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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

On the basis of the experimental studies of the structurally and functionally similar read across chemical and applying the weight of evidence approach and by evaluating the effect of test chemical on test daphnids, the 48 hr EC50/LC50 value can be expected to be in the range 6.4 to 28 mg/l, respectively.

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 and by evaluating the effect of test chemical on test organism, the 48 hr EC50/LC50 value can be expected to be in the range 13.4 to 47.4 mg/l, respectively.

Toxicity to microorganisms

Toxicity to micro-organisms study was conducted using five different microorganisms. The study was performed for 24 hrs at 37°C. Test organism Staphylococcus aureus (IAM-1011, SA) was purchased from Institute of Applied Microbiology, Tokyo university. Escherichia coli (ATCC 11775, (EC)) was purchased from Institute of Medical Science, Tokyo university. Corynebacterium minutissimum (ATCC 23348, (CM)) and Staphylococcus epidermis var.(SE) were gifted from the Department of Dermatology, University of Pennsyvania. Arthrobacter sp. was isolated from Lipo-66. Culture dish of 35 X 10 mm dimension was used as a test vessel. Test chemical solutions were prepared in either ethyl alcohol or DMSO. Muller Hinton agar was used as a test medium. Test bacteria were pre-propagated with sensitivity test broth of NISSUI using shaking culture. Incubated mediums were diluted using 0.75% physiological saline to the microbial concentration of 10e6 CFU/ml. Test medium containing the test chemical was inoculated using 0.1 ml of diluted culture solution. MIC was determined after 24 hrs at 37°C. Based on the effect of test chemical on the growth inhibition of five different organisms such as Corynebacterium minutissimum, Escherichia coli, Staphylococcus aureus, Staphylococcus epidermis, Arthrobacter spp. after the exposure period of 24 hours, the MIC value was determined to be > 2000 mg/l.

Additional information

Short term toxicity to aquatic invertebrates

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

An acute immobilisation test was conducted for 48 hrs for assessing the effect of test chemical on Daphnia magna. The test was performed in accordance to OECD guideline No. 202 “Daphnia sp.,Acute Immobilization Test”. Own breeding stock at University of Chemistry and Technology, Prague of Daphnia magna was used as a test organism for the study.The stock solution 100 mg/l was prepared by dissolving test chemical in reconstituted water. Test solutions of required concentrations were prepared by mixing the stock solution of the test sample in reconstituted water.Nominal test chemical conc. used for the study were0, 0, 0.6, 1.0, 1.7, 2.9, 4.9 and 8.3 mg/L, respectively. Study was performed using total 5 organisms per vessel/replicates in a static fresh water system. Daphnids were exposed to test chemical in 50 ml glass vessel in a volume of 25 ml of liquid solution containing both the chemical and media. The beakers were placed in a room at a temperature of 20±1°C. With the test substance one positive control Potassium dichromate (K2Cr2O7) was also run simultaneously. After the exposure of chemical, effect concentration EC50 was calculated using nonlinear regression by the software Prism 4.0. On the basis of the effect of test chemical on the mobility of the test organism Daphnia magna, the 48 hr EC50 value was determined to be 7 mg/l with a 95% confidence interval value ranging from 5.5 to 8.8 mg/l, respectively. Thus, based on the EC50 value, test chemical can considered as toxic to aquatic invertebrates. Since, the test chemical is readily biodegradable in water, chemical can be considered as non-toxic to aquatic invertebrate and thus can be considered to be not classified as per the CLP classification criteria.

Another acute immobilisation test was conducted for 48 hrs for assessing the effect of test chemical on Daphnia magna. The test was performed following the OECD guideline No. 202 “Daphnia sp.,Acute Immobilization Test”. Own breeding stock at University of Chemistry and Technology, Prague of Daphnia magna was used as a test organism for the study.The stock solution 10.0 g/l was prepared in acetone. Test solutions of required concentrations were prepared by mixing the stock solution of the test sample in reconstituted water. Nominal test chemical concentrations used for the study were 0, 0, 0.5, 1.0, 2.0, 4.0 and 8.0 mg/L, respectively. Study was performed using total 5 organisms per vessel/replicates in a static fresh water system. Daphnids were exposed to test chemical in 50 ml glass vessel in a volume of 25 ml of liquid solution containing both the chemical and media. The beakers were placed in a room at a temperature of 20±1°C. With the test substance one positive control Potassium dichromate (K2Cr2O7) was also run simultaneously. After the exposure of chemical, effect concentration EC50 was calculated using nonlinear regression by the software Prism 4.0. On the basis of the effect of test chemical on the mobility of the test organism Daphnia magna, the 48 hr EC50 value was determined to be 6.4 mg/l. Thus, based on the EC50 value, test chemical can considered as toxic to aquatic invertebrates. Since, the test chemical is readily biodegradable in water, chemical can be considered as non-toxic to aquatic invertebrate and thus can be considered to be not classified as per the CLP classification criteria.

