Reaction product of 1,3,5-Triazine-2,4,6-triamine, polymer with formaldehyde, methylated and C16-18 fatty alcohols

PBT assessment

PBT assessment: overall result

PBT status:

the substance is not PBT / vPvB

Justification:

Justification

The criteria given in the “Guidance on information requirements and chemical safety assessment, Chapter R.11: PBT Assessment” (ECHA, 2017) are used as information to decide whether Reaction product of 1,3,5-Triazine-2,4,6-triamine, polymer with formaldehyde, methylated and C16-18 fatty alcohols may potentially fulfil the PBT or vPvB criteria.

 

Persistence Assessment

Based on the available data (OECD 301B), Reaction product of 1,3,5-Triazine-2,4,6-triamine, polymer with formaldehyde, methylated and C16-18 fatty alcohols is not readily biodegradable (11% biodegradation after 28 d). Thus, the substance may potentially fulfil the P/vP criteria.

 

Bioaccumulation Assessment

Reaction product of 1,3,5-Triazine-2,4,6-triamine, polymer with formaldehyde, methylated and C16‑18 fatty alcohols is characterized by a low water solubility (< 15 µg/L at 20 °C and pH 6.3; OECD 105), a high estimated log Kow (> 7.9 (KOWWIN v1.68) and high molecular weight (> 600 g/mol). Based on the physico/chemical properties such as low water solubility and a high potential for adsorption the substance is not expected to be rapidly bioavailable to aquatic organisms. The highly lipophilic character of the substance indicates a tendency to distribute into cells, particularly fatty tissues. This tendency is, however, reduced by the high molecular weight of the substance which significantly reduces the absorption due to steric hindrance to cross biological membranes. If the substance is taken up by an organism, oral absorption is the most likely route. Evidence indicates that the substance is enzymatically metabolised, yielding hydroxylated breakdown products that are further metabolised in the liver and ultimately excreted via urine. Bioaccumulation in organisms is therefore considered very low. This is further supported by calculated BCF values, none of which raise concern over bioaccumulative behaviour. Long-term toxicity data with mammals did not show any toxicity effects supporting the assumption of no bioaccumulation potential by the substance.

It can be concluded in a weight of evidence approach that the bioaccumulation of Reaction product of 1,3,5-Triazine-2,4,6-triamine, polymer with formaldehyde, methylated and C16-18 fatty alcohols is low.

Thus, taking all information into account, the substance is not considered to be B or vB.

Please refer to IUCLID section 5.3 for a detailed overview on bioaccumulation of the substance.

 

Toxicity Assessment

Short term aquatic toxicity data for the assessment of Reaction product of 1,3,5-Triazine-2,4,6-triamine, polymer with formaldehyde, methylated and C16-18 fatty alcohols are available for two trophic levels (fish, algae). Long-term toxicity testing for the third trophic level (daphnia) is proposed to be conducted since the substance is poorly water soluble. All available data did not result in any toxicity up to the water solubility limit. Moreover, the substance is not classified according to Regulation (EC) No 1272/2008 and the consolidated version of Regulation (EC) No 1272/2008 and further amendments (ATPs). Thus, the criteria given in the “Guidance on information requirements and chemical safety assessment, chapter R.11: PBT Assessment” (ECHA, 2017) are not met and the substance is not considered to meet the T criterion.