Undec-10-enal

Endpoint summary

Description of key information

Short term toxicity to fish:

Short term aquatic toxicity study (96 hrs) was conducted to assess the toxic effects of the test compound. The study was conducted according to the OECD guideline 203 on Zebra fish (Danio rerio) in a fresh water static system at a nominal concentration level of 0.8 mg/L, 1.76 mg/L, 3.87 mg/L, 8.51 mg/L for 96 hrs. Observations for mortality, visible symptoms, pH, Temperature, dissolved oxygen content were recorded after 24 hours, 48 hours, 72 hours and 96 hours after the start of the experiment. No mortality was recorded in any of the concentration upto 8.51 mg/l and the fishes were freely swimming without showing any abnormal symptoms. No mortalities were found in the control aquaria.  Based on nominal concentrations, experimental no lethal concentration [LC-0 (96 h)] for the test chemical on Danio rerio was observed to be at 8.51 mg/L. Mortality were observed at the concentration > 18.72 mg/l. Thus based on the LC50 value, chemical consider to be toxic and classified as aquatic chronic 3 as per the CLP classification criteria.

Long term toxicity to fish:

Using the EPI Suite, the long term toxicity on fish was predicted for test substance. On the basis of no effects observed in a freshwater system, the no observed effect concentration (NOEC) value for the substance is estimated to be 0.213 mg/l for fish for 28 d duration.

Short term toxicity to aquatic invertebrates:

Based on the prediction done by EPI suite, ECOSAR, on the basis of similarity of structure to chemicals for which the aquatic toxicity has been previously measured by structure-activity relationships (SARs) program, the LC 50 value for short term toxicity to aquatic invertebrates was predicted. On the basis of this program, the LC 50 value for short term toxicity to aquatic invertebrates was predicted to be 1.197 mg/l for test chemical in 48 hrs. Based on this value it can be concluded that the substance is considered to be toxic to aquatic environment and can be classified in aquatic chronic 2 category as per the criteria mentioned in CLP regulation.

Long term toxicity to aquatic invertebrates:

Using the EPI Suite, the long term toxicity on aquatic invertebrate daphnia magna was predicted for test substance. On the basis of no effects observed in a freshwater system, the no observed effect concentration (NOEC) value for the substance is estimated to be 0.201 mg/l for fish for 21 d duration. Based on this value, it can be concluded that the test chemical can be considered as toxic to fish at environmentally relevant concentrations and can be considered to be classified in aquatic chronic category 2.

Toxicity to aquatic algae and cyanobacteria:

The effect of test substance was studied on the growth of fresh water green alga Chlorella vulgaris. The study was conducted following OECD guideline 201- Alga growth inhibition test. The test substance was prepared by adding 8.6 mg of test substance in 400 ml of BBM to get the final concentration of 21.5 mg/l. The sock solution was subjected to stirring for 30 minutes to obtain a homogenous solution for the experiment. The remaining test solutions were prepared by dilution from the above stock solution, under aseptic condition. To have a better growth and visibility of cells, the initial cell density of the culture was kept 1 X 10000 cells/ml. Care was taken to have a homogeneous solution for the experiment. The effect of the test substance on the green algae Chlorella vulgaris culture was observed at nominal test concentration of 2.83 mg/l, 4.25 mg/l, 6.37 mg/l, 9.55 mg/l, 14.33 mg/l and 21.5 mg/l. All the six concentration were in geometric series spaced by a factor of 1.5. For the assessment of algal growth, the test was conducted in replicates. The control flask was maintained in triplicates as recommended in the OECD guideline and the test concentration were selected in geometric series which were maintained in duplicates. To obtain a quantitative concentration-response relationship by regression analysis, a linearizing transformation of the response data into probit was performed. Using the same, effective concentration (EC) were determined. Algal growth was calculated daily by counting the cells microscopically with the help of haemocytometer. After 72 hours of exposure to test chemical to various nominal test concentration, EC10 calculated through probit analysis was determine to be 2.23 mg/L based on the effect observed on the growth of green algae Chlorella vulgaris. As the EC10 was calculated which is 2.23 mg/l, thus on that basis chemical cannot be classified in any criteria and can be consider that the EC50 was > 2.23 mg/l.

