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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Under the study conditions, the nominal 96 h LC50 and NOEC were >3 and 3 mg/L, respectively.

 

Long term toxicity to fish

On the basis of the experimental studies of the structurally similar read across chemical and applying the weight of evidence approach and by evaluating the effect of test chemical on test organism, the 28 days NOEC and LOEC value was determined to be 0.16 and 0.5 mg/l (nominal conc.), respectively. Thus on the basis of the NOEC value (i.e., 0.16 mg/l), test chemical was considered as toxic to aquatic fishes and hence, considered to be classified’ in 'aquatic chronic category 3' as per the CLP classification criteria.

 

Short term toxicity to aquatic invertebrates

Under the study conditions, the nominal 48 h EC50 and NOEC were 3.0 and 1.8 mg/L, respectively.

 

Long term toxicity to aquatic invertebrates

On the basis of the experimental studies of the structurally similar read across chemical and applying the weight of evidence approach and by evaluating the effect of test chemical on test organism Daphnia magna, the 21 days NOEC and LOEC value was determined to be 0.9 and 2.7 to 3.6 mg/l, respectively. Based on the NOEC value, test chemical was toxic to aquatic invertebrates and hence, considered to be classified in 'aquatic chronic category 3' as per the CLP classification criteria.

 

Toxicity to aquatic algae and cyanobacteria

Under the study conditions, the nominal 72 h EbC0, EbC50 and ErC50 were found to be 0.3, 1.1 and 8.7 mg/L, respectively.

 

Toxicity to microorganisms

Under the conditions of the study, the nominal 16 h EC50 and EC10 were 6.0 and 0.83 g/L (i.e. 6000 and 830 mg/L), respectively.

Additional information

Short term toxicity to fish

A study was conducted to determine the acute toxicity of the test substance, C8-18 and C18-unsatd. MEAto Rainbow trout (Oncorhynchus mykiss) according to OECD Guideline 203 and EU Method C.1, in compliance with GLP. Based on the results of a range-finding study, fish (10 per group) were exposed to an aqueous dispersion of the test substance at a concentration of 3 mg/L, the highest attainable concentration due to limited water solubility, for 96 h under semi-static conditions. The substance was previously dissolved in tetrahydrofuran and a solvent control was run in parallel with the negative control and the test substance groups. No analytical dose verification was conducted. Under the study conditions, the nominal 96 h LC50 and NOEC were >3 and 3 mg/L, respectively (Wetton, 1996).

 

Long term toxicity to fish

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

 

Chronic study to fish has been carried for assessing the toxic effect of test chemical. The study was performed in a flow through system for a period of 28 days. Oncorhynchus mykiss (Rainbow trout) was used as a test organism.Test chemical conc. (nominal) used for the study were 0, 0.05, 0.16, 0.50, 1.6, and 5.0 mg/l, respectively. On the basis of the reproductive effect of the test chemical on test organism Oncorhynchus mykiss (Rainbow trout), the 28 days NOEC and LOEC value was determined to be 0.16 and 0.5 mg/l (nominal conc.), respectively. 

 

 

Another long term toxicity study to fish has been carried for assessing the toxic effect of test chemical. The study was conducted by following the OECD Guideline 204 (Fish, Prolonged Toxicity Test) in a flow through system for a period of 28 days. Oncorhynchus mykiss (Rainbow trout) was used as a test organism. On the basis of the reproductive effect of the test chemical on test organism Oncorhynchus mykiss (Rainbow trout), the 28 days NOEC and LOEC value was determined to be 0.16 and 0.5 mg/l (nominal conc.), respectively. 

 

 

On the basis of the experimental studies of the structurally similar read across chemical and applying the weight of evidence approach and by evaluating the effect of test chemical on test organism, the 28 days NOEC and LOEC value was determined to be 0.16 and 0.5 mg/l (nominal conc.), respectively. Thus on the basis of the NOEC value (i.e., 0.16 mg/l), test chemical was considered as toxic to aquatic fishes and hence, considered to be classified’ in 'aquatic chronic category 3' as per the CLP classification criteria.

