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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Data available for the structurally and functionally similar read across chemicals has been reviewed todetermine the short term toxicity of fish of the test chemical .The studiesare as mentioned below:

For structurally similar read across substance , a 96 h study was conducted for test material on Danio rerio, at various test concentrations of 5 mg/L, 10 mg/L & 15 mg/L, the fishes were found to be freely swimming in the bowl aquaria and no mortality were observed at test concentrations. No mortalities were found in the control aquaria. Based on nominal concentrations, experimental median lethal concentration [LC-50 (96 h)] for test material on Danio rerio was found to be >15 mg/L.

For , another structurally similar read across substance , the lethal concentration (LC50) value of test material in fish (Oryzias latipes) in a 48 hr study on mortality effect was found to be 2.4 mg/L.

Thus, during the exposure period of 96 hr, test chemical was considered as non-toxic at environmental relevamt concentrations.

Short term toxicity to aquatic invertebrate:

The toxic effect of the test item 12-Hydroxy-N-(2-hydroxyethyl)octadecan-1-amide to Daphnia magna was assessed in a semi-static concentration-response test. The 48-hour NOEC (NOELR) was determined to be ≥ 100.1 mg test item/L. The 48-hour LOEC (LOELR) was determined to be > 100.1 mg test item/L and the 48-hour EC50 (EL50) value was determined to be > 100.1 mg test item/L.The initial concentrations and the maintenance of the exposure concentrations during the test were verified in the analytical part. All reported results refer to nominal values since the concentrations applied reflect the solubility limit of the test substance. Based on the above effect concentration it can be concluded that test substance is not classified as per CLP criteria.

Toxicity to aquatic algae and cyanobacteria:

The influence of 12-Hydroxy-N-(2-hydroxyethyl)octadecan-1-amide on the growth of the freshwater green algae Pseudokirchneriella subcapitata was assessed in a static concentration-response test.The 72-hour EyC50 (EyL50) was determined to be > 100.1 mg test item/L, and the 72-hour ErC50 (ErL50) value was determined to be > 100.1 mg test item/L. The 72-hour NOEyC (NOEyLR) was determined to be ≥ 100.1 mg test item/L and the associated 72-hour LOEyC (LOEyLR) was > 100.1 mg test item/L. The 72-hour NOErC (NOErLR) was determined to be ≥ 100.1 mg test item/L and the associated 72-hour LOErC (NOErLR) was > 100.1 mg test item/L.The initial concentrations and the maintenance of the exposure concentrations during the test were determined in the analytical part. All reported results refer to nominal values since the maximal soluble test item concentration was applied to the test but no effects occured.

Thus, thet test chemical has no adverse effect on aquatic environment and cannot be classified as per CLP Criteria.

Toxicity to microorganisms:

Data available for the functionally similar read across chemicals has been reviewed to determine the toxicity of microorganism of the test chemical.The studiesare as mentioned below:

For structurally similar read across , cell multiplication inhibition test was carried out to study the effects of test material on Pseudomonas putida. The threshold toxcity of test material on cell multiplication inhibition effect on Pseudomonas putida was observed to be 220 mg/L.

For another structurally similar read across , cell multiplication inhibition test was carried out to study the effects of test material on Pseudomonas putida. The threshold toxcity of test material on cell multiplication inhibition effect on Pseudomonas putida was observed to be 62 mg/L. Varied effect of test material on microorganisms were observed.

Additional information

Short term toxicity to fish:

Data available for the structurally and functionally similar read across chemicals has been reviewed todetermine the short term toxicity of fish of the test chemical .The studiesare as mentioned below:

For structurally similar read across substance , a 96 h study was conducted for test material on Danio rerio, at various test concentrations of 5 mg/L, 10 mg/L & 15 mg/L, the fishes were found to be freely swimming in the bowl aquaria and no mortality were observed at test concentrations. No mortalities were found in the control aquaria. Based on nominal concentrations, experimental median lethal concentration [LC-50 (96 h)] for test material on Danio rerio was found to be >15 mg/L.

For , another structurally similar read across substance , the lethal concentration (LC50) value of test material in fish (Oryzias latipes) in a 48 hr study on mortality effect was found to be 2.4 mg/L.

Thus, during the exposure period of 96 hr, test chemical was considered as non-toxic at environmental relevamt concentrations.

Short term toxicity to aquatic invertebrate:

The toxic effect of the test item 12-Hydroxy-N-(2-hydroxyethyl)octadecan-1-amide to Daphnia magna was assessed in a semi-static concentration-response test. The 48-hour NOEC (NOELR) was determined to be ≥ 100.1 mg test item/L. The 48-hour LOEC (LOELR) was determined to be > 100.1 mg test item/L and the 48-hour EC50 (EL50) value was determined to be > 100.1 mg test item/L.The initial concentrations and the maintenance of the exposure concentrations during the test were verified in the analytical part. All reported results refer to nominal values since the concentrations applied reflect the solubility limit of the test substance. Based on the above effect concentration it can be concluded that test substance is not classified as per CLP criteria.

Toxicity to aquatic algae and cyanobacteria:

The influence of 12-Hydroxy-N-(2-hydroxyethyl)octadecan-1-amide on the growth of the freshwater green algae Pseudokirchneriella subcapitata was assessed in a static concentration-response test.The 72-hour EyC50 (EyL50) was determined to be > 100.1 mg test item/L, and the 72-hour ErC50 (ErL50) value was determined to be > 100.1 mg test item/L. The 72-hour NOEyC (NOEyLR) was determined to be ≥ 100.1 mg test item/L and the associated 72-hour LOEyC (LOEyLR) was > 100.1 mg test item/L. The 72-hour NOErC (NOErLR) was determined to be ≥ 100.1 mg test item/L and the associated 72-hour LOErC (NOErLR) was > 100.1 mg test item/L.The initial concentrations and the maintenance of the exposure concentrations during the test were determined in the analytical part. All reported results refer to nominal values since the maximal soluble test item concentration was applied to the test but no effects occured.

Thus, thet test chemical has no adverse effect on aquatic environment and cannot be classified as per CLP Criteria.

Toxicity to microorganisms:

Data available for the functionally similar read across chemicals has been reviewed to determine the toxicity of microorganism of the test chemical.The studiesare as mentioned below:

For structurally similar read across , cell multiplication inhibition test was carried out to study the effects of test material on Pseudomonas putida. The threshold toxcity of test material on cell multiplication inhibition effect on Pseudomonas putida was observed to be 220 mg/L.

For another structurally similar read across , cell multiplication inhibition test was carried out to study the effects of test material on Pseudomonas putida. The threshold toxcity of test material on cell multiplication inhibition effect on Pseudomonas putida was observed to be 62 mg/L. Varied effect of test material on microorganisms were observed.