Registration Dossier
Registration Dossier
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EC number: 268-610-1 | CAS number: 68131-13-5
Endpoint summary
Administrative data
Description of key information
Additional information
The registration substance is a cationic surfactant and sorbs strongly to negatively charged surfaces like glass and biota (e.g fish, algae). This inherent properties is an issue for testing the registration substance under classical Guideline conditions. Therefore the aquatic ecotoxicity tests were carried out in river water to stabilize the registration substance in the test system reducing sorption to glass and biota. Sorption to glass is determined to ensure that it can be neglected and the registration substance is either dissolved in the river water, sorbed to DOC (Dissolved Organic Carbon) or suspended matter, means is available for exposure. The test results can be used directly for the derivation of the so called PNEC aquatic bulk which can be used to derive the Risk Characterisation Ration (RCR) using the PEC local aquatic bulk including the dissolved and the sorbed fraction. Environmental Classification is based on the dissolved substance and as the sorption processes may reduce the observed toxicity, the test result is divided by an assessment factor of 10. This assessment factor is already used when classifying other cationic surfactants. In the table below the available aquatic ecotoxicity results from river water tests are summarized:
| Test type | Guideline | Species | Endpoint | Value | Remark |
| Acute Fish | OECD 203 | Danio rerio | LC50 (96h) | 3.5 mg/L | River water |
| Acute Daphnia | OECD 202 | Daphnia magna | EC50 (48h) | 4 mg/L | River water |
| Algae | OECD 201 | Desmodesmus sups. | ErC50 (72h) | 1.5 mg/L | River water |
| Bacteria | OECD 209 | Non-adapted sludge | EC50 (3h) | 117 mg/L |
The manufacturing and formulation of the registration substance takes place at one site only and sewage is discharge to an industrial STP. The STP effluent is highly diluted and finally discharged into marine water (see details in the EUSES Exposure and Risk Assessment Report attached in Chapter 13). During use in oil field application water is not exposed to the registrations substance. Therefore it is justified to relate the Environmental exposure assessment for the aquatic compartment to the full set of acute data for all three trophic levels (fish, daphnia and algae) only. Chronic ecotoxicity studies are not warranted.
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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