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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Toxicity to soil microorganisms except arthropods:


The toxic effect of Test substance was studied on the earthworm,Eisenia fetidaby artificial soil test. By following OECD 222 guidelies in the artificial soil. Artificial soil was prepared by mixing 5% of sphagnum peat, 20% of kaolin clay (kaolinite content > 30%) and 75% industrial sand (predominantly fine sand with more than 50% of the particles between 50 and 200 microns) on dry weight basis (mass/mass). The pH of the test substrate was 6.21 during the definitive test. A range finding test was carried out to determine test concentrations for the definitive test at 0.1, 1, 10, 100, 250, 500 and 1000 mg/kg dry soil along with control. There were mortalities of 0, 0, 0, 0, 0, 0, 50 and 100 % at the tested concentrations of 0 (control), 0.1, 1, 10, 100, 250, 500 and 1000 mg/kg dry soil on Day 28. No pathological and behavioral symptoms were observed during the test period in the control and treated groups (except decrease in size in 500 mg/kg dry soil test group). Based on the results of range finding test, the definitive test was carried with the test concentrations of0.91, 1.63, 2.94, 5.29, 9.53, 17.15, 30.87, 55.56 and 100.00mg/kg dry soil along with a control (deionized water) and reference substance (Carbendazim).


Before initiating the study the test system was acclimitised under the conditions mentioned below:


 














































Parameters



Range Finding Test



Definitive Test



Adults with well-developed clitellum of age (difference in age of all worms is within 4 weeks)



4 to 4.5 months


 



4.5 to 5 months



Light intensity (Lux)



465 and 482



510 and 540



Temperature (ºC)



20.1 and 20.2



19.9



Feeding with pasteurized cow manure



Yes



Yes



Duration of acclimatization



Above 24 hours



Above 24 hours



Body weight range at start of test (mg)



305.0 to 520.1



322.4 to 400.3



Test containers weight


(to monitor moisture)



Weekly once



Weekly once



There was no mortality of earthworms in control and at the tested concentrations of 0.91, 1.63, 2.94, 5.29, 9.53, 17.15, 30.87, 55.56 and 100.00 mg/kg on Day 28. The percent mortality of earthworms at 3.0 mg a.i. of reference substance/kg dry soil was 17.5%. No pathological and behavioral symptoms were observed in adult worms during the test period in the control and treated groups (including reference substance). No statistically significant reduction in body weight was observed in treated groups (except 5.29, 9.53, 17.15, 30.87, 55.56 and 100.00 mg/kg dry soil and reference substance test group) as compared with the control. No pathological and behavioral symptoms were observed in juveniles on Day 56 in the control and treated groups. No statistically significant reduction in juvenile production was observed in treated groups (except 2.94, 5.29, 9.53, 17.15, 30.87, 55.56 and 100.00 mg/kg dry soil and reference substance test group) as compared with the control. Cocoons were not present in any of tested groups and reference substance group.


The results of active ingredientanalysisof test concentrations of 0.91, 9.53 and 100.00 mg/kg dry are detailed in addtional information. Reference substance (Carbendazim) group exhibited statistically significant reduction in juvenile production at 3 mg a.i./kg dry soil as compared with the control. Hence the test has met the validity acceptance criteria as per test guideline OECD 222, that significant effects should be observed between 1 and 5 mg a.i./kg dry soil in a test. This result infers that the obtained results during this test are valid andhencetest is acceptable. The Day 28 LC50of Tetra butyl ammonium bromide on adult earthworms is more than 100 mg test item/kg dry soil. The day 56 juvenile production NOEC, LOEC and Effective Concentrations value based on the nominal concentration of the test item. After exposure tenure, NOEC, LOEC, EC10 and EC50 was observed to be 1.63, 2.94, 0.5026, and 9.524 mg/kg dry soil, respectively.


