Registration Dossier

Diss Factsheets

Ecotoxicological information

Endpoint summary

Administrative data

Description of key information

Short term toxicity to fish:

Fish Acute Toxicity test according to OECD Guideline 203 was conducted for test chemical. The test substance was slightly soluble in water. Therefore, the test solution was prepared by dissolving 800mg/L of the test substance in 1.8 liters of potable water (passed through reverse osmosis system) with continuous stirring of 48 hrs. After the completion was 48 hrs stirring, the sample was run with HPLC to calculate the actual solubility of substance and the solubility calculated was 1.4 mg/L. the water solubility obtained from the stock prepared is then used for achieving test concentrations of 0.02 mg/L, 0.04 mg/L, 0.06 mg/L, 0.08 mg/L& 0.2 mg/L, respectively. Zebra fishes were exposed to these concentration for 96 hours. The test vessels used were all plastic aquaria having the water capacity of 5 liters. The lethal concentrations LC50 was determine to be > 0.08 mg/L and <0.2 mg/L. Based on the LC50, chemical consider to be classified as aquatic acute 1.

 

Long term toxicity to fish:

Based on the prediction done using ECOSAR class, the long term toxicity on fish was predicted for test substance. On the basis of no effects observed in a static freshwater system, the NOEC value for the substance is estimated to be 0.000192 mg/l for fish for 28 days of exposure 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 1 category as per the CLP classification criteria. 

 

Short term toxicity to invertebrates:

Summarized result for the toxicity of test chemical on the aquatic invertebrate. Three study were reviewed in which the toxicity ranges from 0.42 mg/l to > 5 mg/l. Cardanol had an LC50 of 1.59 mg/L and 0.42 mg/L after 24 and 48 hr exposures respectively. The estimated LC50 value of Cardanol for daphnia magna for 48 hr was found to be 1.0537 mg/l. Thirdly The LC50 & LC90 values of Cardanol in Biomphalaria glabrata (NIH albino or M line) after 48 hr was determine to be >5 mg/l. Thus based on the LC50 value, chemical consider to be toxic and classified as aquatic acute 1 as per the CLP classification criteria.

Long term toxicity to aquatic invertebrates:

Based on the prediction done using ECOSAR class, the long term toxicity on aquatic invertebrate daphnia was predicted for test substance. On the basis of no effects observed in a static freshwater system, the NOEC value for the substance is estimated to be 0.000723 mg/l for daphnia for 21 days of exposure duration. Based on this value, it can be concluded that the test chemical can be considered as toxic to aquatic invertebrate daphnia at environmentally relevant concentrations and can be considered to be classified in aquatic chronic 1 category as per the CLP classification criteria. 

 

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 concentration chosen for the study were 0.4 mg/l, 0.6 mg/l, 0.8 mg/l, 1.0 mg/l, 1.2 mg/l and 1.4 mg/l were prepared using stock solution of the test substance using de-ionized water. As the test substance was poorly soluble in water with experimentally determined water solubility value as 1.4 mg/l, the stock solution of test chemical was prepared by adding 480 mg of test substance in 600 ml of BBM to achieve the maximum dissolution and stirring it for 48 h. The concentration of the stock solution was determined analytically through HPLC after 48 h stirring and it was found to be 1.4 mg/l. The test solutions were prepared by dilution from the above stock solution under aseptic conditions. 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 green alga was exposed to the test concentration for a period of 72 hours to observe average specific growth rate and % growth inhibition under the effect of test substance. EC50 calculated from both, equation and graphically through probit analysis was observed to be 1.41 mg/L. Based on the observed effect chemical consider to be toxic and classifies as aquatic chronic 2 as per the CLP classification criteria.

Toxicity to microorganisms:

In the first key study the IGC50 value of test chemical in microbes (Tetrahymena pyriformis) for 48hr was found to be 36.58 mg/l.

Similarly in the second study fungicidal activity of synthetically modified test chemical were determined. Test chemical liquid (2g) was dissolved in pyridine (5 ml), at 00 C and acetic anhydride (2 ml) was added. The mixture was left at 40 C for 18 h, diluted with methylene chloride and repeatedly washed with water. Concentration of the solvent gave the acetylated product. The IGC50 value of test chemical liquid in cladosporium for 24hr was determine to be 6% (60000ppm).

