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Ecotoxicological information

Endpoint summary

Administrative data

Description of key information

Short term toxicity to fish

Based on the QSAR prediction done using the EPI Suite ECOSAR version 1.10 (2017), the 96 hours LC50 was estimated to be 0.945 mg/l on fish for substance test chemical with mortality effects. Thus based on this value it can be concluded that the test chemical is toxic to fish and can  be classified as 'Aquatic acute 1' as per the criteria of CLP regulation.

Short term toxicity to aquatic invertebrate

Acute Immobilisation Test for 48 h in static method to Daphnia magna STRAUS was performed according to OECD-Guideline 202 for Testing of Chemicals (2004) EC Directive 92/69/EC Method C.2 (1992) (Experimental study report, 2005). The solution (100 mg/L test chemical was weighed out) was prepared with dilution water one day prior to application in the test medium. The solubility of test substance is < 1 mg/L (related to the pigment). The stock solution was shaken at room temperature with 20 rpm for 24 h (rotating shaker 3040, GFL) and membrane filtrated with 0.45 μm .The effect of the saturated solution (100 mg/L) as limit concentration of the test chemical was determined. The limit test was conducted under static conditions over 48 h. 20 test organisms were exposed to the limit concentration and control. No test chemical analysis was carried out. A reference test was carried out with potassium dichromate to determine the toxicity of the reference substance. EC10 and EC50 values were only calculated for the reference chemical via probit according to WEBER (1986). Calculation of the confidence intervals were carried out using standard procedures according to BREITIG & TÜMPLING (1982). The median effect concentration (EC50) of saturated solution of test chemical was observed to be >100 mg/l after 48 hrs of exposure period.

Toxicity to aquatic algae and cyanobacteria

On the basis of the experimental studies of the structurally and functionally similar read across chemical and applying the weight of evidence approach, the EC50 value the test chemical can be expected to be ranges from 0.25 to 0.6 mg/l, respectively.

Toxicity to microorganism

On the basis of the experimental studies of the structurally and functionally similar read across chemical and applying the weight of evidence approach, both the IC50 and EC20 value the test chemical on the test organism was observed to be 0.5 mg/l.

Additional information

Short term toxicity to fish

Predicted data of the target chemical and various experimental studies for its read across substance was reviewed for the short term toxicity to fish end point which is summarized as below:

 

In a prediction done using the EPI Suite ECOSAR version 1.10 (2017), the 96 hours LC50 was estimated to be 0.945 mg/l on fish for substance test substance with mortality effects.

 

Another Prediction done using Danish QSAR database (2018) in which the average value of both models i.e Leadscope and SciMatics SciQSAR model were presented in Battery model. On the basis of this, 96 hours LC50 was estimated to be 0.44 mg/l onPimephales promelasfor test substance with mortality effects.

 

In a supporting weight of evidence study from peer reviewed journal (Kuo-HsiungL et al, 2002), short term toxicity test was performed to evaluate the effect of test material to fishCyprinus carpio. The test animals were fed with yeast in a 224 (diameter), 46 (height)-cm circular plastic pool. Before the experiment, the test organisms were acclimatized in aquaria for 2 weeks under conditions similar to those under which the tests were performed. Four carps of 2 to 6 cm in size, were introduced to each 10-L beaker containing 5 L of different concentrations of test chemical i.e, 10, 50, 100, 200, and 500 mg/l. After 48 h of exposure period, median lethal concentration (LC50) values were calculated by using trimmed Spearman Karber method. The median lethal concentration (LC50) of test material onCyprinus carpioafter 48 h was observed to be 0.022 mg/l.

For the test chemical, another short term toxicity test was performed to evaluate the effect of test material to fish Cyprinus carpio (Kuo-HsiungL et al, 2002). The test procedure and conditions were similar as mentioned above. The median lethal concentration (LC50) of test material on Cyprinus carpio after 48 h was observed to be 0.045 mg/l.

