Registration Dossier

Administrative data

Endpoint:
short-term toxicity to fish
Type of information:
experimental study
Adequacy of study:
key study
Study period:
Range finding test 2005-09-05 to 2005-09-09. Definitive test 2005-09-19 to 2005-09-23. Report signed off 2005-11-30
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Meets the criteria for classification as Reliable without restriction according to Klimisch et al (1997)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2005
Report Date:
2005

Materials and methods

Test guidelineopen allclose all
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
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent

Sampling and analysis

Analytical monitoring:
yes
Details on sampling:
Water samples were taken from the control and each replicate test vessel at 0, 24 and 96h for quantitative analysis.

Test solutions

Vehicle:
no
Details on test solutions:
An amount of test material (4680 mg) was dissolved directly in dechlorinated tap water and the volume adjusted to 1 litre to give a 4006mg active ingredient (ai)/l stock solution. An aliquot (500mg) of this stock solution was added to a final volume of 20 litres of dechlorinated tap water to give the 100 mg ai/l test concentration. This method of preparation was conducted in duplicate.

Test organisms

Test organisms (species):
Oncorhynchus mykiss (previous name: Salmo gairdneri)
Details on test organisms:
TEST ORGANISM
- Common name: Rainbow trout
- Source: Brow Well Fisheries LImited, Hebden, near Skipton, Yorkshire, UK.
- Length at end of study: 4.2 cm (sd=0.3)
- Weight at end of study: 0.97g (sd=0.24)
- Feeding during test: none

ACCLIMATION
- Acclimation period: 12 days
- Acclimation conditions: Same as test (apart from feeding)
- Type of food: Commercial trout pellets
- Feeding frequency: Feeding discontinued 24h prior to the start of the definitive test.

Study design

Test type:
semi-static
Water media type:
freshwater
Limit test:
yes
Total exposure duration:
96 h

Test conditions

Hardness:
approx. 100 mg CaCO3/L
Test temperature:
13.5 - 14.4 degree C
pH:
7.4-8.1
Dissolved oxygen:
84-98 % Air Saturation Value
Nominal and measured concentrations:
Analysis of the test preparations at 0, 24 and 96h showed measured test concentrations to range from 100% to 114% of nominal and so it was considered justifiable to estimate the LC50 value in terms of the nominal test concentrations only.
Details on test conditions:
TEST SYSTEM
- Test vessel: 20L glass vessel
- Type : covered to reduce evaporation
- Aeration: yes
- Renewal rate of test solution: daily
- No. of organisms per vessel: 10
- No. of vessels per concentration (replicates): 2
- No. of vessels per control (replicates):1

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: dechlorinated tap water
- Total organic carbon:1.675 mg/l
- Pesticides: 0.0 ug/l
- Total Chlorine:<0.153 mg/l
- Intervals of water quality measurement: Water temp., pH and dissolved oxygen measured daily.

OTHER TEST CONDITIONS
- Photoperiod: 16h light and 8h dark with 20 min dawn/dusk transition

EFFECT PARAMETERS MEASURED: Any mortalities and sub-lethal effects of exposure were recorded at 3, 6, 24, 45, 72 and 96h after the start of exposure.

TEST CONCENTRATIONS
- Range finding study: In the range finding test fish were exposed to a single nominal test concentration of 100 mg ai/l as the results obtained from a Daphnia magna rangefinding study (Report 2125/025) indicated that toxicity was not expected at this concentration.
- Test concentrations: Based on the results of the range-finding test a limit test was conducted at 100 mg ai/l to confirm that no mortalities or sub lethal effects would be observed at the maximum concnetration given in the OECD test guidelines.
Reference substance (positive control):
no

Results and discussion

Effect concentrationsopen allclose all
Duration:
24 h
Dose descriptor:
LC50
Effect conc.:
> 100 mg/L
Nominal / measured:
nominal
Conc. based on:
act. ingr.
Basis for effect:
mortality
Duration:
48 h
Dose descriptor:
LC50
Effect conc.:
> 100 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality
Duration:
72 h
Dose descriptor:
LC50
Effect conc.:
> 100 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality
Duration:
96 h
Dose descriptor:
LC50
Effect conc.:
> 100 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality
Duration:
96 h
Dose descriptor:
LC100
Effect conc.:
> 100 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality
Duration:
96 h
Dose descriptor:
NOEC
Effect conc.:
100 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality
Details on results:
There was one mortality in the 20 fish exposed to the test concentration of 100 mg ai/l for a period of 96h. This mortality was observed in the 100 mg ai/l replicate 2 at 96h and was considered to be due to natural causes and/or handling stress.

Applicant's summary and conclusion

Validity criteria fulfilled:
yes
Conclusions:
No mortalities were observed in the control during this study and only one mortality was observed at the test concentration of 100 mg ai/l. Therefore the 96h LC50 was determined to be >100 mg ai/l. It is concluded that 100 mg ai/l of the test substance did not have a toxic effect on Oncorhynchus mykiss in this study.
Executive summary:

Introduction

The study was performed to assess the acute toxicity of the test substance to rainbow trout. The method was designed to be compatible with the following guidelines:

OECD Guidelines for Testing of Chemicals (1992) No. 203 Fish Acute Toxicity test.

Method C1 of Commission Directive 92/69/EEC.

Results

One mortality was observed in this study at 96h in a 100 mg ai/l test vessel. This mortality was considered to be due to natural causes or handling stress and not due to toxicity. No mortalities were observed in the control.

Conclusion

The 96h LC50 was determined to be >100 mg ai/l and the 96h NOEC was determined to be 100 mg ai/l. It is concluded that 100 mg ai/l of the test substance did not have a toxic effect on Oncorhynchus mykiss in this study.