 

Toxicity to microorganisms:

2. Based on inhibition in growth of test organism Salmonella choleraesuis subsp. choleraesuis ATCC 35640, the MIC value was determine to be 12.5 mg/l.

3. Based on inhibition in growth of test organism Saccharomyces cerevisiae ATCC 7754, the MIC and MFC value was determine to be 6.25 mg/l, respectively.

4. Based on inhibition in growth of test strain Salmonella choleraesuis subsp. choleraesuis ATCC 35640, the MIC value was determine to be 12.5 mg/l and the test compound did not show any antibacterial activity on test bacterial strain E. coli, E. aerogenes, P. aeruginosa and P. vulgariis, at a conc. upto 800 mg/l, respectively. Thus, the MIC value for these bacterial strains can be determine to be greater than 800 mg/l.

Additional information

Summarized result for the toxicity of test chemical on the growth and mortality of aquatic life’s including fish, invertebrates, algae and microorganism were studied and are as mention below:

Short term toxicity to fish:

Summarized result for the toxicity of test chemical and structurally and functionally similar read across chemicals on the mortality of fishes were reviewed and mention as below:

 

Short term aquatic toxicity study (96 hrs) was conducted to assess the toxic effects of the test compound. The study was conducted according to the OECD guideline 203 on Zebra fish (Danio rerio) in a fresh water static system at a nominal concentration level of 0.8 mg/L, 1.76 mg/L, 3.87 mg/L, 8.51 mg/L for 96 hrs. Observations for mortality, visible symptoms, pH, Temperature, dissolved oxygen content were recorded after 24 hours, 48 hours, 72 hours and 96 hours after the start of the experiment. No mortality was recorded in any of the concentration upto 8.51 mg/l and the fishes were freely swimming without showing any abnormal symptoms. No mortalities were found in the control aquaria.  Based on nominal concentrations, experimental no lethal concentration [LC-0 (96 h)] for the test chemical on Danio rerio was observed to be at 8.51 mg/L. Mortality were observed at the concentration > 18.72 mg/l. Thus based on the LC50 value, chemical consider to be toxic and classified as aquatic chronic 3 as per the CLP classification criteria.

 

Similarly in the second data for read across chemical the acute toxicity of industrial organic chemicals including test chemical to the fathead minnow was determined for 96 hrs. Concentrations were determined by analytical methods utilizing direct aqueous injection and solvent extraction gas chromatographic (GC) techniques, and high pressure liquid chromatographic (HPLC) analyses. GC analyses were performed on a Hewlett-Packard model 5730A gas chromatograph equipped with flame ionization and electron capture detectors. Tests were conducted in diluters with continuous-flow water delivery and toxicant introduction systems. Each of two diluters for binary tests contained a control, and four treatment levels in duplicate at each of seven mixture ratios were distributed between the diluters. This gave a total of 28 treatments in duplicate plus two controls. The seven ratios used to define the binary isobole diagrams were 5:0, 4:1, 2:1, 1:1, 1:2, 1:4, and 0:5. The diluter for equitoxic multiple chemical tests had one control and five single treatment levels. The toxicant concentrations followed a geometric series (0.8 dilution factor) for all tests. The dilution water was fed from a main head tank to a similar tank over each diluter. The water in the head tanks was vigorously aerated to remove excess dissolved gases. The toxicant solutions for binary tests were delivered by FMI metering pumps from separate stock bottles or chemical 'saturators' into a chamber which was designed to dilute each stock solution independently before combining them in mixtures. The toxicant concentrations in each test treatment were thus controlled separately. Test chambers were illuminated with wide spectrum fluorescent bulbs for 16 h daily. This included a 30-rain gradual brightening and dimming period with incandescent light to simulate dawn and dusk. The light intensity at the test water surface ranged from 22 to 38 lumens/ sq ft. 95% confidence intervals were computed by the Trimmed Spearman-Karber Method or a log-probit method. From experimental result the the lethal concentration in 96 hrs exposure period was observed to be 45.9 mg/l with 95% confidence limit (43.5-48.4 mg/l).Thus based on the result it is concluded that the test substance is toxic to fish and thus classified in aquatic chronic 3 as per the CLP criteria.

