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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:
08 Jul - 10 Jul 2014
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2014
Report Date:
2014

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
other: Standard Concerning Testing Facility Relating to New Chemical Substances
Version / remarks:
March 31, 2011; No. 0331-8, Pharmaceutical and Food Safety Bureau, Ministry of Health, Labour and Welfare; March 29, 2011, No. 6, Manufacturing Industries Bureau, Ministry of Economy, Trade and Industry; No. 110331010, Environmental Policy Bureau, Ministry of the Environment, Japan.
Deviations:
not specified
Qualifier:
according to
Guideline:
OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)
Deviations:
no
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent

Sampling and analysis

Analytical monitoring:
yes
Details on sampling:
- Concentrations: control, 100 mg/L
- Sampling method: At the initiation of exposure: an aliquot of remaining unused test solution of each test group was taken; At the termination of exposure: an aliquot was taken from mid-depth of each replicate, without agitation (n = 1)

Test solutions

Vehicle:
no
Details on test solutions:
PREPARATION AND APPLICATION OF TEST SOLUTION
- Method: 0.0592 g of the test substance was weighed with the electronic balance. A stock solution was prepared by mixing the test substance with the dilution water to make a volume of 100 mL and then stirred for 48 h with a magnetic stirrer at 20 ± 1 °C. The test solution at 100 mg/L was prepared by diluting the whole volume of the stock solution with the dilution water to a volume of 500 mL.
- Eluate: no
- Differential loading: no
- Controls: yes, dilution water

Test organisms

Test organisms (species):
Daphnia magna
Details on test organisms:
TEST ORGANISM
- Common name: water flea
- Source: National Institute for Environmental Studies, Japan
- Feeding during test: no
- Age at study initiation: < 24 h

ACCLIMATION
- Acclimation period: 14 d
- Acclimation conditions: the same as test
- Food type: Commercial condensed live Chlorella -V12 and commercial feed for fish (YCT, suspended yeast, dried alfalfa and Tetramin)
- Amount and frequency: 0.1 - 0.2 mg C (organic carbon)/ daphnid / day
- Health during acclimation: 0 % immobilisation; no abnormalitie were observed.

Study design

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

Test conditions

Hardness:
250 mg CaCO3/L
Test temperature:
20.0 - 20.1 °C
pH:
7.9 - 8.0
Dissolved oxygen:
8.2 - 8.6 mg/L
Nominal and measured concentrations:
nominal: control, 100 mg/L
measured: control, 105 mg/L
Details on test conditions:
TEST SYSTEM
- Type: covered with lid
- Material, size, headspace, fill volume: glass, 100 mL, headspace: 0 mL, fill volume: 100 mL
- Aeration: none
- No. of organisms per vessel: 5
- No. of vessels per concentration: 4
- No. of vessels per control: 4

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: artificial reconstituted water, Elendt M4
- Culture medium different from test medium: no
- Intervals of water quality measurement: at initiation and termination of exposure

OTHER TEST CONDITIONS
- Adjustment of pH: no
- Photoperiod: 16 h light/8 hour dark
- Light intensity: Room lighting = 5.31 - 10.20 μE/m²/s (measured)

EFFECT PARAMETERS MEASURED:
- immoblization after 24 h and 48 h

RANGE-FINDING STUDY
- Test concentrations: 10 and 100 mg/L test substance
- Results used to determine the conditions for the definitive study: yes; no effects were observed in the range-finding study
Reference substance (positive control):
yes
Remarks:
potassium dichromate (at 6-month intervals)

Results and discussion

Effect concentrations
Key result
Duration:
48 h
Dose descriptor:
EC50
Effect conc.:
> 105 mg/L
Nominal / measured:
meas. (initial)
Conc. based on:
test mat.
Basis for effect:
mobility
Details on results:
- Cumulative immobilization of control: 0 %

Results with reference substance (positive control):
- Results with reference substance valid? yes
- EC50 (48 h) = 0.97 mg/L
- Historical EC50 (48 h) = 0.81 ± 0.12 mg/L (mean ± S.D., n = 25)

Any other information on results incl. tables

Table 1. Concentrations of the test substance in the test solutions

Nominal concentration of the test substance (mg/L)

Measured concentration of the test substance (mg/L)

0 h

48 h

mean

Dilution water control

< 0.15 #1

< 0.15 #1

-

100

105

[105]

105

[105]

105

[105]

[ ] : Percentage to the nominal concentration ( % )

#1: less than quantification limit

Applicant's summary and conclusion

Validity criteria fulfilled:
yes