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Description of key information

Short-term toxicity to fish

Using the EPI Suite ECOSAR version 1.11, the short term toxicity on fish was predicted for test chemical on the basis of effects observed in a static freshwater system. The lethal concentration LC50 value for the substance was estimated to be 646.836 mg/l for fish for 96 hr exposure duration. Based on this lethal value it can be concluded that the test chemical can be likely to be non toxic to aquatic environment and thus it is considered as not classified as per the CLP classification criteria.

Short-term toxicity to aquatic invertebrates

Using the EPI suite, ECOSAR version 1.1, 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 EPI suite, ECOSAR version 1.1, the LC 50 value for short term toxicity to aquatic invertebrates was predicted to be 340.80 mg/l for test chemical in 48 h. Based on this value it can be concluded that the substance is likely to be non toxic to aquatic environment and can be considered to be not classified as per the criteria mentioned in CLP regulation.

Toxicity to aquatic algae and cyanobacteria

Using the EPI Suite ECOSAR version 1.10, the short term toxicity on green algae was predicted for test chemical. On the basis of effects observed in a static freshwater system, the effect concentration EC50 value for the substance is estimated to be 186.317 mg/l for green algae for 96 h duration. Based on this value, it is concluded that the test chemical can be considered as non-toxic to green algae at environmentally relevant concentrations and considered not-classified as per the CLP classification criteria.

Toxicity to microorganims:

Toxicity of test chemical to microorganisms was determined by performing the experiment for 20 h, the test microorganism used in the study was Chilomonas paramaecium. The EC5 value of test chemical was determined to be 13 mg/L after the exposure of test chemical to Microorganism Chilomonas paramaecium for 20 h.

Additional information

Short-term toxicity to fish

Four studies including predicted data from validated tools and experimental data from authoritative database of test chemical and its structurally similar read across has been reviewed for short term toxicity fish and their results are summarized below

 

In first study by using the EPI Suite ECOSAR version 1.11, the short term toxicity on fish was predicted for test chemical on the basis of effects observed in a static freshwater system. The lethal concentration LC50 value for the substance was estimated to be 646.836 mg/l for fish for 96 h exposure duration. Based on this lethal value it can be concluded that the test chemical can be likely to be nontoxic to aquatic environment and thus it is considered as not classified as per the CLP classification criteria.

 

In another study from secondary source the short term toxicity of test chemical to fish was determined by performing the experiment for 48 h, the test organism used in the study was Leuciscus idus melanotus. The LC0 , LC50 and LC100 value of test chemical was determined to be 1200 mg/L, 1720 mg/L and 2000 mg/L after the exposure of test chemical to Leuciscus idus melanotus for 48 h.

 

Next study was conducted to assess the effect of test chemical on the mortality of fish Danio rerio. Test conducted according to OECD Guideline 203 (Fish, Acute Toxicity Test). The test substance was soluble in water, therefore, the stock solution was prepared by dissolving 1 gm of the test substance in 1 liters of potable water (passed through reverse osmosis system then the Stock solution was used for achieving test concentrations of 6.25 mg/L, 12.5 mg/L, 25 mg/L, 50 mg/L & 100 mg/L, respectively and Zebra Fish Danio rerio were exposed to these concentration for 96 hours. Bowl aquaria containing 2 liters of potable water (passed through reverse osmosis system) were loaded with 8 fishes. A static procedure was used for the study and it was conducted in compliance with the OECD guideline 203. After 96 hours of exposure to test item to various nominal test concentrations, LC0 was determine to be 100 mg/l. Based on the LC0, it can be consider that the chemical was not hazardous and can be consider to be not classified as per the CLP classification criteria.

 

Last study was reviewed from authoritative database in this the short term toxicity of test chemical to fish was determined by performing the experiment for 96 h, the test organism used in the study was Oryzias latipes. The experiment was conducted in semi-static condition at 24±1 °C. The Nominal concentrations used in the study was control, 27, 37, 52, 72, 100 mg/L, at geometric ratio of 1:4. The test vessel used was 5L closed vessel and no aeration was given. The test solution was renewed after every 24h, the number of organisms per vessel were 10/concentration, and number of vessels per concentration (replicates) was one and the Photoperiod given was room light, 16 hours light / 8 hours dark.

 The LC50 value of test chemical was determined to be 106 mg/L after the exposure of test chemical to Oryzias latipes for 96 h. By considering this LC 50 value test chemical it is concluded that test chemical is nontoxic to fish and cannot be classified as per CLP regulation.

 

By considering the results of all the studies mentioned above it is concluded that LC 50calue of test chemical is in range of 106 mg/L to 1720 mg/L. On the basis of this range LC 50 value the test chemical it is considered not hazardous to fish cannot classified as per the CLP classification criteria.

Short-term toxicity to aquatic invertebrates

Four studies including predicted data from validated tools and experimental data from authoritative database of test chemical and its structurally similar read across are reviewed for short term toxicity aquatic invertebrate and their results are summarized below

 

In first study by using the EPI suite, ECOSAR version 1.1, 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 EPI suite, ECOSAR version 1.1, the LC 50 value for short term toxicity to aquatic invertebrates was predicted to be 340.80 mg/l for test chemical in 48 h. Based on this value it can be concluded that the substance is likely to be non toxic to aquatic environment and can be considered to be not classified as per the criteria mentioned in CLP regulation.

 

In another study based on the QSAR prediction done using the Danish (Q)SAR Database, the 48 hours effect concentration i.e EC50 of test chemical was estimated to be 345.183 mg/l on Daphnia Magna for with immobilization effects. Thus based on predicted effect value it can be concluded that the test chemical is not classified as per the criteria of CLP regulation.

