Registration Dossier

Classification & Labelling & PBT assessment

PBT assessment

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Administrative data

PBT assessment: overall result

Reference
Name:
2,2’-anhydro-1-(b-L-arabinofuranosyl)-5-methyluracil
Type of composition:
legal entity composition of the substance
State / form:
solid: bulk
Reference substance:
Composition 1
PBT status:
the substance is not PBT / vPvB
Justification:

The substance has low logKow value -1.97 and is not of greater concern because it has low potential to bio-concentrate in living organisms. Bioconcentration Factor (BCF) is 0.053 - 0.066 and it is an indicator that this substance does not have the tendency to accumulate in the living organism.

It is not readily degradable.

Hydrolysis, the half-life time of the test substance:

at pH = 4 and 7 and Temperature  25 °C is > 1 year;

at pH=9   and  Temperature: 20 °C is 91 days,

Temperature: 25 °C is 43 days

Temperature 60°C is 12 hours.

The substance is solely used in pharmaceutical industry as intermediate.

The substance is 76% converted in the process of synthesizing active pharmaceutical ingredient. Waste stream goes to Waste Water Treatment Plant. Sludge is sent for off-site incineration. No exposure of the environment is expected.