Registration Dossier

Ecotoxicological information

Short-term toxicity to aquatic invertebrates

Currently viewing:

Administrative data

Link to relevant study record(s)

Description of key information

EC50 >0.21 mg/L  (geometric mean of the solubility of the test material), EC50> water solubility ( 0.09 - 0.54 mg/L), dioctyltin oxide, OECD 202, EU Method C.2,  Hooftman & de Wolf 2004

Key value for chemical safety assessment

Additional information

The data requirement was addressed by the key study, Hooftman & de Wolf (2004). The study was performed to GLP and in line with the OECD guideline 202 and EU method C.2. As the study was performed on a read-across substance in the same category as the registered substance (di-n-octyltin oxide), it was assigned a reliability score of 2 (reliable with acceptable restrictions) in accordance with the criteria for assessing data quality as outlined in Klimisch (1997) and considered suitable for assessment as an accurate reflection of the test material.

Due to the insolubility of the test material, the study was performed with a water soluble fraction as a limit test to Daphnia magna. Under the conditions of the study, the 48 h EC50 was found to be greater than the water solubility of the test material (aqueous solubility is between 0.09 and 0.54 mg/L). The EC50 is >0.21 mg/L (geometric mean of the solubility of the test material).

 

Supporting information was available in the form of a study reported by Rufli (1988). The study was performed to the OECD guideline 202 and was also conducted with the read across substance, dioctyltin oxide. However the observations performed during the study did not extend past the 24 hour period, with no explanation as to why the 48 hour observation was not performed. The study lacked details in the reporting in some areas and some deficiencies were present in the performance of the test, such as the test concentrations were not maintained throughout the entire test period. As such the study was assigned a reliability score of 2 in line with the principles of assigning data quality as outlined in Klimisch (1997). As the results of the study confirmed the lack of toxicity observed in the more reliable key study, the study was considered reliable with restrictions and suitable as supporting information to the key study. Under the conditions of the test, the EC50 of the test substance in Daphnia magna was determined to be greater than the water solubility of the test substance.