Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Classification & Labelling & PBT assessment

PBT assessment

Currently viewing:

Administrative data

PBT assessment: overall result

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

An evaluation of the inherent properties of Fatty tetrahydropyrimidine is performed against the ANNEX XIII criteria. If insufficient data were available, the screening criteria as laid down in ECHA Guidance on information requirements and chemical safety assessment Chapter R.11: PBT Assessment (2008) were applied.

The available evidence on degradation is sufficient for an assessment based on the Annex XIII criteria for persistence (P and vP). As the substance is concluded not to be readily biodegradable, the screening criteria for persistence are fulfilled. Based on available evidence it is thus concluded that the substance is P and vP.

The available evidence on bioaccumulation potential and toxicity for Fatty tetrahydropyrimidine is not sufficient for an assessment based on the Annex XIII criteria for these endpoints. The very high log Kow (estimated log Kow > 10) of the substance, its low estimated BCF and very low water solubility very likely limits the bioavailability of the test substance. Therefore it is concluded that the substance does not meet the B- or vB- criteria and that the screening criteria for bioaccumulation (B) are not met.

The NOEC is higher than 0.01 mg/l. Furthermore, the substance is not classified as carcinogenic, mutagenic or toxic for reproduction or R48. However, the substance is classified STOT RE 2. For these reasons, the screening criteria for toxicity (T) are met.

A substance only is identified as a PBT substance if it fulfills all criteria described above According to information summarized above, only the P and T criteria was preliminarily fulfilled and hence the substance Fatty tetrahydropyrimidine (CAS# 68911 -83 -1) is not a PBT substance. A substance only is identified as a vPvB substance if it fulfills both vPvB criteria described above. The P criterion is preliminarily fulfilled, the B criterion is not fulfilled. Therefore, Fatty tetra hydropyrimidine is not a vPvB substance.