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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
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions
Qualifier:
according to guideline
Guideline:
OECD Guideline 203 (Fish, Acute Toxicity Test)
GLP compliance:
no
Analytical monitoring:
yes
Details on sampling:
- Concentrations: 100 mg/L
- Sampling method: test sample of 5 ml was taken from the test vessel at 5 different locations for the top mid and lower layers, on the day of anlytical determinations
- Sample storage conditions before analysis: sample was analysed soon after sampling
Vehicle:
no
Details on test solutions:
PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
Test chemical was prepared by dissolving 1000 mg of test chemical in 1000 ml of RO water to get the final concentration of 1000 mg/L. which was then analytically determine. The final solubility value obtained after analytical detection was 745.93 mg/l.
- Chemical name of vehicle (organic solvent, emulsifier or dispersant): Not applicable
- Concentration of vehicle in test medium (stock solution and final test solution(s) or suspension(s) including control(s)): Not applicable
Test organisms (species):
Danio rerio (previous name: Brachydanio rerio)
Details on test organisms:
TEST ORGANISM
- Common name: Zebra fish
- Strain: Tubingen
- Source: Centre for cellular and molecular biology, India
- Age at study initiation (mean and range, SD): less than 3 months
- Length at study initiation (length definition, mean, range and SD): 1.4 cm


ACCLIMATION
- Acclimation period: Fishes, to be used in this study, are kept in the test water forseven days immediately before testing
- Acclimation conditions (same as test or not): same tes conditions
Photoperiod: 16hour light and 8 hours dark
Temperature range 23.2 °C
pH range 7.7
DO range 7.6 mg/L
Feeding Daily once but not given atleast 48 hours before study
Aeration Continuous
Mortality (%)0

Test type:
static
Water media type:
freshwater
Limit test:
yes
Total exposure duration:
96 h
Test temperature:
22
pH:
7.6
Dissolved oxygen:
7.5
Nominal and measured concentrations:
Nominal concentration: 100 mg/l
Details on test conditions:
TEST SYSTEM
- Test vessel: Glass aquarium
- Type (delete if not applicable): Loosley closed
- Material, size, headspace, fill volume: 4L
- Aeration : No aeration
- Type of flow-through (e.g. peristaltic or proportional diluter): Not applicable
- Renewal rate of test solution (frequency/flow rate): Not applicable
- No. of organisms per vessel: 7
- No. of vessels per concentration (replicates): one vessel per concentration
- No. of vessels per control (replicates): one vessel
- No. of vessels per vehicle control (replicates): Not applicable
- Biomass loading rate: 7 fishes /4 L


OTHER TEST CONDITIONS
- Adjustment of pH: No
- Photoperiod: 16 hours light & 8 hours dark


EFFECT PARAMETERS MEASURED (with observation intervals if applicable) :

TEST CONCENTRATIONS
- Spacing factor for test concentrations: not applicable
Reference substance (positive control):
not required
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:
- Behavioural abnormalities: No abnormal behaviour was observed
- Mortality of control: None
- Other adverse effects control: None
- Abnormal responses: None
Reported statistics and error estimates:
Not applicable
Sublethal observations / clinical signs:

6.6 Standard graph for determining stock solubility
 
Sr. No
Concentrations (mg/L)
Wavelength (nm)
Absorbance
Temperature (°C)
1
Blank
199
0.00
25
2
50 199 0.17
25
3
100 199 0.42
25
4
150 199 0.59
25
5
200 199 0.80
25
6
250 199 1.04
25
7
300 199 1.27
25
8
350 199 1.46
25
9
400 199 1.62
25
10
450 199 1.78
25

Measured Concentration After Analytical Determination

Sr. No

Nominal Conc.

0 Hr

96Hr

Absorbance(mean)

Measured conc.

Absorbance(mean)

Measured conc.

1.

Control

00

00

00

00

2.

100

0.43

88.65

0.42

88.10

MORTALITY AND VISIBLE SYMPTOMS

Sr. No Test concentrations(mg/L) 3 hr 6 hr 24 hr 48 hr 72 hr 96 hr Cumulative Mortality Percent Inhibition
1 control - - - - - - - -
2 100 - - - - - - - -


Sr. No Test concentrations(mg/L) 3 hr 6 hr 24 hr 48 hr 72 hr 96 hr
1 control NS7 NS7 NS7 NS7 NS7 NS7
2 100 NS7 NS7 NS7 NS7 NS7 NS7
Any other symptoms - - - - - -

EXPLANATION OF SYMPTOMS:

