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PBT assessment

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PBT assessment: overall result

Reference
Name:
Balsalazide acid
Type of composition:
legal entity composition of the substance
State / form:
solid: particulate/powder
Reference substance:
Composition 1
PBT status:
the substance is not PBT / vPvB
Justification:

A ready biodegradability study (OECD Guideline 310) showed that balsalazide acid was not biodegradable under aerobic conditions. Furthermore, it is predicted that balsalazide acid would hydrolyse very slowly in the environment. Therefore, it is accepted that the half life of balsalazide acid could exceed 60 days in water and 180 days in soil and sediment and hence balsalazide acid is assigned a vP classification.

 

The partition coefficient of balsalazide acid was determined according to OECD Guideline 117 and was found to be 1.00. Therefore, based on this result, balsalazide acid is predicted not to bioaccumulate.

 

According to the ECHA Guidance on Information Requirements and Chemical Safety Assessment Chapter R.11 (PBT/ vPvB assessment, version 3, 2017) and following the annotated flow chart in the guidance (Figure R.11-5), the T criterion is not fulfilled for balsalazide acid.

 

Since only the vP criterion is fulfilled, the overall conclusion of the PBT assessment is that balsalazide acid is not considered to be a PBT or vPvB substance.