For the test chemical, short term toxicity to aquatic invertebrate study was conducted for 48 hrs for assessing the effect of test chemical onDaphnia magna. The test was performed in accordance with the OECD guideline No. 202 “Daphnia sp.,Acute Immobilization Test”. Own breeding stock at University of Chemistry and Technology, Prague ofDaphnia magna was used as a test organism for the study.The stock solution 100.0 g/l was prepared in acetone. Test solutions of required concentrations were prepared by mixing the stock solution of the test sample in reconstituted water. Nominal test chemical concentrations used for the study were 0, 0, 6.0, 12.0, 25, 50 and 100 mg/L, respectively. Study was performed using 5 organisms per vessel/replicates in a static fresh water system. Daphnids were exposed to test chemical in 50 ml glass vessel in a volume of 25 ml of liquid solution containing both the chemical and media. The beakers were placed in a room at a temperature of 20±1°C. With the test substance one positive control Potassium dichromate (K2Cr2O7) was also run simultaneously. After the exposure of chemical, effect concentration EC50 was calculated using nonlinear regression by the software Prism 4.0. On the basis of the effect of test chemical on the mobility of the test organismDaphnia magna, the 48 hr EC50 value was determined to be 28 mg/l (95 % CI 19.9 - 39.2 mg/l). Thus, based on the EC50 value, test chemical can considered as toxic to aquatic invertebrates. Since, the test chemical is readily biodegradable in water, chemical can be considered as non-toxic to aquatic invertebrate and thus can be considered to be not classified as per the CLP classification criteria.

On the basis of the experimental studies of the structurally and functionally similar read across chemical and applying the weight of evidence approach and by evaluating the effect of test chemical on test daphnids, the 48 hr EC50/LC50 value can be expected to be in the range 6.4 to 28 mg/l, respectively. Thus, based on the EC50 value, test chemical can considered as toxic to aquatic invertebrates. Since, the test chemical is readily biodegradable in water, chemical can be considered as non-toxic to aquatic invertebrate and thus can be considered to be not classified as per the CLP classification criteria.

Toxicity to aquatic algae and cyanobacteria

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

An acute test was conducted for 72 hrs for assessing the effect of test chemical on Desmodesmus subspicatus. The test was performed in accordance to OECD Guideline 201 (Alga, Growth Inhibition Test). Desmodesmus subspicatus (previous name: Scenedesmus subspicatus) of strain 86.81 SAG obtained from Institute of botany of the ASCR with an initial biomass conc. 5x10(3) cells /ml was used as a test organism for the study. The stock solution 100.0 mg/l was prepared by dissolving colourless liquid in growth medium. Test solutions of required concentrations were prepared by mixing the stock solution of the test sample with OECD growth medium and inoculum culture. Nominal test chemical conc. used for the study were 0, 10, 16, 26, 41 and 66 mg/l, respectively.Study was performed using Desmodesmus subspicatus as a test organism in a static fresh water system. Desmodesmus subspicatus were exposed to test chemical in 50 ml glass vessel in a volume of 15 ml of liquid solution containing both the chemical and media. The beakers were placed in a room at a temperature of 23±2°C with a continuous light intensity of 6000-8000 lx, respectively. Alongwith the test chemical, one positive control Potassium dichromate (K2Cr2O7) was also run simultaneously. Cell counting was carried out using microscope with counting chamber Cyrus I or electronic particle counter. ErC50 was calculated using non-linear regression by the software Prism 4.0. On the basis of the effect of test chemical on the growth rate of the test organism Desmodesmus subspicatus, the 72 hr median effect concentration (ErC50) value was determined to be 31.2 mg/l (95 % CI 28.9 - 33.7 mg/l). Thus, based on the EC50 value, test chemical can considered as toxic to aquatic algae. Since, the test chemical is readily biodegradable in water, chemical was considered as non-toxic to aquatic algae and hence, considered to be not classified as per the CLP classification criteria.

