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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

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 material.The test material was soluble in water. Therefore, the test solution was prepared by dissolving 400 mg of the test substance in 1 liters of potable water (passed through reverse osmosis system) with continuous stirring. This test solution was then added to the remaining three liters of water for achieving test concentrations of 100 mg/L.The nominal concentration selected for the experiment were 100 mg/L and Zebra Fish Danio rerio were exposed to these concentration for 96 hours.The lethal concentrations LC50 was determine to be >100 mg/L.

Long term toxicity to fish:

Based on the prediction done using ECOSAR version 1.1, the long term toxicity on fish was predicted for test substance . On the basis of effects observed in a static freshwater system, the NOEC value for the substance is estimated to be6533.201mg/l for fish for 28 days of exposure duration.It can be concluded that the test chemical can be considered as non-toxic to fish at environmentally relevant concentrations and can be considered not-classified as per the CLP classification criteria. 

Short term toxicity to aquatic invertebrate:

Determination of the inhibition of the mobility of daphnids was carried out with the substance ,test materialaccording to OECD Guideline 202.

The test substance was tested at the concentrations 0, 6.24, 12.5, 25, 50, 100 and 200 mg/L. Effects on immobilisation were observed for 48 hours.

The median effective concentration (EC50) for the test substance, , in Daphnia magna was determined to be 31.9 mg/L. Thus considering the CLP Criteria for aquatic classification of the substance, it is concluded thattest substanceexhibits toxicity to aquatic invertebrate (Daphnia magna) in theaquatic acute3 classification category.

Long term toxicity to aquatic invertebrate:

Based on the prediction done using ECOSAR version 1.1, the long term toxicity on aquatic invertebrate was predicted for test substance . On the basis of effects observed in a static freshwater system, the NOEC value for the test substance is estimated to be 1799.134 mg/l for aquatic invertebrate for 21 days of exposure duration. It can be concluded that the test chemical can be considered as non-toxic to aquatic invertebrate at environmentally relevant concentrations and can be considered not-classified as per the CLP classification criteria.

Toxicity to aquatic algae and cyanobacteria:

Freshwater algal growth inhibition test was carried out on Desmodesmus subspicatus with the substance according to OECD Guideline 201.

A limit test at sample concentration of 100 mg/L was performed. Effects on the growth rate of the organism were studied.The median effective concentration (EC50) for the test substance, test material, in Desmodesmus subspicatus was determined to be >100 mg/L. Based on this EC50 value and after comparing with CLP criteria for aquatic classification of the substance it is concluded that thet test substancedoes not exhibit toxicity to aquatic algae (Desmodesmus subspicatus).

Toxicity to microorganism:

The test chemical is not likely to be toxic to microorganism atleast in the dose range of 100-405.0 mg/l

Additional information

Short term toxicity to fish:

Various studies of short term toxicity to fish from experimental study report and peer reviewed journals for the target chemical were reviewed to summarize the following information:

 

Fish Acute Toxicity test according to OECD Guideline 203 was conducted for test material.The test substance was soluble in water. Therefore, the test solution was prepared by dissolving 400 mg of the test substance in 1 liters of potable water (passed through reverse osmosis system) with continuous stirring. This test solution was then added to the remaining three liters of water for achieving test concentrations of 100 mg/L. The nominal concentration selected for the experiment were 100 mg/L and Zebra Fish Danio rerio were exposed to these concentration for 96 hours. The lethal concentrations LC50 was found to be >100 mg/L.

 

Experimental key study report indicate that the Fish Acute Toxicity test according to OECD Guideline 203 was conducted for test chemical .The nominal concentration selected for the experiment were 100 mg/L and Zebra Fish-Danio rerio were exposed to these concentration for 96 hours. The lethal concentrations LC50 was found to be >100 mg/L.

Other supporting study from peer reviewed journal showed short term toxicity study on Fathead Minnows (Pimephales promelas) which was treated with Benzyl triethyl ammonium chloride in a measured concentration of 0, 46.5, 71.5, 110, 170 and 262 mg/l for 96 hours. 50 % mortality was observed at 161 mg/l at confidence limit of 141- 185 mg/l. Loss of schooling behavior, hyperactive and over reactive to external stimuli were observed in treated fish and were darkly colored. Equilibrium loss was not observed prior to death. Therefore, LC50 was considered to be 161 mg/l when Fathead Minnows (Pimephales promelas) treated with test material for 96 hours.