Number behind symbol for symptom = number of affected fish

A:apathy,NR:Narcotic-like state,C:Swimming near water surface,M:Slow movements compared to control,NS:No abnormal symptoms,SC:Schooling effect,L:Loss of equilibrium,SM:Shimming  movement,H1:Hyperactivity,H2:Hypo activityB:Bending behavior,F:Fin rot,IS:Invert swimming,SB:Swimming behavior,RF:Respiratory Function, P:Pigmentation,E:Exophthalmos

TEMPERATURE, AND DISSOLVE OXYGEN

Test Concentration(mg/L) pH
24 Hours 48 Hours 72 Hours 96 Hours
control 7.6 7.6 7.5 7.7
100 8.4 7.9 7.8 7.8

Test Concentration(mg/L) Temperature °C
24 Hours 48 Hours 72 Hours 96 Hours
control 22 23 23 23
100 22 23 23 23

Test Concentration(mg/L) Dissolved Oxygen
24 Hours 48 Hours 72 Hours 96 Hours
control 7.5 6.8 6.5 6.0
100 7.2 6.7 6.4 5.9
 
 
Validity criteria fulfilled:
yes
Conclusions:
The test concentrations were measured and found to be 88.65 mg\L and 88.10 mg/L for 0th hour and 96th hour respectively, whereas the nominal concentration was 100 mg/L. Hence, LC50 (> 100 mg/L ) was expressed based on nominal concentrations.
Executive summary:

The objective of this study is to assess the Acute Toxicity of test chemical in Freshwater Fish (Danio rerio). The study was performed in compliance with OECD 203 Guideline for the testing of chemicals: Fish, Acute Toxicity Testing, (18th June 2019). Prior to performing study fishes of mean size 1.4 cm were acclimatised for at least for 7 days under similar conditions as used in main study. The acclimatisation conditions were 16:8 hours, 23.2°C, 7.7, and 7.6 mg/L of photoperiod, temperature, pH and dissolved oxygen respectively. Under acclimatisation feed was provided daily with continues aeration. Feeding was stopped prior 24 hours to initiation of main study. The test chemical was directly formulated dissolved in the RO water by weighing 1000 mg of test chemical in 1000 ml of water to obtain a final concentration of 1000 mg/L. the analytically determined solubility was 745.93mg/l , carried out using UV Visible spectrophotometer. Based on the available data, main study was conducted with limit concentration, of 100 mg/L under static conditions. Total of 7 fishes were exposed per each concentration and control. The exposure was done in 7 lit of Glass aquarium which was loosely closed to avoid cross over and to reduce chemical evaporation from vessel. The whole setup was maintained at temperature ranging form 22 -23°C and dissolved oxygen concentrations ranging form 6.0-8.3 mg/L. At regular intervals of 24 hours vessels were observed for any behavioural changes and mortality along with that the DO, pH and temperature was measured. Test chemical was sampled from test vessel for analytical determinations at 0 hour and 96 hours. For chemical analysis a linearity range of 20, 40, 60, 80, 100, 120, 140, 160, 180, and 200 mg/l was selected, absorbance was recorded at 199 lamda max. The analytically measured concentrations at 0hour were 88.43 mg/L and 88.10 mg/L at 96 hours, concludes that chemical is within the range of 100±20% of the exposed test concentrations. After the 96 hours of exposure, there was no mortality in the control group, and the dissolved oxygen concentration was 79.76% of the air saturation value. The evaluation study after 96 hours meets all the validity criteria as mentioned in the OECD 203 guidelines and the median lethal concentration was reported to be >100 mg/L Thus, chemical cannot be classified as per CLP classification criteria.

Description of key information

The short term toxicity to fresh water fish was calculated using ECOSAR of EPI suite, the outcome was 126.801 mg/l after 96 hours of exposure. Thus the chemical cannot be classified as per CLP classification criteria.

