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Short-term toxicity to aquatic invertebrates

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Reference
Endpoint:
short-term toxicity to aquatic invertebrates
Type of information:
experimental study
Adequacy of study:
key study
Study period:
31th August to 26th September, 2012
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Study performed following the OECD guideline, with GLP compliance. Deviations observed have no impact on the quality of the report and the study.
Qualifier:
according to guideline
Guideline:
OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)
Deviations:
yes
Remarks:
see below
Qualifier:
according to guideline
Guideline:
EU Method C.2 (Acute Toxicity for Daphnia)
Deviations:
yes
Remarks:
see below
Principles of method if other than guideline:
The pH in the test solution was not in the range 6-9 which is recommended in the guideline. Because the low pH in the highest concentrated treatment was caused by the acidic character of the test item and toxicity was not caused by the low pH, an additional experiment with pH adjustment was not performed.

GLP compliance:
yes (incl. QA statement)
Analytical monitoring:
yes
Details on sampling:
- Concentrations:
- Sampling method: The concentrations were measured after 48h.
- Sample storage conditions before analysis: Temperature storage without details (Filtration over Nylon syringe filters is possible)
Vehicle:
no
Details on test solutions:
A stock solution containing 250 ± 1 mg/L test item in dilution water will be prepared. The solutions of the amount needed will be prepared by dilution of this stock solution with dilu-tion water.
Following concentrations are tested: Control - 50 - 100 - 150 - 200 and 250 mg/L.
Test organisms (species):
Daphnia magna
Details on test organisms:
TEST ORGANISM
- Common name: Daphnia magna (female)
- Variety: STRAUSS
- Strain: Berlin
- Source: Umweltbundesamt Berlin
- Age at study initiation: between 0 and 24 hours
- Weight at study initiation: no data
- Food type: unicellular green algae (Desmodesmus subspicatus)
- Amount: no data
- Frequency: at the beginning of the study


Test type:
static
Water media type:
freshwater
Limit test:
no
Total exposure duration:
48 h
Post exposure observation period:
No
Hardness:
No data
Test temperature:
The following temperature are observed:
- 22.5°C at 0h
- 21.6°C at 24h
- 21.3°C at 48h
Remarks on the deviation: The temperature for the main study lay in a range of 21.3 to 22.5 °C and therefore slightly higher than stated in the study plan. As no immobility was observed in the controls, this deviation was stated as uncritical.
pH:
The pH values in the test media and the control ranged from 5.6 to 7.8.
Dissolved oxygen:
The concentration of dissolved oxygen stayed above 8.1 mg/L.
Salinity:
No data
Nominal and measured concentrations:
Nominal Concentration in mg/L
- 50
- 100
- 150
- 200
- 250

Measured Concentration in mg/L (at 0h):
- 48.86
- 100.36
- 151.04
- 203.06
- 251.57

Measured Concentration in mg/L (at 48h):
- 53.17
- 105.36
- 164.69
- 222.87
- 282.23

% Recovery after 48 h
- 108.81
- 104.98
- 109.03
- 109.75
- 112.19

% of Nominal Concentration (at 0h):
- 97.72
- 100.36
- 100.70
- 101.53
- 100.63

% of Nominal Concentration (at 48h):
- 106.33
- 105.36
- 109.79
- 111.43
- 112.89


Reference substance (positive control):
yes
Remarks:
Potassium dichromate
Duration:
48 h
Dose descriptor:
EC50
Effect conc.:
180 mg/L
Nominal / measured:
meas. (geom. mean)
Conc. based on:
test mat.
Basis for effect:
mobility
Remarks on result:
other: Not determinable
Duration:
48 h
Dose descriptor:
NOEC
Effect conc.:
180 mg/L
Nominal / measured:
meas. (geom. mean)
Conc. based on:
test mat.
Basis for effect:
mobility
Remarks on result:
other: Not determinable
Results with reference substance (positive control):
The 24h-EC50 of potassium dichromate was determined as 1.5 mg/L, lying within the demanded range of 0.6 – 1.7 mg/L.
Validity criteria fulfilled:
yes
Conclusions:
EC50-48h (immobilization) for Reaction mass of N-[2-(2- Oxoimidazolidin-1-yl)ethyl]methacrylamide and methacrylic acid = 180 mg/L. The study satisfy on the OECD guideline requirement and is GLP compliant.
Executive summary:

The 48 hours acute toxicity of Reaction mass of N-[2-(2- Oxoimidazolidin-1-yl)ethyl]methacrylamide and methacrylic acid to Daphnia magna was studied under static conditions.  Daphnids were exposed to control and test chemical at measured concentration from 50 to 250 mg/L (test mat.) for 48 hours. Immobilization was observed daily. The 48 hours EC50was 180 mg/L (test material).

Based on the results of this study, Reaction mass of N-[2-(2- Oxoimidazolidin-1-yl)ethyl]methacrylamide and methacrylic acid was not considered as dangerous for Daphnia magna in accordance with the EC classification criteria.

This study is rated as reliable without restriction and satisfies the guideline requirements for an acute toxicity study with freshwater invertebrate (deviations observed have no impact on the quality of the results of this study).

Description of key information

EC50-48h (immobilization) for Reaction mass of N-[2-(2- Oxoimidazolidin-1-yl)ethyl]methacrylamide and methacrylic acid = 180 mg/L. The study is based on the OECD guideline (202) requirement and is GLP compliant.

Key value for chemical safety assessment

Fresh water invertebrates

Fresh water invertebrates
Effect concentration:
180 mg/L

Additional information

The 48 hours acute toxicity of Reaction mass of N-[2-(2- Oxoimidazolidin-1-yl)ethyl]methacrylamide and methacrylic acid to Daphnia magna was studied under static conditions.  Daphnids were exposed to control and test chemical at measured concentrations from 50 to 250 mg/L (test mat.) for 48 hours. Immobilization was observed daily. The 48 hours EC50was 180 mg/L ( test material).

Based on the results of this study, Reaction mass of N-[2-(2- Oxoimidazolidin-1-yl)ethyl]methacrylamide and methacrylic acid was not considered as dangerous for Daphnia magna in accordance with the EC classification criteria.