Dioctyltin oxide

Biodegradation in soil

Link to relevant study record(s)

Reference

Endpoint:

biodegradation in soil: simulation testing

Remarks:

OECD 307: Aerobic and Anaerobic Transformation in Soil

Data waiving:

study technically not feasible

Justification for data waiving:

other:

Justification for type of information:

- Expert Statement given by Study Director of GLP ecotox studies
- see attached justificatipon

Qualifier:

according to guideline

Guideline:

OECD Guideline 307 (Aerobic and Anaerobic Transformation in Soil)

Deviations:

yes

Remarks:

see free test

Principles of method if other than guideline:

study technical not feasible.

Sediment simulation testing as well as soil simulation testing were waived.
The low water solubility of the test item (<< 15µg/L) impairs / inhibits sediment simulation testing. No aqueous stock solution can be prepared for administering the test item to the overlying surface water in the study design of the sediment simulation test (OECD308). The test item is only soluble in boiling xylene. Xylene itself is readily biodegradable (registration dossier xylene, ECHA) and is therefore in concurrence to the biodegradation of the test item. Furthermore, the amount of carbon from the solvent is in excess compared to the carbon of the test item in the test system.
The same arguments are important for the conclusion that a soil simulation test according to OECD307 is not possible. The test item is a solid (see section 1). In principle, application of the test item to the soil as solid is possible. However, as mentioned before, the water solubility is low and bioavailability of the test item for the microorganisms is questionable. For this reason, biodegradation is unlikely.

GLP compliance:

no

Remarks:

scientific and technical justification why study technical not feasible.

Test type:

not specified

Radiolabelling:

not specified

Oxygen conditions:

not specified

Soil classification:

not specified

Remarks on result:

not determinable because of methodological limitations

Remarks:

see attached justification

Remarks on result:

not determinable

Key result

Remarks on result:

not determinable

Remarks:

see attached justification

Key result

Remarks on result:

not determinable

Remarks:

see attached justification

Transformation products:

not specified

Description of key information

Study Waiver: OECD 307 Aerobic and Anaerobic Transformation in Soil is technically not feasable

An adaptation from the standard data requirements was submitted to address this endpoint. As no exposure is anticipated, and the substance is not considered a concern for the environment, further testing was considered unnecessary.