The objective of this study is to assess the Acute Toxicity of test chemical in Freshwater Fish (Danio rerio). The study was performed in compliance with OECD 203 Guideline for the testing of chemicals: Fish, Acute Toxicity Testing, (18th June 2019). Prior to performing study fishes of mean size 1.4 cm were acclimatised for at least for 7 days under similar conditions as used in main study. The acclimatisation conditions were 16:8 hours, 23.2°C, 7.7, and 7.6 mg/L of photoperiod, temperature, pH and dissolved oxygen respectively. Under acclimatisation feed was provided daily with continues aeration. Feeding was stopped prior 24 hours to initiation of main study. The test chemical was directly formulated dissolved in the RO water by weighing 1000 mg of test chemical in 1000 ml of water to obtain a final concentration of 1000 mg/L. the analytically determined solubility was 745.93mg/l , carried out using UV Visible spectrophotometer. Based on the available data, main study was conducted with limit concentration, of 100 mg/L under static conditions. Total of 7 fishes were exposed per each concentration and control. The exposure was done in 7 lit of Glass aquarium which was loosely closed to avoid cross over and to reduce chemical evaporation from vessel. The whole setup was maintained at temperature ranging form 22 -23°C and dissolved oxygen concentrations ranging form 6.0-8.3 mg/L. At regular intervals of 24 hours vessels were observed for any behavioural changes and mortality along with that the DO, pH and temperature was measured. Test chemical was sampled from test vessel for analytical determinations at 0 hour and 96 hours. For chemical analysis a linearity range of 20, 40, 60, 80, 100, 120, 140, 160, 180, and 200 mg/l was selected, absorbance was recorded at 199 lamda max. The analytically measured concentrations at 0hour were 88.43 mg/L and 88.10 mg/L at 96 hours, concludes that chemical is within the range of 100±20% of the exposed test concentrations. After the 96 hours of exposure, there was no mortality in the control group, and the dissolved oxygen concentration was 79.76% of the air saturation value. The evaluation study after 96 hours meets all the validity criteria as mentioned in the OECD 203 guidelines and the median lethal concentration was reported to be >100 mg/L Thus, chemical cannot be classified as per CLP classification criteria.

Key value for chemical safety assessment

Fresh water fish

Fresh water fish
Effect concentration:
100 mg/L

Additional information

The short term toxicity to fresh water fish was calculated using ECOSAR of EPI suite, the outcome was 126.801 mg/l after 96 hours of exposure. Thus the chemical cannot be classified as per CLP classification criteria.

The objective of this study is to assess the Acute Toxicity of test chemical in Freshwater Fish (Danio rerio). The study was performed in compliance with OECD 203 Guideline for the testing of chemicals: Fish, Acute Toxicity Testing, (18th June 2019). Prior to performing study fishes of mean size 1.4 cm were acclimatised for at least for 7 days under similar conditions as used in main study. The acclimatisation conditions were 16:8 hours, 23.2°C, 7.7, and 7.6 mg/L of photoperiod, temperature, pH and dissolved oxygen respectively. Under acclimatisation feed was provided daily with continues aeration. Feeding was stopped prior 24 hours to initiation of main study. The test chemical was directly formulated dissolved in the RO water by weighing 1000 mg of test chemical in 1000 ml of water to obtain a final concentration of 1000 mg/L. the analytically determined solubility was 745.93mg/l , carried out using UV Visible spectrophotometer. Based on the available data, main study was conducted with limit concentration, of 100 mg/L under static conditions. Total of 7 fishes were exposed per each concentration and control. The exposure was done in 7 lit of Glass aquarium which was loosely closed to avoid cross over and to reduce chemical evaporation from vessel. The whole setup was maintained at temperature ranging form 22 -23°C and dissolved oxygen concentrations ranging form 6.0-8.3 mg/L. At regular intervals of 24 hours vessels were observed for any behavioural changes and mortality along with that the DO, pH and temperature was measured. Test chemical was sampled from test vessel for analytical determinations at 0 hour and 96 hours. For chemical analysis a linearity range of 20, 40, 60, 80, 100, 120, 140, 160, 180, and 200 mg/l was selected, absorbance was recorded at 199 lamda max. The analytically measured concentrations at 0hour were 88.43 mg/L and 88.10 mg/L at 96 hours, concludes that chemical is within the range of 100±20% of the exposed test concentrations. After the 96 hours of exposure, there was no mortality in the control group, and the dissolved oxygen concentration was 79.76% of the air saturation value. The evaluation study after 96 hours meets all the validity criteria as mentioned in the OECD 203 guidelines and the median lethal concentration was reported to be >100 mg/L Thus, chemical cannot be classified as per CLP classification criteria.

To evaluate the acute toxicity of the test item on Zebrafish (Danio rerio) a static 96-hour test according to OECD TG 203, was carried out in compliance with the GLP principles. Based on the results of a preliminary study 10 animals were exposed to a single limit concentration of 100 mg/L (nominal). A negative control with ISO Medium but without the test item was performed in parallel. The test item concentration was analytically verfied by using HPLC-UV and found to be 103 –104 % of the nominal at the start, and 100 % of the nominal at the end of the test. Therefore, all biological results are based on nominal concentrations. Fish were observed at approximately 2, 6, 24, 48, 72 and 96 hours after start of the test for signs of intoxication and mortality. All validity criteria of the test guidelines were fulfilled. As a result, no toxic effect on fish was observed  at the limit concentration of 100 mg/L. Accordingly, the 96-hour LC50 value was determined to be > 100 mg/L. The 96-hour NOEC was determined to be 100 mg/L. Based on the outcomes the test chemical cannot be classified as per CLP classification criteria.