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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Based on limit nominal concentration, experimental median lethal effect of test material on fish was observed to be >100 mg/l, as no effect concentration was observed at the limit test concentration of 100 mg/l.

Short term toxicity to aquatic invertebrates:

Based on the overall result observations and effects on the mobility of aquatic invertebrate Daphnia magna, it was observed that the EC50 was ranges from > 100 mg/l to 116.2 mg/l.

Toxicity to aquatic algae and cyanobacteria:

Under the test condition and on the basis of effects observation on the different species of green algae, it is observed that the test does not shows any toxicity atleast in the concentrations range of 100-640  mg/l.

Toxicity to microorganisms:

WoE 2: A toxicity threshold (TT) value for Pseudomonas putida when exposed to test chemical is >10,000 mg/L.              

WoE 3: EC0 was observed to be 200 mg/l when Gyrodactylus sp. infecting rainbow trout Oncorhynchus mykiss treated with test chemical.

Thus based on the above study results, it is concluded that test substance is likely to be not toxic to aquatic microorganisms at environmentally relevant concentrations.

Additional information

Short term toxicity to fish:

Data available for the test chemical and structurally and functionally similar read across chemicals have been reviewed to determine the short term toxicity of test chemical on the mortality rate of fishes. The studies are as mentioned below:

 

Study was conducted to observe the effect of test chemical on the mortality of fish Danio rerio. Test conducted according to OECD Guideline 203 (Fish, Acute Toxicity Test). The test performed on the limit concentration of 100 mg/l. Aquaria containing 2 liters of potable water (passed through reverse osmosis system) were loaded with 8 fishes and Zebra Fishes Danio rerio were exposed to this concentration for 96 hours. A static procedure was used for the study. After 96 hours of exposure to test chemical to nominal test concentration, LC50 was calculated. Based on limit nominal concentration, experimental median lethal effect of test material on Zebra Fish Danio rerio was determine to be >100 mg/l, no effects concentration was observed at the limit test concentration of 100 mg/l. Based on the LC50 value, it can be consider that the chemical was not toxic and not classified as per the CLP classification criteria.

 

Above study was further supported by the study from authoritative database. Short term toxicity of test material was evaluated according to OECD Guideline 203 (Fish, Acute Toxicity Test). Test conducted under the static system for 96 hours. Thus based on the mortality effect on fish, the median lethal concentration LC50 value was observed to be > 100 mg/l. Based on the above effect concentration, it was considered that test substance is not toxic to fish and not classified as per CLP criteria.

 

Based on the above effect concentrations, it was considered that test substance is not toxic to fish and thus not classified as per the CLP classification criteria.

 

 

Short term toxicity to aquatic invertebrates:

Data available for the test chemical, structurally and functionally similar read across chemicals have been reviewed to determine the toxicity of test chemical on aquatic invertebrates Daphnia magna. The studies are as mentioned below:

 

Aim of this study was to assess the short term toxicity of test chemical 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. 0,18, 30, 49, 78,125, 200 mg/l nominal concentrations 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) of the test substance on Daphnia magna was determined to be 116.2 mg/L on the basis of mobility inhibition effects in a 48 hour study. Based on the EC50 value, substance consider likely to be non-hazardous to aquatic invertebrate and cannot be classified as per the CLP classification criteria.

 

 

Above study was further supported by the study from authoritative database. Principle of this study was to determine the effect of test chemical on the immobility of Daphnia magna in accordance with OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test). Test conducted under the static system for 48 hours. Based on the immobility of Daphnia magna by the test chemical exposure for 48 hours, the EC50 was observed to be > 100 mg/l. Thus based on the EC50 value, test chemical consider to be nontoxic and not classified as per the CLP classification criteria.

 

Thus based on the above both studies, it is observed that the test chemical was nontoxic and not classified as per the CLP classification criteria.