 

Short term toxicity to aquatic invertebrates

A study was conducted to determine the acute toxicity of the test substance, C8-18 and C18-unsatd. MEA, to Daphnia magna according to OECD Guideline 202, in compliance with GLP. Daphnia (20 per group) were exposed to the test substance (directly dispersed in water) at concentrations of 0.10-10 mg/L for 48 h under static conditions. Immobility was determined at 24 and 48 h. No analytical dose verification was conducted. Under the study conditions, the nominal 48 h EC50 and NOEC were 3.0 and 1.8 mg/L, respectively (Wetton, 1996).

 

Long term toxicity to aquatic invertebrates

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

 

Long term toxicity to Daphnia magna study was conducted for 21 days for assessing the effect of test chemical. This study was conducted in accordance with the OECD Guide–line 202, part 2 "Daphnia sp., Reproduction Test" for 21 days under semi-static conditions. Test chemical conc. used for the study were 0, 0.047, 0.188, 0.75, 3.0, and 12 mg/l, respectively. On the basis of the effect on reproduction of the test organism Daphnia magna, the 21 days NOEC and LOEC value was determined to be 0.9 and 3.6 mg/l, respectively. 

 

Another chronic toxicity to Daphnia magna study was conducted for 21 days for assessing the effect of test chemical. This study was conducted in accordance with the "Extended Toxicity test for D. magna determination of the NOEC for Reproductive rate, mortality and timing of Occurrence of offspring, 21 d)". Texts UBA 16/84 issue 5, 133-142. Life cycle test'' for 21 days under flow through conditions. Test method conforms with the OECD Guide–line 202, part 2 "Daphnia sp., Reproduction Test". Test chemical conc. were not verified analytically. On the basis of the effect on reproduction of the test organism Daphnia magna, the 21 days NOEC and LOEC value was determined to be 0.9 and 2.7 mg/l, respectively. 

 

On the basis of the experimental studies of the structurally similar read across chemical and applying the weight of evidence approach and by evaluating the effect of test chemical on test organism Daphnia magna, the 21 days NOEC and LOEC value was determined to be 0.9 and 2.7 to 3.6 mg/l, respectively. Based on the NOEC value, test chemical was toxic to aquatic invertebrates and hence, considered to be classified in 'aquatic chronic category 3' as per the CLP classification criteria.

 

Toxicity to aquatic algae and cyanobacteria

A study was conducted to determine the toxicity of the read across substance, C12-18 and C18-unsatd. MEA, to the green algae Scenedesmus subspicatus according to OECD Guideline 201, in compliance with GLP. Algae were exposed to the test substance at concentration ranges of 0.3 to 1000 mg/L for 72 h under static conditions. The algae cell concentrations were determined at 24, 48 and 72 h. The inhibitory effect on algae biomass growth and growth rate was calculated subsequently. No analytical dose verification was conducted. Under the study conditions, the nominal 72 h EbC0, EbC50 and ErC50 were found to be 0.3, 1.1 and 8.7 mg/L, respectively (Gode, 2001).

 

Toxicity to microorganisms

A study was conducted to assess the toxicity of the read across substance, C8-18 and C18-unsatd. DEAto the bacteria Pseudomonas putida according to DIN Guideline 38412 L8, in compliance with GLP. Pseudomonas putida colonies, in triplicate, were exposed to the test substance (directly diluted in test medium) at nominal concentrations of 0.01, 0.05, 0.10, 0.50, 1.00, 2.50, 5.00 and 10.00 g/L. Inhibition of cell growth compared to controls was recorded after 16 h. Under the conditions of the study, the nominal 16 h EC50 and EC10 were 6.0 and 0.83 g/L (i.e. 6000 and 830 mg/L), respectively (Poth, 1992).