Dodecan-5-olide

Endpoint summary

Description of key information

Short-term toxicity to fish:

 

A short-term toxicity test was performed as per OECD Guideline 203 (Fish, Acute toxicity test) assesses the acute toxic effects (mortality) of various concentrations of a test chemical on a freshwater fish species.  Danio rerio (zebrafish) of length 1.96 cm was used as a test organism under static conditions for 96 hrs of exposure. A group of 7 fish of recommended species was exposed for a period of 96 hrs. The solution was prepared by dissolving 500 mg of the test chemical in 5000 ml of RO water to get the final concentration of 100 mg/L. The remaining test solutions were prepared by dilution from the above stock solution. 7 test concentrations control, 10, 11, 12,19.2,30.72,49.152,78.643 mg/L of test chemical dissolved in 5000 ml of water. The auxiliaries used to prepare the test media were magnetic stirrers. The analytical determinations were performed by UV Spectrophotometer and HPLC. Analytical assessments were performed for selected test concentrations at 0 Hr and 96 Hr. On condition of ACN (100%) (1 ml/min), 25°C with column C-18. For concentrations 12, 19.2, 30.72, 49.152, and 78.643 mg/L analytical were performed by using a UV Spectrophotometer. And for concentrations 10 and 11 mg/L analytical was performed by using HPLC as these lower concentrations were not detected on UV Spectrophotometer because of its limit of detection (LOD is 1 mg/l and LOQ is 10 mg/l). The reproducibility range was between 80-120% of the exposure test chemical. The test substance was identified based on the absorbance at zero-day and 96 hours. The concentration of the test chemical being tested has been satisfactorily maintained within ± 20 % of the nominal concentration throughout the test so, analysis of the results was based on nominal concentration. The test concentrations were measured and found to remain at 120-80% of the nominal. Hence, the LC₅₀ was expressed based on Nominal concentrations and the spacing factor for test concentrations was <2.2. The fish were maintained and kept in a static tank in tap water passed through a reverse osmosis system, under natural conditions along with proper feed and aeration for 7 days. Fishes are kept in the test water for seven days immediately before testing under same condition as like test conditions. Fishes, to be used in this study, are kept for acclimatization in the test water for seven days immediately before testing in the same test conditions. Fishes were fed by standard brand feed daily once but not given at least 48 hours before the study. No mortalities were found during the period of acclimatization. Test condition involves photoperiod 16-hour light and 8 hours dark, temperature range 18 to 22 °C, pH 7.31, DO 7.1-8.2 mg/L, hardness 125 mg/l as CaCO3 respectively. Continuous aeration was provided. Glass aquaria of 7 lit capacity filled with volume 4000 mL for 12, 19.2, 30.72, 49.152, 78.643 mg/L whereas 2500 ml for 10 and 11 mg/L, respectively. No. of organisms per vessel 7 with 1 replicate. The mortality in the controls did not exceed 10% by the end of the test and dissolved oxygen concentration remained above 60% of the air-saturation value throughout the exposure period. Hence, the test fulfilled the validity criteria as per OECD 203. Based on the effect on toxicity to fish, the 96 hr LC50 value of the test chemical was determined to be 10.25 mg/L. Since the test chemical was readily biodegradable, hence the test chemical was not classified as per CLP classification criteria.

 

                                                                                         

Short-term toxicity to aquatic invertebrates:

 

