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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:
The study was conducted between 12 June 2016 and 14 July 2016
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 203 (Fish, Acute Toxicity Test)
Version / remarks:
1992
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method C.1 (Acute Toxicity for Fish)
Version / remarks:
2008
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Specific details on test material used for the study:
SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: Sponsor Lot/Barch number; 5399561P10
- Expiration date of the lot/batch: 25 January 2020
- Purity test date: 25 January 2016

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: Room temperature in the dark
Analytical monitoring:
yes
Remarks:
Water Accomodated Fraction (WAF) was determined
Details on sampling:
- Concentrations: Nominal loading rates of 1, 10 and 100 mg/L for range-finding test and 100 mg/L for definitive test
- Sampling method:
- Sample storage conditions before analysis: Frozen
Vehicle:
no
Details on test solutions:
The loading rate to be used in the definitive test was determined by a preliminary range-finding test.
In the range-finding test, fish were exposed to a series of nominal loading rates of 1.0, 10 and 100 mg/L.
Nominal amounts of test item (22, 220 and 2200 mg) were each separately added to the surface of 22 liters of test water to give the 1.0, 10 and 100 mg/L loading rates, respectively. After the addition of the test item, the test water was stirred by magnetic stirrer using a stirring rate such that a vortex was formed to give a dimple at the water surface. The stirring was stopped after 23 hours and the mixtures allowed to stand for 1 hour. The loading rate to be used in the definitive test was determined by a preliminary range-finding test.
In the range-finding test, fish were exposed to a series of nominal loading rates of 1.0, 10 and 100 mg/L.
Nominal amounts of test item (23, 220 and 2200 mg) were each separately added to the surface of 22 liters of test water to give the 1.0, 10 and 100 mg/L loading rates, respectively. After the addition of the test item, the test water was stirred by magnetic stirrer using a stirring rate such that a vortex was formed to give a dimple at the water surface. The stirring was stopped after 23 hours and the mixtures allowed to stand for 1 hour. The WAFs were removed by filtering through a glass wool plug (2-4 cm in length). A wide bore glass tube, covered at one end with Nescofilm was submerged into the vessel, sealed end down, to a depth of approximately 5 cm from the bottom of the vessel. A length of Tygon tubing was inserted into the glass tube and pushed through the Nescofilm seal. As a precaution, a glass wool plug was insertec into the opposite end of the tubing and the WAF removed by mi-depth siphoning (the first 75-100mL discarded) to give the 1.0, 10 and 100 mg/L loading rate WAFs. Microscopic examinations were performed on the WAFs aftr filtering and showed no microdispersions or undissolved test item to be present.
Test organisms (species):
Oncorhynchus mykiss (previous name: Salmo gairdneri)
Details on test organisms:
TEST ORGANISM
- Common name: Rainb ow trout
- Strain:
- Source: Brow Well Fisheries Limited, Hebden, near Skipton, Yorkshire, UK
- Age at study initiation (mean and range, SD): Juvenile
- Length at study initiation (length definition, mean, range and SD): Mean = 5.8 cm , sd = 0.4
- Weight at study initiation (mean and range, SD): 19. g, sd= 0.3

ACCLIMATION
- Acclimation period: 7 days
- Acclimation conditions (same as test or not): same as test
- Type and amount of food during acclimation: commercial trout pellets
- Feeding frequency during acclimation: daily
- Health during acclimation (any mortality observed): no mortality

QUARANTINE (wild caught)
- Duration:
- Health/mortality:

FEEDING DURING TEST: No
:
Test type:
semi-static
Water media type:
freshwater
Limit test:
yes
Total exposure duration:
96 h
Test temperature:
14 ”C - 15”C
pH:
7.6 - 8.2
Dissolved oxygen:
9.0 - 10.1 mg O2/L
Nominal and measured concentrations:
Range-finding Samples at 0 hr:
Nominal = 1.0, 10 and 100 mg/L
Measured = 0.0157, 0.0330 and 0.0399

Definitive test samples:

Nominal = 100 mg/L
Measured = 0.0603 at 0 h - 0.0104 at 96 h
Details on test conditions:
OTHER TEST CONDITIONS

- Photoperiod: 16h light : 8 h dark


TEST CONCENTRATIONS
- Test concentrations: 1, 10 and 100 mg/L
- Results used to determine the conditions for the definitive study: yes 100 mg/L
Key result
Duration:
96 h
Dose descriptor:
NOELR
Remarks:
Loading rate WAF
Effect conc.:
>= 100 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat. (dissolved fraction)
Basis for effect:
mortality (fish)
Details on results:
Analysis of the test preparations at 0 and 72 hours showed measured test concentrations of 0.060 and 0.026 mg/L, respectively. Chemical analysis of the aged test preparations at 24 and 96 hours showed measured test concentrations of 0.048 and 0.010 mg/L, respectively.

The dissolved test item may have been one of several components in the test item' Given that the toxicity cannot be attributed to a single component or a mixture of components, but to the test item as a whole, the results were based on nominal loading rates only.

There were no mortalities or sub-lethal effects of exposure in 7 fish exposed to a 100 mg/L loading rate WAF for a period of 96 hours. It was considered unnecessary and unrealistic to test at loading rates in excess of 100 mg/L.

The test was considered valid given that none of the control fish died of showed signs of stress during the test and that the oxygen concnetration at the end of the test was >60% ASV in the control and test vessels.
Validity criteria fulfilled:
yes
Conclusions:
The acute toxicity of the test item to the freshwater rainbow trout (Oncorhynchus mykiss) has been investigated and gave a 96-hour LL50 value of greater then 100 mg/L Loading rate WAF. The No Observed Effect Loading rate was 100 mg/L loading rate WAF.

Description of key information

The acute toxicity of the test item to the freshwater fish rainbow trout (Oncorhynchus mykiss) has been investigated and gave a 96-Hour LL50 value of greater than 100 mg/L loading rate WAF. The No Observed Effect Loading rate was 100 mg/L loading rate WAF.

Key value for chemical safety assessment

Fresh water fish

Fresh water fish
Effect concentration:
100 mg/L

Additional information