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PBT assessment

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PBT assessment: overall result

Reference
Name:
Dechlorane Plus®
Type of composition:
boundary composition of the substance
State / form:
solid: bulk
Reference substance:
Composition 1
Reference substance:
Composition 1
PBT status:
the substance is handled as if it were a PBT/vPvB
Justification:

Dechlorane was assessed by member state authorities to be vPvB based on weight-of-evidence expert judgement with subsequent inclusion into SVHC candidate list. This is not consistent with the registrant’s analysis. The registrant acknowledges the conclusion and will manage the substance according to the regulatory decision.

 

The substance does not fulfil the toxicity criterion in REACH Annex XIII and thus is not considered being a PBT substance. Toxicity criteria are of Annex XIII are not fulfilled which is consistent to the authorities opinion on Dechlorane Plus.

The registrant’s evaluation determined also that the currently available data do not allow a conclusive decision about vP and vB criteria. Because of the difficulty to design and carry out any definitive studies to determine vPvB, additional tests were recommended during commenting period from the registrant to evaluated Member State.

 

Although biodegradation data do show a lack of biodegradation, in one experiment primary elimination was seen (almost complete removal of radiolabelled substance in the presence of sewage sludge after six weeks of exposure). Currently available data do not seem to be appropriate to determine biodegradation sufficiently, taking into account the extremely low water solubility of the substance and the lack of available analytical methods with sufficient sensitivity.

 

Similar difficulties exist for the bioaccumulation assessment. Many studies and publications are available on bioaccumulation properties, but the results are inconsistent. Classical OECD 305 studies by aqueous exposure do not appear appropriate, given the high logPow and the extremely low water solubility, exposure via diet may lead to accumulation of precipitates in fish tissue, suggesting higher bioaccumulation than by pure absorption.

There are no consumer or professional uses of the substance. Uses advised against include abrasives and pyrotechnics.

Likely routes of exposure:

Direct exposure of humans to Dechlorane Plus is extremely unlikely except of a very few people being working in the industrial formulation and converting industry handling the substance as such. Assessment of their workplace situation is addressed in section 9 of the chemical safety report.

Indirect exposure of humans might eventually occur through diffuse sources, as Dechlorane Plus has shown to be adsorbing to dust particles and travelling over long distances by air attached to such particles (see Möller et al.), ultimately depositing in the environment and maybe becoming involved in the food-chain. However, data on bioaccumulation in the food-chain are not consistent and only were established near point sources (e.g. manufacturing sites in the US and in China and near e-waste dismantling sites, having extremely poor environmental standards in China). Hence, in lack of conclusive evidence, the substance is handled as if it were a vPvB substance and corresponding risk management measures and operational conditions are described in section 9 of the chemical safety report accordingly.