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Diss Factsheets

Ecotoxicological information

Toxicity to aquatic algae and cyanobacteria

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Administrative data

Link to relevant study record(s)

Description of key information

OECD Guideline 201, GLP, key study, validity 1:
72h-ErC50 (Pseudokirchneriella subcapitata) = 169.4 mg/L (95% CL: 147.3 - 193.2 mg/L) based on geometric mean measured concentrations;
72h-ErC10 (Pseudokirchneriella subcapitata) = 65.8 mg/L (95% CL: 48.0 - 81.9 mg/L) based on geometric mean measured concentrations.

Key value for chemical safety assessment

EC50 for freshwater algae:
169.4 mg/L
EC10 or NOEC for freshwater algae:
65.8 mg/L

Additional information

To assess the toxicity of the registered substance to aquatic algae, two data are available.

The first study (LPL, 2015) was assessed as the key study and was performed on the registered substance according to OECD Guideline 201 with GLP statement. In this study, the registered substance was exposed to the freshwater green algae species Pseudokirchneriella subcapitata at the nominal concentrations of 57.2, 102.9, 185.2, 333.3 and 600 mg/L, and to a control. The inhibition of growth in relation to control cultures was determined over a test period of 72 hours, and thus over several algal generations. The concentrations of the test item (with and without algae) were determined by chemical analyses at the start and the end of the test. Chemical analyses revealed unavoidable test item losses in the presence and absence of algae. Since the deviation of the exposure concentrations of the test substance was greater than ± 20% of the initial concentrations in both abiotic and biotic flasks, the results were based on the geometric means of measured exposure concentrations in the biotic test (0-72 h). The corresponding average exposure concentrations were 29.25, 51.39, 67.63, 222.62 and 442.84 mg/L. According to the results of this study, the 72h-ErC50 and 72h-ErC10 for growth rate were determined to be 169.4 mg/L (95% CL: 147.3 - 193.2 mg/L) and 65.8 mg/L (95% CL: 48.0 - 81.9 mg/L), respectively, based on the geometric mean measured concentrations.

The second data (KREATiS, 2015), assessed as a supporting data, is a QSAR. This QSAR prediction (iSafeRat holistic approach v1.5) was performed on the registered substance, to assess the inhibition of growth to algae of the substance. This QSAR has been validated to be compliant with the OECD recommendations for QSAR modelling (OECD, 2004) and predicts the endpoint value which would be expected when testing the substance under experimental conditions in a laboratory following OECD Guideline 201. The growth inhibition of algae was determined using a validated QSAR for the Mode of Action in question (ester). This QSAR is based on validated data for a training set of 7 chemicals derived from 72-hour ErC50 test on algae, for which the concentrations of the test substance had been determined by chemical analyses over the test period. The water solubility of the substance given as input was predicted using the iSafeRat solubility module at 1,41.10^6 mg/L.The substance falls within the applicability domain of the model. The 72-h ErC50 value based on measured concentrations was determined to be 81 mg/L (95% CL: 29 - 221 mg/L). This predicted toxicity value was found to be comparable to the experimental study report of 169.4 mg/L. Therefore, this QSAR result supports the key study performed on the same substance with an ErC50 value more conservative, validating the model for use with this substance.

In conclusion, according to the keyexperimental study (LPL, 2015), the 72h-ErC50 value on Pseudokirchneriella subcapitata is 169.4 mg/L (95% CL: 147.3 - 193.2 mg/L).