Registration Dossier

Ecotoxicological information

Short-term toxicity to aquatic invertebrates

Administrative data

Endpoint:
short-term toxicity to aquatic invertebrates
Type of information:
experimental study
Adequacy of study:
key study
Study period:
15-17 December 2010
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: The study was conducted following the GLP principles and according to the OECD and Japanese guidelines.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2011
Report Date:
2011

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)
Deviations:
no
Qualifier:
according to
Guideline:
other: "Alga growth inhibition test, Daphnia sp. acute immobilisation test, and fish acute test" Yakushokuhatsu No. 1121002, Heisei 15.11.13 Seikyoku No. 2, Kanpokihatsu No. 031121002, November 21, 2003; the latest revision November 20, 2006.
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): E-Y110
- Substance type: orange powder
- Physical state: solid
- Lot/batch No.: MB-1
- Storage condition of test material: room temperature, shaded, air-tight

Sampling and analysis

Analytical monitoring:
yes
Details on sampling:
- Concentrations: 0 and 100
- Sampling method: from the middle layer of one vessel at teh time of preparation and at the end of exposure
- Sample storage conditions before analysis: not reported

Test solutions

Vehicle:
no
Details on test solutions:
The test solutions were prepared just before exposure. First, 100 mg test substance was dissolved in 1L dilution water resulting in a concentration of 100 mg/L. the solution was mixed by inversion and used as such in the test.

Test organisms

Test organisms (species):
Daphnia magna
Details on test organisms:
TEST ORGANISM
- Common name:Daphnia
- Strain: Daphnia magna
- Source: National Institute for Environmental Studies, Japan
- Age at study initiation (mean and range, SD):< 24 h old juvenile females
- Feeding during test: none


ACCLIMATION
- Acclimation period: 2-4 weeks
- Acclimation conditions (same as test or not): yes
- Type and amount of food: unicellular green algae, Chlorella vulgaris
- Feeding frequency: 6 mg C/2 L/ day
- Health during acclimation (any mortality observed): < 20 % mortality in parental daphnids 2 weeks prior the start of the test.

Study design

Test type:
static
Water media type:
freshwater
Limit test:
no
Total exposure duration:
48 h

Test conditions

Hardness:
248 mgCaCO3/L
Test temperature:
20.0 - 20.2
pH:
7.9 - 8.3
Dissolved oxygen:
8.1 - 8.8
Nominal and measured concentrations:
Nominal: 0 and 100 mg/L
Measured (mean): 102
Details on test conditions:
TEST SYSTEM
- Test vessel: beakers
- Type: closed
- Material, size, headspace, fill volume: glass, 100 ml
- Aeration: no
- No. of organisms per vessel: 5
- No. of vessels per concentration (replicates): 4
- No. of vessels per control (replicates): 4


TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: Elendt M4
- Culture medium different from test medium: no

OTHER TEST CONDITIONS
- Adjustment of pH: no
- Photoperiod: 16 h light/ 8 h darkness
- Light intensity: 800 lux

EFFECT PARAMETERS MEASURED (with observation intervals if applicable) : median effect concentration for immobility

TEST CONCENTRATIONS
- Spacing factor for test concentrations: only 0 and 100 mg/L used
- Range finding study: yes
- Test concentrations: 1.0, 10, 100 mg/L
- Results used to determine the conditions for the definitive study: no immobility was recorded up to 100 mg/L
Reference substance (positive control):
yes
Remarks:
potassium dichromate

Results and discussion

Effect concentrations
Duration:
48 h
Dose descriptor:
EC50
Effect conc.:
> 100 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Remarks:
the measured concentration was within 20% of nominal
Basis for effect:
mobility
Details on results:
- Behavioural abnormalities: no
- Observations on body length and weight: not reported
- Other biological observations: no
- Mortality of control: no
- Other adverse effects control: no
- Abnormal responses: no
- Any observations (e.g. precipitation) that might cause a difference between measured and nominal values: no precipitation, floating solids, suspended solids
- Effect concentrations exceeding solubility of substance in test medium: no
Results with reference substance (positive control):
- Results with reference substance valid? yes
- Mortality: yes
- EC50: 0.81 mg/L (95 C.I. 0.75-0.87 mg/L)
- Other: the sensitivity tests were performed at every 6 months. the above results were the most recent in regard to the date of the experiment start. the historical range (since June 1998) average +/- SD: 0.73 +/- 0.12, n = 25; minimum-maximum: 0.57 - 1.02 mg/L.

Applicant's summary and conclusion

Validity criteria fulfilled:
yes
Conclusions:
Under the conditions of this experiment, E-Y 110 did not induce acute immobilisation in daphnids up to 100 mg/L (EC50 > 100 mg/L).