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
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline study in compliance with GLP-criteria.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1994
Report Date:
1994

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
EU Method C.2 (Acute Toxicity for Daphnia)
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Asta-C6-Acetal (CG-Acl)
- Physical state: fluid
- Stability under test conditions: Not stable against acids/caustic solutions

Sampling and analysis

Analytical monitoring:
yes
Details on sampling:
At the start of the test (after 0 hours) samples from vessels which were not stocked with daphnids were analysed and at the end of the test (after 48 h) samples from stocked and unstocked vessels were analysed.

Test solutions

Vehicle:
no
Details on test solutions:
At the beginning of the test and after 24h the stock solution of the test substance was freshly prepared. A defined amount of the substance was weighed out and suspended directly in the test medium by stirring (about 30 min at 20°C). The nominal concentration of the stock solution was 100 mg/L. By dilution of this stock solution with test medium the following nominal concentrations were prepared.

Test organisms

Test organisms (species):
Daphnia magna
Details on test organisms:
TEST ORGANISM
The clone of Daphnia magna STRAUS used was supplied by Institut National de Recherche Chimique Applique France, in 1978. The daphnids are cultured under standard conditions in the laboratory.

Study design

Test type:
semi-static
Water media type:
freshwater
Limit test:
no
Total exposure duration:
48 h

Test conditions

Hardness:
2.2 - 3.2 mmol/L
Test temperature:
20.2 - 21.3 °C
pH:
7.9 - 8.2
Dissolved oxygen:
7.9 - 8.5 mg/L
Nominal and measured concentrations:
Nominal concentrations:
0; 12.5, 25, 50, 100 mg/L

Measured concentrations (recoveries):
t=0: 89.3-92.7%
t=24h: 53.2-57.7%
t=24h (stocked): 43.8-48.8%
Details on test conditions:
TEST SYSTEM
- Test vessel: 20-mL open flat bottom glass tubes
- Test volume: 10 mL
- Aeration: no
- No. of organisms per vessel: 5
- No. of vessels per concentration (replicates): 4
- No. of vessels per control (replicates): 4
- Loading: 0.5 animals per mL

TEST MEDIUM / WATER PARAMETERS
- Culture medium: synthetic medium M4 as defined in Guideline C.2 is used for the culture and test. The medium is prepared on the basis of on ultrapure, deionized water (conductivity < 0.05 pS/cm).
- Source/preparation of dilution water: according to the test guideline DIN 38412, L 11:
- Ca/mg ratio: 4:1

OTHER TEST CONDITIONS
- Adjustment of pH: yes for two additional concentrations which were tested in parallel (50 and 100 mg/L)
- Photoperiod: 16 : 8 hours day-night regime
- Light intensity: diffuse light (5 µE/m²·s) at 400 - 750 nm wave length

EFFECT PARAMETERS MEASURED
- Test parameter: swimming ability of the test animals, visually after 0, 3, 6, 24 and 48 h.
Reference substance (positive control):
no

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:
mobility
Duration:
48 h
Dose descriptor:
EC50
Effect conc.:
> 71.9 mg/L
Nominal / measured:
meas. (geom. mean)
Conc. based on:
test mat.
Basis for effect:
mobility
Remarks:
lowest measured value corresponding to effect
Details on results:
Only at the highest two test concencentrations was 5% immobility noted after 48 hours exposure.

The low recovery rates after 24 h of 43.5 to 57.7 % are reported to be caused by degradation of the test substance.
Reported statistics and error estimates:
Due to the results of the test a statistical evaluation of the data was unnecessary.

Any other information on results incl. tables

Immobilisation

Nominal conc. (mg/l)

Cumulative immobilisation (n)

3 h

6 h

24 h

48 h

12.5

0

0

0

0

25

0

0

0

0

50

0

0

0

1

100

0

0

0

1

Applicant's summary and conclusion