Registration Dossier

Classification & Labelling & PBT assessment

PBT assessment

Administrative data

PBT assessment: overall result

PBT status:
the substance is not PBT / vPvB
Justification:

8. PBT AND VPVB ASSESSMENT

8.1. Assessment of PBT/vPvB Properties

8.1.1. Summary and overall conclusions on PBT or vPvB properties Persistence Diisotridecyl 3,3'-[(dibutylstannylene) bis(thio)]dipropionate is classified as not readily biodegradable. Although no hydrolysis study is available, in aqueous environments it is known to undergo hydrolysis to DBT oxide. DBT oxide is itself known to be stable to hydrolysis. It is therefore concluded that diisotridecyl 3,3'-[(dibutylstannylene) bis(thio)]dipropionate does not satisfy the persistence criteria, but that the product DBT oxide does. Bioaccumulation No bioaccumulation data are available for diisotridecyl 3,3'-[(dibutylstannylene) bis(thio)] dipropionate, it is not possible to determine the LogKow experimentally and available QSARs are not appropriate for organometallic compounds. However, it has a high molecular weight (807.9 g/mol) and is hydrolyses immediately on contact with water. On this basis the risk of bioaccumulation is considered low and is concluded that diisotridecyl 3,3'-[(dibutylstannylene) bis(thio)]dipropionate does not to satisfy the bioaccumulation criterion. Toxicity The long term NOEC for Daphnia is >0.01 mg/L and all the acute endpoints (EC/LC50s) are >0.1 mg/L. Therefore, based on the environmental data diisotridecyl 3,3'-[(dibutylstannylene) bis(thio)]dipropionate is not considered to satisfy the T criteria. However, diisotridecyl 3,3'-[(dibutylstannylene) bis(thio)]dipropionate is classified as a category 2 mutagen and as category 1B for toxicity for reproduction. Diisotridecyl 3,3'-[(dibutylstannylene) bis(thio)]dipropionate is therefore considered to satisfy the T criteria.

8.1.2. PBT/vPvB criteria and justification Diisotridecyl 3,3'-[(dibutylstannylene) bis(thio)]dipropionate is classified T. Diisotridecyl 3,3'-[(dibutylstannylene) bis(thio)]dipropionate is not classified as P or B

8.2. Emission Characterisation The substance does not meet the PBT or vPvB criteria, however it is classified as dangerous to the environment, therefore emission characterisation is considered to be required.