Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

An acute toxicity test was conducted for 96 hrs for assessing the effect of test chemical on fish (Experimental study report, 2018). The test was performed in accordance with the OECD guideline No. 203 “Fish Acute Toxicity Test”. Zebra fish (Danio rerio) of average weight 0.083 g and average length of 1.96 cm was used as a test organism for the study. Test fishes were kept in a static tank in tap water passed through reverse osmosis system, under natural conditions along with proper feed and aeration. During the housing period, test fishes were fed once daily with standard brand fed. The test conditions during the housing of the test organisms were oxygen content of 7.0 mg/l, pH 7.1, water temperature 24.5°C and under a photoperiod of 16:8 hr light: dark conditions, respectively. Limit test was conducted using 100 mg/l of nominal test chemical concentration which was not verified analytically. Total 8 fishes were exposed to test chemical in a 5 lit bowl aquaria containing 4 liters of potable water. The test vessels were placed in a room at a temperature of 24.5°C, pH 7.1, hardness of water 190 mg of CaCO3 and under a photoperiod of 16:8 hr light: dark conditions, respectively. Aeration in test vessels was provided 1 day before the start of the experiment. No mortalities were observed in the control and test vessel. On the basis of effect of test chemical on mortality of the test organism, the median lethal concentration (LC50 (96 h)) value was determined to be > 100 mg/l. Thus, test chemical was considered as non-toxic to aquatic fishes and hence, considered to be not classified as per the CLP classification criteria.

Short term toxicity to aquatic invertebrates

An acute immobilisation test was conducted for 48 hrs for assessing the effect of test chemical on Daphnia magna (Experimental study report, 2019). The test was performed in accordance to OECD guideline No. 202“Daphnia sp.,Acute Immobilization Test”. The test chemical solution was prepared by dissolving 2 mg of the test chemical in 20 ml of ADaM’s media achieving test concentrations of 100 mg/L. Limit test was performed using 100 mg/l of test chemical concentration. Study was performed using 10 daphnids in a static system. Total 10 Daphnids/conc. were exposed to test chemical in 25 ml beakers in a volume of 20 ml of liquid solution containing both the chemical and media. The beakers were placed in a room at a temperature of 20±2°C, hardness of water 140 mg of CaCO3 and under a photoperiod of 16:8 hr light: dark conditions with light intensity 1000 – 1500 Lux, respectively. One control vessel was also run simultaneously during the study. The animals were exposed to medium (i.e.a beaker containing only medium) and the test chemical concentrations for a period of 48 hour. Potassium dichromate was used as a reference substance for the study. The 48 hr EC50 value of reference substance was determined to be 0.831 mg/l. No Immobility were found in the control test animals and the dissolved oxygen concentration at the end of the test in the control and test vessel was ≥ 3 mg/l, thus validity criterion of the study has been fulfilled. On the basis of effect of test chemical on mobility of the test organism, the median effect concentration (EC50 (48 h)) value was determined to be > 100 mg/L. Thus, based on the EC50 value, test chemical was considered as non-toxic to aquatic invertebrates and hence, considered to be 'not classified' as per CLP classification criteria.

