conclusion

Validity criteria fulfilled:
yes
Conclusions:
According to the results of the test, the EC50 (48 h) is 0.216 mg test item/mL (acutal measurd). The EC0 (48 h) is below 0.0708 mg test item/L (actual measurment). The EC100 (48 h) was observed at 9.20 mg test item /L (actual measurment)