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
Study period:
02.03.2010 to 09.07.2010
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2010
Report Date:
2010

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:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
impurity
Test material form:
solid
Specific details on test material used for the study:
4-(Methacryloyloxy) bezophenone 97.26 %
Benzophenone acetate: 1.95 %

Sampling and analysis

Analytical monitoring:
yes
Details on sampling:
Duplicate samples from the freshly prepared test media of all test concentrations and the control were taken at he start of the test.
Analyses:
For the determination of the stability of the test item under the test conditions and of the maintenance of the test item concentrations during the test period, duplicate samples from the test media of all test concentrations and the controls were collected at the end of the test (after 48 hours) by pouring together the contents of the test beakers of each treatment.
All samples were diluted with methanol by a factor of 2 directly after sampling.

The concentrations of the test item were analysed in the duplicate test media samples from both sampling times (0 and 48 hours). From the control samples only one of the duplicate samples was analysed from
each of both sampling times.

Test solutions

Vehicle:
no
Details on test solutions:
Test water: Elendt "M4"
Solubility Experiment:
In the solubility experiments, the solubility of 4.0, 2.0 and 1.0 mg/L was tested. In all concentrations, paiticles of the test item were at the surface, at the bottom and homogenously distributed in the test medium. After one night, the middle phase of the concentrations
prepared was clear, the bottom of the test vessel and the water surface was still covered with test item.

Range Finding test:
For the determination of the test concentrations a range-finding test was performed. However, according to the EC 440/2008 concentrations in excess of the limit of solubility were not tested.
The solubility pre-experiments and the range-finding test were not performed in compl iance with the GLP-Regulations and are excluded from the Statement of Compliance. However, the raw data of these tests will be archived under the project number of the present study.

Test Concentrations:
An extract of nominal I mg test item/L and subsequent dilutions, resulting in nominal concentrations of 1.0, 0.45, 0.21, 0.094 and 0.043 mg test item/L. Additionally, a control was tested in parallel.
These nominal concentrations correspond to the following arithmetic mean measured concentrations of 0.37, 0.15, 0.054, 0.035 and 0.013 mg test item/L.

Control:
In the control, test water was used without addition of the test item.

Dosage of Test Item:
The test item was 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. Therefore, a stock suspension of 1.0 mg test item/L was prepared by suspending
4.2 mg of test item in 4200 mL of test water. The stock suspension was ultrasonicated for IO sec and stirred for 22.8 hours in the dark to dissolve as much test item as poss ible. Then, the undissolved test item was a llowed to settle down for 3 hours and the required test
concentrations were prepared. The test media were prepared just before introduction of Daphnia.

The appearance of the test item in the test media was observed at the start of the test and after 24 and 48 hours test duration in all test concentrations: No remarkable observations at the end of the test

Test organisms

Test organisms (species):
Daphnia magna
Details on test organisms:
Species: Daphnia magna (Straus), clone 5
Age at Test Start: From 6.25 to 21.75 hours old
Sex: Female
Origin: The Daphnia introduced in the test were taken from our in-house laboratory culture.Breeding
Conditions: The Daphnia were bred in the laboratories of !BACON under similar temperature and light conditions as used in the test. The cultivation of the parentalDaphnia was performed in reconstituted water of a similar quality with regards to pH, the constituent salts and total hardness as the test water used in the test (see 6.5). The test organisms were not first brood progeny. The Daphnia in the stock culture were fed at least all working days with green algae (Desmodesmus
subspicatus) fresh ly grown in the laboratories of IBACON.
Reference Item: For the evaluation of the quality of the Daphnia clone used and the consistency of the experimental conditions, the reference item
potassium dichromate p.a. is tested at least twice a year to demonstrate satisfactory test conditions.
Acclimatisation: Was not necessary, since the test was performed in the same medium as the culturing