Additional information

Short term toxicity to fish:

Fish Acute Toxicity test according to OECD Guideline 203 was conducted for test chemical. The test substance was slightly soluble in water. Therefore, the test solution was prepared by dissolving 800mg/L of the test substance in 1.8 liters of potable water (passed through reverse osmosis system) with continuous stirring of 48 hrs. After the completion was 48 hrs stirring, the sample was run with HPLC to calculate the actual solubility of substance and the solubility calculated was 1.4 mg/L. the water solubility obtained from the stock prepared is then used for achieving test concentrations of 0.02 mg/L, 0.04 mg/L, 0.06 mg/L, 0.08 mg/L& 0.2 mg/L, respectively. Zebra fishes were exposed to these concentration for 96 hours. The test vessels used were all plastic aquaria having the water capacity of 5 liters. The lethal concentrations LC50 was determine to be > 0.08 mg/L and <0.2 mg/L. Based on the LC50, chemical consider to be classified as aquatic acute 1.

 

Long term toxicity to fish:

Based on the prediction done using ECOSAR class, the long term toxicity on fish was predicted for test substance. On the basis of no effects observed in a static freshwater system, the NOEC value for the substance is estimated to be 0.000192 mg/l for fish for 28 days of exposure 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 1 category as per the CLP classification criteria. 

 

Short term toxicity to invertebrates:

Summarized result for the toxicity of test chemical on the aquatic invertebrate. Three study were reviewed in which the toxicity ranges from 0.42 mg/l to > 5 mg/l. Cardanol had an LC50 of 1.59 mg/L and 0.42 mg/L after 24 and 48 hr exposures respectively. The estimated LC50 value of Cardanol for daphnia magna for 48 hr was found to be 1.0537 mg/l. Thirdly The LC50 & LC90 values of Cardanol in Biomphalaria glabrata (NIH albino or M line) after 48 hr was determine to be >5 mg/l. Thus based on the LC50 value, chemical consider to be toxic and classified as aquatic acute 1 as per the CLP classification criteria.

Long term toxicity to aquatic invertebrates:

Based on the prediction done using ECOSAR class, the long term toxicity on aquatic invertebrate daphnia was predicted for test substance. On the basis of no effects observed in a static freshwater system, the NOEC value for the substance is estimated to be 0.000723 mg/l for daphnia for 21 days of exposure duration. Based on this value, it can be concluded that the test chemical can be considered as toxic to aquatic invertebrate daphnia at environmentally relevant concentrations and can be considered to be classified in aquatic chronic 1 category as per the CLP classification criteria. 

 

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 concentration chosen for the study were 0.4 mg/l, 0.6 mg/l, 0.8 mg/l, 1.0 mg/l, 1.2 mg/l and 1.4 mg/l were prepared using stock solution of the test substance using de-ionized water. As the test substance was poorly soluble in water with experimentally determined water solubility value as 1.4 mg/l, the stock solution of test chemical was prepared by adding 480 mg of test substance in 600 ml of BBM to achieve the maximum dissolution and stirring it for 48 h. The concentration of the stock solution was determined analytically through HPLC after 48 h stirring and it was found to be 1.4 mg/l. The test solutions were prepared by dilution from the above stock solution under aseptic conditions. 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 green alga was exposed to the test concentration for a period of 72 hours to observe average specific growth rate and % growth inhibition under the effect of test substance. EC50 calculated from both, equation and graphically through probit analysis was observed to be 1.41 mg/L. Based on the observed effect chemical consider to be toxic and classifies as aquatic chronic 2 as per the CLP classification criteria.

Toxicity to microorganisms:

In the first key study the IGC50 value of test chemical in microbes (Tetrahymena pyriformis) for 48hr was found to be 36.58 mg/l.

Similarly in the second study fungicidal activity of synthetically modified test chemical were determined. Test chemical liquid (2g) was dissolved in pyridine (5 ml), at 00 C and acetic anhydride (2 ml) was added. The mixture was left at 40 C for 18 h, diluted with methylene chloride and repeatedly washed with water. Concentration of the solvent gave the acetylated product. The IGC50 value of test chemical liquid in cladosporium for 24hr was determine to be 6% (60000ppm).