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:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2019
Report date:
2019

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)
Version / remarks:
2004
Deviations:
no
GLP compliance:
yes (incl. QA statement)

Test material

Constituent 1
Reference substance name:
Reaction mass of butyl phenyl hydrogen phosphate and diphenyl hydrogen phosphate and phenyl dihydrogen phosphate
EC Number:
950-250-8
IUPAC Name:
Reaction mass of butyl phenyl hydrogen phosphate and diphenyl hydrogen phosphate and phenyl dihydrogen phosphate
Specific details on test material used for the study:
SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: 73465
- Expiration date of the lot/batch: 22.03.2019

Sampling and analysis

Analytical monitoring:
yes
Details on sampling:
At the start of the exposure and at the renewal (0 and 24 hours), three samples per concentration level and control were taken after
preparation of all concentration levels and analyzed.
At the renewal and at the end of the exposure (24 and 48 hours), three
samples of the 24-hours old media per concentration level and control
were taken directly from the test vessels.

Test solutions

Vehicle:
no
Details on test solutions:
The test item is a complex mixture with differential water solubility of
the components, resulting in a different composition of the dissolved
fraction at different loadings. Thus, the test solutions for aquatic
toxicity tests must not be prepared by dilution of a stock solution, but
should be prepared as differential loadings after prolonged stirring. An
appropriate amount of the test item for each loading was weighed out
and was transferred with an appropriate amount of the dilution water
(Table 1) into a glass flask 48 hours prior to the start of the exposure
(0 hours) and prior to the renewal of the test solutions (24 hours). The
solutions were agitated for 48 hours (1100 rpm, room temperature)
and checked for complete dissolution using the Tyndall effect. No
Tyndall effect was observed. The pH were determined and adjusted
with 1 M NaOH and HCI to the pH of the control group (± 0.2), since
the addition of the test item resulted in pH-values outside the
recommended range

Test organisms

Test organisms (species):
Daphnia magna
Details on test organisms:
TEST ORGANISM
- Common name: water flea
- Strain/clone: 5
- Age at study initiation (mean and range, SD): < 24 h
- Method of breeding: In glass vessels (2 - 3 L capacity) with approximately 1.8 L culture medium, at 20 +- 2 °C, in an incubator, 16 hours illumination, light intensity of max. 1500 lx
- Source: Institut für Wasser-, Boden- und Lufthygiene (WaBoLu), Berlin, Germany
- Feeding during test : none

ACCLIMATION
- Acclimation period: continuous culturing at the test facility
- Acclimation conditions (same as test or not): same
- Type and amount of food: mix of unicellular green algae, e.g. Pseudokirchneriella subcapitata and Desmodesmus subspicatus, ad libitum
- Feeding frequency: 5 times per week

Study design

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

Test conditions

Test temperature:
18 – 22 °C
Nominal and measured concentrations:
Nominal: 25.0, 50.0, 100, 200 and 400 mg/L
Measured (test inition): 26.1, 51.5, 101, 202 and 407 mg/L
Measured (48h): 22.1, 48.1, 96.8, 200 and 388 mg/L
Measured > 80% nominal
Details on test conditions:
TEST SYSTEM
- Test vessel: glass beakers (4 (ID) x 7 (H) cm), 50 mL capacity, loosely covered with watch glasses
- Volume of solution: 20 mL
- Aeration: no
- 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: Elendt M4 medium
- Culture medium different from test medium: no
- Intervals of water quality measurement: At the start of the exposure (0 hours), the water quality parameters of the fresh media (i.e. pH-value, dissolved oxygen concentration) were measured in one additional replicate (without daphnids) per concentration level and control. At the end of the exposure (48 hours), the water quality parameters of the old media were measured in one appropriate replicate (containing daphnids) per concentration level and control. The replicate with the highest immobilization rate per concentration level and control was measured.

OTHER TEST CONDITIONS
- Photoperiod: 16h light
- Light intensity: Diffuse light, light intensity of max. 1500 lx

EFFECT PARAMETERS MEASURED : Immobility was recorded after 24 and 48h exposure time.
Reference substance (positive control):
yes
Remarks:
potassium dichromate

Results and discussion

Effect concentrations
Key result
Duration:
48 h
Dose descriptor:
EC50
Effect conc.:
106 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mobility
Remarks on result:
other: analytically verified
Details on results:
- Behavioural abnormalities: none
- Other biological observations: none
- Mortality of control: no
- Abnormal responses: no
- Any observations (e.g. precipitation) that might cause a difference between measured and nominal values: no
Results with reference substance (positive control):
- Results with reference substance valid? yes
- Relevant effect levels: 24h-EC50 = 2.06 mg/L
- validity range: 0.6 - 2.4 mg/L, acc. to AQS P 9/2 (02/2000); clone 5:

Applicant's summary and conclusion

Validity criteria fulfilled:
yes