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Classification & Labelling & PBT assessment

PBT assessment

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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 (XDI) and its hydrolysis product (XDA) potentially fulfill the PBT or vPvB criteria. Only for assessments for which relevant data is available the results are reported.

Persistence Assessment

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

Bioaccumulation Assessment

For XDI this is not relevant due to its hydrolytical instability. As XDA has a calculated log Kow of 0.15, the B criterion is not potentially fulfilled for XDA.

Toxicity Assessment

Based on the read-across of the 90 day study from NBDI to XDI, XDI fulfils the T criterion for human health as XDI needs to be classified for Specific target organ toxicity – repeated (STOT-RE), Category 1 (H372). As acute EC50 and LC50 values for XDA are above 1 mg/L, the T criterion for environment is not potentially fulfilled for XDA.

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

 

P

B

T

Relevant available (screening) data (XDI)

Not relevant due to its hydrolytical instability

Not relevant due to its hydrolytical instability

Classified as: STOT RE Category 1; EC50 and LC50: >1 mg/L

Relevant available (screening) data (XDA)

Not readily biodegradable

Calculated log Kow: 0.15

 

EC50 and LC50:

>1 mg/L

(Screening) criterion fulfilled (XDI and XDA)

XDI: No

XDA: Yes (screening criterion only)

XDI: No

XDA: No

XDI:

Yes (for human health);

No (for environment)

XDA: No