Toxicity to aquatic algae and cyanobacteria

A freshwater algal growth inhibition test was conducted for 72 hrs for assessing the effect of test chemical on green algae Pseudokirchneriella subcapitata (Experimental study report, 2019). The test was performed in accordance to OECD guideline No. 201 – Alga growth inhibition test under static condition. Initial cell density of the culture was kept at 10000 cells/ml. OECD medium composed of macronutrients, micronutrients, alkaline EDTA solution and iron solution was used as a growth medium. The stock solution was prepared by dissolving 1 gm of test chemical in 1000 mL of OECD media to get the final concentration of 1000 mg/L. Further exposure concentration of 100 mg/l was prepared from the stock solution in OECD media. Green algae were exposed to nominal concentration of test chemical (100 mg/l) in 100 ml conical flasks. Thus, limit test was performed at 100 mg/l test chemical concentration. Test vessel were placed in orbital shaking incubator for 72 hrs at a room at a temperature of 21 to 24 ± 2°C under a photoperiod of 16:8 hr light: dark conditions and with a continuous uniform illumination of 3000-4000 lux light intensity, respectively. The speed of the orbital shaking incubator was set at a 120 revolutions per minute throughout the study period. The cultures were counted and observed daily with the help of a microscope. Potassium dichromate (K2Cr2O7) was used as a reference substance. The 72 hr EC50 value of the reference substance was determined to be 0.809 mg/l. The biomass in the control vessel have increased exponentially by a factor of 16 and the mean coefficient of variation of specific growth rate was not exceeded 35%, thus fulfilling the validity criterion. No significance difference was noted between control and test concentration (100 mg/l) (p<0.05) calculated by using Student's t-test. On the basis of growth rate of the test organism, the 72 hr median effect concentration (EC50) was determined to be > 100 mg/l. On the basis of this value, test chemical was 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 activated sludge study was carried out for 30 mins (Udo Pagga et. al., 1994). The study was performed in accordance with the ISO 8192 (Water quality - Test for inhibition of oxygen consumption by activated sludge for carbonaceous and ammonium oxidation). On the basis of the effect on oxygen consumption of the test organism activated sludge, the30 mins EC0 and EC50 value was determined to be 100 mg/l and > 100 mg/l, respectively.

Additional information

Short term toxicity to fish

Various experimental studies of the test chemical and supporting weight of evidence studies for its functionally similar read across chemicals were reviewed for short term toxicity to fish end point which are summarized as below:

 

In an experimental study from study report (2018), an acute toxicity test was conducted for 96 hrs for assessing the effect of test chemical on fish. The test was performed in accordance with the OECD guideline No. 203 “Fish Acute Toxicity Test”. Zebra fish (Danio rerio) of average weight 0.083 g and average length of 1.96 cm was used as a test organism for the study. Test fishes were kept in a static tank in tap water passed through reverse osmosis system, under natural conditions along with proper feed and aeration. During the housing period, test fishes were fed once daily with standard brand fed. The test conditions during the housing of the test organisms were oxygen content of 7.0 mg/l, pH 7.1, water temperature 24.5°C and under a photoperiod of 16:8 hr light: dark conditions, respectively. Limit test was conducted using 100 mg/l of nominal test chemical concentration which was not verified analytically. Total 8 fishes were exposed to test chemical in a 5 lit bowl aquaria containing 4 liters of potable water. The test vessels were placed in a room at a temperature of 24.5°C, pH 7.1, hardness of water 190 mg of CaCO3 and under a photoperiod of 16:8 hr light: dark conditions, respectively. Aeration in test vessels was provided 1 day before the start of the experiment. No mortalities were observed in the control and test vessel. On the basis of effect of test chemical on mortality of the test organism, the median lethal concentration (LC50 (96 h)) value was determined to be > 100 mg/l.

 

Another short term toxicity to fish study was carried out for 48 hrs (from Yashuhide TONOGAI et. al., 1982, authoritative databases and secondary source). The study was performed according to the procedure of Japan Industrial Standards. The study was based on the effects of the test chemical on Oryzias latipes in a static system at a temperature of 25°C. Oryzias latipes (Himedaka) of the same age (about 2 cm in length, 0.2 g In weight) was used as a test organism. Test organism Oryzias latipes was acclimated for 10 days in the tap water before experiment. Test chemical solution was prepared by dissolving the chemical in water and neutralized with 0.01 N NaOH or HCl, if necessary. Total 10 fishes of Himedaka per one trial were kept in 2 liter of deionized water at 25°C and, after 24 or 48 hrs, lethal concentration of 50% fish was determined. Based on effect on mortality of the test organism Oryzias latipes, the 24 and 48 hrs LC50 value was determined to be 1000 mg/l.

