Registration Dossier

Ecotoxicological information

Short-term toxicity to aquatic invertebrates

Currently viewing:

Administrative data

Link to relevant study record(s)

Reference
Endpoint:
short-term toxicity to aquatic invertebrates
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1998-03-03 to 1998-03-05
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
EU Method C.2 (Acute Toxicity for Daphnia)
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)
GLP compliance:
yes
Analytical monitoring:
yes
Details on sampling:
- Concentrations: 100 mg/L, and blank control
- Sampling method: No data
- Sample storage conditions before analysis: No data
Vehicle:
no
Details on test solutions:
Identity and concentration of auxiliary solvent for dispersal: No auxiliary agent was used.
Test organisms (species):
Daphnia magna
Details on test organisms:
TEST ORGANISM
- Common name: Daphnia magna STRAUS, parthenogenetic females
- Source: cloned at the Federal Health Office (BGA) in Berlin, bred at Bayer AG Leverkusen
- Age at study initiation (mean and range, SD): 0-24 hours
- Weight at study initiation (mean and range, SD): No data
- Length at study initiation (length definition, mean, range and SD): No data
- Medium: In M4 medium according to Elendt and BGA (1992)
- Feeding during test: Not stated

ACCLIMATION
- Acclimation period: No data
- Acclimation conditions (same as test or not): Not stated
- Type and amount of food: Not stated
- Feeding frequency: Not stated
- Health during acclimation (any mortality observed): No data
Test type:
static
Water media type:
freshwater
Limit test:
yes
Total exposure duration:
48 h
Post exposure observation period:
None
Hardness:
15 mg CaCO3/L
Test temperature:
19.9-20 °C
pH:
8.1
Dissolved oxygen:
8.6-8.8 mg/L
Salinity:
Not measured
Nominal and measured concentrations:
Nominal: 100 and 0 mg/L (control)
Measured: 77 mg/L (based on TOC concentrations and molecular weight calculations)
Details on test conditions:
TEST SYSTEM
- Test vessel: cylindrical test vessels (diameter 4.0 cm, height 6.5 cm), 20 ml test medium, not ventilated
- No. of organisms per vessel: 10

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: M4-Medium according to Elendt and BGA (1992)

TEST CONCENTRATIONS
- Nominal test concentrations: 100 mg/L

Assessment of effect: immobilisation of daphnia
Reference substance (positive control):
no
Key result
Duration:
48 h
Dose descriptor:
EC50
Effect conc.:
> 77 mg/L
Nominal / measured:
meas. (arithm. mean)
Conc. based on:
act. ingr.
Basis for effect:
mobility
Details on results:
% loss of test substance over test: >20%
Behavioural abnormalities: Not stated
The immobilisation rates of daphnids after 24 hours of exposure could not be determined because of intensive colour of the test medium.
Results with reference substance (positive control):
Not applicable
Reported statistics and error estimates:
None
Validity criteria fulfilled:
yes
Conclusions:
No toxic effects of Reactive Navy FC63805 to female partheogenetic Daphnia magna were observed after 48 hours at a nominal 100 mg/L concentrations. Therefore the EC50 is > 77 mg/L (measured concentration) at 48 hours.
Executive summary:

The 48-h acute toxicity of Reactive Navy FC63805 to Daphnia magna STRAUS, parthenogenetic females, was studied under static conditions.  Daphnids were exposed to 100 mg/L of the test substance for 48 h. The 48-hr EC0 was > 77 mg/L (measured concentration).

This study is classified as acceptable and satisfies the guideline requirements for an acute toxicity study with freshwater invertebrates.

 

Results synopsis

Test organism age: 0–24 hours

Test type: Static

EC0:  > 77 mg/L at 48 hours

Description of key information

No toxic effects of Reactive Navy FC63805 to female partheogenetic Daphnia magna  were observed. Therefore the (hypothetical) EC0 would be > 77 mg/L at 48 hours.

Key value for chemical safety assessment

Fresh water invertebrates

Fresh water invertebrates
Effect concentration:
100 mg/L

Additional information

Daphnia magna STRAUS, parthenogenetic females, were exposed to a limit test concentration of 100 mg/L test substance in water (nominal). The test substance concentration was analytically confirmed to be 77 mg/L at the end of the exposure. Observations were made on the mobility behaviour after 24 and 48 hours of exposure. No immobility occurred at any point in time during the test. Accordingly, the EC0 at 48 h was >77 mg/L (measured concentration). An EC50 cannot be determined.