Reaction mass of isopentyl salicylate and 2-methylbutyl salicylate

Endpoint summary

Description of key information

Short term toxicity to fish: Data waiving due to the low solubility of the substance in water. (According to Guidance on Information Requirements and Chemical Safety Assessment. Chapter R.7a: Endpoint specific guidance. Low solubility (<0.01 g/L))

Short term toxicity to aquatic invertebrates: Key study. Method according to OECD 202, GLP study. The 48h-EC50 in Daphnia magna, based on immobilisation, was determined to be 1.30 mg/L.

Toxicity to aquatic algae and cyanobacteria: Key study. Method according to OECD 201, GLP study. The 72h-EC50 of the test item in freshwater algae was determined to be 0.681 mg/L, expressed on the measured test item geometric mean concentration based on growth rate. The overall NOEC and LOEC determined for the test item for inhibition of growth rate were 0.282 mg/L and 0.306 mg/L, respectively.

Additional information

Short term toxicity to fish:

Data waiving due to the low solubility of the substance in water. (According to Guidance on Information Requirements and Chemical Safety Assessment. Chapter R.7a: Endpoint specific guidance. Low solubility (<0.01 g/L))

Short term toxicity to aquatic invertebrates:

An acute immobilisation test on Daphnia magna was performed in accordance with OECD Guideline 202, under GLP conditions. Based on the results obtained in a preliminary test, a final test with six nominal test item concentrations (18, 25, 35, 50, 70, 100 mg/L) and a control was performed. Test concentrations were analytically determined (validated method) at the beginning and at the end of the test. Due to the instability of the test item in test media (concentrations not maintained within ± 20% of the measured initial concentration), the immobility of the daphnids was determined in a closed semi-static 48-hours test by visual observation after 24 and 48 hours.The test results were determined and expressed relative to the geometric mean of the measured concentrations. 20 animals were exposed to each concentration divided into 4 replicates with 5 animals in each of 10 ml glass test tubes. The organisms were exposed to the test item or the control for 48 h and immobilisation was recorded at 24 and 48 h. Positive controls (potassium dichromate) are performed at least twice a year to ensure the quality of the results. All validity criteria were met. The 48h-EC50 of the test item in daphnids was determined to be 1.30 mg/L and the 24h-EC10 was >2.39 mg/L.

Toxicity to aquatic algae and cyanobacteria:

A freshwater algae growth inhibition test was performed on the test item, according to OECD 201, under GLP conditions. Based on the results of a preliminary study, Pseudokirchneriella subcapitata was exposed to 0.3, 1,  3, 10, 32, 10 and 328 mg/L test item (nominal) or medium (negative control) for 72h under static conditions. Six replicates were run for the control and 3 for the test item concentrations. The deviation from the measured initial concentration was not within the range of ± 20%, and according to OECD guidelines, the calculation and the test results were determined and expressed relative to the geometric mean of the measured concentrations and not determined and expressed in nominal test item concentrations. The geometric means of the test item measured concentrations were 4.197, 0.282, 0.306, 0.459, 0.532, and 0.681 mg/L. All validity criteria were met. For the evaluation of the quality of the algae and validation of the experimental conditions, a positive control is regularly performed with potassium dichromate. The 72h-ErC50 of the test item was greater than 0.681 mg/L, value expressed in geometric mean measured test item concentration and based on inhibition of growth rate. The NOEC and LOEC determined for the test item for the endpoint inhibition of growth rate were 0.282 mg/L and 0.306 mg/L, respectively.