 

Above studies supported by another authorative database as study indicate that acute toxicity to fish test has been carried out to evaluate the ecotoxicological effects of chemical with dose concentration of 100 mg/L, 180 mg/L, 320 mg/L, 560 mg/L and 1000 mg/L. The test organism was Oryzias latipes and the test carried out in semi-static condition throughout the test temperature maintained at 24 +/- 1 degree C. The 96-h LC50 value was observed to be 694 mg/L when exposed to Oryzias latipes with test chemical.

 

Thus on the basis of the above experimental key study results and peer reviewed journals concluded that the target chemical can be non- hazardous to fish and therefore not consider for the further classification as per the CLP criteria.

 

 

 

Long term toxicity to fish:

Based on the prediction done using ECOSAR, the long term toxicity on fish was predicted for test substance. On the basis of effects observed in a static freshwater system, the NOEC value for the substance is estimated to be6533.201mg/l for fish for 28 days of exposure duration.It can be concluded that the test chemical can be considered as non-toxic to fish at environmentally relevant concentrations and can be considered not-classified as per the CLP classification criteria. 

Short term toxicity to aquatic invertebrate:

Experimental key and supporting study for the target chemical were reviewed to summarize the following information:

 

In key study, determination of the inhibition of the mobility of daphnids was carried out with the substance test material according to OECD Guideline 202.

The test substance was tested at the concentrations 0, 6.24, 12.5, 25, 50, 100 and 200 mg/L. Effects on immobilisation were observed for 48 hours. The stock solution 200.0 mg/L was prepared by dissolving white powder in reconstituted water. The test solutions of required concentrations were prepared by mixing the stock solution of the test sample in reconstituted test water. The substance was declared as light sensitive.- Controls: Reconstituted water as specified in OECD 202, used as a control and for sample dilution.The median effective concentration (EC50) for the test substance, in Daphnia magna was determined to be 31.9 mg/L. Thus considering the CLP Criteria for aquatic classification of the substance, it is concluded that test substance exhibits toxicity to aquatic invertebrate (Daphnia magna) in the aquatic acute 3 classification category.

 

Acute toxicity to aquatic invertebrate test from authoritative database has been carried out to evaluate the ecotoxicological effects of chemical with dose concentration of 8.0 mg/L, 17 mg/L, 38 mg/L, 83 mg/L and 180 mg/L. The test organism was Daphnia magna and the test carried out in static condition throughout the test, temperature maintained at 20 +/- 1 degree C. The 48-h EC50 value was observed to be 63.1 mg/L when exposed to Daphnia magna with test chemical.

  

Considering the above key and supporting data, it can be concluded that the substance exhibits toxicity to aquatic invertebrate (Daphnia magna) in the chronic 3 classification category as per CLP classification criteria.

 

Long term toxicity to aquatic invertebrate:

Based on the prediction done using ECOSAR version, the long term toxicity on aquatic invertebrate was predicted for test substance. On the basis of effects observed in a static freshwater system, the NOEC value for the test substance is estimated to be 1799.134 mg/l for aquatic invertebrate for 21 days of exposure duration. It can be concluded that the test chemical can be considered as non-toxic to aquatic invertebrate at environmentally relevant concentrations and can be considered not-classified as per the CLP classification criteria.

Toxicity to aquatic algae and cyanobacteria:

Various studies for the target chemical were reviewed to summarize the following information for the toxicity to aquatic algae endpoint:

Freshwater algal growth inhibition test was carried out on Desmodesmus subspicatus with the substance according to OECD Guideline 201. A limit test at sample concentration of 100 mg/L was performed. Effects on the growth rate of the organism were studied. The median effective concentration (EC50) for the test substance, test material, in Desmodesmus subspicatus was determined to be >100 mg/L. Based on this EC50 value and after comparing with CLP criteria for aquatic classification of the substance it is concluded that the test substance does not exhibit toxicity to aquatic algae (Desmodesmus subspicatus).

 

Another study was described in authoritative database. Growth Inhibition of test material to Alga (Pseudokirchneriella subcapitata) was observed for 72 h . The Initial cells density precultured algae was 5000 cells/mL etc.), cell aggregation or any difference from the control were not observed for concentrations 1 - 3. On the other hand, enlargement of cell volume (swelling) was found in some cells for concentrations 4 and 5. The effect concentration (EC50) for test material on Pseudokirchneriella subcapitata was observed to be 641 mg/l 95 % CL: 572 - 719 mg/L.Based on this EC50 value and after comparing with CLP criteria for aquatic classification of the substance it is concluded that thet test substance does not exhibit toxicity to aquatic algae.