 


Toxicity to terrestial arthropods:


In accordance with column 2 of Annex IX of the REACH regulation, the study does not need to be conducted because direct and indirect exposure of the soil compartment is unlikely as considering its use as a coating agent and phase transfer catalyst and even if the test chemical is accidentally exposed to the soil compartment, there is likely to be little or no adsorption of chemical in soil compartment on the basis of experimental logKoc value (less than 1.5).


 


Toxicity to terrestial plants:


The study aimed at evaluating the effect of test item on seedling emergence and seedling growth of 6 terrestrial plants was conducted on 2 monocotyledonous and 4 dicotyledonous species. The test item was mixed into the acid washed quartz sand (artificial substrate/soil which was used as the test medium) and exposed as per test guidelines.


A range finding test was carried out with the plant species (onion, corn, cabbage, tomato, soybean, and sunflower) at 10, 100, 500 and 1000 mg test item/kg dry weight of artificial substrate along with vehicle control to determine test concentrations for the definitive test. Effects of test item were observed on seedling emergence, shoot height, and dry shoot weight on day 14 in all the tested plant species after 50% of seedling emergence in control groups.


Based on the range finding results for each plant species, five test concentrations of test item were tested in main study. There was also adequate number of concurrent control group. Seeds of the test species were sown in plastic pots with 2 seeds/pot (corn), 3 seeds/pot (cabbage, tomato, soybean, and sunflower) and 5 seeds/pot (onion). Uniform seeds of the test plant species were sown in chemically inert plastic pots containing the test artificial substrate. Within a given phase of the test, all test plants including the control(s) were from the same source. The plants were grown in non-porous plastic pots with a tray saucer under the pot. The pots were large enough to allow normal growth. A pot was defined as the replicate (diameter: 15.5 cm, surface area about: 189 cm2)


To prepare required test item concentration, required quantity of test item was weighed and mixed with acetone (sonication was made, where essential) followed by introduction into artificial substrate. Vehicle was allowed to dry completely, and this was homogenously mixed using blender. For control, required quantity of artificial substrate was mixed thoroughly with nutrient solution. For vehicle control, required quantity of artificial substrate was mixed with acetone and allowed to dry completely and this was homogenously mixed using blender. After test medium preparation, the pots were filled with uniform quantity of test medium (2 kg). This was followed by addition of required volume (220 mL/pot) of water based on WHCmax (26%) of the artificial substrate.


The concentrations were separated by for of 3 for onion soybean sunflower and tomato. The test concentrations for onion, soybean and sunflower are 15, 45, 135, 405, 1215 mg/kg/dw. For corn and cabbage are it was 1000 mg/kg/dw. For tomato are 5, 15, 45, 135, 405 mg/kg/dw. The experiment was conducted in a special room with PAR lights with light intensity22600 to 24100 Lux, and suitable environmental conditions withair temperature of 19.5 to 23.3 °C and air humidity of 71 to 89 %were provided for plant species. During the experiment, the plants were observed for emergence (every day and then at 7 days interval) and visual phytotoxicity (at 7 and 14 days). The experiment completed on 14 days after the emergence of 50% of the vehicle control seedlings. At the end of the experiment, the number of surviving plants, their height and dry weight were observed. 


Analytical verification of the test medium (test item active ingredient analysis in test medium) was performed using a validated analytical method to determine the test item. The samples from the low, mid and high-test item concentrations were analyzed at the beginning of the test (day 0) along with the control(s). For analysis, required quantity of test medium was sampled on day 0


 


During the observation period, i.e. 14 days after 50% of the control(s) plants have emerged, the plants were observed frequently for emergence and visual phytotoxicity and mortality. At the end of the test, measurement of percent emergence and biomass of surviving plants were recorded, as well as visible detrimental effects on different parts of the plant. The latter include abnormalities in appearance of the emerged seedlings, stunted growth, chlorosis, discoloration, mortality, and effects on plant development. A uniform scoring system for visual injury was used to evaluate the observable toxic responses. The final biomass was measured using final average dry shoot weight of surviving plants, by harvesting the shoot at the soil surface and drying them to constant weight at 60 to 70 ºC. The height of the shoot of surviving plants were measured at the end of the test.


