Registration Dossier
Registration Dossier
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EC number: 204-679-6 | CAS number: 124-09-4
Toxicity to aquatic algae and cyanobacteria
Administrative data
Link to relevant study record(s)
Description of key information
Whereas data were available from study reports and MITI database, none could present chemical analysis. Thus a new GLP study with chemical analyses was performed for the current dossier on the same algae species, showing no toxic effect (Hoffmann and Deierling, 2010) and stability of the substance under static conditions.
Key value for chemical safety assessment
- EC10 or NOEC for freshwater algae:
- 10 mg/L
Additional information
In order to assess the toxicity of the substance on algae, it must be reminded the substance is highly basic in aqueous solution and biodegrades readily.
Four different values for this endpoint were available: three study reports (Anonymous, 1993; Gebski and Roman, 1998; and Hoffmann and Deierling, 2010) following standard guidelines (OECD 201) and one output from the MITI database, each of them using Pseudokirchneriella subcapitata. Most of these studies were not considered to be fully reliable because there were not presenting sufficient information to assign a reliability (MITI database), did not adjust the pH of the test solutions (Gebski and Roma, 1998) no analytical determination of the test substance was performed (Anonymous, 1993; Gebski and Roman, 1998).
A new algae study has been performed on the same algae species complying with Good Laboratory Practices with chemical analysis (Hoffmann and Deierling, 2010) and was reliable without restrictions. This last study, the key study, showed by mass spectrometry substance stability under static conditions during the experimental phase (72 hours). The chemical analyses lead to base results on nominal concentrations. The biological results showed 8.9% of growth inhibition at the highest tested concentration (100 mg/L) and calculated EC10 = 118 mg/L (IC95% = 108 ¿ 130 mg/L) for this endpoint. Yet, due to very low dispersion in replicates, the NOEC was statistically estimated at 10 mg/L.
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