Registration Dossier
Registration Dossier
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EC number: 405-520-5 | CAS number: 95235-30-6 D-8; DD-8
Biodegradation in soil
Administrative data
Link to relevant study record(s)
- Endpoint:
- biodegradation in soil: simulation testing
- Data waiving:
- exposure considerations
- Justification for data waiving:
- the study does not need to be conducted because direct and indirect exposure of soil is unlikely
- Transformation products:
- not measured
Reference
Description of key information
Direct or indirect exposure to soil is not likely to take place.
Key value for chemical safety assessment
Additional information
The performance of tests for biodegradation in soil is scientifically not justified.
REACH Regulation (EC) No 1907/2006, Annex IX, Sect. 9.2.1.3, Col. 2, states as follows:
“9.2.1.3: The study need not to be conducted:
- if the substance is readily biodegradable, or
- if direct and indirect exposure of soil is unlikely. ”
Direct and indirect exposure of the test item to soil is unlikely. D-8 is manufactured and formulated in completely closed systems. Thus, direct and indirect exposure of the soil compartment during manufacturing and formulation is practically negligible. Use of formulated D-8 is also unlikely to result in direct and indirect exposure to the soil compartment. During use D-8 is included in three-dimensional matrices of resinous material and completely retained, therefore, no direct or indirect release of D-8 into the soil compartment is expected. All sludge from the used STPs is collected and incinerated, thus, it is not applied to agricultural soil, which reduces extremely the risk of exposure to the soil compartiment. The test item is well degradable in aquatic systems and showed to be inherently biodegradable. Based on these results and the STP study, no other effects are expected in soil.
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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