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Endpoint summary

Description of key information

Short term toxicity to fish :

 

Based on effect of test chemical on the mortality of the test organism aquatic fishes the 96 hrs LC50 value was estimated to be >100 mg/l (i.e 1790000 mg/l).

 

Short term toxicity to aquatic invertebrates : 

 

Based on effect of test chemical on the mobilty of the test organism aquatic invertebrates, the 48 hrs LC50 value was estimated to be > 100 mg/l (i.e 680000 mg/l).

 

Toxicity to algae study : 

 

Based on effect of test chemical on the growth rate of the test organism green algae, the 96 hrs EC50 value was estimated to be >100 mg/l (i.e 95897 mg/l).

 

Toxicity to microorganism :

 

Based on effect on growth inhibition of test bacteria, the 16 hrs EC50 values were determined to be in range of 435 to1520 mg/l respectively.

Additional information

Short term toxicity to fish :

 

Predicted data of target chemical and supporting weight of evidence studies for it's  structurally similar read across chemicals has been reviewed to determine the effect of the test chemical on aquatic fishes. The studies are as mentioned below:

 

First study includes the toxicity of the test chemical to aquatic fishes was predicted using EPI Suite ECOSAR version 1.11. On the basis of effect of test chemical observed in a static syst tem on the mortality of the test organism during the 96 hr exposure duration, the median lethal concentration (LC50) for the test chemical was estimated to be >100 mg/l (1790000 mg/l). Thus, based on the LC50 value, test chemical can be considered as non-toxic to aquatic fishes and hence, considered to be 'not classified' as per the CLP classification criteria.

 

Second study includes an acute toxicity to fish study was carried out for time period of 96 hrs by following the method of EPA-660/3-75-009 (USEPA 1975). Study was performed under statc condition. Juvenile Lepomis macrochirus which was obtained from Lesser Ketones Manufacturing Association Leesburg, VA of length of of 3.4 cm (range 2.8-4.2 cm) was used as test organism which were acclimated to laboratory conditions a minimum of two weeks before testing of loading rate of 10 fish per exposure vessel total of 80 fish were used. Reconstituted soft-water prepared from glass-distilled water was used as dilution water. Test substance was added directly to exposure vessels and 4.2 mL of methanol added to controls because methanol is released on hydrolysis of test substance. Test solutions for range-finding study were prepared 30 minutes prior to addition of fish.Test was carried out at temperature 22°C of pH 7.2 to 7.6. pH at initiation (t = 0 h) mean 7.2 (range 7.2-7.3) 48 h observation mean 8.5 (range 7.4-9.6). Dissolved oxygen initiation (t = 0 h) mean 13.4 mg/L (range 13.0-13.5 mg/L) termination (t = 96 h) mean 8.4 mg/L (range 8.0-8.5 mg/L). Hardness and alkalinity was 40 to 48 mg CaCO3/L and 3 to 35 mg CaCO3/L respectively. Nominal test concentrations used were 0, 10, 100, 180, 320, 560, 1000 mg/L. Duplicate controls and single exposure concentrations were used.  Polyethylene-lined vessels containing 10 L of dilution water. vessels were aerated before study initiation but not during study.  Time of test solution preparation and time of fish addition were not recorded for the definitive study. Based on effect of mortality of test fishes NOEC, LOEC, LC10 and LC50 values were determined to be 100, 180 127 (65-161; 95% CI) and 200 (157-258; 95% CI) mg/l respectively. Thus, based on LC50 value test chemical was considered as non-toxic to test fishes and hence considered to be not-classified as per CLP classificaton criteria.

 

Third study includes an acute toxicity to fish study was carried out for time period of 96 hrs by following the OECD Guide-line 203 "Fish, Acute Toxicity Test",DIN 38412 Part 1, EG Guideline 92/69 C.1. Study was performed under semistatic condition. Brachydanio rerio was used as test organism. Test was carried out at temperature 20 to 21°C. The pH values ranged from 7.8 to 8.4 units in the controls and 8.2 to 9.3 units in the test chambers. The DO values ranged from 8.0 to 8.9 mg/L in the controls and 7.8 to 9.0 mg/L in the test chambers. water hardness and TOC was determined to be 18 mg/L as CaCO3 and 6 mg/L respectively.Verification was done analytically using TOC-500 Infrared Analyzer.  The tested substance was added to tap water to provide a concentration of 1g/l and stirred for 18 hours. The solution was filtered and the TOC content determined. The test began immediately after preparation of the test solution. The nominal test material concentration was 1000 mg/l. Measured concentrations were 880 mg/l at 0 hours; 922/947 mg/l at 24 hours; 885 mg/l at 72 hours average value of 943 mg/l (water filtered initial solution). 0% mortality in control was observed. Based on effect of mortality, LC0 value was determined to be >= 934mg/l. Based on LC0, LC50 value was considered as > 934 mg/l and hence, test chemical was considered as non-toxic to aquatic fishes and considered to be not-classified a sper CLP classification criteria.