Plant observations on days 7 and 14 recorded normal in control and vehicle control. In certain test item treated groups exhibited visual phytotoxicity (toxic responses) of stunted growth and mortality (except onion, cabbage, and tomato). Effects of test item were observed on seedling emergence, seedling survival (except onion, cabbage, and tomato), shoot height, and dry shoot weight on day 14 in all the tested plant species.


 


Visual assessment is the rating of visual damage based on observations of plant stand, vigour, malformation, chlorosis, necrosis, and overall appearance compared with control(s). Uniform scoring system was used for visual injury to evaluate the observable toxic responses. Plants were observed for severity of the visual phytotoxic effects of test item from the grading scale of 0 to 100 %.


A dose-response relationship was established in terms of a regression equation by using four parameter Model. Different model was used for estimating ECx (EC10, EC20, EC50, EC90) and its confidence limits, where possible. The statistical analysis of the shoot height and shoot weight data was evaluated using licensed copies of SYSTAT Statistical package version 12.0. Data was tested for normality (Shapiro-Wilk test) and homogeneity of variance (Levene’s) before performing further analysis. When data was found as normal and homogeneous, ANOVA was performed, when data was found as non-normal or non-homogeneous, data were transformed, and ANOVA was done on transformed data for overall group comparison. Dunnett’s test was performed for pairwise comparison. Comparison of two group’s mean was done using two-sample t-test.


The present study can be considered valid since, the control(s) satisfies the validity criteria given in the guideline as below.


·     The seedling emergence was at least 90% in all the tested plant species (acceptable criterion: seedling emergence should be at least 70%).


·     The seedlings didn’t exhibited visible phytotoxic effects and the plants exhibited only normal variation in growth and morphology for particular species (acceptable criterion: seedlings do not exhibit visible phytotoxic effects and the plants exhibit only normal variation in growth and morphology for particular species).


·     The mean survival of emerged control(s) seedlings was at least 100% for the duration of the study (acceptable criterion: mean survival of emerged control(s) seedlings should be at least 90% for the duration of the study).


·     Environmental conditions for a particular species was identical and growing media contained the same amount of substrate in all the tested plant species from the same source (acceptable criterion: environmental conditions for a particular species should be identical and growing media should contain the same amount of substrate from the same source)


Based on the outcomes of definitive test by concerning the emergence, the shoot length, and the dry weight were statistically analyzed to determine the EC10, EC20, EC50, EC90, NOEC and LOEC. The NOEC values based on the emergence, the shoot length, and the dry weight, are 135, 1215, 45 (onion), >1000, >1000, >1000 (corn), >1000, >1000, >1000 (cabbage), 15,405,5 (tomato), 135,405, 15 (soybean) and 135, 1215, 15 sunflower


 


Toxicity to soil microorganisms:


In accordance with column 2 of Annex IX of the REACH regulation, the study does not need to be conducted because direct and indirect exposure of the soil compartment is unlikely considering its use as a coating agent and phase transfer catalyst & there is no risk for the sediment compartment since the result of the chemical safety assessment indicates that the PEC/PNEC value is < 1 which indicates no risk, and since the half life value of chemical in soil is 17.33 days (i.e., not persistent) and even if a chemical is accidentally released in soil compartment, there is likely to be negligible adsorption of chemical in soil compartment on the basis of experimental logKoc value (1.280 ± 0.003 as per OECD TG 121).


 


Toxicity to birds:


In accordance with column 2 of Annex IX of the REACH regulation, the study does not need to be conducted because direct and indirect exposure of the soil compartment is unlikely as considering its use as a coating agent and phase transfer catalyst and even if the test chemical is accidentally exposed to the soil compartment, there is likely to be little or no adsorption of chemical in soil compartment on the basis of experimental logKoc value (less than 1.5).

