Iron(II) fumarate

Endpoint summary

Description of key information

Short term toxicity to fish:

Based on the mortality of fishes Brachydanio rerio (Zebrafish) and Lepomis microlophus (Bluegill) due to the test chemical exposure for 48 hours and 96 hours, the lethal concentration i.e. LC50 value was determined to be in the range of 245 mg/l to > 300 mg/l.

Short term toxicity to invertebrates:

Principle of this study was to determine the effect of test chemical on aquatic invertebrates. Test conducted in accordance with the OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test). Daphnia magna used as a test organism. The stock solution 100 mg/l was prepared in reconstituted water. Test solutions of required concentrations were prepared by mixing the stock solution of the test sample with reconstituted test water. Nominal concentrations 0, 10, 18, 32, 58 and 100 mg/l, respectively were used. Effects on immobilisation were observed for 48 hours. With the test substance one positive control Potassium dichromate (K2Cr2O7) was also run simultaneously. Temperature, pH and dissolved oxygen were maintained at 20±1°C, 6.2 to 7.1, higher than 8.1 mg/L at the end of test. After the exposure of chemical, effect concentration EC50 was calculated using nonlinear regression by the software Prism 4.0. In each glass beaker > 24 hrs old 5 Daphnia magna were added. Test performed in the four replicates. Observations for immobilized Daphnids were recorded in the interval of 24 hours (0, 24 and 48 hours of exposure). After the exposure period of 48 hours of test chemical with freshwater aquatic invertebrates Daphnia magna, 50 % immobility were observed. The median effective concentration i.e. EC50 value of the test chemical on Daphnia magna was determined to be 56.3 mg/L. Thus, based on the EC50 value, test chemical considered to be toxic and classified in aquatic chronic category 3 as per the CLP classification criteria. But as the test chemical is readily biodegradable in water, thus consider to be nontoxic and not classified as per the CLP classification criteria.

 

Toxicity to algae:

Principle of this study was to determine the effect of test chemical on the growth of green algae when exposed for 72 hours. Test conducted according to the OECD Guideline 201 (Alga, Growth Inhibition Test). The stock solution 100 mg/l was prepared 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. Various nominal concentrations 0, 12, 20, 35, 59 and 100 mg/l, respectively were used in the study. 50 ml Glass vessel filled with 15 ml of test solution were used in the study, in which 5x10e3 cells/ml were added. Test performed using 3 replicates. Temperature maintained at 23±2°C and pH value 6.6 changes change to 8 during test in sample, whereas for control 8.1 changes to 8.2 during test. 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. Based on the growth rate inhibition of green algae Desmodesmus subspicatus (previous name: Scenedesmus subspicatus) due to the exposure of test chemical for 72 hours, the ErC50 value was determined to be 56.4 mg/l with 95 % CI of 45.6 to 69.8 mg/l. Thus, based on the ErC50 value, test chemical considered to be toxic and classified in aquatic chronic category 3 as per the CLP classification criteria. But as the test chemical was readily biodegradable in water, thus consider to be nontoxic and not classified as per the CLP classification criteria.

Toxicity to microorganisms:

Based on the above studies, growth rate inhibition of Pseudomonas putida due to the test chemical exposure for 6 hours and 16 hours, the EC10 value was determined to be ranges from 23 mg/l to 1190 mg/l.

Additional information

Short term toxicity to fish:

Summarized result from the various experimental sources for the determination of effect of test chemical structurally and functionally similar read across chemicals on the mortality of fishes are as mentioned below:

 

An acute toxicity of test chemical was determined on fish. Test conducted under the static system. Brachydanio rerio (Zebrafish) was used as a test organism. Exposure period of 48 hrs was provided. Mortality were used a key parameter for the effect’s measurement. After the exposure period of 48 hours, mortality was calculated, and the median lethal concentration (LC50) value was observed to be at 245 mg/L.

 

Above data further supported by the study from secondary sources. Principle of this study was to determine the effect of test chemical on the mortality of fishes. Lepomis microlophus (Bluegill) was used as a test organism. Test conducted under the static system for 96 hours. Fingerling age with 38-76 MM length fishes was selected for the study. Test temperature 19.5 to 20.5 °C and dissolved oxygen > 60 % were maintained. Based on the mortality of fishes Lepomis microlophus (Bluegill) due to the test chemical exposure for 96 hours, the lethal concentration i.e. LC50 value was determined to be > 300 mg/l. Thus, on the basis of LC50 value, test chemical considers to be nontoxic and not classified as per the CLP classification criteria.

