Decan-5-olide

Short-term toxicity to fish

Link to relevant study record(s)

Reference

Endpoint:

short-term toxicity to fish

Type of information:

experimental study

Adequacy of study:

key study

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

Analytical monitoring:

yes

Details on sampling:

- Concentrations: 4.8, 8.6, 15.4, 27.8, and 50mg/l
- Sample storage conditions before analysis: the test samples were immediately analysed.

Vehicle:

no

Details on test solutions:

PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Method: Required amount of Test item was weighed individually and dissolved in the ground water. The solution was prepared by simply mixing the test item in natural water (ground water).
- Controls: Natural water
- Chemical name of vehicle (organic solvent, emulsifier or dispersant): no Vehilce was used
- 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
- Source: Tarun aquarium, India
- Age at study initiation (mean and range, SD): juvenile fishJuveniles and it originate from the same source and population to ensure uniformity. The fish was of same age (greater than 30 days but less than 90 days) and have normal appearance.
- Length at study initiation (length definition, mean, range and SD): 1.554 cm
- Weight at study initiation (mean and range, SD): 0.030g
- Method of breeding: Not applicale
- Maintenance of the brood fish: Not applicable

ACCLIMATION
- Acclimation period: The first 48 hours constitute a settling-in period. Then, fish were acclimatised for seven days (48 hours settling-in + 7 days acclimatisation = 9 days)
- Acclimation conditions (same as test or not): yes same as test condition
- Type and amount of food during acclimation: commercial fish food daily at adlibitum
- Feeding frequency during acclimation:
- Health during acclimation (any mortality observed): No mortality was observed during acclimitisation


FEEDING DURING TEST
- Food type: No feed given during study
- Amount: No applicable
- Frequency: Not applicable

Test type:

static

Water media type:

freshwater

Limit test:

no

Total exposure duration:

96 h

Hardness:

160 mg/L CaCO3

Test temperature:

22-23°C

pH:

7.5±0.5

Dissolved oxygen:

> 60% of ASV (9.7-11.3 mg O2/L)

Salinity:

Not applicable

Conductivity:

0.417mS/cm

Nominal and measured concentrations:

Nominal concentrations:
Range finding test: 0.48, 1.53, 4.88, 15.63 and 50.00 mg/L
Definitive test: 4.8, 8.6, 15.4, 27.8 and 50.0 mg/L

Details on test conditions:

TEST SYSTEM
- Test vessel: Glass beaker
- Material, size, headspace, fill volume: Glass beaker, 0.5L heasd space, 2 L fill volume
- 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: 0 7
- No. of vessels per concentration (replicates): No replicate
- No. of vessels per control (replicates): 01
- No. of vessels per vehicle control (replicates): 01
- Biomass loading rate: not exceeded 0.8 g wet weight fish/L

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water:
- Total organic carbon:
- Particulate matter:
- Metals:
- Pesticides:
- Chlorine:
- Alkalinity:
- Ca/mg ratio:
- Culture medium different from test medium:
- Intervals of water quality measurement:

OTHER TEST CONDITIONS
- Adjustment of pH: No pH was adusted
- Photoperiod: 16 hours light and 8 hours dark
- Light intensity: 540-1000 lux.

EFFECT PARAMETERS MEASURED (with observation intervals if applicable) :

TEST CONCENTRATIONS
- Spacing factor for test concentrations: 1.8
- Justification for using less concentrations than requested by guideline: Not applicable
- Range finding study : yes perfomed
- Test concentrations: 0.48, 1.53, 4.88, 15.63 and 50.00 mg/L
- Results used to determine the conditions for the definitive study: Based on the mortality observed test concentration for definitive test was selected

Reference substance (positive control):

not required

Key result

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

18.7 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Remarks on result:

other: 95% CI- 17.65-19.75

Details on results:

- Behavioural abnormalities: Abnormal vertical orientation, Loss of buoyancy, and Hypoactivity was observed at higher concentrations
- Mortality of control: No mortality was observed in control
- Other adverse effects control: No adverse effects was observed

Results with reference substance (positive control):

Not applicable

Reported statistics and error estimates:

Data was analysed using appropriate statistical methods (probit analysis) to calculate the LC50 value and 95% confidence Limits were calculated.