 

Based on effect of test chemical on the mortality of the test organism aquatic fishes the 96 hrs LC50 value was estimated to be >100 mg/l (i.e 1790000 mg/l).

 

Based on above information test chemical was considered as non-toxic to test fishes and considered to be not-classified a sper CLP classification criteria.

 

Short term toxicity to aquatic invertebrates : 

 

Predicted data of target chemical and supporting weight of evidence studies for it's  structurally similar read across chemicals has been reviewed to determine the effect of the test chemical on aquatic invertebrates. The studies are as mentioned below:

 

First study includes the toxicity of the test chemical to aquatic invertebrates was predicted using EPI Suite ECOSAR version 1.11. On the basis of effect of test chemical observed in a static system on the mobilityof the test organism during the 48 hr exposure duration, the median lethal concentration (LC50) for the test chemical was estimated to be >100 mg/l (680000 mg/l). Thus, based on the LC50 value, test chemical can be considered as non-toxic to test daphnids and hence, considered to be 'not classified' as per the CLP classification criteria.

 

Second study includes short term toxicity to aquatic invertebrates study was carried out for time period of 48 hrs by foloowing the OECD Guide-line 202, DIN 38412 Part 1; EG Guideline 92/69/EWG. Study was performed under static condition. Age <24 hours Daphnia Magna was used as test organism which were not fed during the test. Test was carried out at 20°C vessels were kept in the dark and not aerated during the test. The control pH was 7.5 units and the test vessel pH ranged from 7.5 to 8.7 units. The control DO was 8.4 mg/L and the test vessel DO ranged from 7.8 to 8.7 mg/L. Water hardness, alkalinity and TOC were 2.5mmol/L ,0.8 mmol/L and <1 mg/L respectively. Test was carried out at nominl concentrations of 0, 8.7, 16.4, 28.4, 54.7, 94.0, 174.9, 306.0, 546.5, and 983.7 mg/L. Test substance was added to tap water to provide a concentration of 1g/l and stirred for 18 hours. The solution was filtered and the TOC content determined. Glass cylinder was used as test vessel graduated to 10 ml. Each concentration had 4 replicate vessels and each vessel contained 5 test organisms. Based on effect of mobiity of test daphnids NOEC, EC50 values were determined to be 94 and 331(95% confidence limits: 249-441 mg/L) mg/l respectively. Thus, based on EC50 value test chemical was considered as non-toxic to test daphids and hence considered to be not classified as per CLP classification criteria.

 

Third study includes an acute short term toicity to aquatic invertebrates study was carried out for time period of 48 hrs, by following the OECD Guide-line 202. Study was performed under flow through condition. Daphnia magna of age >24hrs which was obtained from Springborn Smithers culture facility and was used as test organism. Daphnids were fed a unicellular green algae (Ankistrodesmus falcatus, 4 x 107 cells/mL) at a rate of 0.5 to 1.5 mL per vessel daily depending on the age of the adult organisms in the culture vessel and 0.5 mL of a combination of yeast, cereal leaves and flaked fish food (YCT) daily. Study was carried out temperature of 20 ± 1 ºC by following 16-hour light, 8-hour dark photoperiod. Dilution water was used from Laboratory well water. The dilution water had a total hardness and alkalinity as CaCO3 of 44 mg/L and 21 mg/L, respectively, a pH range of 6.8 to 7.3. The pH measured in the dilution water control vessel replicates was 7.0 at test initiation and 7.1 at test termination. And a specific conductivity range of 210 to 240 µmhos/cm.  The TOC concentration of the dilution water was 0.58 and 0.48 mg/L. The test area was illuminated with fluorescent bulbs. Light intensity was measured once during the test. The dilution water control vessels had a measured DO concentration range of 9.8 to 9.9 mg/L at test initiation and ranged from 9.4 to 9.5 at test termination. Nominal concentrations used were 7.5, 15, 30, 60, 120 and a control whereas, Measured concentrations used were 5.7, 15, 21, 45 and 100 respectively. Verification was done analytically using GC/FID. 1600-mL square glass battery jars used as test vessel had two 2-cm holes drilled in the sides, 15 cm from the bottom which were covered with Nitex 40 mesh screen for drainage.  The total test solution volume was maintained at 1400 mL.  Two replicate test vessels were established for each treatment level and a dilution water control (two replicates, ten daphnids per replicate vessel). 5% immobilization was observed among daphnids exposed to the control and 10% immobilization was observed among daphnids exposed to the 5.7 mg/l in treatment level. Based on effect of test daphnids, NOEC and EC50 value was determined to be 100 and >100 mg/l respectively. Thus, based on EC50 value test chemical was considered as non-toxic to aquatic invertebrates and hence, considered to be not-classified as per CLP classification criteria.

 

Based on effect of test chemical on the mobilty of the test organism aquatic invertebrates, the 48 hrs LC50 value was estimated to be > 100 mg/l (i.e 680000 mg/l).