Additional information

Toxicity to soil microorganisms except arthropods:


The toxic effect of Test substance was studied on the earthworm,Eisenia fetidaby artificial soil test. By following OECD 222 guidelies in the artificial soil. Artificial soil was prepared by mixing 5% of sphagnum peat, 20% of kaolin clay (kaolinite content > 30%) and 75% industrial sand (predominantly fine sand with more than 50% of the particles between 50 and 200 microns) on dry weight basis (mass/mass). The pH of the test substrate was 6.21 during the definitive test. A range finding test was carried out to determine test concentrations for the definitive test at 0.1, 1, 10, 100, 250, 500 and 1000 mg/kg dry soil along with control. There were mortalities of 0, 0, 0, 0, 0, 0, 50 and 100 % at the tested concentrations of 0 (control), 0.1, 1, 10, 100, 250, 500 and 1000 mg/kg dry soil on Day 28. No pathological and behavioral symptoms were observed during the test period in the control and treated groups (except decrease in size in 500 mg/kg dry soil test group). Based on the results of range finding test, the definitive test was carried with the test concentrations of0.91, 1.63, 2.94, 5.29, 9.53, 17.15, 30.87, 55.56 and 100.00mg/kg dry soil along with a control (deionized water) and reference substance (Carbendazim).


Before initiating the study the test system was acclimitised under the conditions mentioned below:


 














































Parameters



Range Finding Test



Definitive Test



Adults with well-developed clitellum of age (difference in age of all worms is within 4 weeks)



4 to 4.5 months


 



4.5 to 5 months



Light intensity (Lux)



465 and 482



510 and 540



Temperature (ºC)



20.1 and 20.2



19.9



Feeding with pasteurized cow manure



Yes



Yes



Duration of acclimatization



Above 24 hours



Above 24 hours



Body weight range at start of test (mg)



305.0 to 520.1



322.4 to 400.3



Test containers weight


(to monitor moisture)



Weekly once



Weekly once



There was no mortality of earthworms in control and at the tested concentrations of 0.91, 1.63, 2.94, 5.29, 9.53, 17.15, 30.87, 55.56 and 100.00 mg/kg on Day 28. The percent mortality of earthworms at 3.0 mg a.i. of reference substance/kg dry soil was 17.5%. No pathological and behavioral symptoms were observed in adult worms during the test period in the control and treated groups (including reference substance). No statistically significant reduction in body weight was observed in treated groups (except 5.29, 9.53, 17.15, 30.87, 55.56 and 100.00 mg/kg dry soil and reference substance test group) as compared with the control. No pathological and behavioral symptoms were observed in juveniles on Day 56 in the control and treated groups. No statistically significant reduction in juvenile production was observed in treated groups (except 2.94, 5.29, 9.53, 17.15, 30.87, 55.56 and 100.00 mg/kg dry soil and reference substance test group) as compared with the control. Cocoons were not present in any of tested groups and reference substance group.


The results of active ingredientanalysisof test concentrations of 0.91, 9.53 and 100.00 mg/kg dry are detailed in addtional information. Reference substance (Carbendazim) group exhibited statistically significant reduction in juvenile production at 3 mg a.i./kg dry soil as compared with the control. Hence the test has met the validity acceptance criteria as per test guideline OECD 222, that significant effects should be observed between 1 and 5 mg a.i./kg dry soil in a test. This result infers that the obtained results during this test are valid andhencetest is acceptable. The Day 28 LC50of Tetra butyl ammonium bromide on adult earthworms is more than 100 mg test item/kg dry soil. The day 56 juvenile production NOEC, LOEC and Effective Concentrations value based on the nominal concentration of the test item. After exposure tenure, NOEC, LOEC, EC10 and EC50 was observed to be 1.63, 2.94, 0.5026, and 9.524 mg/kg dry soil, respectively.


