Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

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:
24 October 2000 - 26 October 2000
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions
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: The stock solution was analysed at 0 hours, the control was analysed at 0 and 48 hours, and test concentrations were analysed at 0, 24 and 48 hours
Vehicle:
no
Details on test solutions:
PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Method: A stock solution was prepared to give the desired series of test concentrations. 105.9 mg of the test substance were added to 2 litres of dilution water, treated with an ultra turrax for 60 seconds and afterwards stirred for 24 h an a magnetic stirrer.
- Controls: Dilution water
- Evidence of undissolved material (e.g. precipitate, surface film, etc.): Finally undissolved particles of the test substance were removed by filtration.
Test organisms (species):
Daphnia magna
Details on test organisms:
TEST ORGANISM
- Common name: Daphnia magna Straus
- Age of parental stock: Parthenogenetic females of synchronised age
- Feeding during test: None

ACCLIMATION
- Acclimation conditions (same as test or not): Yes
- Type and amount of food: Unicellular green algae (Scenedesmus subspicatus CHODAT)
- Feeding frequency: ad libitum

METHOD FOR PREPARATION AND COLLECTION OF EARLY INSTARS OR OTHER LIFE STAGES: The neonates were separated from their parent Daphnia by filtration prior to the acute test.
Test type:
static
Water media type:
freshwater
Limit test:
no
Total exposure duration:
48 h
Hardness:
271.3 mg/1 CaCO3
Test temperature:
19.9 - 20.2°C
pH:
7.7 - 7.8
Dissolved oxygen:
8.2 - 8.8 mg/L
Nominal and measured concentrations:
Nominal concentrations 1.25, 2.5, 5, 10, 20 and 36 mg/L
Initial measured concentrations 1.2, 2.4, 5.6, 9.8, 21 and 35 mg/L
Measured concentrations at 48 hours 1.3, 2.6, 7, 8.4, 23.8 and 37.8* mg/L
* Measured after 24 hours of exposure because of early 100% immobilisation rates of the daphnids
Details on test conditions:
TEST SYSTEM
- Test vessel: Karlsruher Flaschen
- Type: closed
- Material, size, headspace, fill volume: 250 to 300 mL test medium per vessel
- Aeration: None
- No. of organisms per vessel: 10 neonates per vessel
- 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
- Intervals of water quality measurement: Temperature, pH and dissolved oxygen measured at 0 and 48 hours

OTHER TEST CONDITIONS
- Photoperiod: 16h light: 8h dark

EFFECT PARAMETERS MEASURED (with observation intervals if applicable): Substance-induced alteration of the normal mobility behaviour and the loss of locomotory actions of the neonates were observed at 24 and 48 hours.
Reference substance (positive control):
no
Key result
Duration:
48 h
Dose descriptor:
other: EC0/EC100
Effect conc.:
7.5 mg/L
Nominal / measured:
meas. (geom. mean)
Conc. based on:
test mat.
Basis for effect:
mobility
Duration:
48 h
Dose descriptor:
EC0
Effect conc.:
2.5 mg/L
Nominal / measured:
meas. (arithm. mean)
Conc. based on:
test mat.
Remarks:
Calculated (corresponding to the analytical recovery rate of the highest test concentration) as the concentration to be measured was below the quantitation limit of the TOC method (2 mg/L)
Basis for effect:
mobility
Duration:
48 h
Dose descriptor:
EC100
Effect conc.:
22.4 mg/L
Nominal / measured:
meas. (arithm. mean)
Conc. based on:
test mat.
Basis for effect:
mobility
Duration:
24 h
Dose descriptor:
other: EC0/EC100
Effect conc.:
13.4 mg/L
Nominal / measured:
meas. (geom. mean)
Conc. based on:
test mat.
Basis for effect:
mobility
Duration:
24 h
Dose descriptor:
EC0
Effect conc.:
5 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mobility
Duration:
24 h
Dose descriptor:
EC100
Effect conc.:
36 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mobility
Details on results:
- Measured concentrations: 97.2 — 112% of nominal values at 0 hours, 84 — 140% of nominal values at 48 hours
- Mortality of control: No mortalities occurred throughout the duration of the study
Reported statistics and error estimates:
In those cases where the slope of the concentration/percentage response curve is too steep to permit calculation of the EC50, this value is estimated graphically.
Validity criteria fulfilled:
yes
Remarks:
Immobilisation in the control was < 10% by the end of the test, the dissolved oxygen concentration was >3 mg/L throughout the exposure period, and the concentration of the test substance was within 80% of the initial concentration throughout the study.
Conclusions:
The 48 hour EC0/EC100 was determined to be 7.5 mg/L for Daphnia magna exposed to the test item.
Executive summary:

Short-term toxicity of the test item to Daphnia magna was evaluation in a 48 -hour static test. Daphnia were exposed to nominal test item concentrations of 1.25, 2.5, 5, 10, 20 and 36 mg/L in a closed system, alongisde a dilution water control. Measured test concentrations were 97.2 to 112% of nominal values at 0 hours and 84 to 140% of nominal values at 48 hours based on TOC analysis. The 48-hour EC0/EC100 was determined to be 7.5 mg/L, based on geometric mean measured concentrations. The study was GLP-compliant and was conducted according to EU Method C.2. The study is reliable with restrictions (Klimisch 2) as there were some limitations in the reporting of methods and results.

Description of key information

The 48 hour EC50 was determined to be 7.5 mg/L for Daphnia magna exposed to the test item.
    
    
    
    
    
    
    

The 48-hour EC0/EC100 was determined to be 7.5 mg/L, based on geometric mean measured concentrations.

The 48-hour EC0/EC100 was determined to be 7.5 mg/L, based on geometric mean measured conce

trations.

ons.

Key value for chemical safety assessment

Fresh water invertebrates

Fresh water invertebrates
Effect concentration:
7.5 mg/L

Additional information

Short-term toxicity of the test item to Daphnia magna was evaluated in a 48 -hour static test (2000). Daphnia were exposed to nominal test item concentrations of 1.25, 2.5, 5, 10, 20 and 36 mg/L in a closed system, alongisde a dilution water control. Measured test concentrations were 97.2 to 112% of nominal values at 0 hours and 84 to 140% of nominal values at 48 hours based on TOC analysis. The 48-hour EC0/EC100 was determined to be 7.5 mg/L, based on geometric mean measured concentrations. The study was GLP-compliant and was conducted according to EU Method C.2. The study is reliable with restrictions (Klimisch 2) as there were some limitations in the reporting of methods and results.