 

In a supporting weight of evidence study,short term toxicity to fish study was conducted for 96 hrs for assessing the effect of test chemical (Study report, 2016). The test was performed following the OECD guideline No. 203 “Fish Acute Toxicity Test”. Zebra fish (Danio rerio) of average weight 0.335 g and average length of 3.42 cm was used as a test organism for the study. Test fishes were kept in a static tank in tap water passed through reverse osmosis system, under natural conditions along with proper feed and aeration. During the housing period, test fishes were fed once daily with standard brand fed. The test conditions during the housing of the test organisms were oxygen content of 7.06 mg/l, pH 7.23, water temperature 24.53°C and under a photoperiod of 12:12 hr light: dark conditions, respectively. Limit test was conducted using 100 mg/l of nominal test chemical concentration which was not verified analytically. Total 8 fishes were exposed to test chemical in a 5 lit bowl aquaria containing 4 liters of potable water. The test vessels were placed in a room at a temperature of 25°C, pH 7.01, hardness of water 148.5 mg of CaCO3 and under a photoperiod of 12:12 hr light: dark conditions, respectively. Aeration in test vessels was provided 1 day before the start of the experiment. No mortalities were observed in the control and test vessel. On the basis of effect of test chemical on mortality of the test organism, the median lethal concentration (LC50 (96 h)) value was determined to be > 100 mg/l.

 

For the test chemical, short term toxicity to fish study was conducted for 96 hrs for assessing the effect of test chemical (Secondary source, 2019). Pimephales promelas (Fathead minnow) was used as a test organism. The study was performed under static conditions at a temperature of 15°C, pH 6.6 to 7.1, alkalinity of 19 -32 mg/l as CaCO3 and dissolved oxygen≥ 5 mg/l. On the basis of the effect on mortality of the test organism Pimephales promelas, the 96 hr LC50 was determined to be > 180 mg/l (nominal conc.).  

 

On the basis of the above results, it can be concluded that the test chemical can be considered as non-toxic to fish and hence, considered to be ‘not classified’ as per the CLP classification criteria. 

Short term toxicity to aquatic invertebrates

Experimental study of the test chemical and supporting weight of evidence study for its functionally similar read across chemical were reviewed for short term toxicity to aquatic invertebrate end point which are summarized as below:

 

In an experimental study from study report (2019), 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”. The test chemical solution was prepared by dissolving 2 mg of the test chemical in 20 ml of ADaM’s media achieving test concentrations of 100 mg/L. Limit test was performed using 100 mg/l of test chemical concentration. Study was performed using 10 daphnids in a static system. Total 10 Daphnids/conc. were exposed to test chemical in 25 ml beakers in a volume of 20 ml of liquid solution containing both the chemical and media. The beakers were placed in a room at a temperature of 20±2°C, hardness of water 140 mg of CaCO3 and under a photoperiod of 16:8 hr light: dark conditions with light intensity 1000 – 1500 Lux, respectively. One control vessel was also run simultaneously during the study. The animals were exposed to medium (i.e.a beaker containing only medium) and the test chemical concentrations for a period of 48 hour. Potassium dichromate was used as a reference substance for the study. The 48 hr EC50 value of reference substance was determined to be 0.831 mg/l. No Immobility were found in the control test animals and the dissolved oxygen concentration at the end of the test in the control and test vessel was ≥ 3 mg/l, thus validity criterion of the study has been fulfilled. On the basis of effect of test chemical on mobility of the test organism, the median effect concentration (EC50 (48 h)) value was determined to be > 100 mg/L.

 

For the test chemical, short term toxicity to aquatic invertebrate study was conducted for 48 hrs for assessing the effect of test chemical (Experimental study report, 2016). The test was performed in accordance to OECD guideline No. 202 “Daphnia sp.,Acute Immobilization Test”. Daphnia magna was used as a test organism for the study. The stock solution 200 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 concentrations used for the study were 0, 10, 20, 40, 80 and 100 mg/l, respectively. Study was performed using total 5 organisms per vessel/replicates in a static 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. Control solution vessel containing reconstituted water without the test chemical was also setup during the study. 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. EC50 was calculated using non linear regression by the software Prism 4. In the control vessel containing reconstituted water without the test chemical, no daphnids were immobilized at the end of the test. On the basis of the mobility of the test organism Daphnia magna due to the exposure of test chemical, the 48hr median effect concentration (EC50) value was determined to be 202.6 mg/l (95 % C. I. - 146.1 to 280.9 mg/l ).

 

On the basis of the above results, it can be concluded that the test chemical was considered as non-toxic to aquatic invertebrates and hence, considered to be ‘not classified’ as per the CLP classification criteria. 

