Registration Dossier

Ecotoxicological information

Short-term toxicity to fish

Currently viewing:

Administrative data

Link to relevant study record(s)

Reference
Endpoint:
short-term toxicity to fish
Type of information:
experimental study
Adequacy of study:
key study
Study period:
January 14 - 18, 2013
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to
Guideline:
OECD Guideline 203 (Fish, Acute Toxicity Test)
Deviations:
no
GLP compliance:
yes (incl. certificate)
Analytical monitoring:
yes
Details on test solutions:
PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Method: The stock solution was prepared by solving an appropriate amount of the test item in purified water and stirring carefully to avoid formation of air bubbles for about 2 hours at room temperature.
Test organisms (species):
Oncorhynchus mykiss (previous name: Salmo gairdneri)
Details on test organisms:
TEST ORGANISM
- Common name: Oncorhynchus mykiss
- Strain: Rainbow trout
- Source: Sauerländer Forellen GmbH, Saalhauser Str. 8, 57368 Lennestadt-Gleierbrück, Germany
- Age at study initiation (mean and range, SD):
- Length at study initiation (length definition, mean, range and SD): The fish lengths were in the range of 5.0 – 5.7 cm.
- Weight at study initiation (mean and range, SD): The mean weight resulted in a loading of 0.6 g/L test medium
Test type:
semi-static
Water media type:
freshwater
Limit test:
no
Total exposure duration:
96 h
Hardness:
1 mmol/L
Test temperature:
14.8 °C until 15.2 °C
pH:
The pH in the test vessels was between 7.9 and 8.3
Dissolved oxygen:
oxygen saturation in all test vessels was between 94 % and 108 %
Salinity:
not stated
Nominal and measured concentrations:
A non-GLP pre-test was conducted using the following nominal concentrations: control, 1, 10, and 100 mg/L (corresponding to 0.36, 3.6, and 35.8 mg a.i./L). Based on the results of the range-finder test, the nominal concentrations of the test item used were 0.625, 1.25, 2.5, 5.0, and 10 mg/L (corresponding to 0.22, 0.45, 0.90, 1.79, and 3.58 mg a.i./L).
Details on test conditions:
TEST SYSTEM
- Test vessel: The test vessels were full glass aquaria of 28 L for keeping up to 20 litres of test solution. Glass vessels were pre-saturated with the test item. For this a volume of approximately 500 mL of test solution was filled into the glass vessel, was followed by gentle moving of the aquaria resulting in a complete coverage of the glass surface. Afterwards, the test media was discarded and the glass vessels were filled with the remaining solution.
- Type (delete if not applicable): open
- Material, size, headspace, fill volume: 28 L
- Aeration: The test vessels were slightly aerated via a glass capillary.
- Type of flow-through (e.g. peristaltic or proportional diluter):
- Renewal rate of test solution (frequency/flow rate): Test media were changed daily.
- No. of organisms per vessel: Seven fish each were exposed to five nominal concentrations for a period of 96 h and seven fish were used for the control

OTHER TEST CONDITIONS
- Photoperiod: The tanks were subjected to a light/dark cycle of 14/10 hours


EFFECT PARAMETERS MEASURED (with observation intervals if applicable): Mortality and clinical signs (sub-lethal and abnormal behavior) were recorded at 3 h, 24 h, 48 h, 72 h and 96 h after fish addition.

TEST CONCENTRATIONS
- Spacing factor for test concentrations: 2
- Justification for using less concentrations than requested by guideline:
- Range finding study
- Test concentrations: Based on the results of the range-finder test, the nominal concentrations of the test item used were 0.625, 1.25, 2.5, 5.0, and 10 mg/L (corresponding to 0.22, 0.45, 0.90, 1.79, and 3.58 mg a.i./L).
- Results used to determine the conditions for the definitive study: yes
Reference substance (positive control):
no
Duration:
96 h
Dose descriptor:
LC10
Effect conc.:
1.4 mg/L
Nominal / measured:
meas. (geom. mean)
Conc. based on:
test mat.
Basis for effect:
mortality
Duration:
96 h
Dose descriptor:
LC10
Effect conc.:
1.4 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality
Duration:
96 h
Dose descriptor:
LC50
Effect conc.:
1.9 mg/L
Nominal / measured:
meas. (geom. mean)
Conc. based on:
test mat.
Basis for effect:
mortality
Remarks on result:
other: 1.5-2.2
Duration:
96 h
Dose descriptor:
LC50
Effect conc.:
1.8 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality
Remarks on result:
other: 1.5-2.1
Duration:
96 h
Dose descriptor:
LC50
Effect conc.:
0.68 mg/L
Nominal / measured:
meas. (geom. mean)
Conc. based on:
act. ingr.
Basis for effect:
mortality
Remarks on result:
other: 0.54-0.79
Details on results:
- Other biological observations: Clinical signs were observed at 0.625, 2.5, 5.0 and 10 mg test item/L. Total fish mortality was observed at 5.0 and 10 mg test item/L.

Reported statistics and error estimates:
Where the test results show mortality around 50 % they will be statistically analysed to determine LC10 and LC50 values together with 95 % confidence intervals using Probit-analysis assuming log-normal distribution of the values.
If it is not possible to determine LC50 because no mortality was observed, the LC50 will be reported as being > highest concentration tested. The evaluation of the effects will be based on loading concentrations for the test solution preparations.
The computer program ToxRat will be used for statistical evaluations.
Validity criteria fulfilled:
yes
Conclusions:
The LC50 for acute toxicity of rainbow trout by amides, C12-C18 (even numbered), N[3-(dimethylamino)propyl], N’-oxides) is 1.8 mg test item/L, corresponding to 0.64 mg a.i./L. The NOEC is 1.3 mg test item/L (0.47 mg a.i./L).

Description of key information

Key study (Teigeler, 2013): OECD guideline 203 and EU guideline C.1. GLP study. The 96-Hour LC50 based on measured geometric mean test concentrations was 0.68 mg a.i./L with 95% confidence limits of 0.5 - 0.8 mg a.i./L

Key value for chemical safety assessment

LC50 for freshwater fish:
0.68 mg/L

Additional information

Three studies were available for this endpoint on the test substance.

A new study was selected as key study [(Teigeler, 2013)]. This study was run according to the OECD guideline 203 and EU guideline C.1. The 96-Hour LC50 based on measured geometric mean test concentrations was 0.68 mg a.i./L with 95% confidence limits of 0.5 - 0.8 mg a.i./L.

Two other studies are available which gave a 96 -Hour LC50 of 2.06 and 0.75 mg a.i./L respectively [Kamp (1997) and Wetton (2000)]. However these studies were not used for the risk assessment but are considered supporting studies.