 


Toxicity to terrestial arthropods:


In accordance with column 2 of Annex IX of the REACH regulation, the study does not need to be conducted because direct and indirect exposure of the soil compartment is unlikely as considering its use as a coating agent and phase transfer catalyst and even if the test chemical is accidentally exposed to the soil compartment, there is likely to be little or no adsorption of chemical in soil compartment on the basis of experimental logKoc value (less than 1.5).


 


Toxicity to terrestial plants:


The study aimed at evaluating the effect of test item on seedling emergence and seedling growth of 6 terrestrial plants was conducted on 2 monocotyledonous and 4 dicotyledonous species. The test item was mixed into the acid washed quartz sand (artificial substrate/soil which was used as the test medium) and exposed as per test guidelines.


A range finding test was carried out with the plant species (onion, corn, cabbage, tomato, soybean, and sunflower) at 10, 100, 500 and 1000 mg test item/kg dry weight of artificial substrate along with vehicle control to determine test concentrations for the definitive test. Effects of test item were observed on seedling emergence, shoot height, and dry shoot weight on day 14 in all the tested plant species after 50% of seedling emergence in control groups.


Based on the range finding results for each plant species, five test concentrations of test item were tested in main study. There was also adequate number of concurrent control group. Seeds of the test species were sown in plastic pots with 2 seeds/pot (corn), 3 seeds/pot (cabbage, tomato, soybean, and sunflower) and 5 seeds/pot (onion). Uniform seeds of the test plant species were sown in chemically inert plastic pots containing the test artificial substrate. Within a given phase of the test, all test plants including the control(s) were from the same source. The plants were grown in non-porous plastic pots with a tray saucer under the pot. The pots were large enough to allow normal growth. A pot was defined as the replicate (diameter: 15.5 cm, surface area about: 189 cm2)


To prepare required test item concentration, required quantity of test item was weighed and mixed with acetone (sonication was made, where essential) followed by introduction into artificial substrate. Vehicle was allowed to dry completely, and this was homogenously mixed using blender. For control, required quantity of artificial substrate was mixed thoroughly with nutrient solution. For vehicle control, required quantity of artificial substrate was mixed with acetone and allowed to dry completely and this was homogenously mixed using blender. After test medium preparation, the pots were filled with uniform quantity of test medium (2 kg). This was followed by addition of required volume (220 mL/pot) of water based on WHCmax (26%) of the artificial substrate.


The concentrations were separated by for of 3 for onion soybean sunflower and tomato. The test concentrations for onion, soybean and sunflower are 15, 45, 135, 405, 1215 mg/kg/dw. For corn and cabbage are it was 1000 mg/kg/dw. For tomato are 5, 15, 45, 135, 405 mg/kg/dw. The experiment was conducted in a special room with PAR lights with light intensity22600 to 24100 Lux, and suitable environmental conditions withair temperature of 19.5 to 23.3 °C and air humidity of 71 to 89 %were provided for plant species. During the experiment, the plants were observed for emergence (every day and then at 7 days interval) and visual phytotoxicity (at 7 and 14 days). The experiment completed on 14 days after the emergence of 50% of the vehicle control seedlings. At the end of the experiment, the number of surviving plants, their height and dry weight were observed. 


Analytical verification of the test medium (test item active ingredient analysis in test medium) was performed using a validated analytical method to determine the test item. The samples from the low, mid and high-test item concentrations were analyzed at the beginning of the test (day 0) along with the control(s). For analysis, required quantity of test medium was sampled on day 0


 


During the observation period, i.e. 14 days after 50% of the control(s) plants have emerged, the plants were observed frequently for emergence and visual phytotoxicity and mortality. At the end of the test, measurement of percent emergence and biomass of surviving plants were recorded, as well as visible detrimental effects on different parts of the plant. The latter include abnormalities in appearance of the emerged seedlings, stunted growth, chlorosis, discoloration, mortality, and effects on plant development. A uniform scoring system for visual injury was used to evaluate the observable toxic responses. The final biomass was measured using final average dry shoot weight of surviving plants, by harvesting the shoot at the soil surface and drying them to constant weight at 60 to 70 ºC. The height of the shoot of surviving plants were measured at the end of the test.


