Registration Dossier
Registration Dossier
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EC number: 424-180-9 | CAS number: - MIGLYOL 8810
PBT assessment
Administrative data
PBT assessment: overall result
- PBT status:
- PBT assessment does not apply
- Justification:
According to Regulation (EC) No. 1907/2006, a substance must fulfil all three criteria for persistence, bioaccumulation and toxicity to be considered as PBT, as listed in part 1 of Annex XIII, and it must fulfil the criteria for persistence and bioaccumulation stated in part 2 of Annex XIII to be considered vPvB.
Data for the definitive conclusion on the PBT or vPvB properties according to the criteria set in Regulation (EC) No. 1907/2006, Annex XIII, parts 1 and 2, are not available for all three criteria. Thus, the screening criteria given in the ‘Guidance on information requirements and chemical safety assessment - Chapter R.11: PBT assessment’ (ECHA, 2012) are used as surrogate information to decide whether the substance may potentially fulfil the PBT or vPvB criteria.
Persistence (P) Assessment:
A valid screening criterion to evaluate persistence (P) is the potential of a substance for ready biodegradability. The substance is readily biodegradable. Therefore, it is not expected to be persistent in the environment and it does not meet the Persistent (P) or very Persistent (vP) criteria.
Bioaccumulation (B) Assessment:
Due to the rapid environmental biodegradation and metabolization via enzymatic hydrolysis of the substance, a relevant uptake and bioaccumulation in aquatic organisms is not expected. Based on the available information, the substance does not meet the B or vB criteria.
Toxicity (T) Assessment:
The available data on short-term and long-term toxicity indicate that the substance is not chronically toxic. The criteria set out in Annex XIII of Regulation (EC) No. 1907/2006 are not met and the substance is considered to be not T.
In conclusion, "A mixture of: but-1,3-diyl didecanoate; but-1,3-diyl dioctanoate; but-1,3-diyl 1-decanoate-3-octanoate; but-1,3-diyl 1-octanoate-3-decanoate" is considered not to be PBT or vPvB.
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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