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Short-term toxicity to fish

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Reference
Endpoint:
short-term toxicity to fish
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2003-10-13 to 2003-10-17
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 203 (Fish, Acute Toxicity Test)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method C.1 (Acute Toxicity for Fish)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Specific details on test material used for the study:
SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: Batch no.: 42638, Test substance no.: 03/0183-1

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: At room temperature, store under N2
- Stability under test conditions: The stability under storage conditions were determined by reanalysis. The results were reported in an amendment to the study report.

TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing: The test substance was melted at a temperature of approx. 80°C and was weighed into a beaker.

FORM AS APPLIED IN THE TEST (if different from that of starting material): liquid
Analytical monitoring:
yes
Details on sampling:
- Concentrations: 0 and 100 mg/L
- Sampling method: Samples for analytical determination of the concentration were taken within the first hour after the start of exposure and at the end of the exposure after approx. 96 hours. Water samples were taken from the middle of the test vessel using a beaker and were transported to the analytical laboratory in glass ampoulles, which were rinsed with test solution before they were filled.
- Sample storage conditions before analysis: ambient temperature; The transport to the Analytical Laboratory was done the on day of sampling.
Vehicle:
no
Details on test solutions:
PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Method: The test concentrations were prepared separately for each test vessel. The test substance was melted at a temperature of approx. 80°C and was weighed into a beaker. The defined volume of test water was filled into the test vessel. An aliquot from the test water in the test vessel was taken and mixed with the test substance in the beaker using ultra turrax. The mixture was poured into the test vessel and the whole test batch was homogenized again with an ultra turrax.
Weighed amount of test substance (g): 1.0016; Volume of test water (L): 10
- Evidence of undissolved material (e.g. precipitate, surface film, etc.): no remarkable observations, clear test medium.
Test organisms (species):
Danio rerio (previous name: Brachydanio rerio)
Details on test organisms:
TEST ORGANISM
- Common name: Zebrafish
- Source: Zierfisch-Center Klöckner, Ludwigshafen, Germany
- Age at study initiation (mean and range, SD): Approx. 6 months
- Length at study initiation (length definition, mean, range and SD): 4.0 cm (3.6 - 4.2 cm)
- Weight at study initiation (mean and range, SD): 0.61 g (0.46 - 0.95 g)

ACCLIMATION
- Acclimation period: 14 d
- Type and amount of food during acclimation: Commercial fish diet "Tetramin", supplier Tetra-Werke, Melle, Germany, ad libitum, additionally generally on workdays live brine shrimp (artemia).
- Feeding frequency during acclimation: daily, Withdrawal of feed: During the last day before start of exposure
- Health during acclimation (any mortality observed): 0 % mortality

FEEDING DURING TEST: None
Test type:
static
Water media type:
freshwater
Limit test:
yes
Total exposure duration:
96 h
Hardness:
Approx. 2.5 mmol/L = 250 mg/L CaCO3
Test temperature:
24°C
Temperature was measured in each test vessel within 1 hour after start of exposure and after 24, 48, 72 and 96 hours.
pH:
7.9 - 8.1
PH-value was measured in each test vessel within 1 hour after start of exposure and after 24, 48, 72 and 96 hours.
Dissolved oxygen:
6.8 - 8.1 mg/L
Oxygen content was measured in each test vessel within 1 hour after start of exposure and after 24, 48, 72 and 96 hours.
Conductivity:
Approx. 550 µS/cm (at 25°C)
Nominal and measured concentrations:
Nominal: 0 and 100 mg /L
Measured: 0 and 80.5 (0 h) and 89.1 (96 h)
Details on test conditions:
TEST SYSTEM
- Test vessel: Aquaria
- Material, size, headspace, fill volume: Material: glass; Size: 30 cm long, 22 cm wide, 24 cm high; Volume of water: 10 L
- Aeration: Slight
- No. of organisms per vessel: 10
- No. of vessels per concentration (replicates): 1
- No. of vessels per control (replicates): 1
- Biomass loading rate: 0.6 g fish/L water

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: Non chlorinated charcoal filtered tap water (Frankenthal, Germany), aerated
- Ca/mg ratio: 80/10 mg/L
- Intervals of water quality measurement: The test water is regularly assayed for chemical contaminants by the municipal authorities of Frankenthal and the Technical Services of BASF Aktiengesellschaft as well as for presence of microbes by a contract laboratory.

