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:
Start of study: January 26 - End of study: January 28, 2000
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: 1a: GLP guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2000
Report date:
2000

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)
Qualifier:
according to guideline
Guideline:
EU Method C.2 (Acute Toxicity for Daphnia)
GLP compliance:
yes
Remarks:
Principles of Good Laboratory Practice, annex of paragraph 19a, section 1 of the chemical law

Test material

Constituent 1
Chemical structure
Reference substance name:
α,α-Dimethyl-ethyl ester benzeneacetic acid
EC Number:
608-307-7
Cas Number:
2901-13-5
Molecular formula:
C12 H16 O2
IUPAC Name:
α,α-Dimethyl-ethyl ester benzeneacetic acid
Details on test material:
Name: EDMPA
Synonyms: Ethyldimethylphenylacetat, 2-Phenylisobutyrsäureethylester
Chemical name: 2-methyl-2-phenyl-propionic acid ethyl ester
Certificate of analysis: August 26, 1999
Purity: 99.8%
Appearance: clear, colorless liquid
Batch number: C 0086
Date of production: August 26, 1999
Date of expiry: August 26, 2000
Storage conditions: darkness at approximately 5°C in a refrigerator

Sampling and analysis

Analytical monitoring:
yes
Details on sampling:
The samples were diluted with water.

Test organisms

Test organisms (species):
Daphnia magna
Details on test organisms:
TEST ORGANISM
- Common name: Daphnia magna
- Source: Stock culture of Aventis Pharma Deutschland GmbH, ProTox
- Feeding during test: daphnids were not fed during the entire study period.
- Food type: The supplied diet was based on the amount of organic carbon (C).
- Amount: The ration level is 0.2 mg carbon/day/animal.
- Frequency: three times a week with monocellular green algae (Scenedesmus subspicatus).

ACCLIMATION
- Feeding frequency: three times a week with monocellular green algae (Scenedesmus subspicatus).

Study design

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

Test conditions

Hardness:
2.3 mmol Ca²+ + Mg²+/L
Test temperature:
21 ± 1 °C
pH:
Control group: 7.9-8.0
Controls: 7.8-7.9
Dissolved oxygen:
Control group: 8.8-9.3 mg/L
Controls: 8.9-9.1 mg/L
Nominal and measured concentrations:
Nominal test concentrations: 0-10-22-50-100 mg/L
Mean measured concentrations: 0-12.6-20.6-47.4-85.5 mg/L
Details on test conditions:
TEST SYSTEM
- Material, size, headspace, fill volume: 250 ml beakers (height 110 mm, diameter 70 mm, water level about 75 mm), each filled with 200 ml test water.
- No. of organisms per vessel: 10 daphnids (=20/concentration) in each test chamber

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: reconstituted fresh water was used for breeding and dilution. Demineralized water with a conductance of < 1 µS/cm was used for preparing the artificial fresh water (according to Elendt).
- Ca/mg ratio:6.57
- Conductivity: < 1 µS/cm

- Light intensity: The room was illuminated by fluorescent tubes for 16 hours each day.

TEST CONCENTRATIONS
- Spacing factor for test concentrations: 24h
- Test concentrations: 0/10/22/50/100 mg/L

Results and discussion

Effect concentrationsopen allclose all
Duration:
24 h
Dose descriptor:
EC0
Effect conc.:
12.6 mg/L
Nominal / measured:
meas. (geom. mean)
Basis for effect:
mobility
Duration:
48 h
Dose descriptor:
EC0
Effect conc.:
12.6 mg/L
Nominal / measured:
meas. (geom. mean)
Basis for effect:
mobility
Duration:
24 h
Dose descriptor:
EC50
Effect conc.:
39.2 mg/L
Nominal / measured:
nominal
Basis for effect:
mobility
Remarks on result:
other: 32.1-47.0
Duration:
24 h
Dose descriptor:
EC50
Effect conc.:
36.9 mg/L
Nominal / measured:
meas. (geom. mean)
Basis for effect:
mobility
Remarks on result:
other: 30.4-43.9
Duration:
48 h
Dose descriptor:
EC50
Effect conc.:
33.2 mg/L
Nominal / measured:
nominal
Basis for effect:
mobility
Remarks on result:
other: 27.8-39.6
Duration:
48 h
Dose descriptor:
EC50
Effect conc.:
31.3 mg/L
Nominal / measured:
meas. (geom. mean)
Basis for effect:
mobility
Remarks on result:
other: 26.1-37.4
Duration:
24 h
Dose descriptor:
EC100
Effect conc.:
85.5 mg/L
Nominal / measured:
meas. (geom. mean)
Basis for effect:
mobility
Duration:
48 h
Dose descriptor:
EC100
Effect conc.:
85.5 mg/L
Nominal / measured:
meas. (geom. mean)
Basis for effect:
mobility

Applicant's summary and conclusion

Validity criteria fulfilled:
yes
Conclusions:
EC50 (48h) = 33.2 mg/l under the conditions of the test.