Toxicity to aquatic algae and cyanobacteria

Experimental study of the test chemical and supporting weight of evidence study for its functionally similar read across chemical were reviewed for toxicity to aquatic algae and cyanobacteria end point which are summarized as below:

 

In an experimental study from study report (2019), a freshwater algal growth inhibition test was conducted for 72 hrs for assessing the effect of test chemical on green algae Pseudokirchneriella subcapitata. The test was performed in accordance to OECD guideline No. 201 – Alga growth inhibition test under static condition. Initial cell density of the culture was kept at 10000 cells/ml. OECD medium composed of macronutrients, micronutrients, alkaline EDTA solution and iron solution was used as a growth medium. The stock solution was prepared by dissolving 1 gm of test chemical in 1000 mL of OECD media to get the final concentration of 1000 mg/L. Further exposure concentration of 100 mg/l was prepared from the stock solution in OECD media. Green algae were exposed to nominal concentration of test chemical (100 mg/l) in 100 ml conical flasks. Thus, limit test was performed at 100 mg/l test chemical concentration. Test vessel were placed in orbital shaking incubator for 72 hrs at a room at a temperature of 21 to 24 ± 2°C under a photoperiod of 16:8 hr light: dark conditions and with a continuous uniform illumination of 3000-4000 lux light intensity, respectively. The speed of the orbital shaking incubator was set at a 120 revolutions per minute throughout the study period. The cultures were counted and observed daily with the help of a microscope. Potassium dichromate (K2Cr2O7) was used as a reference substance. The 72 hr EC50 value of the reference substance was determined to be 0.809 mg/l. The biomass in the control vessel have increased exponentially by a factor of 16 and the mean coefficient of variation of specific growth rate was not exceeded 35%, thus fulfilling the validity criterion. No significance difference was noted between control and test concentration (100 mg/l) (p<0.05) calculated by using Student's t-test. On the basis of growth rate of the test organism, the 72 hr median effect concentration (EC50) was determined to be > 100 mg/l. On the basis of this value, test chemical was considered as non-toxic to aquatic algae and hence, considered to be 'not classified' as per the CLP classification criteria.

For the test chemical, an acute test was conducted for 48 hrs for assessing the effect of test chemical (Experimental study report, 2016). 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 solution 100 mg/l was prepared by dissolving test chemical in OECD growth medium. Nominal test chemical conc. used for the study was 100 mg/l, i.e, limit test was conducted. 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. Alongwith the test chemical, one positive control Potassium dichromate (K2Cr2O7) was also run simultaneously. Cell counting was carried out using electronic particle counter. The differences in means of control and sample were estimated by the t-test for independent groups at a 95 % confidence level, all individual replicates were used (STATISTICA CZ – data analysis software system, version 9.0, StatSoft, Inc.). Statistically significant differences are for p < 0.05. On the basis of the effect of test chemical on the growth rate of the test organism Desmodesmus subspicatus, the 72hr Inhibition percentage (I%) value was determined to be 4.8% at 100.0 mg/l of test chemical concentration. Thus, EC50 can be considered to be > 100 mg/l, indicating that the test chemical is non-toxic to aquatic algae and therefore considered to be 'not classified' as per the CLP classification criteria.

 

On the basis of the above results, it can be concluded that the test chemicalwas considered as non-toxic to aquatic algae and hence, considered to be ‘not classified’ as per the CLP classification criteria. 

Toxicity to microorganisms

Various experimental studies of the test chemical and supporting study for its read across chemical were reviewed for toxicity to microorganism end point which are summarized as below:

 

In an experimental key study (Udo Pagga et. al., 1994), toxicity to activated sludge study was carried out for 30 mins. The study was performed in accordance with the ISO 8192 (Water quality - Test for inhibition of oxygen consumption by activated sludge for carbonaceous and ammonium oxidation). On the basis of the effect on oxygen consumption of the test organism activated sludge, the30 mins EC0 and EC50 value was determined to be 100 mg/l and > 100 mg/l, respectively.

 

For the test chemical, toxicity to Tetrahymena pyriformis study was carried out (Handbook, 2008). The study was based on the effects of the test chemical on test organism. On the basis of effect of test chemical on test organism, the 24 hr LC100 value was determined to be 400 mg/l.

 

On the basis of the above results, it can be concluded that the test chemical can be considered to be non-toxic to microorganisms.

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