Registration Dossier

Administrative data

Endpoint:
short-term toxicity to fish
Type of information:
experimental study
Adequacy of study:
key study
Study period:
November 26 - 30, 2007
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Study has been performed according to OECD and EC guidelines and according to GLP principles.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2008
Report Date:
2008

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 203 (Fish, Acute Toxicity Test)
Deviations:
no
Qualifier:
according to
Guideline:
EU Method C.1 (Acute Toxicity for Fish)
Deviations:
no
Qualifier:
equivalent or similar to
Guideline:
ISO 7346-1 (Determination of the Acute Lethal Toxicity of Substances to a Freshwater Fish [Brachydanio rerio Hamilton-Buchanan (Teleostei, Cyprinidae)] - Part 1: Static Method)
Deviations:
no
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Corsair Clear #34
- Substance type: Clear white lumpy solid
- Physical state: Solid
- Stability under test conditions: Stable
- Storage condition of test material: At room temperature in the dark

Sampling and analysis

Analytical monitoring:
yes
Details on sampling:
- Concentrations: 0 and 100 mg/l
- Sampling method: 40 ml at t = 0 and t = 96 h
- Sample storage conditions before analysis: refrigerator

Test solutions

Vehicle:
no
Details on test solutions:
PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Method: The test substance was ground before weighing. Preparation of the test solution started with loading rates of 100 mg/l. The aqueous mixtures were treated with ultrasonic waves for 15 minutes, followed by a 24-hour magnetic stirring period and a 2¼ hour stabilisation period. The resulting mixtures were slightly hazy with a floating layer and precipitate. Therefore, the mixtures were passed over glass wool, after which they were clear and colourless. Finally, the solutions were combined and used for the test.
- Controls: Test medium without test substance or other additives

Test organisms

Test organisms (species):
Cyprinus carpio
Details on test organisms:
TEST ORGANISM
- Common name: carp
- Strain: Cyprinus carpio
- Source: Zodiac, proefacc, "De Haar Vissen", Wageningen University and Research Centre, The Netherlands.
- Age at study initiation (mean and range, SD): not indicated
- Length at study initiation (length definition, mean, range and SD): 2.4 ± 0.2 cm
- Weight at study initiation (mean and range, SD): 0.43 ± 0.09 g
- Method of breeding: F1 from a single parent-pair bred in UV-treated water.
- Feeding during test: no feeding

ACCLIMATION
- Acclimation period: At least 12 days after delivery

Study design

Test type:
static
Water media type:
freshwater
Limit test:
yes
Total exposure duration:
96 h
Post exposure observation period:
No post exposure observations

Test conditions

Hardness:
180 mg CaCO3 per litre
Test temperature:
21.4 - 23.0°C
pH:
7.3 - 8.0
Dissolved oxygen:
6.0 - 9.2 mg/l
Nominal and measured concentrations:
Loading rate 0 mg/l t=0h : TOC = 1.804 mg/l
Loading rate 0 mg/l t=96h : TOC = 0.9977 mg/l
Loading rate 100 mg/l t=0h : TOC = 1.947 mg/l
Loading rate 100 mg/l t=96h: TOC = 0.7114 mg/l
The TOC contents in treated samples were comparable to those in control samples, indicating that the actual test substance concentration was very low. This is not unexpected considering the presence of a floating layer and undissolved test substance in the solution, which were removed by passing the solution over glass wool.
Details on test conditions:
TEST SYSTEM
- Test vessel: 10 litres, all-glass, containing 9 litres of test solution.
- Aeration: Aeration was introduced after 2 days of exposure and continued for 23 hours.
- No. of organisms per vessel: 7
- No. of vessels per concentration (replicates): 1
- No. of vessels per control (replicates): 1
- Biomass loading rate: 0.33 g fish/litre

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: Adjusted ISO medium, formulated using RO-water (tap-water purified by reverse osmosis) with the following composition: CaCl2.2H2O 211.5 mg/l
MgSO4.7H2O 88.8 mg/l
NaHCO3 46.7 mg/l
KCl 4.2 mg/l

OTHER TEST CONDITIONS
- Adjustment of pH: 7.7 +/- 0.3
- Photoperiod: 16 hours daily

EFFECT PARAMETERS MEASURED: LC50 daily
Reference substance (positive control):
yes
Remarks:
pentachlorophenol

Results and discussion

Effect concentrations
Duration:
96 h
Dose descriptor:
LC50
Effect conc.:
> 100 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Remarks:
loading rate
Basis for effect:
mortality
Details on results:
No lethal or sublethal effects were observed in the control or the test concentration.
Results with reference substance (positive control):
- Results with reference substance valid: Yes
- Mortality: 0% at 0.10 mg/l; 100% at 0.22 and 0.46 mg/l
- LC50: 96h-LC50 = 0.15 mg/l with a 95% confidence interval between 0.10 and 0.22 mg/l.

Applicant's summary and conclusion

Validity criteria fulfilled:
yes
Conclusions:
Under the conditions of the present test Corsair Clear #34 induced no visible effects in carp at a loading rate of 100 mg/l (NOEC).
Due to the very low solubility of Corsair Clear #34 in water, concentration levels that might be toxic for fish could not be reached. Hence the 96h-LC50 was above a loading rate of 100 mg/l.