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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:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Study was conducted in conformance to GLP and on the basis of OECD Guideline 211 (Daphnia magna Reproduction Test).
Qualifier:
according to
Guideline:
OECD Guideline 211 (Daphnia magna Reproduction Test)
GLP compliance:
yes (incl. certificate)
Specific details on test material used for the study:
Details on properties of test surrogate or analogue material (migrated information):
PHYSICO-CHEMICAL PROPERTIES
- Vapour pressure: at 20 C : 4 mbar
at 50 C : 8 mbar
Analytical monitoring:
yes
Details on sampling:
- Concentrations:
- Sampling method: HPLC and MSD detection
- Sample storage conditions before analysis:Sample were analyzed immediately
Test organisms (species):
Daphnia magna
Details on test organisms:
TEST ORGANISM
- Common name: Daphnia magna STRAUS
- Strain/clone: Daphnia magna
- Source: Strain of Bundesgesundheisamt Berlin
- Age of parental stock (mean and range, SD):
- Feeding during test
- Food type: Desmodesmus subspicatus
- Amount: day 0-7: 0.1 mg C/Daphnia/day
day 8 - 21: 0.2 mg C / Daphnia / day
- Frequency: 0-7 and 8-21


ACCLIMATION
- Acclimation conditions (same as test or not): Same as test
- Type and amount of food: Same as above
- Feeding frequency: Same as above
- Health during acclimation (any mortality observed): Were recorded daily in asemi-quantitative way


Test type:
static
Water media type:
freshwater
Total exposure duration:
21 d
Hardness:
15.0 - 15.4 dH
Test temperature:
18 - 22 C (mean +/- 2 C)
pH:
7.8 - 7.9
Dissolved oxygen:
8.4 - 8.8 mg/l
Salinity:
NA
Nominal and measured concentrations:
Nominal Conc: 0.1, 0.316, 1, 3.16,  10 mg/l and control
Mean measured Conc: 0.1, 0.3, 0.8, 2.6 and 8.5
Details on test conditions:
TEST SYSTEM
- Test vessel:150 ml glass beaker holding 1 neonate in 100 ml of the  test medium
- Type (delete if not applicable): open / closed
- Material, size, headspace, fill volume: 100 ml
- Aeration:
- Type of flow-through (e.g. peristaltic or proportional diluter): semi-static system
- Renewal rate of test solution (frequency/flow rate): renewal of the test media on  Monday, Wednesday and Friday
- No. of organisms per vessel: 1 neonate per vessel
- No. of vessels per concentration (replicates): 10 per concentration and control
- No. of vessels per control (replicates):10 per concentration and control


TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: M4 medium
- Culture medium different from test medium: Same

OTHER TEST CONDITIONS
- Adjustment of pH: Yes
- Photoperiod:a light-dark cycle with 16 h light and 8 h darkness
- Light intensity:illumination not exceeding 800 lux


EFFECT PARAMETERS MEASURED (with observation intervals if applicable) : Inhibitory effect on the parthenogenetic reproduction rate and mobility behaviour / mortality rate of parent Daphnia, all effects were assessed at leats three times a week

RANGE-FINDING STUDY
- Test concentrations:
- Results used to determine the conditions for the definitive study:
Duration:
21 d
Dose descriptor:
NOEC
Effect conc.:
>= 8.5 mg/L
Nominal / measured:
meas. (geom. mean)
Conc. based on:
test mat.
Basis for effect:
reproduction
Duration:
21 d
Dose descriptor:
LOEC
Effect conc.:
> 8.5 mg/L
Nominal / measured:
meas. (geom. mean)
Conc. based on:
test mat.
Basis for effect:
reproduction
Details on results:
- Mortality of parent animals: at 10 mg/l : 10% mortality
- No. of offspring produced per female: 143.2 - 149.7
- Time to first brood release or time to hatch: 7 days
Reported statistics and error estimates:
NOEC and LOEC according to Dunnett's Multiple t-test

21 d-NOEC : >= 8.5 mg/l
21 d-LOEC : >  8.5 mg/l

Description of key information

The 21d-NOEC in a OECD 211 guideline study is ≥ 8.5 mg/l (nominal) for all endpoints.

Key value for chemical safety assessment

Additional information

Chronic toxicity to invertebrates has been investigated in a reproduction test with Daphnia magna following the OECD guideline 211 using semi-static exposure. No effects were observed at the maximum concentration test (10 mg/l nominal and 8.5 mg/l measured) and the NOEC are reported ≥ 8.5 mg/l (measured) for reproduction and mortality. Exposure concentrations were verified by mean of HPLC-MSD.