Registration Dossier

Administrative data

Endpoint:
biodegradation in soil: simulation testing
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
the study does not need to be conducted because direct and indirect exposure of soil is unlikely
Justification for type of information:
According to REACH Annex IX (Degradation, biotic) column 2, 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). Also, Soil simulation testing does not need to be conducted if direct and indirect exposure of soil is unlikely. Last but not least, testing only needs to be conducted for substances with a high potential for adsorption to sediment, which is with a logPow of 3.18, 3.39 and 3.19, respectively, and a water solubility (at 20°C) of 101 mg/L, 60 mg/L and 70 mg/L, respectively at pH 5, 7 and 9 each not given.

The substance is manufactured as a feed additive only, no other uses were identified. Ethoxyquin as such is listed in the European Union Register of Feed Additives pursuant to Regulation (EC) No 1831/2003, on Annex I: List of additives (Released 19.09.2016, Edition 241), by the DIRECTORATE-GENERAL FOR HEALTH AND FOOD SAFETY, Directorate E - Food and feed safety, innovation, Unit E5 – Animal nutrition, veterinary medicines. As an approved feed additive, it is hence completely covered under the feed and food law and so not under the scope of REACH. Due to a change of the therein legally specified impurity profile, the substance as it is produced, does not fulfill these requirements any more, and is therefore, as a chemical substance not covered by other legislations, subject to REACH. After manufacture however, the substance will be directly purified to match the legal requirements for a feed additive. Hence, after purification the feed and food law will be applicable again, and the substance is no longer subject to REACH. Hence, only the very short service life of manufacture and transport needs to be regarded under REACH. During that period, sufficient precautions and safety measures are taken to completely avoid a release of the substance in the environment, so no exposure of the environment to the substance is given: Emission to the soil compartment can be completely ruled out during the manufacture of the substance. All relevant manufacture processes take place indoor. Loading operations to be performed prior to shipment of the substance do not bear a risk for soil exposure either.

In consequence, as no release into the environment and hence soil is given, testing can be waived.

Data source

Materials and methods

Results and discussion

Applicant's summary and conclusion