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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:
From 07 SEP 2020 to 11 SEP 2020
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
EU Method C.1 (Acute Toxicity for Fish)
Version / remarks:
as of 30 May 2008
Deviations:
yes
Remarks:
Light intensity was lower than stated in the guideline (540 – 1000 lux). The range 400–800 lux is the light intensity in the husbandry which is run successfully for many years. Deviation can be stated as uncritical.
Qualifier:
according to guideline
Guideline:
OECD Guideline 203 (Fish, Acute Toxicity Test)
Version / remarks:
as of 18 June 2019
Deviations:
yes
Remarks:
Light intensity was lower than stated in the guideline (540 – 1000 lux). The range 400–800 lux is the light intensity in the husbandry which is run successfully for many years. Deviation can be stated as uncritical.
Qualifier:
according to guideline
Guideline:
other: OECD guidance document no. 23, GUIDANCE DOCUMENT ON AQUEOUS-PHASE AQUATIC TOXICITY TESTING OF DIFFICULT TEST CHEMICALS
Version / remarks:
second edition, as of 8 Feb 2019
Qualifier:
according to guideline
Guideline:
other: OECD guidance document No. 126, SHORT GUIDANCE ON THE THRESHOLD APPROACH FOR ACUTE FISH TOXICITY
Version / remarks:
as of 31 May 2010
GLP compliance:
yes (incl. QA statement)
Analytical monitoring:
yes
Details on sampling:
- Concentrations: 100 mg/L
- Sampling method: Samples were taken from the test vessels and measured immediately after sampling at the beginning and at the end of the test.
Vehicle:
no
Details on test solutions:
PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Method: On the day of the start of the test, a stock solution containing 1001 mg/L in tap water was prepared. The concentration to be tested (100 mg/L) was prepared by diluting of this stock solution with tap water.
- Controls: blank control with tap water
- Test concentration separation factor: none, only one test concentration
- Evidence of undissolved material (e.g. precipitate, surface film, etc.): no
Test organisms (species):
Danio rerio (previous name: Brachydanio rerio)
Details on test organisms:
TEST ORGANISM
- Common name: zebrafish
- Source: originally from university Heidelberg, offsprings of original animals were used in the test
- Age at study initiation (mean and range, SD): sexually immature young fish
- Length at study initiation (length definition, mean, range and SD): 1.2-1.8 cm
- Weight at study initiation (mean and range, SD): 0.1018-0.1423g
- Method of breeding: in polyethylene aquaria filled with tap water (23 +/- 2°C), fed two times each working day with warm-water fish food, light intensity: 400-800 lux (12:12 hrs light/dark)
Test type:
static
Water media type:
freshwater
Remarks:
tap water
Limit test:
yes
Total exposure duration:
96 h
Hardness:
195.8 mg CaCO3/L on day 0
Test temperature:
water temperature: 21.1-22.7°C in the blank control and 21.2-22.7°C in the test concentration 100 mg/L
pH:
8.2-8.3 in the blank control and 7.0-8.1 in the test concentration 100 mg/L
Dissolved oxygen:
8.2-8.7 mg/L in blank control and 8.2-8.8 mg/L in test concentration 100 mg/L
Salinity:
not specified
Conductivity:
not specified
Nominal and measured concentrations:
Nominal test concentration: 100 mg/L
Mean measured test concentration at the beginning: 104.5 mg/L
Mean measured test concentration at the end (after 96 hrs): 109.5 mg/L
Details on test conditions:
TEST SYSTEM
- Test vessel: glass aquaria, maximal volume 12 L
- Type (delete if not applicable): open
- Material, size, headspace, fill volume: glass, max. volume 12 L, filled with 7 L solution in the test
- Aeration: yes, through glass tubes
- Feeding: 24 hours before the start of the test, the test fish were no longer fed.
- No. of organisms per vessel: 7 fish
- No. of vessels per concentration (replicates): 1
- No. of vessels per control (replicates): 1
- Biomass loading rate: 1 fish per litre

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: drinking water (tap water)
- Total organic carbon: <0.5 mg/L
- Pesticides: - Metals: sodium 5.2 mg/L, potassium 2.2 mg/L, calcium 40 mg/L, magnesium 4.5 mg/L, remaining metals <0.01 mg/L
- Ca/mg ratio: 40:4.5
- hardness: 1.18 mmol/L
- pH: 8.12
- Culture medium different from test medium: no
- Intervals of water quality measurement: once a year

OTHER TEST CONDITIONS
- Adjustment of pH: no
- Photoperiod: 12:12 light/dark
- Light intensity: 400-800 lux

EFFECT PARAMETERS MEASURED (with observation intervals if applicable):
Observations were made after 1 ± 0.5 h, 4 ± 1 h and 24 ± 2 h after the start of the exposure (day 0-1). On days 2-4 of the test, all vessels with living fish were inspected twice per day (morning and afternoon). Test criterion is the death of the fish (=mortality).

