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Administrative data

Endpoint:
short-term toxicity to fish
Type of information:
experimental study
Adequacy of study:
other information
Study period:
24th April 2006 - 28th April 2006
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2006
Report date:
2006

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
EU Method C.1 (Acute Toxicity for Fish)
Version / remarks:
29 December 1992
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 203 (Fish, Acute Toxicity Test)
Version / remarks:
17 July 1992
GLP compliance:
yes

Test material

Constituent 1
Test material form:
solid: particulate/powder
Details on test material:
Light pink tinted powder
Specific details on test material used for the study:
Physical state/Appearance: Lightly pink tinted powder
Batch: Batch ref Y12511/002/001, bottle no. 287981)
Purity: 99.8% w/w
Expiry Date: not specified
Storage Conditions: Room temperature in the container it was received

Sampling and analysis

Analytical monitoring:
yes
Details on sampling:
- Concentrations:
- Sampling method: Samples were taken from the solvent control, dilution water control and the 2.0, 4.0, 8.0, 16 and 32 mg/L test group. Samples were taken from the centre of the test solution
- Sample storage conditions before analysis: The samples were analyzed on the day of receipt

Test solutions

Vehicle:
yes
Remarks:
Dimethylformamide
Details on test solutions:
PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Method:. A 10 ml volume, nominal 320000 mg/l stock solution of UL125 was prepared by dissolving 3.200g of test substance in dimethylformamide (DMF), forming a clear dark brown solution.
Test substance concentrations were prepared by the addition of appropriate volume of stock solution to 20 l volumes of test dilution water, pre dispensed into the test tanks. Where appropriate, equalising volumes of DMF were pre-added, such that the final solvent concentration was 100 µl/l in all cases. the colvent control was prepared by the addition of 2000 µl of DMF to 20 l dilution water. Post additions, all were stirred using the glass aeration pipettes. the contol sonsisted of dilution water only.
- Controls:The control and the solvent control groups were maintained under identical conditions but not exposed to the test item.
- Chemical name of vehicle (organic solvent, emulsifier or dispersant):dimethylformamide.
- Concentration of vehicle in test medium (stock solution and final test solution(s) or suspension(s) including control(s)):100 μL/L

Test organisms

Test organisms (species):
Oncorhynchus mykiss (previous name: Salmo gairdneri)
Details on test organisms:
TEST ORGANISM
- Common name: Rainbow trout
- Strain: Oncorhynchus mykiss
- Source (laboratory, culture collection): farm

ACCLIMATION
- Acclimation period: 7 days
- Two mortalities were observed in the bacth of fish in the 7 days days prior to the test. the fish showed no evidence of disease during holding but were treated prophylactically for 13 days post arrival in 255 seawater.

Study design

Test type:
static
Water media type:
other: dechlorinated tap water, which had been passed through activated carbon, coarsely filtered to remove particulate material and dechlorinated with sodium thiosulphate. Salts were added to maintain minimum hardness levels.
Remarks:
The treated water was then passed through an ultraviolet steriliser to a section set of 20 and 10 µm filters. the supply was then delivered to a temperature-controlled header tank in the test laboratory set to nominal test temperature +/- 1 degree c
Limit test:
no
Total exposure duration:
96 h

Test conditions

Hardness:
43.7 mg CaCO3/L
Test temperature:
15 +/- 1 degrees centigrade
pH:
7.6 to 7.8
Dissolved oxygen:
9.4 to 10.0 mg/l - at no point during the course of the study was dissolved oxygen concentration in any of the test veseels less than 60% of the air-saturation value (at 6.1 mg/l)
Conductivity:
232 µS/cm @ 25 degrees centigrade
Nominal and measured concentrations:
the measured concentrations at the start of the test ranged from 50 to 55% of the nominal values. The measured concentrations at the end of the test ranged from 65 to 75% of the nominal values. No measured losses in test substance concentration were determined over the test period. On the basis of the analytical data, the arithmetic means of the measured UL125 concentrations were adopted for the calculation and reporting of the results.
Details on test conditions:
TEST SYSTEM
- Test vessel: single borosilicate glass vessels (external dimentions: 400mm x 280mm x 280 mm; length x width x heght) were used for the dilution water control and the exposure solution. the vessels had a working volume of 20 l.

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: dechlorinated tap water, which had been passed through activated carbon, coarsely filtered to remove particulate material and dechlorinated with sodium thiosulphate. Salts were added to maintain minimum hardness levels. The treated water was then passed through an ultraviolet steriliser to a section set of 20 and 10 µm filters. the supply was then delivered to a temperature-controlled header tank in the test laboratory set to nominal test temperature +/- 1 degree c

OTHER TEST CONDITIONS
- Adjustment of pH: no
- Photoperiod 16 hours fluorescent light and 8 hours dark with 20 minute dawn and dusk transition period commencting at 06:00 and 21:40 hours.
- Temperature: 15 ± 1 °C under

EFFECT PARAMETERS MEASURED (with observation intervals if applicable):
Observations for mortalities and symptoms of toxicity were made at 3, 24, 48, 72 and 96 hours.

TEST CONCENTRATIONS
- Spacing factor for test concentrations: not applicable – limit test
- Test concentrations: control, solvent control (DMF) and nominal concentration of 2.0, 4.0, 8.0, 16 and 32 mg/l

Results and discussion

Effect concentrationsopen allclose all
Duration:
24 h
Dose descriptor:
LC50
Effect conc.:
7.2 mg/L
Basis for effect:
mortality (fish)
Duration:
48 h
Dose descriptor:
LC50
Effect conc.:
6.2 mg/L
Basis for effect:
mortality (fish)
Duration:
72 h
Dose descriptor:
LC50
Effect conc.:
4.8 mg/L
Basis for effect:
mortality (fish)
Duration:
96 h
Dose descriptor:
LC50
Effect conc.:
4 mg/L
Basis for effect:
mortality (fish)
Duration:
96 h
Dose descriptor:
LC100
Effect conc.:
10 mg/L
Basis for effect:
mortality (fish)
Duration:
96 h
Dose descriptor:
NOEC
Effect conc.:
2.5 mg/L
Details on results:
no Mortality observed in 4 mg/l or below nominal concentrations.
Mortality observed from 8 mg/l nominal concentration at 48 hour exposure - 48 hour 14%, 72 hour 57%, 96 hour 86%.
100% mortality observed from 48 hours in both 16 mg/l and 32 mg/l nominal concentrations.

Applicant's summary and conclusion

Validity criteria fulfilled:
yes

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