Validity criteria fulfilled:

yes

Remarks:

The mortality in the control did not exceed 10 percent. The dissolved oxygen concentration is > 60 per cent of the ASV The concentration of the test item maintained to within 80% to 120% of the initial concentration throughout the duration of the test.

Conclusions:

Based on the results of this study, the LC50 value for 96 hours of test substance was found to be 18.70 mg/L with 95% confidence limits between 17.65 mg/L and 19.75 mg/L.

Executive summary:

The objective of this study was to assess the acute toxicity of test chemical in fresh water 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). Solubility of the test item was performed by weighed 25.7 mg of the test item in a 250 ml volumetric flask dissolved and made up to the mark using natural water and the resulting concentration was 102.8 mg/L. Stability of the test item in natural water determined by analyzing the test concentrations of 0.1 and 100 mg/L at 0 hour, 24 hour, 48 hour, 72 hour and 96 hour showed that the test item concentration remained 80% to 120% (98.37% to 99.09% for 0.1 mg/L and 98.29% to 99.03% for 100 mg/L) with respect to initial measured concentration and hence the dose verification for definitive test was performed at the beginning and at the termination of the test. Range finding test was conducted with test concentration of 0.48 and 50.00 mg/L along with a control groups without test item by static method. Each concentration contained seven fish. Test item was formulated in dilution water. The treated fish was maintained in a test condition with pH value within 6.0 -8.5, hardness between 40 -250 caco3 and conductivity 0.417 mS/cm. No cumulative mortality (percent) observed in control group and 0.48, 1.53, 4.88 mg/L whereas, 14.29% and 100% in the tested concentration of 15.63 and 50.00 mg/L for a period of 96 hours. No Fish exhibited any abnormal behaviour in control group and 0.48, 1.53, 4.88 mg/L whereas, Loss of buoyancy control and Hypoactivity behaviours were observed in the tested concentration of 15.63 and 50.00 mg/L for a period of 96 hours.

Based on the results of range finding test, the definitive test was conducted with test concentration of 4.8, 8.6, 15.4, 27.8 and 50.0 mg/L, in a geometric series with a sacing factor of 1.8 along with a control group without test item by static method. Each concentration contained seven fish. Test item was formulated in dilution water. The treated fish was maintained in a test condition. No cumulative mortality (percent) observed in control group and 4.8 and 8.6 mg/L whereas, 14.29%, 100% and 100% in the tested concentration of 15.4, 27.8 and 50.0 mg/L for a period of 96 hours. No Fish exhibited any abnormal behaviour in control group and 4.8, 8.6, 15.4 mg/L whereas, Loss of buoyancy control and abnormal vertical orientation behaviours were observed in the tested concentration of 27.8 and 50.0 mg/L on day 0. The test item available in the test medium natural water was determined by a validated GC method. The test item concentration of test item in the test medium at the initiation (0 hour) and 96 hours was 99.14% to 100.01 % and 98.80 % to 99.32 % at 4.8, 8.6, 15.4, 27.8 and 50.0 mg/L, of the nominal test concentrations. The concentration of the test item has been satisfactorily maintained within 80 to 120% of the nominal concentration during the exposure period. Based on the results of this study, the LC50 value for 96 hours of 6-pentyloxan-2-one was found to be 18.70 mg/L with 95% confidence limits between 17.65mg/L and 19.75 mg/L. The results observed in the present study meets all the validity criteria as per OECD 203 Test guideline. Based on the median lethal concentration test chemical can be classified into aquatic chronic category 3 as per CLP classication criteria.