Thus based on the above values, chemical consider to be toxic and classified as aquatic chronic 3 as per the CLP classification criteria.

Long term toxicity to fish:

Using the EPI Suite, the long term toxicity on fish was predicted for test substance. On the basis of no effects observed in a freshwater system, the no observed effect concentration (NOEC) value for the substance is estimated to be 0.213 mg/l for fish for 28 d duration.

 

Short term toxicity to aquatic invertebrates:

Summarized result for the toxicity of test chemical and structurally and functionally similar read across chemicals were reviewed and mention as below:

Based on the prediction done by EPI suite, ECOSAR, on the basis of similarity of structure to chemicals for which the aquatic toxicity has been previously measured by structure-activity relationships (SARs) program, the LC 50 value for short term toxicity to aquatic invertebrates was predicted. On the basis of this program, the LC 50 value for short term toxicity to aquatic invertebrates was predicted to be 1.197 mg/l for test chemical in 48 hrs. Based on this value it can be concluded that the substance is considered to be toxic to aquatic environment and can be classified in aquatic chronic 2 category as per the criteria mentioned in CLP regulation.

 

Above result was supported by the second data from authoritative database. Objective of this study was to evaluate the range of toxicity of test chemical on the mobility of daphnia magna. Test conducted in accordance with OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test) for 48 hrs under the static system. Based on the immobility of daphnia magna after the exposure period of 48 hrs, EC50 was determine to be 1.3 mg/l. Thus based on the EC50 value, chemical consider to be toxic and classified as aquatic chronic 2 as per the CLP classification criteria.

 

Similar short term toxicity study for aquatic invertebrate Daphnia magna was performed for the test chemical according to OECD Guideline 202. The test concentration were0.13, 0.25, 0.50, 1.0, 2.0, 4.0 mg/l. Dimethyl formamide) was used as a solvent control. No immobilization occurred in the control or in the solvent control group. No immobilization was noted after 48 hours up to the treatment level of 0.25 mg/L. After 48 hours immobilization in the treatment groups of 0.50, 1.0, 2.0 and 4.0 mg/L was 15 %, 30 %, 30 % and 75 % respectively. The effect concentration for 50% immobilization of Daphnia magna after 48 h short term toxicity test was observed to be 2.3 mg/l. Based on the EC50 value, chemical consider to be toxic and classified in aquatic chronic 2 as per the CLP classification criteria.

 

Similar short term toxicity of test material was evaluated for 48 h according to OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test).HCO-40 was used in this test to prepare the test solution due to low water solubility and the limit test at 5.00 mg/L was performed. The EC50 after 48 h was evalauted to be >5.00 mg/l. EC50 (48h) was greater than the concentration used in the limit test because there was only 10 % immobility during the exposure. No effects were observed till the last limit of solubility.

 

Thus based on the overall studies and effects, chemical consider to be toxic and classified as aquatic chronic 2 as per the CLP classification criteria.

 

Long term toxicity to aquatic invertebrates:

Summarized result for the toxicity of test chemical and structurally and functionally similar read across chemicals were reviewed and mention as below:

Using the EPI Suite, the long term toxicity on aquatic invertebrate daphnia magna was predicted for test substance. On the basis of no effects observed in a freshwater system, the no observed effect concentration (NOEC) value for the substance is estimated to be 0.201 mg/l for fish for 21 d duration. Based on this value, it can be concluded that the test chemical can be considered as toxic to fish at environmentally relevant concentrations and can be considered to be classified in aquatic chronic category 2.

