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EC number: 203-347-8
CAS number: 105-95-3
Weight of Evidence approach; geometric mean between the two results (experimental and QSAR results):- 96h-LC50 = 1.87 mg/L.
Due to a suspected analytical problem in the
experimental study (EU Method C.1 with GLP statement), a weight of
evidence approach with ECOSAR estimation has been applied to assess the
acute toxicity of the substance to fish.
In a the
acute toxicity study, according to EU Method C.1 with GLP statement,
zebra fish (Brachydanio rerio) were exposed to the substance at
nominal concentrations of 0 (blank control), 0.3, 0.6, 1.25, 2.5, and 5
semi-static conditions. Analytical
monitoring of the concentrations was performed. An analytical problem is
suspected based on the unexpectedly low analytical measurement in the
old media, especially for the highest concentrations. Such behaviour is
not expected for a relatively low volatility substance that is tested
below its water solubility limit as is the case here. Based on this,
this study should be considered as reliable but with restrictions. The
LC50 value was recalculated with ToxRat Professional v2.10 using the
geometric mean of the initial measured concentrations only during the
recalculated 96h-LC50 for fish was determined to be 2.13 mg/L.
In addition, the acute toxicity of the
substance to fish was estimated using the ECOSAR v1.11 QSAR model
available from the U.S. EPA. The estimation 96h-LC50 was 1.64 mg/L
(esters class), calculated from a measured log Kow value (4.3) and a
linear regression. The substance falls within the applicability domain
and therefore the predicted value can be considered reliable.
To obtain a more reliable LC50 value, the
geometric mean between these two results was determined to be 1.87 mg/L.
Further investigation is ongoing on this
difficult substance in order to determine whether instability or
analytical issues account for the rapid loss observed under
ecotoxicological test conditions.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
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