Registration Dossier
Registration Dossier
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EC number: 942-754-1 | CAS number: -
Endpoint summary
Administrative data
Description of key information
Reliable calculation method results are available to assess the aquatic toxicity of the registered substance, on aquatic invertebrates, algae and fish, for acute and chronic exposure.
The algorithm is based on a QSAR model which has been validated to be compliant with the OECD recommandations for QSAR modeling (OECD, 2004b, 2007). The ecotoxicological predictions were determined using iSafeRat® calculation method adapted for a mixture of compounds with the Mechanism of Action (MechoA) in question (MechoA 1.1, i.e.non-polar narcosis). QSAR models are based on validated data for training sets for which the concentrations of the test substance had been determined by chemical analyses over the test period.
According to these predictions and the experimental study:
- No toxic effects were observed up to the attainable limit of solubility of the substance in experimental acute studies for the three trophic levels (fish, aquatic invertebrates and algae). Maximal solubility of the test item in water, is the loading rate of 2.73 mg/L
-The chronic 21d-EL10 value for aquatic invertebrates, based on reproduction, was predicted to be 0.23 mg/L
- The chronic 32d-EL10 value for fish, based on growth or reproduction, was predicted to be 0.46 mg/L
In addition, an experimental acute Daphnia study (NOACK, 2015) is available. In this study, two non GLP range-finding tests were performed on the registered substance according to OECD Guideline 202 and EU Method C.2. The biological effects of the first and the second range-finding tests are consistent at 0.7 mg/L (5% immobilisation) and 1 mg/L (10% immobilisation). Therefore, the 48h-EC50 value is expected to be greater than 1 mg/L based on analytically confirmed nominal concentrations. As this value strongly supports the acute iSafeRat® prediction obtained on aquatic invertebrates, and the substance falls under the definition of "difficult to test" according to OECD guidance No. 23, the definitive study was not considered necessary.
One experimental long term toxicity study to aquatic invertebrates is avalaible. - The chronic 21d-EC10 value for aquatic invertebrates, based on reproduction, was determined to be 0.268 mg/L (95% CL: 0.194 - 0.371 mg/L). The value predited by calculation method (KREATiS, 2021) supports this value.
Finally, an experimental study is available to assess the toxicity of the registered substance to microorganisms. In this study (Envigo, 2017), performed according to OECD Guideline 209, no statistically significant toxic effects were observed on the respiration of activated sludge microorganisms after a contact time of 3 hours at all of the test concentrations employed (10, 100 and 1000 mg/L). The 3h-EC50 value was determined to be greater than 1000 mg/L and the 3h-NOEC was 1000 mg/L.
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.
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.