 

Thus, on the basis of above all studies and effects observations, test chemical consider to be nontoxic and not classified as per the CLP classification criteria.

 

Short term toxicity to invertebrates:

Summarized result from the various experimental sources for the determination of effect of test chemical and structurally and functionally similar read across chemicals on the mobility of aquatic invertebrates are as mentioned below:

Principle of this study was to determine the effect of test chemical on aquatic invertebrates. Test conducted in accordance with the OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test). Daphnia magna used as a test organism. The stock solution 100 mg/l was prepared in reconstituted water. Test solutions of required concentrations were prepared by mixing the stock solution of the test sample with reconstituted test water. Nominal concentrations 0, 10, 18, 32, 58 and 100 mg/l, respectively were used. Effects on immobilisation were observed for 48 hours. With the test substance one positive control Potassium dichromate (K2Cr2O7) was also run simultaneously. Temperature, pH and dissolved oxygen were maintained at 20±1°C, 6.2 to 7.1, higher than 8.1 mg/L at the end of test. After the exposure of chemical, effect concentration EC50 was calculated using nonlinear regression by the software Prism 4.0. In each glass beaker > 24 hrs old 5 Daphnia magna were added. Test performed in the four replicates. Observations for immobilized Daphnids were recorded in the interval of 24 hours (0, 24 and 48 hours of exposure). After the exposure period of 48 hours of test chemical with freshwater aquatic invertebrates Daphnia magna, 50 % immobility were observed. The median effective concentration i.e. EC50 value of the test chemical on Daphnia magna was determined to be 56.3 mg/L. Thus, based on the EC50 value, test chemical considered to be toxic and classified in aquatic chronic category 3 as per the CLP classification criteria. But as the test chemical is readily biodegradable in water, thus consider to be nontoxic and not classified as per the CLP classification criteria.

 

Above experimental study further supported by the second study from experimental source. Principle of this study was to determine the effect of test chemical on aquatic invertebrates. Test conducted in accordance with the OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test). Daphnia magna used as a test organism. The stock solution 120 mg/l was prepared in reconstituted water. Test solutions of required concentrations were prepared by mixing the stock solution of the test sample with reconstituted test water. Nominal concentrations 0, 14, 23, 39, 70 and 120 mg/l, respectively were used. Effects on immobilisation were observed for 48 hours. With the test substance one positive control Potassium dichromate (K2Cr2O7) was also run simultaneously. Temperature, pH and dissolved oxygen were maintained at 20±1°C, 7.1, higher than 8.7 mg/L. After the exposure of test chemical with Daphnia magna, effect concentration EC50 value was calculated using nonlinear regression by the software Prism 4.0. In each glass beaker > 24 hrs old 5 Daphnia magna were added. Test performed in the four replicates. Observations for immobilized Daphnids were recorded in the interval of 24 hours (0, 24 and 48 hours of exposure). After the exposure period of 48 hours of test chemical with aquatic invertebrates Daphnia magna, 50 % immobility were observed. The median effective concentration i.e. EC50 value of the test chemical on Daphnia magna was determined to be 67.9 mg/L with 95% CI of 56.6 to 81.3 mg/l. Thus, based on the EC50 value, test chemical considers to be toxic and classified in aquatic chronic category 3 as per the CLP classification criteria. But as the test chemical is readily biodegradable in water, thus consider to be nontoxic and not classified as per the CLP classification criteria.

 

Similarly, an acute study was performed to determine the effect of test chemical on the aquatic invertebrates. Test conducted according to the “Methods for Acute Toxicity Tests with Fish, macro invertebrates and Amphibians.” <24 hr larvae, 1st instar Daphnia magna was used as a test organism. Static system was used, and chemical exposed for 48 hours with Daphnids. 5 daphnia were added in each vessel and test conducted in duplicates. Hardness, temperature, and pH were maintained at 154. 5mg/l CaCO3, 22 °C and 7.7. Immobility of Daphnia were used as a key parameter for the effect determination. Based on the immobility of Daphnia magna due to the test chemical exposure for 48 hours, the EC50 value was determined to be 212 mg/l. Thus, on the basis of EC50 value, test chemical was considered to be non-toxic to aquatic invertebrates and can be considered to be not classified as per the CLP regulations.

