Registration Dossier

Administrative data

Endpoint:
short-term toxicity to fish
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP-guideline study with analytical monitoring

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2003
Report Date:
2003

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 203 (Fish, Acute Toxicity Test)
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Tridecanol A
- Physical state: liquid/colourless-clear
- Analytical purity: 99.95%

Sampling and analysis

Analytical monitoring:
yes

Test solutions

Vehicle:
yes
Details on test solutions:
PREPARATION AND APPLICATION OF TEST SOLUTION
- Method: Concentrations were prepared separately. The weighted test substance was dissolved with 1 mL ethanol and filled up with the required amount of water in the test vessel. An aliquot of the test water was taken and mixed with the ethanolic solution was purred into the test vessel and the whole test batch was homogenized again.
- Chemical name of vehicle: Ethanol

Test organisms

Test organisms (species):
Danio rerio (previous name: Brachydanio rerio)
Details on test organisms:
TEST ORGANISM
- Common name: Zebra fish
- Source: Zierfisch Center Kloeckner Ludwigshafen, Germany
- Age at study initiation: approximately 4 months
- Length at study initiation (mean, range): 3.4 cm (3.0 - 3.9 cm)
- Weight at study initiation (mean and range): 0.38 g (0.24 - 0.63 g)
- Method of breeding:
- Feeding during test: Withdrawal of feed during the last day before start of exposure
- Food type: commercial fish diet Tetramin, Tetra Werke Melle, Germany
- Amount and frequency: ad libitum, additionally generally on workdays live brine shrimp

ACCLIMATION
- Acclimation period: 14 days
- Acclimation conditions: same as test
- Medical treatment: none
- Mortality: none

Study design

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

Test conditions

Hardness:
ca. 2.5 mmol/L
Test temperature:
23 - 24 °C
pH:
7.8 - 8.4
Dissolved oxygen:
- > 60% at the start of the intervals
- about 52% - 79% at the end of the 24 hour interval
Nominal and measured concentrations:
Nominal test concentrations: control, 1.0, 2.2, 5.0 mg/L
Recovery rate (initially): 68 - 120%
Recovery rate (end of intervals): 20 - 32%
Details on test conditions:
TEST SYSTEM
- Test vessel:
- Material, size, fill volume: glass aquaria, 30 x 22 x 24 cm, 10 L
- Aeration: Test batches were not aerated because of high losses of the test substance in preliminary tests
- Renewal rate of test solution: 24 hours interval
- No. of organisms per vessel: 10
- No. of vessels per concentration (replicates): 1
- No. of vessels per control (replicates): 1
- No. of vessels per vehicle control (replicates): 1
- Biomass loading rate: 0.4 g fish/L
- Feeding: None

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: Non-chlorinated charcoal filtered tap water, aerated
- Acid capacity: ca. 5.5 mmol/L
- Ca/mg ratio: 8:1
- Conductivity: ca. 550 µS/cm (25 °C)
- Intervals of water quality measurement: Temperature, oxygen content and pH value were measured directly after introduction of fish and shortly before removal after 24 hours for each of the 4 test intervals.

OTHER TEST CONDITIONS
- Photoperiod: 16 h light, 8 h dark

EFFECT PARAMETERS MEASURED: Survival and toxic signs after 1, 4, 24, 48, 72, 96 h

Results and discussion

Effect concentrationsopen allclose all
Duration:
96 h
Dose descriptor:
LC0
Effect conc.:
0.6 mg/L
Nominal / measured:
meas. (not specified)
Conc. based on:
test mat.
Basis for effect:
mortality
Duration:
96 h
Dose descriptor:
LC50
Effect conc.:
0.8 mg/L
Nominal / measured:
meas. (not specified)
Conc. based on:
test mat.
Basis for effect:
mortality
Duration:
96 h
Dose descriptor:
LC100
Effect conc.:
1.1 mg/L
Nominal / measured:
meas. (not specified)
Conc. based on:
test mat.
Basis for effect:
mortality
Details on results:
- Any observations that might cause a difference between measured and nominal values: Aqueous phase was clear, at interval start undissolved test substance was visible on the surface (concentrations >= 2.2 mg/L), but at interval end the concentrations containing solvent were turbid.
Reported statistics and error estimates:
The mean lethal concentration after 1, 4, 24, 48, 72 and 96 hours were calculated with the probit analysis (Finney DJ, 1971)

Any other information on results incl. tables

Cumulative Mortality (number of dead animals):
-----------------------------------------------
Nominal
Conc.
mg/L fish No. 1h 4 h 24h 48h 72h 96h
0 10 0 0 0 0 0 0
0* 10 0 0 0 0 0 0
1.0 10 0 0 0 0 0 0
2.2 10 0 0 0 10 10 10
5.0 10 0 0 10 10 10 10
----------------------------------------------
0*: solvent control


Symptoms:
-----------------------------------------------
Nominal
Conc.
mg/L fish No. 1h 4 h 24h 48h 72h 96h
0 10 n n n n n n
0* 10 n n n n n n
1.0 10 n n n n n n
2.2 10 n n A(1) - - -
5.0 10 n n A(1) - - -
D(5)
----------------------------------------------
0*: solvent control
n: no symptoms observed
A: apathy
D: swimming at the bottom
-: all animals dead
Numbers in brackets = number of animals affected
Results on the basis of the nominal concentrations:
NOEC (96 h): 1.0 mg/L
LC0 (96 h): 1.0 mg/L
LC50 (96 h): 1.5 mg/L
LC100 (96 h): 2.2 mg/L

Applicant's summary and conclusion