Similarly in the second study from authoritative database long term toxicity of aquatic invertebrates was evaluated for 21days according OECD Guideline 211 (Daphnia magna Reproduction Test). DMF and HCO-40 were used in this test to prepare the test solution due to low water solubility. Three test concentrations were prepared at 0.30, 0.55 and 1.00 mg/L as nominal concentration. However, Since the measured concentrations in groups tested at 21 day were different over 20% from their corresponding nominal concentration, the concentrations were expressed by timeweighted as 0.24, 0.49 and 0.84 mg/L.The concentration of vehicles used was 40 mg/L in the final test solution which has no significant effect on reproduction as revealed by a vehicle only control and is less than the recommended concentration of vehicle, i.e. 100 mg/L). No significant difference on cumulative number of dead parental was observed among control, vehicle control and treated groups. NOEC (21d) and EC50 (21d) was observed to be >0.84 mg/l . The effect concentration were greater than the highest concentration used in the test because there was no statistical difference on cumulative number of juveniles produced per adult alive for 21 days.

 

Toxicity to aquatic algae and cyanobacteria:

The effect of test substance was studied on the growth of fresh water green alga Chlorella vulgaris. The study was conducted following OECD guideline 201- Alga growth inhibition test. The test substance was prepared by adding 8.6 mg of test substance in 400 ml of BBM to get the final concentration of 21.5 mg/l. The sock solution was subjected to stirring for 30 minutes to obtain a homogenous solution for the experiment. The remaining test solutions were prepared by dilution from the above stock solution, under aseptic condition. To have a better growth and visibility of cells, the initial cell density of the culture was kept 1 X 10000 cells/ml. Care was taken to have a homogeneous solution for the experiment. The effect of the test substance on the green algae Chlorella vulgaris culture was observed at nominal test concentration of 2.83 mg/l, 4.25 mg/l, 6.37 mg/l, 9.55 mg/l, 14.33 mg/l and 21.5 mg/l. All the six concentration were in geometric series spaced by a factor of 1.5. For the assessment of algal growth, the test was conducted in replicates. The control flask was maintained in triplicates as recommended in the OECD guideline and the test concentration were selected in geometric series which were maintained in duplicates. To obtain a quantitative concentration-response relationship by regression analysis, a linearizing transformation of the response data into probit was performed. Using the same, effective concentration (EC) were determined. Algal growth was calculated daily by counting the cells microscopically with the help of haemocytometer. After 72 hours of exposure to test chemical to various nominal test concentration, EC10 calculated through probit analysis was determine to be 2.23 mg/L based on the effect observed on the growth of green algae Chlorella vulgaris. As the EC10 was calculated which is 2.23 mg/l, thus on that basis chemical cannot be classified in any criteria and can be consider that the EC50 was > 2.23 mg/l.

 

Toxicity to microorganisms:

Various studies available for the test chemical and structurally and functionally similar read across chemicals were reviewed to determine the toxic nature of test chemical on the growth and other activity of microorganisms. The studies are as mentioned below:

 

In the first study toxicity to micro-organisms study was conducted on Salmonella choleraesuis subsp. choleraesuisATCC35640 for 24 hrs. Broth macrodilution method was used for the antibacterial assay. The test chemical solution was prepared by dissolving the test substance in N,N-dimethyl formamide (DMF). The highest conc. of test chemical used for the study was 1600 mg/l. Test organism Salmonella choleraesuis subsp. choleraesusATCC35640, was obtained from American Type Culture Collection (Manassas, VA, USA). The cells of Salmonella choleraesuis subsp. choleraesuisATCC35640 were precultured in 3 ml of NYG broth without shaking at 37°C for 16 h. This preculture was used for the antibacterial assay. Serial two fold dilutions of the test compound was prepared in DMF, and 30 µl of each dilution was added to 3 ml of Nutrient broth-yeast extract-glucose (NYG) broth (0.8% nutrient broth, 0.5% yeast extract, 0.1% glucose). These were inoculated with 30 µl of preculture of Salmonella choleraesuis. After the incubation of the cultures at 37°C for 24 h, the minimum inhibitory concentration (MIC) was determined as the lowest conc. of the test compound that demonstrated no visible growth. The MBC was also determined. After the determination of MIC, 100-fold dilutions with drug-free NYG broth from each tube showing no turbidity were incubated at 37°C for 48 hrs. After 48 hrs, the MBC was calculated. MBC was defined as the lowest conc. of the test compound that showed no visible growth in the drug-free cultivation. Based on inhibition in growth of test organism Salmonella choleraesuis subsp. choleraesuisATCC35640, the MIC and MBC value was determine to be 12.5 mg/l, respectively.