TEST CONCENTRATIONS
- Spacing factor for test concentrations: none, only one test concentration

- Range finding study
- Test concentrations: The concentration to be tested was based on the result of a non-GLP pre-test. In the non-GLP pre-test, no toxicity
was observed. Therefore, a limit test was conducted.
Reference substance (positive control):
no
Key result
Duration:
96 h
Dose descriptor:
LC50
Effect conc.:
> 100 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality (fish)
Details on results:
- No mortality was observed in any treatment at any time during the test.
- Other biological observations: No abnormal behaviour of the surviving fish was observed.
- Mortality of control: no mortality
- Other adverse effects control: none
- At the beginning and at the end of the test, the content of the test item in the test solutions was determined using HPLC-determination. The measured concentration was 105 % of the nominal concentration at the beginning and 109 % at the end of the test.
Therefore, the determination of the biological result was based on the nominal concentration (see Guidance Doc. No.23 (§176)).
Reported statistics and error estimates:
No statistical analysis was performed, since no effects were observed in the treatment.
Validity criteria fulfilled:
yes
Remarks:
Did the mortality in the blank control exceed 1 fish at the end of the test? No. Has the dissolved oxygen concentration been at least 60% throughout the test? Yes (93.5% at a minimum).
Conclusions:
An acute toxicity study was performed with the zebrafish (Danio rerio) exposed to 5-sulfosalicylic acid for a test duration of 96 hrs using static test conditions. The study was performed in accordance with OECD TG 203, wherefore it is considered to be acceptable for the assessment of the acute toxicity of the test substance to fish.
Under the conditions used for the test no toxicity of 5-sulfosalicylic acid to zebrafish was observed. Thus, the 96h-LC50 for 5-salicylic acid is given as >100 mg/L.
No observations were made which might cause doubts concerning the validity of the study outcome. All validity criteria were met. The result of the test is considered valid.
Executive summary:

The acute toxicity of the test substance to fish was investigated in this study according to OECD TG 203 and GLP. Danio rerio (zebra fish) was used as test organism and exposed to one nominal test concentration (100 mg/L) for 96 hours of test duration under static test conditions. A blank control was running in parallel containing dilution water only. The test was carried out at a temperature between 21.1 and 22.7°C, with a pH range of 7.0-8.3 and an oxygen concentration above the saturation concentration (≥ 90% ASV) throughout the test. In the treatment and in the control, no fish died or showed abnormal behaviour. Based on the obtained results, the 96h-LC50 was determined to be nominal >100 mg/L. At the beginning and at the end of the test, the content of the test item in the test solutions was determined using HPLC-determination. The measured concentration was 105 % of the nominal concentration at the beginning and 109 % at the end of the test. Therefore, the biological result was based on the nominal concentration.

Description of key information

OECD 203, GLP, Danio rerio, 100 mg/L, static, freshwater 96h: LC50 (96h) > 100 mg/L nominal

Key value for chemical safety assessment

Fresh water fish

Fresh water fish
Dose descriptor:
LC50
Effect concentration:
> 100 mg/L

Additional information

The acute toxicity of the test substance to fish was investigated in this study according to OECD TG 203 and GLP. Danio rerio (zebra fish) was used as test organism and exposed to one nominal test concentration (100 mg/L) for 96 hours of test duration under static test conditions. A blank control was running in parallel containing dilution water only. The test was carried out at a temperature between 21.1 and 22.7°C, with a pH range of 7.0-8.3 and an oxygen concentration above the saturation concentration (≥ 90% ASV) throughout the test. In the treatment and in the control, no fish died or showed abnormal behaviour. Based on the obtained results, the 96h-LC50 was determined to be nominal >100 mg/L. At the beginning and at the end of the test, the content of the test item in the test solutions was determined using HPLC-determination. The measured concentration was 105 % of the nominal concentration at the beginning and 109 % at the end of the test. Therefore, the biological result was based on the nominal concentration.