On the basis of the available information, test chemical is toxic to aquatic fish and can be classified as ‘Aquatic acute 1 category’ as per the criteria of CLP regulation.

Short term toxicity to aquatic invertebrate

Acute Immobilisation Test for 48 h in static method to Daphnia magna STRAUS was performed according to OECD-Guideline 202 for Testing of Chemicals (2004) EC Directive 92/69/EC Method C.2 (1992) (Experimental study report, 2005). The solution (100 mg/L test chemical was weighed out) was prepared with dilution water one day prior to application in the test medium. The solubility of test substance is < 1 mg/L (related to the pigment). The stock solution was shaken at room temperature with 20 rpm for 24 h (rotating shaker 3040, GFL) and membrane filtrated with 0.45 μm .The effect of the saturated solution (100 mg/L) as limit concentration of the test chemical was determined. The limit test was conducted under static conditions over 48 h. 20 test organisms were exposed to the limit concentration and control. No test chemical analysis was carried out. A reference test was carried out with potassium dichromate to determine the toxicity of the reference substance. EC10 and EC50 values were only calculated for the reference chemical via probit according to WEBER (1986). Calculation of the confidence intervals were carried out using standard procedures according to BREITIG & TÜMPLING (1982). The median effect concentration (EC50) of saturated solution of test chemical was observed to be >100 mg/l after 48 hrs of exposure period.

Toxicity to aquatic algae and cyanobacteria:

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

 

Short term toxicity to aquatic algae study was carried out for 72 hrsfor assessing the effect of test chemical on Selenastrum capricornutum. The study was performed in accordance with the OECD Guideline 201 (Alga, Growth Inhibition Test) in a static fresh water system. Selenastrum capricornutum ATCC 22662 (Green algae) was used as test organism.8 different nominal concentrations of test chemical were used. Test chemical conc. ranges from 0.058 to 3.2 mg/l, respectively. Stock solution of test chemical was prepared with DMSO (100 mg/l). No analytical monitoring of test chemical concentration were done. On the basis of effect of the test chemical on biomass of the test organism Selenastrum capricornutum, the 72 hr NOEC and EC50 value was determined to be 0.10 and 0.25 mg/l, respectively.

 

For the test chemical, short term toxicity to aquatic algae study was carried out for 72 hrs for assessing the effect of test chemical on Scenedesmus subspicatus. The study was performed in accordance with the OECD Guideline 201 (Alga, Growth Inhibition Test) in a static fresh water system. Scenedesmus subspicatus (Green algae) was used as test organism. On the basis of effect of the test chemical on growth rate of the test organism Scenedesmus subspicatus, the 72 hr ErC50 value was determined to be 0.6 mg/l.

 

On the basis of the experimental studies of the structurally and functionally similar read across chemical and applying the weight of evidence approach, the EC50 value the test chemical can be expected to be ranges from 0.25 to 0.6 mg/l, respectively. Thus, based on the EC50 value, test chemical can be considered as toxic to aq. algae and thus can be considered to be classified in ‘Aquatic acute 1 category’ as per CLP classification criteria.

Toxicity to microorganism

Data available for the structurally and functionally similar read across chemicals has been reviewed to determine the toxic effect of the test chemical on micro-organisms. The studies are as mentioned below:

 

The test material was evaluated for its antimicrobial effect on Tetrahymena pyriformis. The inhibitory effect concentration (IC50) for Tetrahymena pyriformis was observed to be 0.5 mg/l . Nonetheless, the test material also inhibited the protozoan reproduction.

 

For the test chemical, another short term toxicity to Vibrio fischeri study was carried out.The study was performed in accordance with the standard method ‘DIN 38412 Part 34’. On the basis of the effect of test chemical on luminescence of the test organism Vibrio fischeri, the EC20 value was determined to be 0.5 mg/l.

 

On the basis of the experimental studies of the structurally and functionally similar read across chemical and applying the weight of evidence approach, both the IC50 and EC20 value the test chemical on the test organism was observed to be 0.5 mg/l.