Plant observations on days 7 and 14 recorded normal in control and vehicle control. In certain test item treated groups exhibited visual phytotoxicity (toxic responses) of stunted growth and mortality (except onion, cabbage, and tomato). Effects of test item were observed on seedling emergence, seedling survival (except onion, cabbage, and tomato), shoot height, and dry shoot weight on day 14 in all the tested plant species.


 


Visual assessment is the rating of visual damage based on observations of plant stand, vigour, malformation, chlorosis, necrosis, and overall appearance compared with control(s). Uniform scoring system was used for visual injury to evaluate the observable toxic responses. Plants were observed for severity of the visual phytotoxic effects of test item from the grading scale of 0 to 100 %.


A dose-response relationship was established in terms of a regression equation by using four parameter Model. Different model was used for estimating ECx (EC10, EC20, EC50, EC90) and its confidence limits, where possible. The statistical analysis of the shoot height and shoot weight data was evaluated using licensed copies of SYSTAT Statistical package version 12.0. Data was tested for normality (Shapiro-Wilk test) and homogeneity of variance (Levene’s) before performing further analysis. When data was found as normal and homogeneous, ANOVA was performed, when data was found as non-normal or non-homogeneous, data were transformed, and ANOVA was done on transformed data for overall group comparison. Dunnett’s test was performed for pairwise comparison. Comparison of two group’s mean was done using two-sample t-test.


The present study can be considered valid since, the control(s) satisfies the validity criteria given in the guideline as below.


·     The seedling emergence was at least 90% in all the tested plant species (acceptable criterion: seedling emergence should be at least 70%).


·     The seedlings didn’t exhibited visible phytotoxic effects and the plants exhibited only normal variation in growth and morphology for particular species (acceptable criterion: seedlings do not exhibit visible phytotoxic effects and the plants exhibit only normal variation in growth and morphology for particular species).


·     The mean survival of emerged control(s) seedlings was at least 100% for the duration of the study (acceptable criterion: mean survival of emerged control(s) seedlings should be at least 90% for the duration of the study).


·     Environmental conditions for a particular species was identical and growing media contained the same amount of substrate in all the tested plant species from the same source (acceptable criterion: environmental conditions for a particular species should be identical and growing media should contain the same amount of substrate from the same source)


Based on the outcomes of definitive test by concerning the emergence, the shoot length, and the dry weight were statistically analyzed to determine the EC10, EC20, EC50, EC90, NOEC and LOEC. The NOEC values based on the emergence, the shoot length, and the dry weight, are 135, 1215, 45 (onion), >1000, >1000, >1000 (corn), >1000, >1000, >1000 (cabbage), 15,405,5 (tomato), 135,405, 15 (soybean) and 135, 1215, 15 sunflower


 


Toxicity to soil microorganisms:


In accordance with column 2 of Annex IX of the REACH regulation, the study does not need to be conducted because direct and indirect exposure of the soil compartment is unlikely considering its use as a coating agent and phase transfer catalyst & there is no risk for the sediment compartment since the result of the chemical safety assessment indicates that the PEC/PNEC value is < 1 which indicates no risk, and since the half life value of chemical in soil is 17.33 days (i.e., not persistent) and even if a chemical is accidentally released in soil compartment, there is likely to be negligible adsorption of chemical in soil compartment on the basis of experimental logKoc value (1.280 ± 0.003 as per OECD TG 121).


 


Toxicity to birds:


In accordance with column 2 of Annex IX of the REACH regulation, the study does not need to be conducted because direct and indirect exposure of the soil compartment is unlikely as considering its use as a coating agent and phase transfer catalyst and even if the test chemical is accidentally exposed to the soil compartment, there is likely to be little or no adsorption of chemical in soil compartment on the basis of experimental logKoc value (less than 1.5).