Registration Dossier
Registration Dossier
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EC number: 946-006-5 | CAS number: 1175539-64-6
Endpoint summary
Administrative data
Description of key information
Two QSAR results (iSafeRat® Holistic HA-QSAR v1.7) performed on the registered substance and two experimental studies (based on international guidelines and GLP compliance) performed on a source substance are available to assess the aquatic toxicity of the registered substance on aquatic invertebrates and algae.
The QSAR data, assessed as key data points, used a calculation method to predict the acute toxicity of the registered substance, an UVCB substance, to aquatic invertebrates Daphnia sp. and algae. This calculation method predicts the endpoint value which would be expected when testing the substance under experimental conditions in a laboratory following OECD Guidelines adapted for testing as a mixture using the WAF method. This method has previously been validated in an internal publication (Bicherel and Thomas, 2014).This algorithm is based on a QSAR model (iSafeRat® Holistic HA-QSAR v1.7) which has been validated to be compliant with the OECD recommendations for QSAR modelling (OECD, 2004). The QSAR is based on validated data for a training set chemicals derived from test on daphnids and algae, for which the concentrations of the test item had been determined by chemical analyses over the test period. Further to this, the effective loading rate of the WAF is determined by using a series of calculation steps using phase equilibrium thermodynamics and excluding the non-bioavailable fraction. The 48h-EL50 value based on mobility of aquatic invertebrates and the 72h-ErL50 value based on growth rate of algae were determined to be 5.1 and 6.0 mg/L, respectively.
To support these predictions and reinforce the correct order of magnitude, experimental WAF studies performed according to OECD Guidelines with GLP statement on a source substance were provided in the dossier. Both substances (the target and the source substances) are UVCB substances with very similar compositions. The main components of both substances have the same mode of action (MoA 1, non-polar narcosis) with similar log Kow values. In these experimental studies, the 48h-EL50 value on Daphnia magna and the 72h-ErL50 value on Pseudokirchneriella subcapitata were determined to be 15 mg/L and 9.1 mg/L, respectively.
The experimental results on the source substance supports the QSAR results performed on the target substance, with predicted EL50 values more conservative. The ecotoxicological properties between the target and source substances are pronounced. Therefore, it’s considered suitable and scientifically justified to read-across the data between the two substances to fill the short-term toxicity to aquatic invertebrates and the toxicity to aquatic algae endpoints in the present dossier, as supporting information.
Additional information
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.
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