A study was performed to assess the Acute Immobilization of test chemicals to Daphnia Magna STRAUS (Common Name: Water Flea) under static conditions. The study was conducted by OECD Guideline for the testing of chemicals No. 202, Daphnia, Acute Immobilization Test Adopted on 13 April 2004. The main test was conducted under static conditions with the solution unchanged throughout the 48 hours duration.  Daphnia Magna STRAUS of size 0.45 cm from MicroBio tests Kleimoer 15B-9030 MARIAKERKE (GENT) BELGIUM and maintained at ESSEM Compliance Solutions Private Limited, Nagpur. A population of Daphnia Magna of synchronized age structure has been maintained for the last two months after its procurement from DTU in the test facility under constant temperature conditions (18 to 22 °C) at a 16: 8-hour light-dark photoperiod (illumination: > 1000 lux). The culture media (M7 medium') was partly renewed twice a week. The Daphnia were exclusively fed with unicellular green algae (Selenestrum capricornutum). Media renewal of Daphnia culture was done twice a week and pH, DO, and the temperature was recorded daily. M7 medium was used for the maintenance of test animals, preparation of the stock solution, and the test solutions of chemicals.  A group of 20 Daphnids each recommended was exposed for a period of 48 hours to a test concentration i.e., control,1,2,4,8,16 mg/L of Test chemical dissolved in media.  Range finding test was performed using 0.1, 1, 10, and 100 mg/L of test concentrations. A definitive test was performed and five test concentrations in replicates were selected, which were arranged in geometric series by considering factor 2. The stock solution was prepared by dissolving 10.1 mg of the test chemical in 100 ml of M7 medium to get the final concentration of 100 mg/L. The remaining test solutions were prepared by dilution from the above stock solution. The analytical determinations were performed by HPLC. The pre-treated stock solution was then diluted with media to get the required test solutions ranging from concentrations 1.15, 11.5, 115, and 1150 mg/L. The absorbance of the resulting solution was measured using HPLC against the corresponding blank. A standard curve was plotted against concentration versus area and the maximum solubility was determined from the above standard curve. Analytical assessments were performed for selected test concentrations at 0 hours and 48 hours. During the test, a temperature range of 18 - 22°C, was maintained in the test beakers throughout the exposure period. The pH and oxygen values were measured at the beginning of the test and every 24 hours thereafter. The hardness of the media was above 175 mg/L CaCO3 during the test. The Daphnids were exposed to the test chemicals and dissolved in the M7 media. Immobilization was recorded at 24 hours and 48 hours and EC50 was calculated from probit analysis. Reference chemical Potassium dichromate (K2Cr2O7) was tested for 24 hours to assure the test conditions are reliable. After 48 hr of exposure period, in the control, there was no immobilisation of test daphnids or other clinical signs throughout the test. The dissolved oxygen concentration at the end of the test was 8.2 (i.e., ≥3 mg/l) in control and test vessels. Hence, the test is valid as per OECD guideline 203. Concentrations were measured and found to remain within ±20% of nominal concentrations. Based on the effect on the immobilization of test daphnids, the effective dose concentration EC50 was determined to be 8.8 mg/L. Since the test chemical was readily biodegradable, the test chemical was considered to be not classified as per CLP classification criteria.

 

Toxicity to aquatic algae and cyanobacteria:

Data available for the structurally and functionally similar read across chemicals has been reviewed to determine the toxicity of aquatic algae and cyanobacteria of the test chemical .The studies are as mentioned below:

To study the effects of test material toxicity to aquatic algae and cyanobacteria test was carried out for 72 hr.Effective concentration EC50 to 50% of Desmodesmus subspicatus when expeosed to test material for 72 hr is 6.61 mg/L.The BCF value of test material reported was not >= 500 as well as the substance was found to be rapidly degradable. Since the additional criteria mentioned in the CLP regulation related to BCF, biodegradability and Log Kow is not satisfied thus the substance has not been considered for aquatic toxicity classification.

 

In another data for similar read across substance test material was used to evaluate its toxicity on Chlorococcales green algae for 24 hrs in static condition . The effect concentration (EC50) at which population of algae was effect was observed to be 230 mg/l.

 

The test chemical is not likely to be toxic to aquatic algae and cyanobacteria  in the dose range of 230 mg/l.The BCF value of test chemical reported was not >= 500 as well as the substance was found to be rapidly degradable. Since the additional criteria mentioned in the CLP regulation related to BCF, biodegradability and Log Kow is not satisfied thus the substance has not been considered for aquatic toxicity classification.

 

 

Toxicity to microorganisms:

Data available for the functionally similar read across chemicals has been reviewed to determine the toxicity of microorganism of the test chemical .The studiesare as mentioned below:

Cell multiplication inhibition test was carried out to study the effects of test material on Pseudomonas putida. The threshold toxcity of test material on cell multiplication inhibition effect on Pseudomonas putida was observed to be 220 mg/L.

For another read across substance cell multiplication inhibition test was carried out to study the effects of test material on Pseudomonas putida. The threshold toxcity of test material on cell multiplication inhibition effect on Pseudomonas putida was observed to be 62 mg/L.

Eventhough the solubility of target in water is less , the target as well as the structurally similar read across substance are redialy biodegradable . Since the additional criteria mentioned in the CLP regulation related to BCF, biodegradability and Log Kow is not satisfied thus the substance has not been considered for aquatic toxicity classification.

