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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:
September 8- December 8 2020
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:
2019
GLP compliance:
yes (incl. QA statement)
Specific details on test material used for the study:
SOURCE OF TEST MATERIAL
- Source (i.e. manufacturer or supplier) and lot/batch number of test material: Sponsor, 191217
- Purity, including information on contaminants, isomers, etc.: 98.50 %

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: At room temperature
Analytical monitoring:
yes
Details on sampling:
Samples taken from the limit test concentration and the control were analysed. The measured
concentration was 70 mg/L at the start of the test and remained stable throughout the first 48
hours of exposure, i.e. was at 96% relative to the nominal value in the 48-hour old solution.
The concentration in the freshly prepared solution upon renewal was 67 mg/L, i.e. 96% relative to the nominal concentration. Similar as during the first renewal interval, the concentration remained stable and was at 92% relative to nominal at the end of the test. No test item was detected in the samples taken from the control solutions.
Based on these results, effect parameters were expressed in terms of analytically confirmed
nominal concentrations.
Vehicle:
yes
Remarks:
test medium
Details on test solutions:
Trial formulations were prepared in propylene glycol at 1 mg/mL and 200 mg/mL.
Formulations were solutions.
The concentrations analyzed in the trial formulations were in agreement with target concentrations (i.e. mean accuracies between 90% and 110%).
The formulations were homogeneous (i.e. coefficient of variation ≤ 5%).
Formulations were stable when stored at room temperature under normal laboratory light
conditions for at least 24 hours, in a refrigerator (2-8°C) for at least 8 days, and in a freezer
(≤ -15°C) for at least 22 days (3 weeks).
Resuspension homogeneity was demonstrated (i.e. coefficient of variation ≤ 5%).
Test organisms (species):
Cyprinus carpio
Details on test organisms:
TEST ORGANISM
- Common name: Carp
- Strain: Cyprinus carpio, Teleostei Cyprinidae
- Source: ‘De Haar Vissen’, Zodiac proefacc. Wageningen University &Research, The Netherlands. In case of a different supplier,details of the source will be included in the report
- Length at study initiation (length definition, mean, range and SD): 2.8 ± 0.1 cm
- Weight at study initiation (mean and range, SD): 0.26 ± 0.05 g
- Method of breeding: F1 from a single parent-pair bred in UV-treated water


ACCLIMATION
- Acclimation period: At least 12 days after delivery
- Acclimation conditions (same as test or not): same
- Type and amount of food during acclimation: Daily with pelleted fish food (F-0.5 GR Pro Aqua Brut, Skretting, Fontaine-lès-Vervins, France) until at the latest 24 hours before the start of exposure).
- Health during acclimation (any mortality observed): In the batch of fish used for the test, mortality during the seven days prior to the start of the test was less than 5%.

FEEDING DURING TEST (as applicable)
- Food type: Daily with pelleted fish food (F-0.5 GR Pro Aqua Brut, Skretting, Fontaine-lès-Vervins, France) until at the latest 24 hours before the start of exposure).
- Frequency: No feeding from 24 hours prior to the test and during the total exposure period


Test type:
semi-static
Water media type:
saltwater
Limit test:
yes
Total exposure duration:
96 h
Nominal and measured concentrations:
Nominal concentration 70 mg/L (limit test)
Details on test conditions:
Test type: Semi-static, with renewal of test solutions after 48 hours
Test vessels: 6.5 litres, all-glass, containing 5 litres of test solution
Test medium: The following salts (analytical grade) were added to tap water purified by Reverse Osmosis (RO-water, GEON Waterbehandeling, Berkel-Enschot, The Netherlands):
CaCl2.2H2O 211.5 mg/L
MgSO4.7H2O 88.8 mg/L
NaHCO3 46.7 mg/L
KCl 4.2 mg/L
The hardness of test medium expressed as CaCO3: 180 mg/L.
Number of fish: 7 fish per test group
Loading: 0.36 g fish/litre, i.e. 7 fish per 5 litres of test medium
Illumination: 16 hours photoperiod daily with a light intensity ranging between 555 – 603 lux.
Aeration: The test solutions were not aerated during the test.
Feeding: No feeding from 24 hours prior to the test and during the total exposure period
Introduction of fish: Within 40 minutes after preparation of the test media from a holding tank with comparable water quality parameters and pH and temperature differences between test and holding tank media of less than 1 unit and 1°C, respectively.
Key result
Duration:
96 h
Dose descriptor:
LC50
Effect conc.:
> 70 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Details on results:
No mortality or clinical effects were observed in the control group throughout the test. Although no mortality was recorded at the limit concentration throughout the 96-hour test period, all seven fish were immobilized already after 2¾ hours of exposure. These fish showed no swimming behaviour (immobility) and a reduced respiration (i.e. slow gill movement) compared to the control group. Hence, this test item is expected to have a narcotic effect on fish.

Table 1. shows the mortality data recorded during the final test. Table 2 specifies the clinical
effects observed at different test concentrations.
No mortality or clinical effects were observed in the control group throughout the test.
Although no mortality was recorded at the limit concentration throughout the 96-hour test
period, all seven fish were immobilized already after 2¾ hours of exposure. These fish
showed no swimming behaviour (immobility) and a reduced respiration rate (i.e. slow gill
movement) compared to the control group. Hence, this test item is expected to have a narcotic
effect on carp.
Since the aim of this study was to assess lethal acute toxicity of the test item on fish, the
96h-LC50 was beyond the threshold concentration of 70 mg/L.
Sublethal observations / clinical signs:

Table 1. Incidence of Mortality and Total Mortality in the Limit Test










































Test Item Nominal concentration (mg/L)



Initial


Number


of fish



Cumulative mortality



Total Mortality



 



 



2¾h



24h



48h



72h



96h



 



Control



7



0



0



0



0



0



0



70 mg/L



7



0



0



0



0



0



0



Table 2. Clinical Effects Observed in the Limit Test






































Test Item Nominal concentration (mg/L)



Time of recording (hours)



Specification of effects



Relative number



 


 


70



2¾h



 



7



24h



Immobile, slow gill movement



7



48h



 



7



72h



Immobile



2



96h



Immobile



7



 

Validity criteria fulfilled:
yes
Remarks:
1. No mortality was observed in the control throughout the test. 2. The dissolved oxygen concentration has been at least 60% of the air saturation value throughout the test (>5 mg/L at 22°C). 3. Test concentrations have been analytically measured.
Conclusions:
In conclusion, the 96h-LC50 for carp (Cyprinus carpio) exposed to PU-2020-905 was beyond the threshold concentration of 70 mg/L, i.e. exceeded an analytically confirmed nominal concentration of 70 mg/L.

Description of key information

Key value for chemical safety assessment

Fresh water fish

Fresh water fish
Dose descriptor:
LC50
Effect concentration:
> 70 mg/L

Additional information