Registration Dossier

Diss Factsheets

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:
2010-07-27 to 2010-07-29
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 guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)
Deviations:
no
GLP compliance:
yes (incl. QA statement)

Test material

Constituent 1
Chemical structure
Reference substance name:
Ethylene dinitrate
EC Number:
211-063-0
EC Name:
Ethylene dinitrate
Cas Number:
628-96-6
Molecular formula:
C2H4N2O6
IUPAC Name:
ethane-1,2-diyl dinitrate
Specific details on test material used for the study:
Test substance was produced on site in a micro-reactor and used on the same day it was produced. Purity was reported as >99% using HPLC; batch number was EGDN-LN-20100727. Stability of the test solutions was checked at the start and end of the exposure period (48 h), and measured concentrations were within 20% of nominal concentrations for most treatments and final concentrations were within 10% of initial concentrations for all treatments.

Test solutions

Vehicle:
no

Test organisms

Test organisms (species):
Daphnia magna
Details on test organisms:
Test species was Daphnia magna. Test organisms were obtained from a culture that has been maintained on site since 2007. The culture organisms were maintained at 20 ± 2°C with a photoperiod of 16 h light and 8 h dark using neon tubes and fed a diet of unicellular green algae (Desmodesmus subspicatus) twice a week. Starter cultures were obtained from Umweltbundesamt Berlin.
Five daphnia were randomly assigned to each replicate for a total of 20 animals per control or test concentration.
Test organisms (<24 h old neonates) were not fed before test initiation or during the test. The test was conducted in closed glass flasks in the dark.

Study design

Test type:
static
Water media type:
not specified
Limit test:
no
Total exposure duration:
48 h

Test conditions

Test temperature:
The range of temperature (20.0°C to 22.6°C) was outside of the range required in the test method (18°C to 22°C and not constant to ±1°C), but this deviation was deemed by the test facility not to have adversely affected immobilization of the daphnids.
Dissolved oxygen:
Range of dissolved oxygen and pH were within ranges specified in the test method.
Nominal and measured concentrations:
The test substance is volatile; therefore, closed test vessels were used. No other physical/chemical properties were expected to be critical for study design. Measured concentrations were close to nominal concentrations indicating stability of EGDN in the test medium.
Nominal concentrations of 1.0, 2.2, 4.6, 10, 22, 46 and 100 mg/L were investigated.
Details on test conditions:
Temperature, dissolved oxygen, and pH were monitored and reported.
Photoperiod was 24 h dark.
The range of temperature (20.0°C to 22.6°C) was outside of the range required in the test method (18°C to 22°C and not constant to ±1°C), but this deviation was deemed by the test facility not to have adversely affected immobilization of the daphnids. Range of dissolved oxygen and pH were within ranges specified in the test method.
Reference substance (positive control):
yes
Remarks:
Potassium dichromate K2Cr2O7 (CAS No. 7778-50-9) was used as positive control.

Results and discussion

Effect concentrationsopen allclose all
Duration:
48 h
Dose descriptor:
EC50
Effect conc.:
> 100 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality
Duration:
48 h
Dose descriptor:
EC100
Effect conc.:
> 100 mg/L
Nominal / measured:
meas. (initial)
Conc. based on:
test mat.
Basis for effect:
mortality
Duration:
48 h
Dose descriptor:
NOEC
Effect conc.:
ca. 100 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality
Results with reference substance (positive control):
The 24h-EC50 of potassium dichromate was tested in a current reference test. The value was determined as 1.6 mg/L, lying within the demanded range of 0.6 - 1.7 mg/L.
Reported statistics and error estimates:
No statistical analysis was required because there were no effects on immobilization observed in any treatment.

Applicant's summary and conclusion

Validity criteria fulfilled:
yes
Conclusions:
Within the course of a short-term toxicity test on aquatic invertebrates (species: Daphnia magna) according to OECD guideline 202, the following results were determined for the test item ethylene glycol dinitrate:
24h-NOEC = 100 mg/L
48h-NOEC = 100 mg/L
24h-EC50 > 100 mg/L
48h-EC50 > 100 mg/L