Study design

Test type:
static
Water media type:
freshwater
Total exposure duration:
48 h

Test conditions

Hardness:
2.5 mmol/L (= 250 mg/L) as CaC03
Test temperature:
20 to 21 °C at test start; 21 °C at test end.
pH:
7.0 at test start; 7.6 to 7.7 at test end; and thus the pH-value did not vary by more than 1.5 units
Dissolved oxygen:
8.3 to 8.7 mg/L at test start; 8.4 mg/L at test end
Nominal and measured concentrations:
An extract of nominal I mg test item/L and subsequent dilutions, resulting in nominal concentrations of 1.0, 0.45, 0.21, 0.094 and 0.043 mg test item/L. Additionally, a control was tested in parallel.
These nominal concentrations correspond to the following arithmetic mean measured concentrations of 0.37, 0.15, 0.054, 0.035 and 0.013 mg test item/L.
Details on test conditions:
Glass beakers of 100 mL volume containing approximately 60 mL of test medium. The test vessels were covered with a lid to reduce theloss of water due to evaporation and to avoid the entry of dust into the solutions.
Light regime: 16 h light: 8 h dark
Light Intensity: The light intensity was 430 - 560 lux (measured once during the test).
Reference substance (positive control):
no

Results and discussion

Effect concentrationsopen allclose all
Key result
Duration:
48 h
Dose descriptor:
EC50
Effect conc.:
> 0.37 mg/L
Nominal / measured:
meas. (arithm. mean)
Conc. based on:
test mat.
Basis for effect:
mobility
Remarks on result:
other:
Remarks:
> 1.0 mg/l nominal concentration
Duration:
48 h
Dose descriptor:
NOEC
Effect conc.:
> 0.37 mg/L
Nominal / measured:
meas. (arithm. mean)
Conc. based on:
test mat.
Basis for effect:
mobility
Remarks on result:
other:
Remarks:
> 1.0 mg/l nominal concentration
Duration:
48 h
Dose descriptor:
LOEC
Effect conc.:
> 0.37 mg/L
Nominal / measured:
meas. (arithm. mean)
Conc. based on:
test mat.
Basis for effect:
mobility
Remarks on result:
other:
Remarks:
> 1.0 mg/l nominal concentration
Reported statistics and error estimates:
No statistical analysis was perfonned.

Any other information on results incl. tables

 

Influence of 4-(Methacryloyloxy) benzophenone on the Mobility of Daphnia magna

Concentration of the test item

No. of Daphnia tested

No. of immobilized Daphnia after

% of immobilized Daphnia after

[mg/l]

 

24 h

48 h

24 h

48 h

control

20

0

0

0

0

0.043

20

0

0

0

0

0.093

20

0

0

0

0

0.21

20

0

0

0

0

0.45

20

0

0

0

0

1.0

20

1

1

5

5

 

 

Applicant's summary and conclusion

Validity criteria fulfilled:
yes
Conclusions:
The toxic effect of the test item 4-(Methacryloyloxy)benzophenone to Daphnia magna was assessed in a static dose-response test.
The 48-hour NOEC was determined to be >= 1.0 mg test item/L (>=0.37 mg test item/L, based on arithmetic mean measured concentrations).
The 48-hour LOEC was determined to be > 1.0 mg test item/L (> 0.37 mg test item/L, based on arithmetic mean measured concentrations).
The 48-hour EC50 value was determined to be > 1.0 mg test item/L (> 0.37 mg test item/L, based on arithmetic mean measured concentrations).
Executive summary:

Acute Toxicity of 4-(Methacryloyloxy) benzophenone to Daphnia magna was tested in a static 48-hour Immobilisation Test acc. OECD 202 (Commission Regulation (EC) No 440/2008, Annex, Part C, C.2.)

The study encompassed 6 treatment groups (5 dose rates of the test item, control) each containing 20 individuals. The immobility of the Daphnia was determined in a static 48-hour test by visual observation after 24 and 48 hours. The samples collected at start and after 48 hours were analysed via HPLC-method. Nominal concentrations of 1.0, 0.45, 0.21, 0.094 and 0.043 mg test item/L and a control were tested corresponding to 0.37, 0.1 5, 0.054, 0.035 and 0.013 mg test item/L arithmetic mean measured concentrations.

The 48-hour EC50 value was determined to be > 0.37 mg test item/L, based on arithmetic mean measured concentration (> 1.0 mg test item/L nominal concentration).