Registration Dossier

Environmental fate & pathways

Biodegradation in soil

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Endpoint:
biodegradation in soil: simulation testing
Data waiving:
exposure considerations
Justification for data waiving:
other:

Description of key information

Key value for chemical safety assessment

Additional information

Further biotic degradation testing shall be proposed by the registrant if the chemical safety assessment according to Annex I indicates the need to investigate further the degradation of the substance and its degradation products. The choice of the appropriate test(s) depends on the results of the chemical safety assessment and may include simulation testing in appropriate media (e.g. water, sediment or soil). Exposure of the soil compartment is unlikely, that is the reason why we don't propose a simulation biodegradation tests in soil.

Chemicals can reach the soil via several routes:

1.                 Application of sewage sludge in agriculture.

Organic peroxides, when released into the sewage of a plant production or of a downstream’s user plant, are treated with other substances in dedicated sewage treatment plants. The activated sludge stemmed from these sewage treatment plants are then extracted and treated as chemical waste in most cases.

From the production plant, the release of organic peroxide into the sewage is very limited, not to say completely negligible. The waste water from production plant is usually treated: at least a physical/chemical treatment, which will neutralize potential residual organic peroxide, and that can be followed by a biological treatment. So it is expected that organic peroxides are present only at very lowconcentrations in sludge.

Regarding the rest of the lifecycle, organic peroxides are mainly used as cross-linking agent/polymerization initiator for the production of resins/rubbers/polymers. Based upon the fact that organic peroxides are totally consumed during the process (>99%) and that those processes are water-free (so no production of sewage sludge), it is assumed that the soil is not exposed to organic peroxides via use of sludge.

As a consequence, we can assume that exposure of soil to organic peroxides is negligible via the application of sewage sludge in agriculture.

2.                 Direct application of chemicals.

Based on the uses inventoried for organic peroxides we can consider that there is no direct application of these substances on the soil compartment. Hereunder, the relevant Environmental Release Categories (ERC), as described in guidance R12 (version 2.0, dated 7/11/2010)

3.                 3.  Deposition from the atmosphere.

Deposition from the atmospheric compartment involves volatilization, vaporization or direct release of a considered substance into the atmosphere. Due to their dangerous intrinsic physico-chemical properties, organic peroxides are carefully handle in closed systems and their transport and production are ruled by several regulations. Based on organic peroxides uses too, we may assume that deposition on soil from the atmosphere is unexpected.