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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:
17.03.1999 - 16.09.1999
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: The study was conducted in GLP compliance and in accordance with an OECD guideline

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1999
Report Date:
1999

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)
Qualifier:
according to
Guideline:
EPA OPPTS 850.1010 (Aquatic Invertebrate Acute Toxicity Test, Freshwater Daphnids)
Qualifier:
according to
Guideline:
EU Method C.2 (Acute Toxicity for Daphnia)
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
other: liquid
Details on test material:
- Name of test material (as cited in study report): AGEE 623 Amine
- Physical state: liquid
- Analytical purity: 80.6%
- Composition of test material, percentage of components: batch contains about 20% solvent
- Purity test date: CoA date: 20.05.1998
- Lot/batch No.: T29844
- Expiration date of the lot/batch: 31.12.1999
- Stability under test conditions: for at least 48 hours
- Storage condition of test material: in original container, at approximate1y + 4 °C, in the dark
- Other:

Sampling and analysis

Analytical monitoring:
yes

Test organisms

Test organisms (species):
Daphnia magna
Details on test organisms:
TEST ORGANISM
- Common name: Daphnia magna (Straus)
- Sex: female
- Strain: clone 5
- Source: supplied 1997 by the Umweltbundesamt, Institut für Wasser-, Boden- und Lufthygiene, Berlin, Germany
- Age at study initiation (mean and range, SD): 7 - 22 hours old

ACCLIMATION
- Acclimation conditions (same as test or not): for 7 hours under test conditions


Study design

Test type:
not specified
Total exposure duration:
48 h

Test conditions

Hardness:
water Hardness: 2.5 mmol/L (= 250.0 mg/L) as CaC03
Test temperature:
21- 22 °C
pH:
pH 7.6 to 7.9
Dissolved oxygen:
at least 7.4 mg/L or higher
Salinity:
CaCI2 x 2H2O: 2.0 mmol/L
MgSO4 X 7H20: 0.5 mmol/L
NaHC03: 0.75 mmol/L
KCI: 0.075 mmol/L
Nominal and measured concentrations:
measured: 1.0, 2.0,4.0, 8.0 and 16.5 mg/L
Details on test conditions:
TEST SYSTEM
- Test vessel: glass beakers of 100 mL volume with 50 mL testmedium
- No. of organisms per vessel: 10
- No. of vessels per concentration (replicates): 2
- No. of vessels per control (replicates): 2


TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water:
- Total organic carbon:
- Particulate matter:
- Metals:
- Pesticides:
- Chlorine:
- Alkalinity:
- Ca/mg ratio:
- Conductivity:
- Culture medium different from test medium:
- Intervals of water quality measurement:

OTHER TEST CONDITIONS
- Adjustment of pH:
- Photoperiod:
- Light intensity:

EFFECT PARAMETERS MEASURED (with observation intervals if applicable) :

TEST CONCENTRATIONS
- Spacing factor for test concentrations:
- Justification for using less concentrations than requested by guideline:
- Range finding study
- Test concentrations:
- Results used to determine the conditions for the definitive study:
Reference substance (positive control):
yes
Remarks:
potassium dichromate (tested twice per year)

Results and discussion

Effect concentrationsopen allclose all
Duration:
48 h
Dose descriptor:
EC50
Effect conc.:
3.3 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality
Remarks on result:
other: lower 95% confidence value: 2.5 mg/L / higher 95% confidence value: 4.4 mg/L
Duration:
48 h
Dose descriptor:
EC0
Effect conc.:
1 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality
Duration:
48 h
Dose descriptor:
NOEC
Effect conc.:
1 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality
Duration:
48 h
Dose descriptor:
EC100
Effect conc.:
8 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality
Details on results:
Control: The experiment is valid because the mortality of Daphnia magna in the control (reconstituted water) did not exceed 10 % and no Daphnia were trapped at the water surface.
Reported statistics and error estimates:
The 24-hour and 48-hour EC 50 and the 95 % confidence
Iimits were calculated by the Moving average interpolation.
The NOEC, EC 0 and EC 100 were determined directly from
the raw data.

Any other information on results incl. tables

Signs of lntoxication after 24 hours:

After 24 hours in the control and in the test concentrations

up to 4.0 mg test substance/L no mortality or immobilization

of the test animals was observed (see Table 1). At the

test concentration of 8.0 mg test substance/L immobilization

rate of 30 % was determined after 24 hours. At the

highest test concentration of 16.5 mg test substance/L 75%

of the Daphnia were immobile after 24 hours test duration.

Results after 24 hours:

The 24-hour EC 50 of the test substance was calculated to be 12.4 mg test substance/L with 95 % confidence Limits from 7.6 to 20.3 mg/L. The 24-hour EC 0 was 4.0 mg test substance/L, the 24-hour EC 100 was higher than 16.5 mg test substance/L.

Signs of Intoxication after 48 hours:

After 48 hours of exposure the toxicity of the test substance to Daphnia magna had increased. In the control and up to and including the test concentration of nominal 1.0 mg test substance/L no significant immobility or mortality of the test animals or other signs of intoxication were determined

during the test period of 48 hours. At the test concentration

of nominal 2.0 mg test substance/L 5 test animals were

immobile at the observation after 48 hours (immobilization

rate of 25 % ). At the next high er test concentration of

4.0 mg test substaueeiL 55 % immobilization was determined.

At the two highest test concentrations of 8.0 and

16.5 mg test substance/L all Daphnia were dead after

48 hours test duration.

Results after 48 hours:

The 48-hour EC 50 was calculated to be 3.3 mg test substaueeiL with 95 % confidence Iimits from 2.5 to 4.4 mg/L. The 48-hour EC 0 and the 48-hour NOEC (highest concentration tested without toxic effects after 48 hours) of AGEE 623 Amine was 1.0 mg test substance/L, since no significant immobilization rate and no other signs of intoxication were observed at the test animals up to and including this test concentration. The 48-hour EC 100 amounted to 8.0 mg test substance/L.

Applicant's summary and conclusion

Validity criteria fulfilled:
yes
Conclusions:
The 48-hour EC 50 was calculated to be 3.3 mg test substance/L
with 95 % confidence Iimits from 2.5 to 4.4 mg/L.
The 48-hour EC 0 and the 48-hour NOEC (highest concentration
tested without toxic effects after 48 hours) of
AGEE 623 Amine was 1.0 mg test substance/L, since no
significant immobilization rate and no other signs of intoxication
were observed at the test animals up to and including
this test concentration. The 48-hour EC 100
amounted to 8.0 mg test substance/L.