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:
20/12/2010-22/12/2010
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: The study was conducted according to OECD guidelines and following GLP criteria.

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
Guideline:
OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)
Qualifier:
equivalent or similar to guideline
Guideline:
other: Alga growth inhibition test, Daphnia Sp. acute immobilisation test, and fish acute toxicity 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

Constituent 1
Reference substance name:
E-BK105
IUPAC Name:
E-BK105
Details on test material:
- Name of test material (as cited in study report): E-BK105
- Substance type: black powder
- Physical state: solid
- Lot/batch No.: MB-1
- Stability under test conditions: stable
- Storage condition of test material: in a desiccator (room temperature, shaded, air-tight)

Sampling and analysis

Analytical monitoring:
yes
Details on sampling:
- Concentrations: 100 mg/L
- Sampling method: collection from the middle layer of the vessel

Test solutions

Vehicle:
no
Details on test solutions:
Test solutions were prepapred just prior to the exposure, by addition of 100 mg test substance to 1000 ml dilution water. The mixing method was by inversion.

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): less than 24-h old (females)
- Feeding during test: no feeding during the test


ACCLIMATION
- Acclimation period: 28 days or less
- Acclimation conditions (same as test or not): yes
- Type and amount of food: Chlorella vulgaris, 6mg C/2L
- Feeding frequency: daily
- Health during acclimation (any mortality observed): the mortality in the parenthal Daphnids during 2-weeks period prior to start of exposure was 20% or less

Study design

Test type:
static
Water media type:
freshwater
Limit test:
yes
Total exposure duration:
48 h

Test conditions

Hardness:
234 mg/L
Test temperature:
20.0-20.3 C
pH:
7.8-8.1
Dissolved oxygen:
8.6-8.8 mg/L
Nominal and measured concentrations:
Nominal: 100 mg/L
Measured: 100 mg/L (mean)
Details on test conditions:
TEST SYSTEM
- Test vessel: beaker
- Type: closed
- Material, size, headspace, fill volume: 100 ml, glass
- Aeration: no
- No. of organisms per vessel: 5
- No. of vessels per concentration (replicates): 4
- No. of vessels per control (replicates): 4
- Biomass loading rate: 5 daphnids per vessel

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: Elendt M4
- Culture medium different from test medium: no
- Intervals of water quality measurement: 0 and 48 h

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

EFFECT PARAMETERS MEASURED (with observation intervals if applicable) : median effect concentration with observation intervals of 24 h

TEST CONCENTRATIONS
- Spacing factor for test concentrations: only 0 and 100 mg/L used in the final test
- Range finding study: yes
- Test concentrations: 0; 1; 10 and 100 mg/L
- Results used to determine the conditions for the definitive study: after 48 h and for all concentrations, no immobility of Daphnids was observed
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:
measured concentration was within 20% of nominal
Basis for effect:
mobility
Results with reference substance (positive control):
- Results with reference substance valid? yes
- EC50: 0.81 mg/L ( 95% C.I. 0.75-0.87 mg/L)
- Other: the sensitivity to the reference substance was tested periodically. The results indicated here are from the testing period 20-22 July 2010. The EC50 falls within the lab's historical range (since 1998) of 0.57-1.02 mg/L

Applicant's summary and conclusion

Validity criteria fulfilled:
yes
Conclusions:
Under the conditions of the present study. E-BK 105 at a concentration of 100 mg/L did not cause immobility in Daphnia (EC50 > 100 mg/L).