Registration Dossier

Ecotoxicological information

Long-term toxicity to aquatic invertebrates

Currently viewing:

Administrative data

Link to relevant study record(s)

Reference
Endpoint:
long-term toxicity to aquatic invertebrates
Type of information:
experimental study
Adequacy of study:
key study
Study period:
11 Jul - 01 Aug 1990
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions
Remarks:
The study was peformed under GLP and according to a clear guideline. No analysis has been performed, this is the major restriction of the study.
Qualifier:
according to guideline
Guideline:
other: OECD 202 part II ( at least 14 days)
GLP compliance:
yes
Analytical monitoring:
yes
Vehicle:
no
Details on test solutions:
PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Method: a stock solution was prepared by adding 200 mg/L test substance to the test medium. The stock solution was stirred for 1 h using a magnetic stirrer. The test solutions were prepared by diluting the stock solution.
Test organisms (species):
Daphnia magna
Details on test organisms:
TEST ORGANISM
- Source: klone obtained from Bundesgesundheitsam, Berlin, Germany, reared at testing facility
- Age of parental stock (mean and range, SD): 6-24 h

- Feeding during test: yes
- Food type: green algae Scenedesmus subspicatus
- Amount and Frequency:
Day 0-1: 1.7E+6 cells
Day 2-3: 2.0E+6 cells
Day 4-5: 2.7E+6 cells
Day 6-7: 3.3E+6 cells
Day 8-20:: 6.7E+6 cells
Test type:
semi-static
Water media type:
freshwater
Limit test:
no
Total exposure duration:
21 d
Test temperature:
18.0 - 20.8 °C
pH:
control: 7.7 - 8.7
treatments: 7.8 - 8.9
Dissolved oxygen:
8.2-11.7 mg/L
Nominal and measured concentrations:
Nominal test substance concentrations: 1.0, 3.2, 10, 32, 100 mg/L

DOC Analysis determined DOC values of >62 - >100 mg/L
Details on test conditions:
16h light/8 dark. The organisms will be held in 250 ml jars and each will contain 5 animals; in eight parallels. Total number per concentration thus is 40. TEST SYSTEM
- Test vessel: glass beakers (diameter 9.5 cm, height: 11.5 cm)
- Fill volume: 250 mL
- Aeration: none
- Renewal rate of test solution (frequency/flow rate): every second day
- No. of organisms per vessel: 5
- No. of vessels per concentration (replicates): 8
- No. of vessels per control (replicates): 8

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: test medium acc. to Elendt (1990)

OTHER TEST CONDITIONS
- Adjustment of pH:
- Photoperiod: 16:8 h day-night regime
- Light intensity: 60 - 80 µS/m²*s

EFFECT PARAMETERS MEASURED (with observation intervals if applicable) :
Mortalitiy and number of offspring at days: 0, 2, 5, 7, 9, 12, 14, 16, 19 and 21
Reference substance (positive control):
no
Duration:
21 d
Dose descriptor:
EC50
Effect conc.:
> 3.2 - < 10 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
immobilisation
Duration:
21 d
Dose descriptor:
EC50
Effect conc.:
> 10 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
reproduction
Duration:
21 d
Dose descriptor:
EC10
Effect conc.:
1.9 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
reproduction
Remarks on result:
other: re-calculated
Details on results:
The validity criteria of 60 juvenils per adult were not met in control replicates 2 and 8
Validity criteria fulfilled:
yes
Conclusions:
The EC50s (immobilisation and reproduction) were determined to be 3.2-10 and 10 mg/L, respectively. The study was peformed under GLP and according to a clear guideline. No analysis has been performed and that is the major restriction of the study. This will limit the use of the data when looking at the bioavailable fraction of the test substance. The reviewer calculated an EC10, based on the available raw data with the use of toxcalc 5.0.
Executive summary:

The EC50s (immobilisation and reproduction) were determined to be 3.2-10 and 10 mg/L, respectively. The test was done according to the OECD 202, part II guideline (1984). Test was done under GLP and is valid.

Description of key information

EC10 (21 d):1.9 mg/L (nominal) 

Key value for chemical safety assessment

Fresh water invertebrates

Fresh water invertebrates
Effect concentration:
1.9 mg/L

Additional information

The long-term toxicity of the substance was investigated in a study following OECD 202 part II (at least 14 days). Daphnia magna were exposed to the test substance for 21 days in a semi-static test system. The tested nominal exposure concentrations were 1.0, 3.2, 10, 32 and 100 mg/L. After an exposure period of 21 days an EC50 value of >3.2 - <10 mg/L based on the mobility of the parental animals was recorded. After 21 days an EC50 of >10 mg/L (nominal) based on the reproduction rate was determined. The EC10 of 1.9 mg/L was determined via interpolation (toxcalc v 5.0).