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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Based on the prediction done by EPI suite, ECOSAR version 1.1, on the basis of similarity of structure to chemicals for which the aquatic toxicity has been previously measured by structure-activity relationships (SARs) program, the LC 50 value for short term toxicity to fish was predicted.On the basis of this program, the LC 50 value for short term toxicity to fish was predicted to be 1101 mg/l for test materialin 96 hrs.Based on this value it can be concluded that the substance is considered to be not toxic to aquatic environment and can not be classified in as per the criteria mentioned in CLP regulation.

Short term toxicity to aquatic invertebrate:

Aim of this study was to assess the short term toxicity of test material to aquatic invertebrates daphnia magna. Study was performed according to the OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test) in a static system for the total exposure period of 48 hrs.The stock solution 200.0 mg/l was prepared by dissolving colourless liquid in reconstituted water. The test solutions of required concentrations were prepared by mixing the stock solution of the test sample in reconstituted water.10.0 , 20.0, 40.0, 60.0, 180.0 mg/lconcentrations were used in the study. Effects on immobilisation were observed for 48 hours. 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. The median effective concentration (EC50) for the test substance, in Daphnia magna was determined to be 30.9 mg/L on the basis of mobility inhibition effects in a 48 hour study.Tested substance is an acid and that is why the higher concentration the lower pH. The optimum pH for daphnids is 6.0 - 9.0. The inhibition of the mobility of daphnids could be influenced by pH at the concentration 160 mg/l and that is why EC50 was calculated also for results without the concentration 160.0 mg/l with low pH.The test material can not be classified based on the above effect concentration as the inhibition of the mobility of daphnids could be influenced by pH.

Toxicity to aquatic algae and cyanobacteria:

Aim of this study was to evaluate the nature of chemical test chemical when comes in contact with the test organism Desmodesmus subspicatus (previous name: Scenedesmus subspicatus). Test was conducted according to the OECD guideline 201.The stock solution 100.0 mg/l was prepared by dissolving colourless liquid in OECD 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.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. Effect on the growth of algae was determine after an exposure period of 72 hrs. The nominal concentration were selected as20, 30, 44 , 66, 100 mg/l . Tested substance is an acid and that is why the higher concentration the lower pH. The optimum pH for algae is about 8.0. The highest concentration could be influenced by lower pH. Adjustment of pH would change substance properties.The median effective concentration (EC50) for the test substance, in algae was determined to be 83.1mg/L on the basis of growth rate inhibition effects in a 72 hour study.The test material can not be classified based on the above effect concentration as the inhibition of the mobility of daphnids could be influenced by pH.

Toxicity to microorganism:

Data available for the test chemicals has been reviewed to determine the toxicity of microorganism of the test chemical .The studies are as mentioned below:

1)Test material was used as a test material to evaluate toxicity to microorganisms as per OECD guideline 209. Activated sludge was used as the test culture at pH 7.5 for 3 h The EC50 value on the basis of respiration inhibition test was observed to be >1000 mg/l.

2)In a study of toxicity of test mateial to the Marine Dinoflagellate Gymnodinium breve the effect of Potassium hydrogen phthalate was evaluated. The test substance was tested in a concentration of 0,1,10, 20, 50, 100, 200, 500, 1000 and 1000 ppm. The results show Median growth when concentration of test material (ppm) versus the growth rate (linear axis of graph), expressed as a percentage of the growth of a "no-add" control at 498.52 and 997 mg/l. Therefore, EC50 of test material was considered to be be 498.52 and 997 mg/l when tested on Marine Dinoflagellate Gymnodinium breve for 96 hours.

Additional information

Short term toxicity to fish:

Short term toxicity to fish for test material was evalauted , prediction and data from peer reviewed journal was used to concluded the toxicity potential of test material on fish as summarized below.

Based on the prediction done by EPI suite, ECOSAR version 1.1, on the basis of similarity of structure to chemicals for which the aquatic toxicity has been previously measured by structure-activity relationships (SARs) program, the LC 50 value for short term toxicity to fish was predicted.On the basis of this program, the LC 50 value for short term toxicity to fish was predicted to be 1101 mg/l for test materialin 96 hrs.Based on this value it can be concluded that the substance is considered to be not toxic to aquatic environment and can not be classified in as per the criteria mentioned in CLP regulation.

The above prediction was further supported by data from reviewed handbooks and peer reviewed journals,In acute fish toxicity study on species Carassius auratus (Goldfish) time to 50% mortality of organisms (LC50) of test substance was reported to be 480 mg/l on the basis of mortality effect with exposure period 3.02 hrs.Mentioned concentration indicate that the test substance was non toxic to fish.

