Registration Dossier
Registration Dossier
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EC number: 903-161-3 | CAS number: -
PBT assessment
Administrative data
PBT assessment: overall result
- PBT status:
- further information relevant for the PBT assessment is necessary
- Justification:
The available toxicity data for EC 903-161-3 demonstrate an absence of toxicity and confirm that the substance should not be classified as PBT. Further persistence and/or bioaccumulation data are required to draw definitive conclusions on vPvB. Testing proposals for further investigation of persistence and bioaccumulation potential have been made by the Lead Registrant
Results from an OECD 301B ready biodegradation study show the material to not be readily biodegradable, however it is considered that accurate conclusions on P/vP properties cannot be drawn using solely this information. Therefore in line with ECHA guidance document R.11 further testing is proposed in the form of a Biodegradation test in water and sediment/soil.
The estimated LogKow value of >6.3 suggests that EC 903-161 -3 may have the potential to bioaccumulate, however it is not considered appropriate to draw conclusions on the B/vB potential of the material based solely on this estimated value. Therefore further bioaccumulation testing has been proposed in the form of an OECD 305 study. Testing to investigate P/vP properties should be conducted first to minimise unnecessary vertebrate testing required to investigate B/vB properties. This follows the approach outlined in ECHA guidance on Information Requirements and Chermical Safety Assessment, Chapter R.11.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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