 

Hence, based on above all studies and effects observation, test chemical considers to be nontoxic and not classified as per the CLP classification criteria.

 

Toxicity to algae:

Summarized result from the various experimental sources for the determination of effect of test chemical and structurally and functionally similar read across chemicals on the algae are as mentioned below:

Principle of this study was to determine the effect of test chemical on the growth of green algae when exposed for 72 hours. Test conducted according to the OECD Guideline 201 (Alga, Growth Inhibition Test). The stock solution 100 mg/l was prepared 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. Various nominal concentrations 0, 12, 20, 35, 59 and 100 mg/l, respectively were used in the study. 50 ml Glass vessel filled with 15 ml of test solution were used in the study, in which 5x10e3 cells/ml were added. Test performed using 3 replicates. Temperature maintained at 23±2°C and pH value 6.6 changes change to 8 during test in sample, whereas for control 8.1 changes to 8.2 during test. 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. Based on the growth rate inhibition of green algae Desmodesmus subspicatus (previous name: Scenedesmus subspicatus) due to the exposure of test chemical for 72 hours, the ErC50 value was determined to be 56.4 mg/l with 95 % CI of 45.6 to 69.8 mg/l. Thus, based on the ErC50 value, test chemical considered to be toxic and classified in aquatic chronic category 3 as per the CLP classification criteria. But as the test chemical was readily biodegradable in water, thus consider to be nontoxic and not classified as per the CLP classification criteria.

 

Above experimental data further supported by the second study from peer authoritative databases. Principle of this study was to determine the effect of test chemical on the growth rate inhibition of green algae. The study was performed according to other guideline UBA algal growth inhibition test. Scenedesmus subspicatus was used as a test organism and exposed for 72 hours with test chemical. Test conducted under the static system. Based on the growth rate inhibition of test organism Scenedesmus subspicatus, the 72 hours EC10, EC50 and EC90 value was determined to be 32, 41 and 49 mg/l, respectively. On the basis of EC50 value, it can be concluded that the substance can be considered to be toxic to aquatic organisms and classified in aquatic chronic category 3. Since the test chemical is readily biodegradable in nature, thus, chemical can be considered as non-toxic to Scenedesmus subspicatus at environmentally relevant concentrations and can be considered to be not-classified as per the CLP classification criteria.

 

Similar study was conducted to determine the toxicity of test chemical on the population growth rate inhibition of green algae. Test conducted on freshwater Haematococcus pluvialis. Based on the population growth rate inhibition of green algae Haematococcus pluvialis due to the test chemical exposure, the EC50 value was determined to be 125 mg/l. Thus, on the basis of EC50 value, test chemical considers to be nontoxic and not classified as per the CLP classification criteria.

 

Hence, considering above all studies from different sources, it was concluded that the test chemical was nontoxic and not classified as per the CLP classification criteria.

 

Toxicity to microorganisms:

Summarized result from the various experimental sources for the determination of effect of test chemical and structurally and functionally similar read across chemicals on the growth of microorganisms are as mentioned below:

 

Principle of this study was to determine the effect of test chemical on the growth of Pseudomonas putida. Test chemical exposed for 6 hours with Pseudomonas putida. Based on the growth rate inhibition of Pseudomonas putida due to the test chemical exposure for 6 hours, the EC10 value was determined to be 23 mg/l.

 

Above study further supported by the second study from handbook. Principle of this study was to determine the effect of test chemical on the growth of Pseudomonas putida. Test chemical exposed for 16 hours with Pseudomonas putida. Based on the growth rate inhibition of Pseudomonas putida due to the test chemical exposure for 6 hours, the EC10 value was determined to be 1190 mg/l.

 

Based on the above studies, growth rate inhibition of Pseudomonas putida due to the test chemical exposure for 6 hours and 16 hours, the EC10 value was determined to be ranges from 23 mg/l to 1190 mg/l.