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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:

PBT-Assessment justification for 2-diisopropylaminoethanol (CAS 96-80-0) ‘pure substance’:

The available evidence on biodegradation is not sufficient for an assessment based on the Annex XIII criteria for Persistence (P and vP). As the substance is concluded to be not readily biodegradable as well as to be hydrolytically stable, it should be considered as potentially P/vP from a precautionary point of view, until further data become available. 

The log Kow indicates no potential for bioaccumulation; therefore, the substance is not B/vB.

Regarding “T”, experimental chronic toxicity data are not available; the substance does not hold any relevant official classifications. In addition, the screening criteria for T based on acute toxicity data are not fulfilled.  

 

In conclusion, 2-diisopropylaminoethanol (CAS 96-80-0) ‘pure substance’ is assessed to neither fulfill the PBT criteria (not PBT) nor the vPvB criteria (not vPvB).

 

PBT-Assessment justification for 2-diisopropylaminoethanol (CAS 96-80-0) ‘crude material’:

The ‘crude material’ of 2-diisopropylaminoethanol is a mixture (CAS 96-80-0) that consists of the following classified constituents:

- 2-Diisopropylaminoethanol (CAS 96-80-0): 92 – 96 % (w/w);

- Diisopropylamine (CAS 108-18-9): 2 – 5 % (w/w);

- Ethylene glycol (CAS 107-21-1): 1 – 2 % (w/w);

- Diethylene glycol (CAS 111-46-6): 0.1 – 0.2 % (w/w);

 

According to the REACh guidance document chapter R.11, constituents being present in a concentration of ≥ 0.1 % (w/w) are defined to be relevant for PBT/vPvB assessment. Therefore, the assessment is performed on each relevant constituent:

 

- 2-Diisopropylaminoethanol (CAS 96-80-0): 92 – 96 % (w/w)

The substance does not meet the criteria for PBT classification (see PBT-Assessment justification for 2-diisopropylaminoethanol (CAS 96-80-0) ‘pure substance’).

 

- Diisopropylamine (CAS 108-18-9): 2 - 5 % (w/w)

The substance does not meet the criteria for PBT classification. The available evidence on biodegradation is not sufficient for an assessment based on the Annex XIII criteria for Persistence (P and vP). As the substance is concluded to be not readily biodegradable as well as to be hydrolytically stable, it should be considered as potentially P/vP from a precautionary point of view, until further data become available. The log Kow indicates no potential for bioaccumulation; therefore, the substance is not B/vB. The substance is assessed to be “not T”, based on experimental chronic toxicity data available for fish and algae; the substance does not hold any relevant official classifications. In addition, the screening criteria for T based on acute toxicity data are not fulfilled.  

In summary, diisopropylamine (CAS 108-18-9) does not meet the criteria for PBT classification.

 

- Ethylene glycol (CAS 107-21-1): 1 – 2 % (w/w)

The substance assessed to be “not P” and “not vP”; based on the results from a DOC-die-away test (OECD 301A) the substance is readily biodegradable according to OECD criteria The log Kow indicates no potential for bioaccumulation; therefore, the substance is not B/vB. The substance is considered to be “T” due to its STOT RE category 2 classification.

In summary, ethylene glycol (CAS 107-21-1) does not meet the criteria for PBT classification.

 

- Diethylene glycol (CAS 111-46-6): 0.1 – 0.2 % (w/w)

The substance assessed to be “not P” and “not vP”; based on the results from a DOC-die-away test (OECD 301A) and a CO2 evolution test (OECD 301B) the substance is readily biodegradable according to OECD criteria. The log Kow indicates no potential for bioaccumulation; therefore, the substance is not B/vB. The substance is considered to be “T” due to its STOT RE category 2 classification.

In summary, diethylene glycol (CAS 111-46-6) does not meet the criteria for PBT classification.

 

Conclusion:

Based on the single PBT/vPvB assessments performed on each relevant constituent, the ‘crude material’ of 2-diisopropylaminoethanol (CAS 96-80-0) is concluded to neither fulfill the PBT criteria (not PBT) nor the vPvB criteria (not vPvB).
Likely routes of exposure:

Because the pure substance as well as the crude material do not fulfill the PBT and vPvB criteria, no emission characterisation is performed.