Registration Dossier

Classification & Labelling & PBT assessment

PBT assessment

Currently viewing:

Administrative data

PBT assessment: overall result

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

Persistence Assessment

A substance is not considered to be persistent if it can be demonstrated that it has potential to degrade (via photolysis, hydrolysis and/or biodegradation). The assessment of biodegradation was based on a study conducted with the structurally similar substance TRIS AMINO, which is readily biodegradable according to OECD criteria and based on the analogy it can be concluded that TRIS HCl is also readily biodegradable.

Therefore, TRIS HCl does not meet the Persistent (P) or very Persistent (vP) criteria.

Bioaccumulation Assessment

Since the log Kow value of TRIS HCl (-3.6) is below 4.5 the substance is not expected to be bioaccumulative,based on the screening criteria for bioaccumulation, stipulated in the ECHA’s Guidance on information requirements and chemical safety assessment.

Toxicity Assessment

 

The substance does not meet the classification for toxic (T) in the environment because the short term data available with aquatic fish, invertebrates and algae present EC values >1 mg/l. Thus, the criteria set out in Annex XIII of Regulation (EC) No. 1907/2006 are not met and the test substance is not considered to meet the T criterion.

 

TRISHCl is not classified as carcinogenic, mutagenic or toxic for reproduction, nor is there any evidence of chronic toxicity according to Directive 67/548/EEC and Regulation (EC) No 1272/2008. This can be concluded by using TRISHCldata and data within the analogue approach.

 

Thus, TRIS HCl based on the available data on ecotoxicological and toxicological endpoints, the substances do not meet the toxicity criterion (T).

Summary and overall Conclusions on PBT or vPvB Properties

TRIS HCl is not identified as PBT or as a vPvB substance on the basis of the relevant data provided and discussed.