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Short-term toxicity to fish

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Endpoint:
short-term toxicity to fish
Type of information:
experimental study
Adequacy of study:
key study
Study period:
01/10/2007-12/12/2007
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Remarks:
Performed under GLP
Reason / purpose:
reference to same study
Qualifier:
according to
Guideline:
EU Method C.1 (Acute Toxicity for Fish)
Deviations:
no
Qualifier:
according to
Guideline:
OECD Guideline 203 (Fish, Acute Toxicity Test)
Deviations:
no
Principles of method if other than guideline:
Not relevant
GLP compliance:
yes
Specific details on test material used for the study:
Details on properties of test surrogate or analogue material (migrated information):Not relevant
Analytical monitoring:
yes
Details on sampling:
- Concentrations: Nominal concentrations 0.50, 1.6, 5.0, 16 and 50 mg/l- Sampling method: All samples were taken from the approximate center of the test vessels without mixing of the test media. Due to analytical requirements, to all samples methanol was added (0.05 ml methanol per 1 ml test medium). Four samples were taken from each test medium and from the control just before test start, on the last day of preparation, at the end of the first test medium renewal period and at the end of the last renewal period. However, no samples were taken from the highest nominal test concentration of 50 mg/l on days 1, 3 and 4 since all fish were dead at this concentration by that time.- Sample storage conditions before analysis: Immediately after sampling and addition of methanol, samples were deep-frozen (at about -20°C)
Vehicle:
no
Details on test solutions:
PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)- Method: The test medium with the highest test concentration of nominal 50 mg/l was freshly prepared at the start of the test by weighing 550 mg of test item completely in 11 liters of test water. At the test medium renewal dates, 275 mg were weighed into 5.5 liters of test water. For this, stirring for 20 minutes at room temperature in a completely filled and tightly closed stirring vessel was applied. This test medium with the highest test concentration was also used as a stock solution to prepare the test media with lower concentrations.The test media were freshly prepared just before introduction of the fish at the start of the test and before each test medium renewal. The actual concentrations were analytically determined. - Controls: Test water without test item was used as a control.
Test organisms (species):
Danio rerio (previous name: Brachydanio rerio)
Details on test organisms:
TEST ORGANISM- Common name: Zebra fish- Source: RCC laboratories- Length at study initiation (length definition, mean, range and SD): mean body length 3.0 ± 0.08 cm (mean ± SD)- Weight at study initiation (mean and range, SD): mean body wet weight 0.22 ± 0.01 g (mean ± SD)ACCLIMATION- Acclimation period: one week- Acclimation conditions : same test water and temperature as test- Type and amount of food: commercial fish diet (Tetra Min Hauptfutter) until one day before the start of the test- Health during acclimation (any mortality observed): No mortality during the last two weeks prior to the test in the test fish batch and all fish were healthy
Test type:
semi-static
Water media type:
freshwater
Limit test:
no
Total exposure duration:
96 h
Post exposure observation period:
None.
Hardness:
Water hardness 1.25 mmol/l, 125 mg/l as CaCO3
Test temperature:
22-23°C during the test period
pH:
7.4-7.5
Dissolved oxygen:
6.0-9.0 mg/l
Salinity:
Not relevant
Nominal and measured concentrations:
Nominal concentrations: 0.50, 1.6, 5.0, 16 and 50 mg/lSince the Limit of Quantification for the test material was 1.9 mg/l and the 96-hour NOEC was 5.0 mg/l, the samples taken from the lowest test concentrations of 0.50 and 1.6 mg/l were not analyzed. Therefore measured concentrations are only available for the highest 3 concentrations.Mean measured concentrations: 4.85, 16.1 and 52.9 mg/l (97, 101 and 106% of nominal). Mean concentration is over start and end exposure concentration for 2 renewal periods
Details on test conditions:
TEST SYSTEM- Test vessel: - Type (delete if not applicable): closed - Material, size, headspace, fill volume: 5 liter Erlenmeyer flask, nearly completely filled to keep the air space in the flasks as small as possible, tightly sealed. - Aeration: The test media were slightly aerated during the test period. For this, the air from the small air-space above the test media was sucked off by means of a pump and was slowly bubbled back into the test medium at the bottom of the test flask. In this way, the dissolved oxygen concentrations in the test media was kept sufficiently high, and additionally evaporated test item was dosed back into the test medium.- Renewal rate of test solution (frequency/flow rate): daily test medium renewal- No. of organisms per vessel: 7- No. of vessels per concentration (replicates): 1- No. of vessels per control (replicates): 1- Biomass loading rate: 0.3 g fish wet weight per liter test mediumTEST MEDIUM / WATER PARAMETERS- Source/preparation of dilution water: reconstituted test water ISO 6341 at 50 % of concentrations- Alkalinity: 0.4 mmol/l- Ca/Mg ratio: 4:1- Culture medium different from test medium: no- Intervals of water quality measurement: 24 hoursOTHER TEST CONDITIONS- Photoperiod: 16-hour light to 8-hour dark, with a 30-minute transition period- Light intensity: 50-500 lux EFFECT PARAMETERS MEASURED (with observation intervals if applicable) : The test fish were observed after approximately 2, 24, 48, 72 and 96 hours test duration for mortality and visible abnormalities. TEST CONCENTRATIONS- Spacing factor for test concentrations: 3.2- Justification for using less concentrations than requested by guideline: The enlarged spacing factor of 3.2 between the test concentrations was chosen, because according to the results of the range-finding test the concentration-effect relationship was rather fat and thus a large concentration range had to be tested.
Reference substance (positive control):
no
Duration:
96 h
Dose descriptor:
NOEC
Effect conc.:
5 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Duration:
96 h
Dose descriptor:
LC0
Effect conc.:
5 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Duration:
96 h
Dose descriptor:
LOEC
Effect conc.:
16 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality
Duration:
96 h
Dose descriptor:
LC100
Effect conc.:
16 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality
Duration:
2 h
Dose descriptor:
LC50
Effect conc.:
28 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality
Remarks on result:
other: 95% CL: 16-50 mg/l
Duration:
24 h
Dose descriptor:
LC50
Effect conc.:
28 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality
Remarks on result:
other: 95% CL: 16-50 mg/l
Duration:
48 h
Dose descriptor:
LC50
Effect conc.:
20 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality
Remarks on result:
other: 95% CL: 8.1-51 mg/l
Duration:
72 h
Dose descriptor:
LC50
Effect conc.:
11 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality
Remarks on result:
other: 95% CL: 5.1-21 mg/l
Duration:
96 h
Dose descriptor:
LC50
Effect conc.:
8.9 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality
Remarks on result:
other: 95% CL: 5.0-16 mg/l
Details on results:
- Behavioural abnormalities: Apathy, fish mainly at the bottom of the aquarium, tumbling during swimming.- Mortality of control: 0%
Results with reference substance (positive control):
Not relevant
Reported statistics and error estimates:
The LC50 and the 95%-confidence interval at the observation dates after 2, 72 and 96 hours were calculated by Moving Average Interpolation. The LC50 at the observation intervals after 24 and 48 hours could not be calculated by Probit Analysis or Moving Average Interpolation due to the steep concentration-effect relationship. Instead, the LC50-values were determined as a geometric mean value of the two consecutive test concentrations with 0 and 100% mortality, and the 95% confidence limits for the LC50 as the test concentrations with 0 and 100% mortality. The NOEC, LOEC, LC0 and LC100 were determined directly from the raw data.