In another study , short term fish toxicity of test chemical on test species Oryzias latipes (Japanese Medaka) the lethal concentration (LC50) for exposure period of 48 hrs. in static freshwater system and test temperature 30 deg.C was observed to be 1000 mg/l. Thus based on the lethal concentration it is concluded that the test substance was non hazardous to aquatic environment.

In another study the effect of test material on the mortality of Danio rerio. The study was conducted in accordance with OECD Guideline 203 (Fish, Acute Toxicity Test) in a static sysytem. Preparation of the test solutions/dispersions :The test solution was prepared by dissolving 1 g of the test substance in 10 liters deionized water with continuous stirring.Observations (mortality, visible symptoms, pH, Temperature, dissolved oxygen content) were recorded after 24 hours, 48 hours, 72 hours and 96 hours of the start of the experiment.Based on nominal concentration, the median lethal concentration LC-50 (96 h) for test substance on Danio rerio was found to be >100 mg/L according to probit analysis. The fishes were found to be freely swimming in the bowl aquaria without showing any abnormal symptoms. No mortalities were observed at the test concentration of 100 mg/l. It can be concluded from the value that the test substance is not toxic to the aquatic environment can be considered to be “not classified” as per the CLP classification criteria.

Short term toxicity to aquatic invertebrate:

Aim of this study was to assess the short term toxicity of test material to aquatic invertebrates daphnia magna. Study was performed according to the OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test) in a static system for the total exposure period of 48 hrs.The stock solution 200.0 mg/l was prepared by dissolving colourless liquid in reconstituted water. The test solutions of required concentrations were prepared by mixing the stock solution of the test sample in reconstituted water.10.0 , 20.0, 40.0, 60.0, 180.0 mg/lconcentrations were used in the study. Effects on immobilisation were observed for 48 hours. 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. The median effective concentration (EC50) for the test substance, in Daphnia magna was determined to be 30.9 mg/L on the basis of mobility inhibition effects in a 48 hour study.Tested substance is an acid and that is why the higher concentration the lower pH. The optimum pH for daphnids is 6.0 - 9.0. The inhibition of the mobility of daphnids could be influenced by pH at the concentration 160 mg/l and that is why EC50 was calculated also for results without the concentration 160.0 mg/l with low pH.The test material can not be classified based on the above effect concentration as the inhibition of the mobility of daphnids could be influenced by pH

Toxicity to aquatic algae and cyanobacteria:

Aim of this study was to evaluate the nature of chemical test chemical when comes in contact with the test organism Desmodesmus subspicatus (previous name: Scenedesmus subspicatus). Test was conducted according to the OECD guideline 201.The stock solution 100.0 mg/l was prepared by dissolving colourless liquid in OECD 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.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. Effect on the growth of algae was determine after an exposure period of 72 hrs. The nominal concentration were selected as20, 30, 44 , 66, 100 mg/l . Tested substance is an acid and that is why the higher concentration the lower pH. The optimum pH for algae is about 8.0. The highest concentration could be influenced by lower pH. Adjustment of pH would change substance properties.The median effective concentration (EC50) for the test substance, in algae was determined to be 83.1mg/L on the basis of growth rate inhibition effects in a 72 hour study.The test material can not be classified based on the above effect concentration as the inhibition of the mobility of daphnids could be influenced by pH.

Toxicity to microorganism:

Data available for the test chemicals has been reviewed to determine the toxicity of microorganism of the test chemical .The studies are as mentioned below:

1)Test material was used as a test material to evaluate toxicity to microorganisms as per OECD guideline 209. Activated sludge was used as the test culture at pH 7.5 for 3 h The EC50 value on the basis of respiration inhibition test was observed to be >1000 mg/l.

2)In a study of toxicity of test mateial to the Marine Dinoflagellate Gymnodinium breve the effect of Potassium hydrogen phthalate was evaluated. The test substance was tested in a concentration of 0,1,10, 20, 50, 100, 200, 500, 1000 and 1000 ppm. The results show Median growth when concentration of test material (ppm) versus the growth rate (linear axis of graph), expressed as a percentage of the growth of a "no-add" control at 498.52 and 997 mg/l. Therefore, EC50 of test material was considered to be be 498.52 and 997 mg/l when tested on Marine Dinoflagellate Gymnodinium breve for 96 hours.