 

In next study short term toxicity of test chemical to aquatic invertebrate was determined by performing the experiment for 24 h using test guideline DIN 38412 Teil 11, the test organism used in the study was Daphnia magna. The EC0, EC50 and EC100 value of test chemical was determined to be 13 mg/L, 556 – 714 mg/L and 1000 mg/L after the exposure of test chemical to Daphnia magna for 24 h.

 

In last study the short term toxicity of test chemical to aquatic invertebrate was determined by performing the experiment for 24 h using test guideline OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test) , the test organism used in the study was Daphnia magna. The effect concentration EC50 value of test chemical was determined to be >98 mg/L on the basis of immobilization effect after the exposure of test chemical to Daphnia magna for 48 h.

 

By considering the results of all the studies mentioned above it is concluded that EC50 value of test chemical is in range of >98 mg/L to 714 mg/L. On the basis of this range EC50 value the test chemical it is considered nonhazardous to aquatic invetebrates cannot classified as per the CLP classification criteria.

Toxicity to aquatic algae and cyanobacteria

Three studies including predicted data from validated tools and experimental data from authoritative database of test chemical and its structurally similar read across has been reviewed for toxicity aquatic algae endpoint and their results are summarized below

 

In first study using the EPI Suite ECOSAR version 1.10, the short term toxicity on green algae was predicted for test chemical. On the basis of effects observed in a static freshwater system, the effect concentration EC50 value for the substance is estimated to be 186.317 mg/l for green algae for 96 h duration. Based on this value, it is concluded that the test chemical can be considered as non-toxic to green algae at environmentally relevant concentrations and considered not-classified as per the CLP classification criteria.

 

In another study the toxicity of test chemical to aquatic algae was determined by performing the experiment for 8 d, the test microorganism used in the study was Microcystis aeruginosa. The EC3 value of test chemical was determined to be 78 mg/L after the exposure of test chemical to aquatic algae Microcystis aeruginosa for 8 days.

 

In last study the experiment was conducted to determine the effect of test chemical on aquatic algae by using OECD guideline 201 (Alga, Growth Inhibition Test), the test organisms used in this study was green alga Chlorella vulgaris. The test chemical solution was prepared by adding 70mg of test chemical in 350 ml of BBM to get the final concentration of 200 mg/L. The remaining test solutions were prepared by dilution from the above stock solution. To have a better growth and visibility of cells, the initial cell density of the culture was kept 1 X 10E4cells/ml. Care was taken to have a homogeneous solution for the experiment. The experiment was carried out in 100mL conical flasks which were carefully autoclaved and sterilized. The test solution in each of these test vessels was kept constant which is 60 ml so that a sufficient amount of head space was left.

  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. For microscopic observations the cultures were observed daily with the help of a microscope to verify a normal and healthy appearance of the algal culture and also to observe any abnormal appearance of the algae (as may be caused by the exposure of the test item). Apart from this, the cell count of each test vessel was also noted with the help of a microscope and haemocytometer. By spectrophotometer the absorbance values of each test vessel and control vessel was noted at 680nm.The BBM was taken as blank for both control and test vessels. The absorbance value of each vessel was in line with the average specific growth rate.

 After 72 hours of exposure to test chemical to various nominal test concentrations, EC50 was determined to be >200 mg/l graphically and through probit analysis. Based on the EC50, it can be concluded that the chemical was not toxic and can be consider to be not classified as per the CLP classification criteria.

 

By considering the results of all the studies mentioned above it is concluded that EC50 value of test chemical is in range of 186.317 mg/L to >200mg/L. On the basis of this range EC50 value the test chemical it is considered nonhazardous to aquatic algae cannot classified as per the CLP classification criteria.

Toxicity to microorganims:

Experimental studies for the test chemical and its read across chemical are reviewed for toxicity for microorganisms endpoint and their results are summarized below.

 

In first study the toxicity of test chemical to microorganisms was determined by performing the experiment for 20 h, the test microorganism used in the study was Chilomonas paramaecium. The EC5 value of test chemical was determined to be 13 mg/L after the exposure of test chemical to Microorganism Chilomonas paramaecium for 20 h.

 

In another study the toxicity of test chemical to microorganisms was determined by performing the experiment for 20 h, the test microorganism used in the study was Entosiphon sulcatum. The EC5 value of test chemical was determined to be 79 mg/L after the exposure of test chemical to Microorganism Entosiphon sulcatum for 20 h.

 

In third study the toxicity of test chemical to microorganisms was determined by performing the experiment for 16 h, the test microorganism used in the study was Pseudomonas putida. The EC3 value of test chemical was determined to be 1.6 mg/L after the exposure of test chemical to Microorganism Pseudomonas putida for 16 h.

 

Next study the toxicity of test chemical to microorganisms was determined by performing the experiment for 20 h, the test microorganism used in the study was Uronema parduzci. The EC5 value of test chemical was determined to be 86 mg/L after the exposure of test chemical to microorganism Uronema parduzci for 20 h.

 

In last toxicity to microorganism study for test material the biological effect was evaluated by using analogous methods of the cell multiplication inhibition test, the toxicity threshold (TT) of test chemical was determined to be 79 mg/l for Entosiphon sulcatum. Therefore EC0 was considered to be <79mg/l for 72h for Entosiphon sulcatum.

 

By considering result of all the studies mentioned above it is concluded that EC 5 value of test chemical is in range of 13 mg/L and 36 mg/L.