Not relevant.

Validity criteria fulfilled:
yes
Remarks:
Mortality < 10%, oxygen concentration > 60% of saturation value, exposure concentrations > 80% of nominal concentrations, the tes system ensured maintenance of constant conditions and test substance concentrations
Conclusions:
The 96h LC50 of Tetrahydrolinalool for zebra fish is 8.9 mg/l, with 95% conficence interval 5.0 - 16 mg/l. The NOEC for visible abnormalities was 5.0 mg/l.
Executive summary:

The toxicity of Tetrahydrolinalool to zebra fish (Brachydanio rerio) was determined in a 96-hour semi-static test with a daily test medium renewal according to the OECD Guideline for Testing of Chemicals No. 203 (1992), under GLP. Validity criteria for the test were met. The 96h LC50 was found to be 8.9 mg/l (95%-confidence interval 5.0 -16 mg/l). The NOEC for visible abnormalities was 5.0 mg/l.

Endpoint:
short-term toxicity to fish
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Justification for type of information:
See attached justification
Reason / purpose:
read-across source
Key result
Duration:
96 h
Dose descriptor:
LC50
Effect conc.:
8.9 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality
Remarks on result:
other: 95% CL: 5.0-16 mg/l
Duration:
96 h
Dose descriptor:
NOEC
Effect conc.:
5 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Conclusions:
The 96h LC50 of Tetrahydrolinalyl acetate for zebra fish is 0.225 mg/l.
Executive summary:

The toxicity of Tetrahydrolinalyl acetate to zebra fish (Brachydanio rerio) was read across from Tetrahydrolinalool. For this substance the toxicity was determined in a 96-hour semi-static test with a daily test medium renewal according to the OECD Guideline for Testing of Chemicals No. 203 (1992), under GLP. Validity criteria for the test were met. The 96h LC50 was found to be 8.9 mg/l (95%-confidence interval 5.0 -16 mg/l). The NOEC for visible abnormalities was 5.0 mg/l. For justifying read across to THLA, a molecular weight correction was applied together with applying a safety factor of 50. This thus results in a LC50 of 0.225 mg/L.

Description of key information

The toxicity of Tetrahydrolinalyl acetate to zebra fish (Brachydanio rerio) was read across from Tetrahydrolinalool. For this substance the toxicity was determined in a 96-hour semi-static test with a daily test medium renewal according to the OECD Guideline for Testing of Chemicals No. 203 (1992), under GLP. Validity criteria for the test were met. The 96h LC50 was found to be 8.9 mg/l (95%-confidence interval 5.0 -16 mg/l). The NOEC for visible abnormalities was 5.0 mg/l. For justifying read across to THLA, a molecular weight correction was applied together with applying a safety factor of 50. This thus results in a LC50 of 0.225 mg/L.

Key value for chemical safety assessment

LC50 for freshwater fish:
0.225 mg/L

Additional information