Additional information

Short-term toxicity to fish:

 

A short-term toxicity test was performed as per OECD Guideline 203 (Fish, Acute toxicity test) assesses the acute toxic effects (mortality) of various concentrations of a test chemical on a freshwater fish species.  Danio rerio (zebrafish) of length 1.96 cm was used as a test organism under static conditions for 96 hrs of exposure. A group of 7 fish of recommended species was exposed for a period of 96 hrs. The solution was prepared by dissolving 500 mg of the test chemical in 5000 ml of RO water to get the final concentration of 100 mg/L. The remaining test solutions were prepared by dilution from the above stock solution. 7 test concentrations control, 10, 11, 12,19.2,30.72,49.152,78.643 mg/L of test chemical dissolved in 5000 ml of water. The auxiliaries used to prepare the test media were magnetic stirrers. The analytical determinations were performed by UV Spectrophotometer and HPLC. Analytical assessments were performed for selected test concentrations at 0 Hr and 96 Hr. On condition of ACN (100%) (1 ml/min), 25°C with column C-18. For concentrations 12, 19.2, 30.72, 49.152, and 78.643 mg/L analytical were performed by using a UV Spectrophotometer. And for concentrations 10 and 11 mg/L analytical was performed by using HPLC as these lower concentrations were not detected on UV Spectrophotometer because of its limit of detection (LOD is 1 mg/l and LOQ is 10 mg/l). The reproducibility range was between 80-120% of the exposure test chemical. The test substance was identified based on the absorbance at zero-day and 96 hours. The concentration of the test chemical being tested has been satisfactorily maintained within ± 20 % of the nominal concentration throughout the test so, analysis of the results was based on nominal concentration. The test concentrations were measured and found to remain at 120-80% of the nominal. Hence, the LC₅₀ was expressed based on Nominal concentrations and the spacing factor for test concentrations was <2.2. The fish were maintained and kept in a static tank in tap water passed through a reverse osmosis system, under natural conditions along with proper feed and aeration for 7 days. Fishes are kept in the test water for seven days immediately before testing under same condition as like test conditions. Fishes, to be used in this study, are kept for acclimatization in the test water for seven days immediately before testing in the same test conditions. Fishes were fed by standard brand feed daily once but not given at least 48 hours before the study. No mortalities were found during the period of acclimatization. Test condition involves photoperiod 16-hour light and 8 hours dark, temperature range 18 to 22 °C, pH 7.31, DO 7.1-8.2 mg/L, hardness 125 mg/l as CaCO3 respectively. Continuous aeration was provided. Glass aquaria of 7 lit capacity filled with volume 4000 mL for 12, 19.2, 30.72, 49.152, 78.643 mg/L whereas 2500 ml for 10 and 11 mg/L, respectively. No. of organisms per vessel 7 with 1 replicate. The mortality in the controls did not exceed 10% by the end of the test and dissolved oxygen concentration remained above 60% of the air-saturation value throughout the exposure period. Hence, the test fulfilled the validity criteria as per OECD 203. Based on the effect on toxicity to fish, the 96 hr LC50 value of the test chemical was determined to be 10.25 mg/L. Since the test chemical was readily biodegradable, hence the test chemical was not classified as per CLP classification criteria.

 

 

Short-term toxicity to aquatic invertebrates:

 