 

 

Above study was supported by the second study from peer reviewed journal. Toxicity to micro-organisms study was conducted on Saccharomyces cerevisiae ATCC 7754 for 48 hrs. Broth macrodilution method was used for the assay. The test chemical solution was prepared by dissolving the test substance in N,N-dimethyl formamide (DMF). The highest conc. of test chemical used for the study was 1600 mg/l. Test organism Saccharomyces cerevisiae ATCC 7754, was obtained from American Type Culture Collection (Manassas, VA).S. cerevisiae was maintained at -80°C in yeast nitrogen broth (YNB) containing 25% glycerol and subcultured at 30°C in Sabouraud’s dextrose agar (SDA) medium (Bactopeptone 1%, dextrose 4%, Bacto-agar 1.8%). A fresh culture was preincubated with shaking for 16 h at 30°C in 2.5% malt extract (ME) medium (BBL). Serial 2-fold dilutions of the test compounds were made in DMF, and 30µL of the sample solution was added to 3 mL of malt extract medium. These were inoculated with 30µL of seed culture to give the final inoculum of 105CFU/mL. The assay tubes were incubated without shaking at 30°C for 48 h, the minimum inhibitory concentration (MIC) was determined as the lowest conc. of the test compound that demonstrated no visible growth. After the MIC had been determined, MFC was also determined. For determination of MFC, a 30µl aliquot was taken from each clear tube and added into 3 mL of drug-free fresh medium. After 48 h of incubation, the MFC was determined as the lowest concentration of the test compounds in which no recovery of microorganism was observed. Based on inhibition of growth of test organism Saccharomyces cerevisiae ATCC 7754, the MIC and MFC value was determine to be 6.25 mg/l, respectively.

 

Similar study of toxicity to micro-organisms study was conducted on Salmonella choleraesuis subsp. choleraesuisATCC35640,E. coli ATCC 9673,Enterobacter aerogenes ATCC 13048,Pseudomonas aeruginosa ATCC 10145, and Proteus Vulgaris ATCC 13315 for 24 hrs. Broth dilution method was used for the antibacterial assay. The test chemical solution was prepared by dissolving the test substance in N,N-dimethyl formamide (DMF). The highest conc. of test chemical used for the study was 1600 mg/l. Test organism Salmonella choleraesuis subsp. choleraesuisATCC35640,E. coli ATCC 9673,Enterobacter aerogenes ATCC 13048,Pseudomonas aeruginosa ATCC 10145, and Proteus Vulgaris ATCC 13315 were obtained from American Type Culture Collection (Manassas, VA, USA).The test bacterial strains were precultured in 3 ml of NYG broth without shaking at 37°C for 16 h. This preculture was used for the antibacterial assay. Serial 2-fold dilutions of the test compound was prepared in DMF, and 30 µl of each dilution was added to 3 ml of Nutrient broth-yeast extract-glucose (NYG) broth (0.8% nutrient broth, 0.5% yeast extract, 0.1% glucose). These were inoculated with 30 µl of the exponentially growing bacterial cells of Salmonella choleraesuis, E. coli, E. aerogenes, P. aeruginosa and P. vulgaris. After the incubation of the cultures at 37°C for 24 h, the minimum inhibitory concentration (MIC) was determined as the lowest conc. of the test compound that demonstrated no visible growth. The MBC was also determined. After the determination of MIC, 100-fold dilutions with drug-free NYG broth from each tube showing no turbidity were incubated at 37°C for 48 hrs. After 48 hrs, the MBC was calculated. MBC was defined as the lowest conc. of the test compound that showed no visible growth in the drug-free cultivation. Based on inhibition in growth of test strain Salmonella choleraesuis subsp. choleraesuisATCC35640, the MIC value was found to be 12.5 mg/l and the test compound did not show any antibacterial activity of test bacterial strain E. coli, E. aerogenes, P. aeruginosa and P. vulgaris, at a conc. upto 800 mg/l, respectively. Thus, the MIC value for these bacterial strains was to be greater than 800 mg/l.