Registration Dossier
Registration Dossier
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EC number: 294-705-2 | CAS number: 91745-35-6
Toxicity to soil microorganisms
Administrative data
Link to relevant study record(s)
Description of key information
No toxicity to soil microorganisms data are available. Significant exposure of the soil compartment to the substance is considered unlikely and the substance has shown no hazardous properties in the toxicity tests that have been conducted, including an activated sludge respiration inhibition study. Consequently, the conduct of tests in soil microorganisms is considered unnecessary.
Key value for chemical safety assessment
Additional information
The provision for toxicity to soil microorganisms testing is contained within Column 1 of Annex IX of REACH. Column 2 of this Annex, describing the Specific Rules for Adaptation from Column 1, states:
"These studies do not need to be conducted if direct and indirect exposure of the soil compartment is unlikely."
Direct exposure of the soil compartment to the substance from its manufacture and use (see IUCLID Section 3) is considered negligible. Indirect exposure of the soil compartment might be possible via the spreading of sludge from sewage treatment plants (STPs) to land. However, loss of the substance to STPs during manufacture, and disposal of the substance to STP during use and end of life, is expected to be minimal. During manufacture, all necessary measures are taken to prevent releases to the water table, including no water washing of equipment and the use of waste water traps to limit release due to accidental spillage and rain water run-off. The substance is used as an additive in fuel; therefore, its end of life is its incineration.
The substance is also readily biodegradable (see IUCLID Section 5.2), further limiting the amount of intact substance that might be contained within sewage sludge applied to land. Consequently, it is reasonable to conclude that significant exposure of the soil compartment is unlikely.
The substance also demonstrated no hazardous properties in an activated sludge respiration inhibition test (see IUCLID Section 6.1.7), or in mammalian toxicity and aquatic ecotoxicity testing. This further supports the notion that the substance is unlikely to represent a threat to soil microorganisms and, in accordance with the Standard Information Requirements laid down by REACH (Annexes VII to X), toxicity to soil microorganisms studies do not need to be conducted.
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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