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Ecotoxicological information

Short-term toxicity to fish

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Administrative data

Endpoint:
short-term toxicity to fish
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2013.01.11 - 2013.08.06
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:
2013

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 203 (Fish, Acute Toxicity Test)
Deviations:
no
Qualifier:
according to
Guideline:
ISO 7346-1 (Determination of the Acute Lethal Toxicity of Substances to a Freshwater Fish [Brachydanio rerio Hamilton-Buchanan (Teleostei, Cyprinidae)] - Part 2: Semi-static method)
GLP compliance:
yes (incl. certificate)
Remarks:
(Not the chemical analyses)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
other: 51 % w/w solution in water, stabilized with X % NaOH
Details on test material:
- Substance type: Liquid
- Physical state: Light brown liquid
Specific details on test material used for the study:
Details on properties of test surrogate or analogue material (migrated information):
PHYSICO-CHEMICAL PROPERTIES of read-across material
- Boiling point: 107 °C
- Water solubility (under test conditions): > 1000 g/L
- pH 12-14
- log Pow: 1.67

Sampling and analysis

Analytical monitoring:
yes
Details on sampling:
- Concentrations: (Nominal) 0; 125; 250; 500; 1,000 and 2,000 mg/L
- Sampling method: Samples were collected at test start, before and after renewal of the test solutions and at the end of the test for chemical analysis of the test product. Duplicate samples of 10 mL were collected in 20 mL plastic vials for later analysis. Only one of these samples were analysed and only those relevant for calculation of the LCx concentrations. The spare samples were discarded after sponsor approved the report.
- Sample storage conditions before analysis: at - 20 ˚C ± 2.0˚C

Test solutions

Vehicle:
no
Details on test solutions:
A stock solution of 2000 mg/l were prepared by weighing out 4000 mg of the test product and dissolving it in 2 l of zebra fish test medium. The test solution were prepared by diluting the stock solution in the zebra fish test medium. A fresh stock solution were prepared for renewal for the test solution after 48 hours.
The chemical analysis of IBP1-Na in samples collected during the test showed that the concentrations of IBP1-Na were 73-80% of the estimated nominal concentrations. As, on average, the measured concentrations of IBP1-Na in percentage of the estimated nominal concentrations were 78% and thus not within ± 20% of the estimated nominal IBP1-Na concentrations, the statistical calculation was made on the basis of the measured concentrations.

Test organisms

Test organisms (species):
Danio rerio (previous name: Brachydanio rerio)
Details on test organisms:
TEST ORGANISM
- Common name: Zebra fish
- Source: Credo Fish, Nørresundby, Denmark

Study design

Test type:
semi-static
Water media type:
freshwater
Limit test:
no
Total exposure duration:
96 h

Test conditions

Test temperature:
22.4 ± 0.5 ˚C
pH:
7.7 ± 0.3
Dissolved oxygen:
94-100%
Nominal and measured concentrations:
See table below
Details on test conditions:
TEST SYSTEM
- Test vessel: aquarium
- Type (delete if not applicable): open
- Material, size, headspace, fill volume: Glass, 4-L, 2 litres of test soltion
- Renewal rate of test solution (frequency/flow rate): all test media were renewed after 48 hours.
- No. of organisms per vessel: 10
- No. of vessels per concentration (replicates): 1
- No. of vessels per control (replicates): 1

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water:
- Total organic carbon:
- Particulate matter:
- Metals:
- Pesticides:
- Chlorine:
- Alkalinity:
- Ca/mg ratio:
- Conductivity:
- Culture medium different from test medium:
- Intervals of water quality measurement:

OTHER TEST CONDITIONS
- Adjustment of pH:
- Photoperiod:
- Light intensity:

EFFECT PARAMETERS MEASURED (with observation intervals if applicable) :

TEST CONCENTRATIONS
- Spacing factor for test concentrations:
- Justification for using less concentrations than requested by guideline:
- Range finding study
- Test concentrations:
- Results used to determine the conditions for the definitive study:
Reference substance (positive control):
yes
Remarks:
K2Cr2O7, CAS no 7778-50-9

Results and discussion

Effect concentrations
Duration:
96 h
Dose descriptor:
LC50
Effect conc.:
> 791 mg/L
Nominal / measured:
meas. (initial)
Conc. based on:
act. ingr.
Basis for effect:
mortality
Remarks on result:
other: Nor mortality or any other significant effects were observed in even the highest exposed concentrations, nominal > 2000 mg/L measured concentration >1551 mg/L
Details on results:
- Behavioural abnormalities: None observed
- Behavioural abnormalities: None observed
- Mortality of control: None
- Other adverse effects control: None
Results with reference substance (positive control):
- Results with reference substance valid?
- Mortality: 7 at 200 mg/L, 10 at 300 mg/L, 10 at 400 mg/L
- LC50: 189 mg/L (48 hours)
- Other adverse effects: Swimming behavior, off balance

Applicant's summary and conclusion

Validity criteria fulfilled:
yes
Remarks:
The mortality in the controls <10% . The dissolved oxygen concentration > 60%. The average fish loading of 0.59 g/L met recommendation. Reference substance with LC50 189 mg/L is below normal 200-400 mg/L slightly higher sensitivity of fish.
Conclusions:
LC50(96h) of the test item, sodium O,O-diisobutyl dithiophosphate, CAS No. 53378-51-1 exceeds 791 mg/L for Danio rerio
Remark: the test solution contains NaOH due to the production method.