Formaldehyde, reaction products with N,N-dimethylbenzenamine and N-methylbenzenamine, oxidized, hydrochlorides

PBT assessment

PBT assessment: overall result

PBT status:

the substance is not PBT / vPvB

Justification:

Classification of Formaldehyde, reaction products with N,N-dimethylbenzenamine and N-methylbenzenamine, oxidized, hydrochlorides for effects in the environment

In determining the classification appropriate to Formaldehyde, reaction products with N,N-dimethylbenzenamine and N-methylbenzenamine, oxidized, hydrochlorides, it is necessary to consider all available evidence concerning its persistence, potential to accumulate and predicted or observed environmental fate and behaviour that may present a long-term and/or delayed danger to the structure and/or functioning of aquatic ecosystems. These points are considered below. 

 

Persistence assessment

Available data indicates that Formaldehyde, reaction products with N,N-dimethylbenzenamine and N-methylbenzenamine, oxidized, hydrochlorides is not persistent in the aquatic and soil environment. However, its persistent characteristic is only observed in the sediment compartment and Fugacity modelling shows that sediment is an important environmental fate (32.2% when estimated by EPI Suite version 4.1).

Hence it has been concluded that Formaldehyde, reaction products with N,N-dimethylbenzenamine and N-methylbenzenamine, oxidized, hydrochlorides is persistent in nature.  

 

Thus, Formaldehyde, reaction products with N,N-dimethylbenzenamine and N-methylbenzenamine, oxidized, hydrochlorides is classified as a persistent chemical (P) but not very persistent (not vP) since only estimated half-life values for the same are available. 

Bioaccumulation assessment

Bioaccumulation (BCF) value of the substance 2-hydroxynaphthalene-1-carbaldehyde [(2-hydroxy-1-naphthyl)methylene]hydrazone was calculated using the software BCFBAF (v3.01).

The LOG BCF value was estimated based on regression based method to 3.162 L/Kg wet-weight (calculated by EPI suite version 4.1). The log Kow was also below the threshold value of 4.5 (Log Kow = 0.3303). Hence, this compound was predicted to have low potential of bioaccumulation in fish and food chains.

Thus, Formaldehyde, reaction products with N,N-dimethylbenzenamine and N-methylbenzenamine, oxidized, hydrochlorides does not satisfy the criterion for classification as bioaccumulative (not B/vB).

Toxicity assessment

The estimated NOEC values reported for Formaldehyde, reaction products with N,N-dimethylbenzenamine and N-methylbenzenamine, oxidized, hydrochlorides in fish, invertebrate and algae are 452.89 mg/L; 171.74 mg/L and 197.86 mg/L respectively and and therefore several orders of magnitude above the screening criterion.

Based on these values, it can be concluded that Formaldehyde, reaction products with N,N-dimethylbenzenamine and N-methylbenzenamine, oxidized, hydrochlorides is is not toxic for marine/ freshwater organisms as per the criteria set out in Annex XIII..

In addition to aquatic toxicity, the substance, Formaldehyde, reaction products with N,N-dimethylbenzenamine and N-methylbenzenamine, oxidized, hydrochlorides, is not classified as carcinogenic (category 1A or 1B), germ cell mutagenic (category 1A or 1B), or toxic for reproduction (category 1A, 1B or 2) according to CLP (Regulation (EC) No 1272/2008) and there is no evidence of chronic toxicity, as identified by the classifications STOT (repeated exposure) according to Regulation (EC) No 1272/2008.

Thus, Formaldehyde, reaction products with N,N-dimethylbenzenamine and N-methylbenzenamine, oxidized, hydrochlorides does not meet the Annex XIII criterion for classification as toxic (not T).

 

Thus, in accordance with the requirements of Annex XIII; it can be inferred that Formaldehyde, reaction products with N,N-dimethylbenzenamine and N-methylbenzenamine, oxidized, hydrochlorides is a not a PBT (including vPvB) substance.