Registration Dossier

Some information in this page has been claimed confidential.

Administrative data

Endpoint:
short-term toxicity to fish
Type of information:
experimental study
Adequacy of study:
key study
Study period:
The range-finding test was conducted between 6 January 2003 and 10 January 2003 and the definitive test between 3 February 2003 and 7 February 2003. Report issued 24 March 2003.
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:
2003
Report Date:
2003

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 203 (Fish, Acute Toxicity Test)
Deviations:
no
Qualifier:
according to
Guideline:
other: 92/69/EEC, method C1, which constitutes Annex V of council directive 67/548/EEC
Deviations:
no
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid

Sampling and analysis

Analytical monitoring:
yes

Test solutions

Vehicle:
no

Test organisms

Test organisms (species):
other: Rainbow trout (Oncorhynchus mykiss)
Details on test organisms:
The test was carried out using juvenile rainbow trout (Oncorhynchus mykiss). Fish were received on 8 January 2003. Fish were maintained in a glass fibre tank with a "single pass" water renewal system. Fish were acclimatised to test conditions from 22 January 2003 to 3 February 2003. The lighting cycle was controlled to give a 16 hours light and 8 hours darkness cycle with 20 minute dawn and dusk transition periods.The water temperature was controlled at 14°C with a dissolved oxygen content of greater than or equal to 9.6 mg 02/l. These parameters were recorded daily. The stock fish were fed commercial trout pellets which was discontinued approximately 24 hours prior to the start of the definitive test. There was zero mortality in the 7 days prior to the start of the test and the fish had a mean standard length of 4.5 cm (sd = 0.5) and a mean weight of 1.24 g (sd = 0.33) at the end of the definitive test. Based on the mean weight value this gave a loading rate of 0.62g Body weight litre.The diet and diluent water are considered not to contain any contaminant that would affect the integrity and outcome of the study.

Study design

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

Test conditions

Hardness:
CA 100 mg CaCO3/L
Test temperature:
12.0 - 13.8 degrees CThe temperature at some time points was outside the protocol of 14+/- 1 degree C. This was not considered to affect the results or validity of the test.
pH:
7.5-8.3
Dissolved oxygen:
8.0-8.8 mg O2/l
Nominal and measured concentrations:
The test material concentration was determined spectrophometrically using an external standard. The test material remained stable in the test medium for the duration of media renewal.
Details on test conditions:
TEST SYSTEM- Test vessel: 20L glass vessels- Aeration: yes- Renewal rate of test solution: Daily renewal of test solutions- No. of organisms per vessel: 10OTHER TEST CONDITIONS- Photoperiod: 16hr light and 8hr dark with 20 min. dawn/dusk transitionEFFECT PARAMETERS MEASURED : mortality and sub-lethal effectsTEST CONCENTRATIONS- Range finding study: 1.0, 10.0, 100 mg/L- Test concentrations (main test): 100mg/L
Reference substance (positive control):
no

Results and discussion

Effect concentrationsopen allclose all
Key result
Duration:
24 h
Dose descriptor:
LC50
Effect conc.:
> 100 mg/L
Basis for effect:
mortality
Key result
Duration:
48 h
Dose descriptor:
LC50
Effect conc.:
> 100 mg/L
Basis for effect:
mortality
Key result
Duration:
72 h
Dose descriptor:
LC50
Effect conc.:
> 100 mg/L
Basis for effect:
mortality
Key result
Duration:
96 h
Dose descriptor:
LC50
Effect conc.:
> 100 mg/L
Basis for effect:
mortality
Key result
Duration:
96 h
Dose descriptor:
LC100
Effect conc.:
> 100 mg/L
Basis for effect:
mortality
Key result
Duration:
96 h
Dose descriptor:
NOEC
Effect conc.:
100 mg/L
Details on results:
There were no sublethal exposure effects recorded.

Applicant's summary and conclusion

Validity criteria fulfilled:
yes
Conclusions:
The acute toxicity of the test substance to the freshwater rainbow trout was investigated and was determined to have a 96hr LC50 of >100 mg/L. The No Observed Effect Concentration was determined to be 100 mg/L.
Executive summary:

Introduction.

A study was performed to assess the acute toxicity of the test material to rainbow trout (Oncorhynchus mykiss). The method followed that described in the OECD Guidelines for Testing of Chemicals (1992) No 203, "Fish, Acute Toxicity Test" referenced as Method C.l of Commission Directive 92/69EEC (which constitutes Annex V of Council Directive 67/548/EEC).

Methods.

Following a preliminary range-finding test, fish were exposed, in groups of ten, to an aqueous solution of the test material over a range of concentrations of 1.0, 10 and 100 mg/l for a period of 96 hours at a temperature of approximately 14°C under semi-static test conditions. The number of mortalities and any sub-lethal effects of exposure in each test and control vessel were determined 3 and 6 hours after the start of exposure and then daily throughout the test until termination after 96 hours.

Results

The results of the definitive test showed the highest test concentration resulting in 0% mortality to be greater than or equal to 100 mg/l, the lowest test concentration resulting in 100% mortality to be greater than 100 mg/l and the No Observed Effect Concentration (NOEC) to be 100 mg/l. The No Observed Effect Concentration is based upon zero mortalities and the absence of any sublethal effects of exposure at this concentration.

Conclusion

The acute toxicity of the test material to the freshwater fish rainbow trout (Oncorhynchus mykiss) has been investigated and gave a 96-Hour LCso of greater than 100 mg/l. Correspondingly the No Observed Effect Concentration was 100 mg/l.