Description of key information

Short tertm toxicity to fish:

The objective of this study was to assess the acute toxicity of test chemical in fresh water 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). Solubility of the test item was performed by weighed 25.7 mg of the test item in a 250 ml volumetric flask dissolved and made up to the mark using natural water and the resulting concentration was 102.8 mg/L. Stability of the test item in natural water determined by analyzing the test concentrations of 0.1 and 100 mg/L at 0 hour, 24 hour, 48 hour, 72 hour and 96 hour showed that the test item concentration remained 80% to 120% (98.37% to 99.09% for 0.1 mg/L and 98.29% to 99.03% for 100 mg/L) with respect to initial measured concentration and hence the dose verification for definitive test was performed at the beginning and at the termination of the test. Range finding test was conducted with test concentration of 0.48 and 50.00 mg/L along with a control groups without test item by static method. Each concentration contained seven fish. Test item was formulated in dilution water. The treated fish was maintained in a test condition with pH value within 6.0 -8.5, hardness between 40 -250 caco3 and conductivity 0.417 mS/cm. No cumulative mortality (percent) observed in control group and 0.48, 1.53, 4.88 mg/L whereas, 14.29% and 100% in the tested concentration of 15.63 and 50.00 mg/L for a period of 96 hours. No Fish exhibited any abnormal behaviour in control group and 0.48, 1.53, 4.88 mg/L whereas, Loss of buoyancy control and Hypoactivity behaviours were observed in the tested concentration of 15.63 and 50.00 mg/L for a period of 96 hours.

Based on the results of range finding test, the definitive test was conducted with test concentration of 4.8, 8.6, 15.4, 27.8 and 50.0 mg/L, in a geometric series with a sacing factor of 1.8 along with a control group without test item by static method. Each concentration contained seven fish. Test item was formulated in dilution water. The treated fish was maintained in a test condition. No cumulative mortality (percent) observed in control group and 4.8 and 8.6 mg/L whereas, 14.29%, 100% and 100% in the tested concentration of 15.4, 27.8 and 50.0 mg/L for a period of 96 hours. No Fish exhibited any abnormal behaviour in control group and 4.8, 8.6, 15.4 mg/L whereas, Loss of buoyancy control and abnormal vertical orientation behaviours were observed in the tested concentration of 27.8 and 50.0 mg/L on day 0. The test item available in the test medium natural water was determined by a validated GC method. The test item concentration of test item in the test medium at the initiation (0 hour) and 96 hours was 99.14% to 100.01 % and 98.80 % to 99.32 % at 4.8, 8.6, 15.4, 27.8 and 50.0 mg/L, of the nominal test concentrations. The concentration of the test item has been satisfactorily maintained within 80 to 120% of the nominal concentration during the exposure period. Based on the results of this study, the LC50 value for 96 hours of 6-pentyloxan-2-one was found to be 18.70 mg/L with 95% confidence limits between 17.65mg/L and 19.75 mg/L. The results observed in the present study meets all the validity criteria as per OECD 203 Test guideline. Based on the median lethal concentration test chemical can be classified into aquatic chronic category 3 as per CLP classication criteria.

Key value for chemical safety assessment

Fresh water fish

Fresh water fish

Effect concentration:

18.7 mg/L

Additional information

Experimental study of the test chemical and supporting weight of evidence study for its functionally similar read across chemical were reviewed for the short term toxicity to fish end point which are summarized as below:

