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Short-term toxicity to fish

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Description of key information

The acute toxicity of the test substance XDA to Oryzias latipes was studied according to the OECD 203 Guideline under semi-static conditions and in compliance with GLP principles. The 96h-LC50 was determined to be 87.6 mg XDA/L based on analytically confirmed nominal concentrations. For classification purposes, this result was recalculated to 120.9 mg XDI/L.

Key value for chemical safety assessment

LC50 for freshwater fish:
87.6 mg/L

Additional information

Two acute fish studies are available: one with XDI and one with the main transformation product XDA. Based on the rapid transformation of the parent material XDI to XDA, it was deemed important to also evaluate the toxicity of the pure transformation product XDA.

The acute toxicity of XDI to Oryzias latipes was tested in a semi-static test system in accordance with OECD guideline 203 and the principles of Good Laboratory Practice. Test solutions were prepared by adding XDI to test medium, and allowing the substance to dissociate completely. The results were expressed as mean measured concentrations of the transformation product XDA (instead of nominal concentrations of XDI) and subsequently recalculated to the parent material XDI. So, the 96h-LC50 values were > 11 mg XDA/L and > 15.2 mg XDI/L.

Both studies were reviewed and determined to be reliable. Although the XDA study received a lower Klimisch value due to a pH issue (pH partly out of the range advised by the test guideline), it was judged that this issue did not influence the results of the study.

The results of both studies were of the same magnitude. Based on the fact that the results of the acute fish study with XDA were bound values and the results with XDI unbound values (> values), it was decided to use the bound values of XDA as key value for this endpoint.

Key value for chemical safety assessment: 96h-LC50 for freshwater fish: 87.6 mg XDA/L

Key value for classification purposes: 96h-LC50 for freshwater fish: 120.9 mg XDI/L