 

Based on above information test chemical was considered as non-toxic to aquatic invertebrates and hence, considered to be not-classified as per CLP classification criteria.

 

Toxicity to algae study : 

 

Predicted data of target chemical and supporting weight of evidence studies for it's  structurally similar read across chemicals has been reviewed to determine the effect of the test chemical on algae. The studies are as mentioned below:

 

First study includes the toxicity of the test chemical to green algae was predicted using EPI Suite ECOSAR version 1.11. On the basis of effect of test chemical observed in a static system on the growth rate of the test organism during the 96 hr exposure duration, the median effect concentration (EC50) for the test chemical was estimated to be >100 mg/l (i.e 95897 mg/l). Thus, based on the EC50 value, test chemical can be considered as non-toxic to aquatic algae and hence, considered to be 'not classified' as per the CLP classification criteria.

 

Seond study includes toxicity to algae study was carried out for time period of 72 hrs by following the guideline OECD 201. Study was performed unser static condition. Scenedesmus subspicatus was used as test organism. Test was carried out at temperature of 24°C of TOC <1mg/L. Verification was done by using TOC-500 Infrared Analyzer. Test substance was added to synthetic fresh water to provide a concentration of 1g/l and stirred for 18 hours. The solution was filtered and the TOC content determined. Based on effect of growwth rate of test algae NOEC, EC10 and EC50 values were determined to be 1.3, 38 and 603 mg/l respectively. Thus, based on EC50 value test chemical was considered as non-toxic to test algae and hence considered to be not classified as per CLP classification criteria.

 

Third study includes toxicity to algae study was carried out for time period of 72 hrs by following the method of Directive 92/69/EEC, C.3. Study was performed under static condition at temperature 24 +/- 2 deg C. Scenedesmus subspicatus was used as test organism. Test medium used was as described in guideline 92/69/EEC C.3. (1992). Stock solution was prepared as1 g/l of the test item was equilibrated in deionized water, stirred for 18 hours, and filtered. Green algae were exposed at concentrations of 0, 29, 53, 84, 147, 252, and 420 mg/l. Light intensity used was 8000 lux, white. pH at beginning of test 6.9-7.6 and end of test was 8.3-8.9 respectively. sterile-aerated Erlenmeyer flasks was used as test vessel. The analyses were carried out by measurement of dissolved organic carbon. The DOC content was determined with a Shinadzu TOC Analyzer 500. Based on effect of biomass of test algae, the 72 hrs NOEC, EC10 and EC50 values were determined to be 53, 91 and 255 mg/l respectively. Thus, based on EC50 value test chemical was considered as non-toxic to test algae and hence, considered to be not-classified as per CLP classification criteria.

 

Based on effect of test chemical on the growth rate of the test organism green algae, the 96 hrs EC50 value was estimated to be >100 mg/l (i.e 95897 mg/l).

 

Based on above information test chemical was considered as non-toxic to test algae and hence, considered to be not-classified as per CLP classification criteria.

 

Toxicity to microorganism :

 

 

Data available of the structurally similar read across chemicals has been reviewed to determine the effect of the test chemical on microorganism. The studies are as mentioned below:

 

First study includes toxicity to microorganism study was carried out for time period of 5 hrs. Study was performed under static condition. Pseudomonas putida was used as test bacteria. Tes was carried out at temperature 25°C. Four 100-ml von Loh bottles with ground glass stoppers were coated with the culture solution, the bacterial suspension, and the test substance in staged concentrations (0, 500, 1000, 1500 and 2000 ul/l), were sealed without air, and were incubated for 5 hours. Two were treated with HgCl2 solution to kill the bacteria. Nine control bottles without the test substance were used as reference, four of these contained HgCl2 to determine the final oxygen content. Based on effect on growth inhibition of test bacteria, EC10 value was determined to be 1520 mg/l, hence EC50 value was considered as > 1520 mg/l. Thus, based on EC50 alue test chemical was considered as non-toxic to test bacteria.

 

Second study includes toxicity to microorganism study was carried out for time period of 5 hrs. Study was performed under static condition. Pseudomonas putida was used as test bacteria. Tes was carried out at temperature 25°C. Four 100-ml von Loh bottles with ground glass stoppers were coated with the culture solution, the bacterial suspension, and the test substance in staged concentrations (0, 500, 1000, 1500 and 2000 ul/l), were sealed without air, and were incubated for 5 hours. Two were treated with HgCl2 solution to kill the bacteria. Nine control bottles without the test substance were used as reference, four of these contained HgCl2 to determine the final oxygen content. Based on effect on growth inhibition of test bacteria, EC10 value was determined to be 1520 mg/l, hence EC50 value was considered as > 1520 mg/l. Thus, based on EC50 alue test chemical was considered as non-toxic to test bacteria.

 

Based on effect on growth inhibition of test bacteria, the 16 hrs EC50 values were determined to be in range of 435 to1520 mg/l respectively.

 

Based on above information test chemical was considered as non-toxic to microorganism.