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 ready biodegradability of TRIS AMINO was demonstrated in the OECD ready biodegradation test.

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

Bioaccumulation Assessment

Since the log Kow value of TRIS AMINO (-2.31) 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 - Part C: PBT Assessment (2008).

Environmental Toxicity:

According to Annex XIII of REACH Regulation (EC) No 1907/2006, a substance is considered to be toxic in terms of PBT criteria if EC50 values for aquatic organisms are lower than 0. 1 mg/L. Effect values are greater than 300 mg/L thus Tris Amino is not considered as toxic regarding ecotoxicological

 

Human Health Hazards Assessment:

TRIS AMINO 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 TRIS AMINO data and data within the analogue approach.

AEPD 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) 1272/2008. The same applies for AMPD and APD. This is concluded by using screening studies and data within the analogue approach.There is no indication of a mutagenic or carcinogenic potential and neither systemic toxicity nor toxicity to reproduction are evidenced for AMPD and APD. Thus, according to Directive 67/548/EEC and Regulation (EC) 1272/2008, AMPD and APD are not classified as carcinogenic, mutagenic or toxic for reproduction and no evidence of chronic toxicity was found.

 

Thus, TRIS AMINO, AEPD, AMPD and APD are not considered to be toxic, based on the available data on ecotoxicological and toxicological endpoints, and therefore the substances do not meet the toxicity criterion (T).

Summary and overall Conclusions on PBT or vPvB Properties

According to Annex XIII of the REACH Regulation (EC) No 1907/2006, a PBT substance has to fulfil all three of the criteria for persistence, bioaccumulation and toxicity, as listed in part 1 of Annex XIII, and a vPvB substance has to fulfil all criteria for persistence and bioaccumulation, as listed in part 2 of Annex XIII.

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