Registration Dossier

Diss Factsheets

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:
1999-04-30 to 1999-06-10
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method C.2 (Acute Toxicity for Daphnia)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Analytical monitoring:
yes
Details on sampling:
- Concentrations: analysis of the only test concentration plus a control at test start and after 48 hours of exposure.
Vehicle:
no
Details on test solutions:
PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Method: a 1.6 fold amount of the maximum water solubility (s= 73 mg/L at 20 °C) was taken (120 mg/L). Test substance was weighed into water, treated for 60 seconds at 8000 rpm. with an ultra-turrax and afterwards stirred for 24 hours an a magnetic stirrer.
- Controls: yes, M4-Medium according to Elendt and BGA (1992)
- Evidence of undissolved material (e.g. precipitate, surface film, etc): resulting emulsion was filtered using a folded filter of the pore size 7-12 µm to remove undissolved particles

Test organisms (species):
Daphnia magna
Details on test organisms:
TEST ORGANISM
- Common name: Daphnia magna STRAUS
- Age at study initiation: 0-24 hours
- Other: Origin of species: cloned at the Federal Health Office (BGA) in Berlin and Test animals: laboratory bred at Bayer AG Leverkusen
Test type:
static
Water media type:
freshwater
Limit test:
yes
Total exposure duration:
48 h
Hardness:
14.9°dH (dilution water)
Test temperature:
19.6°C (48 h)
pH:
7.9 (48 h)
Dissolved oxygen:
5.5 - 8.9 mg/L (48 h)
Nominal and measured concentrations:
- nominal: 0 (control), 73 mg/L
- measured: 0 h: 4.5 (control), 67.5 mg/L; 48 h:
Details on test conditions:
TEST SYSTEM
- Test vessel: so called "Karlsruher bottles" with stoppers
- Type: closed
- Material, size, headspace, fill volume: 250 - 300 mL and had space
- Aeration: not ventilated
- 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: M4-Medium according to Elendt and BGA (1992)
- Culture medium different from test medium: no
- Other: Water hardness: 14.9 [°dH]

OTHER TEST CONDITIONS
- Photoperiod: 16 hours light / 8 hours dark

EFFECT PARAMETERS MEASURED (with observation intervals if applicable):
- number of immobile daphnids after 24 h and 48 h
Reference substance (positive control):
no
Duration:
48 h
Dose descriptor:
EC0
Effect conc.:
>= 73 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mobility
Remarks on result:
other: The mean recovery is 92% based on TOC analysis; nominal concentrations are used for assessment
Key result
Duration:
48 h
Dose descriptor:
EC0
Effect conc.:
>= 67 mg/L
Nominal / measured:
meas. (arithm. mean)
Conc. based on:
test mat.
Basis for effect:
mobility

Table 1: Results after 24 and 48 h

Nominal concentration [mg/L]

Results after 24 h and 48 h                    

Immobile daphnids    

Oxygen content [mg/L] after 48 h

pH after 48 h

Temperature [°C] after 48 h

absolute

%

 24 h

48 h

24 h

48 h

0 (control) 

0

0

0

0

8.9

7.9

19.6

73

0

0

0

0

5.5

7.9

19.6

Validity criteria fulfilled:
yes
Conclusions:
The toxicity of the test item on Daphnia magna was tested in a limit test according to OECD Test guideline 202 and in compliance with GLP. Individuals were exposed to 73 mg/L nominal concentration, equivalent with a measured concentration of 67 mg/L. The test concentrations were analytically verified by TOC determination. The EC0 value obtained for the test substance was >= 73 mg/L (nominal) and >= 67 mg/L (measured).

Description of key information

EC0 (48 h): >= 67 mg/L based on mean measured concentrations.

Key value for chemical safety assessment

Fresh water invertebrates

Fresh water invertebrates
Effect concentration:
67 mg/L

Additional information

The toxicity of the test item on Daphnia magna was tested in a reliable limit test according to OECD 202 and in compliance with GLP. Individuals were exposed to 73 mg/L nominal concentration, equivalent with a measured concentration of 67 mg/L. The test concentrations were analytically verified by TOC determination. The EC0 value obtained for the test substance was >= 73 mg/L (nominal) and >= 67 mg/L (measured).