A study was performed to assess the Acute Immobilization of test chemicals to Daphnia Magna STRAUS (Common Name: Water Flea) under static conditions. The study was conducted by OECD Guideline for the testing of chemicals No. 202, Daphnia, Acute Immobilization Test Adopted on 13 April 2004. The main test was conducted under static conditions with the solution unchanged throughout the 48 hours duration.  Daphnia Magna STRAUS of size 0.45 cm from MicroBio tests Kleimoer 15B-9030 MARIAKERKE (GENT) BELGIUM and maintained at ESSEM Compliance Solutions Private Limited, Nagpur. A population of Daphnia Magna of synchronized age structure has been maintained for the last two months after its procurement from DTU in the test facility under constant temperature conditions (18 to 22 °C) at a 16: 8-hour light-dark photoperiod (illumination: > 1000 lux). The culture media (M7 medium') was partly renewed twice a week. The Daphnia were exclusively fed with unicellular green algae (Selenestrum capricornutum). Media renewal of Daphnia culture was done twice a week and pH, DO, and the temperature was recorded daily. M7 medium was used for the maintenance of test animals, preparation of the stock solution, and the test solutions of chemicals.  A group of 20 Daphnids each recommended was exposed for a period of 48 hours to a test concentration i.e., control,1,2,4,8,16 mg/L of Test chemical dissolved in media.  Range finding test was performed using 0.1, 1, 10, and 100 mg/L of test concentrations. A definitive test was performed and five test concentrations in replicates were selected, which were arranged in geometric series by considering factor 2. The stock solution was prepared by dissolving 10.1 mg of the test chemical in 100 ml of M7 medium to get the final concentration of 100 mg/L. The remaining test solutions were prepared by dilution from the above stock solution. The analytical determinations were performed by HPLC. The pre-treated stock solution was then diluted with media to get the required test solutions ranging from concentrations 1.15, 11.5, 115, and 1150 mg/L. The absorbance of the resulting solution was measured using HPLC against the corresponding blank. A standard curve was plotted against concentration versus area and the maximum solubility was determined from the above standard curve. Analytical assessments were performed for selected test concentrations at 0 hours and 48 hours. During the test, a temperature range of 18 - 22°C, was maintained in the test beakers throughout the exposure period. The pH and oxygen values were measured at the beginning of the test and every 24 hours thereafter. The hardness of the media was above 175 mg/L CaCO3 during the test. The Daphnids were exposed to the test chemicals and dissolved in the M7 media. Immobilization was recorded at 24 hours and 48 hours and EC50 was calculated from probit analysis. Reference chemical Potassium dichromate (K2Cr2O7) was tested for 24 hours to assure the test conditions are reliable. After 48 hr of exposure period, in the control, there was no immobilisation of test daphnids or other clinical signs throughout the test. The dissolved oxygen concentration at the end of the test was 8.2 (i.e., ≥3 mg/l) in control and test vessels. Hence, the test is valid as per OECD guideline 203. Concentrations were measured and found to remain within ±20% of nominal concentrations. Based on the effect on the immobilization of test daphnids, the effective dose concentration EC50 was determined to be 8.8 mg/L. Since the test chemical was readily biodegradable, the test chemical was considered to be not classified as per CLP classification criteria.

 

Toxicity to aquatic algae and cyanobacteria:

Data available for the structurally and functionally similar read across chemicals has been reviewed to determine the toxicity of aquatic algae and cyanobacteria of the test chemical .The studies are as mentioned below:

To study the effects of test material toxicity to aquatic algae and cyanobacteria test was carried out for 72 hr.Effective concentration EC50 to 50% of Desmodesmus subspicatus when expeosed to test material for 72 hr is 6.61 mg/L.The BCF value of test material reported was not >= 500 as well as the substance was found to be rapidly degradable. Since the additional criteria mentioned in the CLP regulation related to BCF, biodegradability and Log Kow is not satisfied thus the substance has not been considered for aquatic toxicity classification.

 

In another data for similar read across substance test material was used to evaluate its toxicity on Chlorococcales green algae for 24 hrs in static condition . The effect concentration (EC50) at which population of algae was effect was observed to be 230 mg/l.

 

The test chemical is not likely to be toxic to aquatic algae and cyanobacteria  in the dose range of 230 mg/l.The BCF value of test chemical reported was not >= 500 as well as the substance was found to be rapidly degradable. Since the additional criteria mentioned in the CLP regulation related to BCF, biodegradability and Log Kow is not satisfied thus the substance has not been considered for aquatic toxicity classification.

 

 

Toxicity to microorganisms:

Data available for the functionally similar read across chemicals has been reviewed to determine the toxicity of microorganism of the test chemical .The studiesare as mentioned below:

Cell multiplication inhibition test was carried out to study the effects of test material on Pseudomonas putida. The threshold toxcity of test material on cell multiplication inhibition effect on Pseudomonas putida was observed to be 220 mg/L.

For another read across substance cell multiplication inhibition test was carried out to study the effects of test material on Pseudomonas putida. The threshold toxcity of test material on cell multiplication inhibition effect on Pseudomonas putida was observed to be 62 mg/L.

Eventhough the solubility of target in water is less , the target as well as the structurally similar read across substance are redialy biodegradable . Since the additional criteria mentioned in the CLP regulation related to BCF, biodegradability and Log Kow is not satisfied thus the substance has not been considered for aquatic toxicity classification.