Registration Dossier

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:
other information
Study period:
2008-01-15 to 2008-01-17
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP guideline study with analytical monitoring

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2008
Report Date:
2008

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Batch-Identification: 76584075L0
- Purity: 99.8 area-%
- Homogeneity: Homogeneous
- Storage stability: Expiry date: 17 January 2009
- Physical state/ Appearance: Liquid / colorless, clear

Sampling and analysis

Analytical monitoring:
yes
Details on sampling:
- Sampling method: At the start of the exposure (0 h) samples from vessels without daphnids and at the end of the exposure (48 h) samples from vessels with daphnids were analyzed. The samples were transported to the Analytical Laboratory on the day of sampling. The samples from end of exposure were brietly stored in the freezer, prior to transport due to a technical delay at the analytical laboratory. The retained samples were stored in the freezer.

Test solutions

Vehicle:
no
Details on test solutions:
PREPARATION AND APPLICATION OF TEST SOLUTION
- Method: The test solution (100 mg/L) was prepared by dissolving of 200 mg of test substance in 2 L test medium and stirring for approximately 10 min at 20 ± 2 °C. The solution was neutralized with 1 M HCl to a pH-value equivalent to the control test media and then checked for complete dissolution of the test substance. The lower test concentrations were prepared by dilution of this neutralized solution. All test solutions were visibly clear over the exposure period.

Test organisms

Test organisms (species):
Daphnia magna
Details on test organisms:
TEST ORGANISM
- Common name: Water flea
- Source: The clone of Daphnia magna STRAUS 1820 used was supplied by the Institut National de Recherche Chimique Appliquée, France, in 1978.
From this date on this clone was cultured and bred continuously in the Ecotoxicology Laboratory of Experimental Toxicology and Ecology, BASF SE, Ludwigshafen Germany.
- Age at study initiation: < 24 h
- Feeding during test: No feeding during the exposure period.

CULTURE CONDITIONS
- Photoperiod: 16 hours light, 8 hours dark
- Water quality: See 3.3.1.
- Temperature: 20 ± 1 °C
- Diet: Unicellular algae Desmodesmus subspicatus, cultured continuously at the test facility
- Feeding: Daily
- Renewal of the culture water: Twice weekly


Study design

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

Test conditions

Hardness:
2.20 – 3.20 mmol/L
Test temperature:
20.2 – 21.0 °C


pH:
7.9 – 8.1
Dissolved oxygen:
8.4 - 8.8 mg/L
Nominal and measured concentrations:
Nominal concentrations: 0, 10, 22, 50 and 100 mg/L
The analytically determined concentrations of the test substance in the test solutions were within ± 20% of the nominal concentrations.
Details on test conditions:
TEST SYSTEM
- Test vessel: Test tubes (glass) with flat bottom (nominal volume 20 mL, fill volume 10 mL)
- Aeration: None
- No. of organisms per vessel: 5
- No. of vessels per concentration (replicates): 4
- No. of vessels per control (replicates): 4

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: According to guideline
- Acid capacity up to pH 4.3: 0.80 – 1.00 mmol/L
- Conductivity: 550 - 650 μS/cm
- Intervals of water quality measurement: At test start and at test end

OTHER TEST CONDITIONS
- Photoperiod: 16 hours light : 8 hours darkness
- Light: Artificial light, type warm white (OSRAM L58 W31), 390 – 480 Lux at a wave length of 400 - 750 nm

EFFECT PARAMETERS MEASURED: Mobility

TEST CONCENTRATIONS
- Spacing factor for test concentrations: 2
- Range finding study: yes, in a preliminary range finding test (experimental conduct in accordance with GLP but without a GLP status) the 48 hour EC50 was between 10 and 100 mg/L.
Reference substance (positive control):
yes
Remarks:
Potassium dichromate

Results and discussion

Effect concentrationsopen allclose all
Duration:
48 h
Dose descriptor:
EC0
Effect conc.:
22.9 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mobility
Remarks on result:
other: Test concentrations were analytically verified.
Duration:
48 h
Dose descriptor:
EC50
Effect conc.:
53 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mobility
Remarks on result:
other: Test concentrations were analytically verified.
Duration:
48 h
Dose descriptor:
EC100
Effect conc.:
98.3 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mobility
Remarks on result:
other: Test concentrations were analytically verified.
Details on results:
- Immobility of control: None
- Any observations (e.g. precipitation) that might cause a difference between measured and nominal values: All of the test solutions were visibly clear over the exposure period.
Results with reference substance (positive control):
- Results with reference substance valid? Yes
- EC50: The EC50(24h) of the reference substance potassium dichromate was 1.01 mg/L (experiment date: 18 Dec 2007, project number: 50E0063/043039).

Applicant's summary and conclusion

Validity criteria fulfilled:
yes