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EC number: 823-920-1
CAS number: 5341-95-7
Table 1: ECOSAR v2.2 results table for Neutral Organics
Max Log Kow
The long-term toxicity in fish was calculated using ECOSAR v2.2 from US Environmental Protection Agency. The ChV (chronic value) was estimated to be 1780 mg/L.
The adequacy of a prediction depends on the following conditions:
a) the (Q)SAR model is scientifically valid: the scientific validity is established according to the OECD principles for (Q)SAR validation;
b) the (Q)SAR model is applicable to the query chemical: a (Q)SAR is applicable if the query chemical falls within the defined applicability domain of the model;
c) the (Q)SAR result is reliable: a valid (Q)SAR that is applied to a chemical falling within its applicability domain provides a reliable result;
d) the (Q)SAR model is relevant for the regulatory purpose.
For assessment and justification of these 4 requirements the QMRF and QPRF files were developed and attached to this study record.
Description of the prediction Model
The prediction model was descriped using the harmonised template for summarising and reporting key information on (Q)SAR models. For more details please refer to the attached QSAR Model Reporting Format (QMRF) file.
Assessment of estimation domain
The assessment of the estimation domain was documented in the QSAR Prediction Reporting Format file (QPRF). Please refer to the attached document for the details of the prediction and the assessment of the estimation domain.
According to REACH Annex XI, paragraph 1.3 results obtained from valid QSAR models may be used instead of testing. A QSAR calculation is available for this endpoint showing that the substance is not chronic toxic to fish.
Based on the results of the QSAR calculation for the long-term toxicity to fish, the information from the short-term aquatic toxicity tests with fish, daphnia and algae and the information from the chronic algae and daphnia tests - it can be shown that the substance is not aquatic toxic. Thus, to avoid unnecessary testing on vertebrate animals no additional test on long-term toxicity to fish is needed to be able to conclude on the non-toxicity of the substance for aquatic organisms.
Furthermore, this is supported by the good solubility in water (531000 mg/L) and the low bioaccumulation potential (log Kow = -0.81). For further justification, please refer to 'Additional information'.
Long-term toxicity testing on fish (Annex IX, Section 9.1.6.; test method: EU C.47./OECD TG 210)
The Registrant adapts the information requirements under Annex IX of REACH with regard to long-term toxicity testing on fish in accordance with REACH Annex XI, Section 1.3 by providing the requested information using an appropriate QSAR method. A robust study summary of the QSAR estimation is provided below.
QSAR data on long-term toxicity to fish
The long-term toxicity on fish has been assessed using ECOSAR v2.2 (US Environmental Protection Agency). The long-term toxicity value for fish was calculated to be 1780 mg/L, showing that the substance is not chronic toxic to fish. The substance is within the applicability domain of the model.
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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