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Long-term toxicity to aquatic invertebrates

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Reference
Endpoint:
long-term toxicity to aquatic invertebrates
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Study period:
Not reported
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions
Qualifier:
according to guideline
Guideline:
OECD Guideline 211 (Daphnia magna Reproduction Test)
Deviations:
not specified
GLP compliance:
yes
Analytical monitoring:
yes
Vehicle:
yes
Details on test solutions:
PREPARATION AND APPLICATION OF TEST SOLUTION
- Stock solution: 1 g/L test material + 1 g/L vehicle, the calculated test concentrations of 0.19, 0.39, 0.77 mg/L contained 2.0 mg/L vehicle (nominal)
- Chemical name of vehicle: 1 g/L MARLOWET R 40
Test organisms (species):
Daphnia magna
Details on test organisms:
TEST ORGANISM
- Common name: water flea
- Strain/clone: clone 5
- Source: own breeding
- Feeding during test
- Food type: green algae
- Amount: 0.5E7 cells/daphnid from day 0 to day 6; 1.0E7 cells/daphnid from day 7 to day 21
- Frequency: daily
- Age of test organisms: < 24 hours

HOUSING
- Housing medium: M4-medium (Elendt, 1990)
- Housing conditions: each test organism were kept separate in 60 mL test water
Test type:
semi-static
Water media type:
freshwater
Limit test:
no
Total exposure duration:
21 d
Test temperature:
20 °C
pH:
7.8 - 8.6
Dissolved oxygen:
94 - 107 mg/L
Nominal and measured concentrations:
Nominal test concentrations: 0.5, 1.0, 2.0 mg/L
Measured concentrations: 0.19, 0.39, 0.77 mg/L (geometric mean, biological active)
Details on test conditions:
TEST SYSTEM
- Test vessel:
- Material, total volume, fill volume: glass beakers, 150 mL, 100 mL
- Renewal rate of test solution (frequency): after 2, 6, 7, 9, 12, 14, 16, 19 days
- No. of organisms per vessel: 1
- No. of vessels per concentration (replicates): 10
- No. of vessels per control (replicates): 10
- No. of vessels per vehicle control (replicates): 10
- Biomass loading rate: 1 daphnid/100 mL

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: synthetic freshwater according to Elendt (M4-medium)
- Culture medium different from test medium: no
- Intervals of water quality measurement: pH-value and oxygen content of the new test solutions at day 2, 12, 16 and of the old test solutions at day 6, 14, 19.

OTHER TEST CONDITIONS
- Photoperiod: 16 hours light and 8 hours darkness
- Light intensity: approx. 450 and 95 lux

EFFECT PARAMETERS MEASURED: mortality and reporduction after 2, 6, 7 9, 12, 14, 16, 19, 21 days

VEHICLE CONTROL PERFORMED: yes
Duration:
21 d
Dose descriptor:
NOEC
Effect conc.:
>= 0.77 mg/L
Nominal / measured:
meas. (geom. mean)
Conc. based on:
test mat.
Basis for effect:
reproduction
Duration:
21 d
Dose descriptor:
LOEC
Effect conc.:
> 0.77 mg/L
Nominal / measured:
meas. (geom. mean)
Conc. based on:
test mat.
Details on results:
Toxic effects on the reproduction and mortality of the adult daphnids, respectively, are above the water solubility of the test material.
Validity criteria fulfilled:
not specified
Conclusions:
Under the conditions of the study, the No Oberved Effect Concentration was determined to be greater than or equal to 0.77 mg/L.
Executive summary:

The long term toxicity of the test material to aquatic invertebrates was investigated in a GLP study which was conducted in accordance with the standardised guideline OECD 211 under semi-static conditions. Under the conditions of the study, the No Oberved Effect Concentration was determined to be greater than or equal to 0.77 mg/L.

Description of key information

Study conducted to recognised testing guideline with acceptable restrictions.

Key value for chemical safety assessment

Fresh water invertebrates

Fresh water invertebrates
Effect concentration:
0.77 mg/L

Additional information

The long term toxicity of the test material to aquatic invertebrates was investigated in a GLP study which was conducted in accordance with the standardised guideline OECD 211 under semi-static conditions. Under the conditions of the study, the No Observed Effect Concentration was determined to be greater than or equal to 0.77 mg/L.

The study was conducted to GLP and a standardised guideline. Since the study was conducted with the structural analogue, bis(2-ethylhexyl) adipate, it was assigned a reliability score of 2 and considered suitable for assessment as an accurate reflection of the test substance.

The available data are considered to be complete and the result determined, 21 d NOEC value of ≥ 0.77 mg/L, was taken forward for risk assessment.