Registration Dossier

Classification & Labelling & PBT assessment

PBT assessment

Administrative data

PBT assessment: overall result

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

As the available data does not allow a definitive conclusion on the PBT or vPvB properties, the screening criteria as mentioned in the ECHA Guidance on information requirements and chemical safety assessment Chapter R.11: PBT Assessment (Table R. 11-1) are used to decide whether the substance (NBDI) and its hydrolysis product (NBDA) potentially fulfill the PBT or vPvB criteria.

Persistence Assessment

For NBDI this is not relevant due to its hydrolytical instability. As NBDA has been shown to be not readily biodegradable, the P criterion is potentially fulfilled for NBDA. No conclusion can therefore be drawn for NBDA based on the available data.

Bioaccumulation Assessment

For NBDI this is not relevant due to its hydrolytical instability. As NBDA has a calculated log Kow of 0.96 (and a measured BCF of 22 L/kg), the B criterion is not (potentially) fulfilled for NBDA.

Toxicity Assessment

As NBDI is classified for Specific target organ toxicity – repeated (STOT-RE), Category 1 (H372), NBDI fulfills the T criterion for human health. As acute EC50 and LC50 values for NBDA are above 10 mg/L, the T criterion for environment is not potentially fulfilled for NBDA. The T criterion for environment is not relevant for NBDI.

Overall conclusion: Based on the assessment described in the subsections above the submission substance (NBDI) and its hydrolysis product (NBDA) are not considered as PBT / vPvB;

 

P

B

T

Relevant available (screening) data (NBDI)

Not relevant due to its hydrolytical instability

Not relevant due to its hydrolytical instability

Classified as: STOT RE Category 1

Relevant available (screening) data (NBDA)

Not readily biodegradable

 

BCF: 22 L/kg (measured)

Log Kow: 0.96 (calculated)

EC50 and LC50: >10 mg/L

 

 

 

 

(Screening) criterion fulfilled (NBDI)

 

No

No

T criterion fulfilled (for human health);

T criterion not fulfilled (for environment)

(Screening) criterion fulfilled (NBDA)

 

Yes, NBDA is potentially P

No

No