OTHER TEST CONDITIONS
- Photoperiod: 16 hours Iight, 8 hours darkness
- Light intensity: Approx. 75 - 236 Lux (the Iight intensity is determined in regular intervais at the surface of the aquaria)

EFFECT PARAMETERS MEASURED (with observation intervals if applicable) :
The fish were observed for survival and toxic signs (changes in appearance, swimming behaviour and behaviour in comparison to the control group) within 1 hour after start of exposure and 4, 24, 48, 72 and 96 hours after start of exposure. Fish were considered dead if there was no visible movement and no reaction after touching. Dead fish were removed from the test vessels.

TEST CONCENTRATIONS
- Range finding study: The test concentrations were selected on the basis of the non-GLP range finding the part of study. The raw data of this part are archived together with the raw data of this study.
- Results used to determine the conditions for the definitive study: LC50 range derived from 96 hour range finding: > 100 mg/L
Reference substance (positive control):
no
Key result
Duration:
96 h
Dose descriptor:
LC50
Effect conc.:
> 100 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality (fish)
Duration:
96 h
Dose descriptor:
LC50
Effect conc.:
> 84.4 mg/L
Nominal / measured:
meas. (geom. mean)
Conc. based on:
test mat.
Basis for effect:
mortality (fish)
Duration:
96 h
Dose descriptor:
NOEC
Effect conc.:
>= 100 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality (fish)
Duration:
96 h
Dose descriptor:
NOEC
Effect conc.:
>= 84.4 mg/L
Nominal / measured:
meas. (geom. mean)
Conc. based on:
test mat.
Basis for effect:
mortality (fish)
Details on results:
- Behavioural abnormalities: no symptoms observed
- Mortality of control: none
- Other adverse effects control: none
- Abnormal responses: none

Sublethal observations / clinical signs:

Table 1: Cumulative mortality (number of dead animals)

nominal

concentration (mg/L)

Number of fish

1 hour

4 hours

24 hours

48 hours

72 hours

96 hours

0

10

0

0

0

0

0

0

100

10

0

0

0

0

0

0

 

Table 2: Symptoms

nominal

concentration (mg/L)

Number of fish

1 hour

4 hours

24 hours

48 hours

72 hours

96 hours

0

10

n

n

n

n

n

n

100

10

n

n

n

n

n

n

Explanation of abreviations

n         no symptoms observed                       T         tottering

D        swimming at the bottom                      C     swimming at the surface

A         apathy                                              -          not observed/all animals dead

Numbers in brackets = number of animals affected

 

 

Table 2: The recoveries of the test substance during exposure in the aquaria

nominal

concentration (mg/L)

analytically determined concentration (mg/L)

at start of exposure*

after 96 hours*

mean

% of nominal

0

n.d.

n.d.

 

 

100

80.5

89.1

84.8

85 %

*        mean values of two measurements

n.d.    not detected

-         not measured

Validity criteria fulfilled:
not specified
Conclusions:
The effect values LC50 and NOEC were both determined as > 100 mg/L of Nonane-1,9-diol based on nominal concentrations.
Executive summary:

The toxicity of Nonane-1,9-diol to Danio rerio was determined in a reliable limit test according to OECD 203 and in compliance with GLP. Individuals of D. rerio were exposed to the substance in a concentration of 100 mg/L, equivalent to 84.8 mg/L mean measured concentration for 96 hours. The concentration was analytically verified via GC-FID. No mortality and no abnormal behaviour were observed within the 96 hours. The effect values LC50 and NOEC were both determined as > 100 mg/L of Nonane-1,9-diol based on nominal concentrations.

Description of key information

LC50 (96 h) > 100 mg/L (nominal)

NOEC (96 h) > 100 mg/L (nominal)

Key value for chemical safety assessment

Fresh water fish

Fresh water fish
Effect concentration:
100 mg/L

Additional information

The toxicity of Nonane-1,9-diol to Danio rerio was determined in a reliable limit test according to OECD 203 and in compliance with GLP. Individuals of D. rerio were exposed to the substance in a concentration of 100 mg/L, equivalent to 84.8 mg/L mean measured concentration for 96 hours. The concentration was analytically verified via GC-FID. No mortality and no abnormal behaviour were observed within the 96 hours. The effect values LC50 and NOEC were both determined as > 100 mg/L of Nonane-1,9-diol based on nominal concentrations.

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