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Ecotoxicological information

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:
18 July 2014 - 06 July 2015
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 203 (Fish, Acute Toxicity Test)
GLP compliance:
yes (incl. QA statement)
Specific details on test material used for the study:
Test substance name: Adoxal
Batch number: SC00010875
Expiry date: 09 April 2015
Analytical monitoring:
yes
Details on sampling:
Samples were taken from the controls and the 0.67 mg/L test concentration at 0 (fresh media), 24, 48, 72 (old and fresh media) and 96 hours (old media) for analysis.
Vehicle:
yes
Remarks:
Acetone
Details on test solutions:
The test substance is poorly water soluble. The determined water solubility of the substance is 0.67 mg/L (Smithers Viscient study number 3200705).
The preliminary solubility work determined that the highest attainable concentration in the test water was approximately 0.51 mg/L by spiking a preliminary solvent stock solution, prepared in acetone, into the test water, indicating this to be the solubility limit of the test item under test conditions.
Test organisms (species):
Oncorhynchus mykiss (previous name: Salmo gairdneri)
Details on test organisms:
Healthy Oncorhynchus mykiss (rainbow trout) were supplied by Brow Well Fisheries, United Kingdom, details of which are maintained in Smithers Viscient (ESG) Ltd. records.
Test type:
semi-static
Water media type:
freshwater
Limit test:
yes
Total exposure duration:
96 h
Nominal and measured concentrations:
The definitive test was conducted as a ‘Limit Test’ at a single nominal test concentration of 0.67 mg/L (maximum water solubility) to confirm that at the highest attainable test concentration, no mortality or adverse reactions to exposure were observed.
The geometric mean of the initial mean measured concentration was 0.6087 mg/L, which was considered to be the solubility limit of the test item under test conditions.
Details on test conditions:
Due to the possible volatile nature of the test substance, the test was conducted using completely filled and sealed vessels.
Reference substance (positive control):
yes
Remarks:
Control and solvent control groups were also included.
Key result
Duration:
96 h
Dose descriptor:
LC50
Effect conc.:
> 0.609 mg/L
Nominal / measured:
meas. (initial)
Conc. based on:
test mat.
Basis for effect:
mortality (fish)
Remarks on result:
other: solubility limit
Key result
Duration:
96 h
Dose descriptor:
LC50
Effect conc.:
> 0.474 mg/L
Nominal / measured:
meas. (geom. mean)
Conc. based on:
test mat.
Basis for effect:
mortality (fish)
Details on results:
Analytical results showed that a reduction in the measured concentrations occurred over the course of the 24 hour renewal period. Therefore the results have been expressed as a geometric mean measured concentration which was 0.4738 mg/L.
As the test was conducted in sealed vessels, with no head space in an effort to maintain the concentrations, the results have also been based on the geometric mean of the initial measured concentrations (i.e. 0, 24, 48 and 72 fresh media). The geometric mean of the initial mean measured concentration was 0.6087 mg/L, which was considered to be the solubility limit of the test item under test conditions.
Validity criteria fulfilled:
yes
Conclusions:
In conclusion this study showed that there were no toxic effects at the limit of solubility (i.e. at the maximum attainable dissolved concentration of the test item under the conditions of the test)
Executive summary:

The objective of the study was to determine the 96-hour acute toxicity of Adoxal to Oncorhynchus mykiss. The study was conducted in accordance with the requirements of OECD Chemicals Testing Guideline No.203 Fish, Acute Toxicity Test (adopted 17 July 1992). The study was conducted using a semi-static test design with daily renewal of test media during the test. Based on the results of a range-finding test, for which only the key findings have been reported, the definitive test was conducted as a ‘Limit Test’ at a single nominal test concentration of 0.67 mg/L (maximum water solubility) to confirm that at the highest attainable test concentration, no mortality or adverse reactions to exposure were observed. Control and solvent control groups were also included. Due to the possible volatile nature of the test substance, the test was conducted using completely filled and sealed vessels. Duplicate 39 L constructed glass aquaria containing 39 L of media were used for the control, solvent control and test vessels each containing five fish.

Analytical results showed that a reduction in the measured concentrations occurred over the course of the 24 hour renewal period. Therefore the results have been expressed as a geometric mean measured concentration which was 0.4738 mg/L. As the test was conducted in sealed vessels, with no head space in an effort to maintain the concentrations, the results have also been based on the geometric mean of the initial measured concentrations. The geometric mean of the initial mean measured concentration was 0.6087 mg/L, which was considered to be the solubility limit of the test item under test conditions. The aLC50 values and corresponding bNOEC values were derived empirically and are presented in table below and on the following page. The results are presented in terms of geometric mean measured concentrations and the geometric mean of the initial measured concentrations.

No mortality or sub-lethal effects were observed at the highest test concentration of 0.4738 mg/L (geometric mean measured concentration) and 0.6087 mg/L (geometric mean of the initial measured concentrations). In conclusion this study showed that there were no toxic effects at the limit of solubility (i.e. at the maximum attainable dissolved concentration of the test item under the conditions of the test)

Description of key information

No toxic effects at the limit of solubility.

Key value for chemical safety assessment

Additional information

The acute toxicity of Adoxal to Oncorhynchus mykiss was studied under semi-static conditions for 96 hours. Based on the results of a range-finding test, the definitive test was conducted as a Limit Test at a single nominal test concentration of 0.67 mg/L (equivalent to the determined water solubility of the test substance) to confirm that at the highest attainable test concentration, no mortality or adverse reactions to exposure were observed. Control and solvent control groups were also included. Due to the possible volatile nature of the test substance, the test was conducted using completely filled and sealed vessels.

Analytical results showed that a reduction in the measured concentrations occurred over the course of the 24 hour renewal period. Therefore the results have been expressed as a geometric mean measured concentration which was 0.4738 mg/L. As the test was conducted in sealed vessels, with no head space in an effort to maintain the concentrations, the results have also been based on the geometric mean of the initial measured concentrations (0, 24, 48 and 72h fresh media). The geometric mean of the initial mean measured concentration was 0.6087 mg/L, which was considered to be the solubility limit of the test item under test conditions.

No mortality or sub-lethal effects were observed. In conclusion this study showed that there were no toxic effects at the limit of solubility (i.e. at the maximum attainable dissolved concentration of the test item under the conditions of the test).