 

The study was designed to assess the toxic effects of the test compound on the green alga Chlorella vulgaris. Test was conducted in compliance with the OECD guideline 201 (Alga, Growth Inhibition Test). Test 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. The test substance was prepared by adding 50 mg of test item in 250 ml of BBM to get the final concentration of 200mg/L. This stock solution was kept for stirring/ sonication for 0 minutes to obtain a homogenous solution for the experiment. The test concentrations6.25mg/l, 12.5mg/l, 25mg/l, 50mg/l and 100mg/l,200mg/l were chosen according to the available data of the test item. The concentrations chosen were set up to the water solubility limit. The remaining test solutions were prepared by dilution from the above stock solution. 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. As per OECD 201, the biomass in the control cultures should have increased exponentially by a factor of at least 16 within the 72 hr test period. This corresponds to a specific growth rate of 0.92 per day. Thus, the observed specific growth rate in the control cultures during the experiment was 0.358 per day. Secondly the mean coefficient of variation for section by section specific growth rates (days 0-1, 1-2 & 2-3, for 72 hr tests) in the control cultures must not exceed 35%. Thus, the observed mean coefficient of variation in the control cultures during the experiment was 33.42%. Thirdly the coefficient of variation of average specific growth rates during the whole test period in replicate control cultures must not exceed 10%. Thus, the observed coefficient of variation of average specific growth rates during the experiment in control cultures was 8.26%. Hence, the test is considered valid as per OECD guideline, 201. After 72 hours of exposure to test item to various nominal test concentrations, EC50 was determine to be 9.836mg/l graphically and through probit analysis. Based on the EC50, it can be concluded that the chemical was and can be consider to be classified as aquatic acute 2 as per the CLP classification criteria.

Another study was described in peer reviewed journal. Toxicity to algae test material was performed in Scendesmus Obliquus Algae to observe the toxicity of Freshwater green algae Scendesmus Obliquus was obtained from algae laboratory of the girls college, Ainshams University. The algae was taken and transferred into a series of 100 ml cotton stoppered Erlenmeyer flasks containing 50ml modified Bold' s basal medium then chemical added at different concentrations as 0, 0.1, 0.3, 0.5, 1.0, 1.5, 2.0, 5, 10,15 and 20 mg/l and growth was monitored by chlorophyll-a content estimation using a method describe by APHA. Based on the experiment the EC 50 value for test material for toxicity to algae was determined to be 1.2 mg/l after 72 hrs.

Since, Data from study report and peer reviewed journal suggests that the test substance is not toxic to aquatic algae and cyanobacteria, hence test material can be considered to be not classified as per CLP criteria.

Toxicity to microorganisms:

Data available for the functionally similar read across chemicals has been reviewed to determine the short term toxicity of microorganism of the test chemical .The studies are as mentioned below:

 

In the first study the organobentonites were prepared from sodium bentonite by interchange with test material, using 1.0 and 2.1 times the cation exchange capacity (CEC) of the clay. The enzymatic activities of the lipase immobilized in the two organobentonites were 511.5 and 177.8 U/g support, while the activity recoveries were 33.5% and 14.7%. C. rugosa lipase immobilized on BTEA-1.0-Bent was found to be the optimal system studied, and it showed the greatest activity recovery with respect to the hydrolysis of olive oil (33.5%). This result is due to the smaller charge compensated by the organic cations, allowing for the dispersion of the lipase on the support, preventing its aggregation and maintaining its activity. However, the CRL/BTEA-2.1-Bent system showed a higher thermal stability between the range of 35 and 45 ◦C and pH 6.5.

 

Above data is supported by another data from journal. Toxicity to V. fischeri was measured as inhibition of bioluminescence using Microtoxs M500 Rapid Toxicity Testing System equipment and consumables. The assay was carried out in accordance with the 90% basic test for pure compounds protocol, as described in the Microtox user’s manual. The EC50 values of the tested chemical for V. fischeri range from 1.3 to 284 mg L1. The differences tested by ANOVA are highly significant (P o 0.001). In experiment the 50% effect concentrations (EC50) of the test chemical to Vibrio fischeri in a 15 min inhibition of bioluminescence test was observed to be 284 mg/l with 95% confidence limit (241–336).

 

Hence, based on the data available for the functionally similar read across, test chemical is not likely to be toxic at least in the dose range of 511 mg/L.

As the effect were only observed on the aquatic invertebrates, thus on that basis chemical consider to be toxic and classified as aquatic chronic 3 as per the CLP classification criteria.