The objective of this study was to assess the acute toxicity of test chemical in fresh water 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). Solubility of the test item was performed by weighed 25.7 mg of the test item in a 250 ml volumetric flask dissolved and made up to the mark using natural water and the resulting concentration was 102.8 mg/L. Stability of the test item in natural water determined by analyzing the test concentrations of 0.1 and 100 mg/L at 0 hour, 24 hour, 48 hour, 72 hour and 96 hour showed that the test item concentration remained 80% to 120% (98.37% to 99.09% for 0.1 mg/L and 98.29% to 99.03% for 100 mg/L) with respect to initial measured concentration and hence the dose verification for definitive test was performed at the beginning and at the termination of the test. Range finding test was conducted with test concentration of 0.48 and 50.00 mg/L along with a control groups without test item by static method. Each concentration contained seven fish. Test item was formulated in dilution water. The treated fish was maintained in a test condition with pH value within 6.0 -8.5, hardness between 40 -250 caco3 and conductivity 0.417 mS/cm. No cumulative mortality (percent) observed in control group and 0.48, 1.53, 4.88 mg/L whereas, 14.29% and 100% in the tested concentration of 15.63 and 50.00 mg/L for a period of 96 hours. No Fish exhibited any abnormal behaviour in control group and 0.48, 1.53, 4.88 mg/L whereas, Loss of buoyancy control and Hypoactivity behaviours were observed in the tested concentration of 15.63 and 50.00 mg/L for a period of 96 hours.

Based on the results of range finding test, the definitive test was conducted with test concentration of 4.8, 8.6, 15.4, 27.8 and 50.0 mg/L, in a geometric series with a sacing factor of 1.8 along with a control group without test item by static method. Each concentration contained seven fish. Test item was formulated in dilution water. The treated fish was maintained in a test condition. No cumulative mortality (percent) observed in control group and 4.8 and 8.6 mg/L whereas, 14.29%, 100% and 100% in the tested concentration of 15.4, 27.8 and 50.0 mg/L for a period of 96 hours. No Fish exhibited any abnormal behaviour in control group and 4.8, 8.6, 15.4 mg/L whereas, Loss of buoyancy control and abnormal vertical orientation behaviours were observed in the tested concentration of 27.8 and 50.0 mg/L on day 0. The test item available in the test medium natural water was determined by a validated GC method. The test item concentration of test item in the test medium at the initiation (0 hour) and 96 hours was 99.14% to 100.01 % and 98.80 % to 99.32 % at 4.8, 8.6, 15.4, 27.8 and 50.0 mg/L, of the nominal test concentrations. The concentration of the test item has been satisfactorily maintained within 80 to 120% of the nominal concentration during the exposure period. Based on the results of this study, the LC50 value for 96 hours of 6-pentyloxan-2-one was found to be 18.70 mg/L with 95% confidence limits between 17.65mg/L and 19.75 mg/L. The results observed in the present study meets all the validity criteria as per OECD 203 Test guideline. Based on the median lethal concentration test chemical can be classified into aquatic chronic category 3 as per CLP classication criteria.

 

In an experimental study from study report (2018), an acute toxicity test was conducted for 96 hrs for assessing the effect of test chemical on fish. The test was performed in accordance with the OECD guideline No. 203 “Fish Acute Toxicity Test”. Zebra fish (Danio rerio) of average weight 0.0792 g and average length of 1.88 cm was used as a test organism for the study. Test fishes were kept in a static tank in tap water passed through reverse osmosis system, under natural conditions along with proper feed and aeration. During the housing period, test fishes were fed once daily with standard brand fed. The test conditions during the housing of the test organisms were oxygen content of 7.0 mg/l, pH 7.1, water temperature 24°C and under a photoperiod of 16:8 hr light: dark conditions, respectively. Test chemical concentrations were not verified analytically. Nominal concentrations of test chemical used for the study were 0, 6.25, 12.5, 25, 50 and 100mg/l, respectively. Total 8 fishes were exposed to test chemical in a 5 lit bowl aquaria containing 4 liters of potable water. The test vessels were placed in a room at a temperature of 24°C, pH 6.9, hardness of water 200 mg of CaCO3 and under a photoperiod of 16:8 hr light: dark conditions, respectively. Aeration in test vessels was provided 1 day before the start of the experiment. No mortalities were observed in the control vessel. On the basis of effect of test chemical on mortality of the test organism, the median lethal concentration (LC50 (96 h)) and LC100 value was determined to be > 6.25 and 12.5 mg/l.

 

On the basis of the above results, it can be concluded that the test chemical can be considered as toxic to fish and considered to be classified in ‘aquatic chronic category 3’ as per CLP classification criteria.