 

 

Toxicity to aquatic algae and cyanobacteria:

Data available for the test chemical, structurally and functionally similar read across chemicals have been reviewed to determine the toxicity of test chemical on aquatic algae. The studies are as mentioned below:

 

The cell multiplication inhibition of green algae Scenedesmus quadricauda by the test chemical exposure for 7 days was performed. Test conducted under the static system on nominal test concentration. Test solutions prepared in the Erlenmeyer flasks in which the stock solution was added obtain from the laboratory. Before preparing the test cultures, the solution has been neutralize having a known pollutant content in sterile double-distilled water to be tested using the minimum volume acid or alkaline solution. After the exposure period of 7 days, turbidity and colourations were observed. Effects on the growth of test organism Scenedesmus quadricauda was observed on the basis of toxicity threshold of green algae (TTsc). The toxicity threshold of Scendesmus quadricauda (green algae) TTsc when exposed to test material for 7 days was 640 mg/L. Based on the above effects, can be concluded that the test chemical was nontoxic.

 

Above study was further supported by the study from authoritative database. Principle of this study was to observe the effect of test chemical on the growth of aquatic algae. Study conducted under the static system for 72 hours in accordance with OECD Guideline 201 (Alga, Growth Inhibition Test). After the exposure period of test chemical with green algae, effects on the growth of algae was calculated. Based on the growth rate inhibition of aquatic algae by the chemical exposure for 72 hours, the EC50 and NOEC was observed to > 100 mg/l and ≥ 100 mg/l, respectively. Thus based on the EC50 value, it is concluded that the test chemical was nontoxic and not classified as per the CLP classification criteria.

 

Thus based on the above both studies, it is observed that the test chemical was nontoxic and not classified as per the CLP classification criteria.

 

Toxicity to microorganisms:

Following studies have been summarized to determine the effect of test chemical and structurally and functionally similar read across chemicals on micro-organisms, has been reviewed and mention as below:

 

To study the effects of test chemical on micro-organisms. Test conducted under the static system for 16 hours. 300 ml Erlenmeyer flasks was used. Concentration of the bacterial suspension measured turbidimetrically, and expressed as extinction of the primary light of monochromatic radiation at 436nm for a layer 10mm thick. The concentration at which the inhibitory action of a pollutant starts will be present in that step of a dilution series of the pollutant having an extinction value at the end of the test period that is ≥3% below the mean value of extinction for non-toxic dilutions of the test cultures. A toxicity threshold (TT) value for Pseudomonas putida when exposed to test chemical is >10,000 mg/L. Thus based on the effect concentration, it is observed that the chemical was nontoxic.

 

Study was conducted to determine the effect of test chemical on the growth reduction of Gyrodactylus salaris. In an in - vitro toxicity study, Gyrodactylus sp. infecting rainbow trout Oncorhynchus mykiss treated with test chemical in the concentration of 200 mg/l. No effect were observed on Percentage reduction and number of dead (immobile) Gyrodactylus salaries. Therefore, EC0 was considered to be 200 mg/l when Gyrodactylus sp. infecting rainbow trout Oncorhynchus mykiss treated with test chemical. Thus chemical consider to be nontoxic.

 

 

Similar study from peer reviewed journal supports the nontoxic nature of test chemical. Study was conducted to determine the effect of test chemical on the growth reduction of Gyrodactylus salaris. In an in - vitro toxicity study, Gyrodactylus sp. infecting rainbow trout Oncorhynchus mykiss

treated with test chemical in the concentration of 200 mg/l. No effect were observed on Percentage reduction and number of dead (immobile) Gyrodactylus salaries. Therefore, EC0 was considered to be 200 mg/l when Gyrodactylus sp. infecting rainbow trout Oncorhynchus mykiss treated with test chemical. Thus chemical consider to be nontoxic.

 

Thus based on the above study results, it is concluded that test substance is likely to be not toxic to aquatic microorganisms at environmentally relevant concentrations.

 

Thus based on the above all studies, it is observed that the test chemical was nontoxic and not classified as per the CLP classification criteria.