Another acute test was conducted for 72 hrs for assessing the effect of test chemical on green algae. The test was performed in accordance with the OECD Guideline 201 (Alga, Growth Inhibition Test). Desmodesmus subspicatus (previous name: Scenedesmus subspicatus) of strain 86.81 SAG was used for the study and obtained from Institute of botany of the ASCR with an initial biomass conc. 5x10e3cells /ml was used as a test organism for the study. The stock solution 100.0 mg/l was prepared by dissolving colourless liquid in acetone. Test solutions of required concentrations were prepared by mixing the stock solution of the test sample with OECD growth medium and inoculum culture. Nominal test chemical conc. used for the study were 0, 0, 5.0, 7.5, 11, 16.5 and 25 mg/l, respectively. Study was performed using Desmodesmus subspicatus as a test organism in a static system. Desmodesmus subspicatus were exposed to test chemical in 50 ml glass vessel in a volume of 15 ml of liquid solution containing both the chemical and media. The beakers were placed in a room at a temperature of 23±2°C with a continuous light intensity of 6000-8000 lx, respectively. Along with the test chemical, one positive control Potassium dichromate (K2Cr2O7) was also run simultaneously. Cell counting was carried out using microscope with counting chamber Cyrus I or electronic particle counter. ErC50 was calculated using non-linear regression by the software Prism 4.0. On the basis of the effect of test chemical on the growth rate of the test organism Desmodesmus subspicatus, the 72 hr median effect concentration (ErC50) value was determined to be 13.4 mg/l (95 % CI 12.5 - 14.4 mg/l). Thus, based on the ErC50 value, test chemical can considered as toxic to aquatic algae. Since, the test chemical is readily biodegradable in water, chemical was considered as non-toxic to aquatic algae and hence, considered to be not classified as per the CLP classification criteria.

Toxicity to aquatic algae study was conducted for 72 hrs for assessing the effect of test chemical on Desmodesmus subspicatus. The test was performed in accordance to OECD Guideline 201 (Alga, Growth Inhibition Test). Desmodesmus subspicatus (previous name: Scenedesmus subspicatus) of strain 86.81 SAG obtained from Institute of botany of the ASCR with an initial biomass conc. 5x10e3 cells /ml was used as a test organism for the study. The stock solution 100.0 g/l was prepared in acetone. Test solutions of required concentrations were prepared by mixing the stock solution of the test sample with OECD growth medium and inoculum culture. Nominal test chemical concentrations used for the study were 0, 0, 5.0, 10.0, 20.0, 40.0, 60.0 and 80 mg/l, respectively. Study was performed under static system. Desmodesmus subspicatus were exposed to test chemical in 50 ml glass vessel in a volume of 15 ml of liquid solution containing both the chemical and media. The beakers were placed in a room at a temperature of 23±2°C with a continuous light intensity of 6000-8000 lx, respectively. Along with the test chemical, one positive control Potassium dichromate (K2Cr2O7) was also run simultaneously. Cell counting was carried out using microscope with counting chamber Cyrus I or electronic particle counter. ErC50 was calculated using non-linear regression by the software Prism 4.0. On the basis of the effect of test chemical on the growth rate of the test organism Desmodesmus subspicatus, the 72 hr median effect concentration (ErC50) value was determined to be 47.4 mg/l (95 % CI 39.7 - 56.7 mg/l). Thus, based on the ErC50 value, test chemical can considered as toxic to aquatic algae. Since, the test chemical is readily biodegradable in water, chemical can be considered as non-toxic to aquatic algae and thus can be considered to be not classified as per the CLP classification criteria.

On the basis of the experimental studies of the structurally and functionally similar read across chemical and applying the weight of evidence approach and by evaluating the effect of test chemical on test organism, the 48 hr EC50/LC50 value can be expected to be in the range 13.4 to 47.4 mg/l, respectively.

Thus, based on the ErC50 value, test chemical can considered as toxic to aquatic algae. Since, the test chemical is readily biodegradable in water, chemical can be considered as non-toxic to aquatic algae and hence, considered to be not classified as per the CLP classification criteria.

Toxicity to microorganisms

Toxicity to micro-organisms study was conducted using five different microorganisms. The study was performed for 24 hrs at 37°C. Test organism Staphylococcus aureus (IAM-1011, SA) was purchased from Institute of Applied Microbiology, Tokyo university. Escherichia coli (ATCC 11775, (EC)) was purchased from Institute of Medical Science, Tokyo university. Corynebacterium minutissimum (ATCC 23348, (CM)) and Staphylococcus epidermis var.(SE) were gifted from the Department of Dermatology, University of Pennsyvania. Arthrobacter sp. was isolated from Lipo-66. Culture dish of 35 X 10 mm dimension was used as a test vessel. Test chemical solutions were prepared in either ethyl alcohol or DMSO. Muller Hinton agar was used as a test medium. Test bacteria were pre-propagated with sensitivity test broth of NISSUI using shaking culture. Incubated mediums were diluted using 0.75% physiological saline to the microbial concentration of 10e6 CFU/ml. Test medium containing the test chemical was inoculated using 0.1 ml of diluted culture solution. MIC was determined after 24 hrs at 37°C. Based on the effect of test chemical on the growth inhibition of five different organisms such as Corynebacterium minutissimum, Escherichia coli, Staphylococcus aureus, Staphylococcus epidermis, Arthrobacter spp. after the exposure period of 24 hours, the MIC value was determined to be > 2000 mg/l.

On the basis of the available information of aquatic toxicity studies, it can be concluded that the test chemical was considered astoxic to aquatic organisms. Since, the chemical is readily biodegradable in water, chemical was considered as non-toxic at environmental relevant concentrations and hence, considered to be ‘not classified’as per CLP classification criteria.