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Classification & Labelling & PBT assessment

PBT assessment

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PBT assessment: overall result

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Name:
Formaldehyde, reaction products with ethylenediamine
Type of composition:
boundary composition of the substance
State / form:
solid: particulate/powder
Reference substance:
Composition 1
Reference substance:
Composition 1
Reference substance:
Composition 1
Reference substance:
Composition 1
Name:
Formaldehyde, reaction products with ethylenediamine
Type of composition:
legal entity composition of the substance
State / form:
solid: particulate/powder
Related composition:
Composition 2
Reference substance:
Composition 1
Reference substance:
Composition 1
Reference substance:
Composition 1
Reference substance:
Composition 1
PBT status:
the substance is not PBT / vPvB
Justification:

8.PBT AND vPvB ASSESSMENT

 

Assessment of PBT/vPvB properties

 

The assessment of PBT/vPvB properties has been done on the basis of the data available from the testing programme as well as from some calculated approaches.

 

Persistent assessment

To evaluate the persistence of formaldehyde, reaction products with ethylenediamine, a biodegradability study in saltwater has been carried out. In the experiment, the substance reached a degradation of 70% within 20 days therefore it can be considered biodegradable. Also a hydrolysis evaluation has been carried out, but the half life of the substance is 104 days at a temperature of 12°C, therefore, hydrolysis is not expected to be a relevant pathway of removal from the environment.  

The logKoc for formaldehyde, reaction products with ethylenediamine is > 5 at pH 3.5 and < 1.5 at pH 9.5 and the pKa is 8.18. If released in sea, formaldehyde, reaction products with ethylenediamine may bind to sediment, because the seawater pH is about 8 and the logKoc value is expected to be near 5, while, if release in soil, formaldehyde, reaction products with ethylenediamine is expected to have a low to high mobility, depending on the soil pH.

If released in the atmosphere, formaldehyde, reaction products with ethylenediamine may be present, at a moderate extent, as vapour, basing on a vapour pressure of 2,176 Pa at 20°C (water: 3,200 Pa at 25°C).

 As a result of the previous considerations, formaldehyde, reaction products with ethylenediamine does not meet the criteria of Annex XIII of Regulation EC 1907/2006 for the classification as “Persistent”.

  

Bioaccumulation assessment

 

As a result of the low value of logKOW(< -2), and considering the low bioaccumulation potential (BCF: 1,41 L/kg ww) of formaldehyde, reaction products with ethylenediamine,the substanceis not expected to bioaccumulate in aquatic organisms.

On the basis of the above consideration, the substance is not expected to meet the criteria of Annex XIII of Regulation EC 1907/2006 for the classification as “Bioaccumulative”.

 

Toxicity assessment

 

In acute toxicity studies with aquatic organism, the substance showed L(E)C50 values > than 1 mg/L and it is not of concern for its aquatic toxicity. The substance is classified neither as Toxic according to Directive 67/548/EEC nor as carcinogenic (category 1 or 2), mutagenic (category 1 or 2), or toxic for reproduction (category 1A, 1B or 2) according to Regulation 1272/2008/EC. Basing on the available data, the substance is not of concern for its chronic toxicity.

On the basis of the above consideration, it can be reasonably assumed that the substance does not meet the criteria ofAnnex XIII of Regulation EC 1907/2006 for the classification as “Toxic”.

  

Summary and overall conclusions on PBT or vPvB properties

 

On the basis of the available data, formaldehyde, reaction products with ethylenediamine, if released in the environment, will mainly distribute into the aquatic compartment, where it is expected to degrade through a biotic pathway, and in soil, depending on its pH. Moreover, the substance is not expected to bioaccumulate and it is of moderate toxicity for aquatic organisms, as indicated by the short-term ecotoxicity studies on fish, crustaceans and algae preformed in freshwater and in saltwater.

In conclusion, considering all the available data, the substance does not meet the criteria ofAnnex XIII of Regulation EC 1907/2006 for the classification as “Persistent”, “Bioaccumulative” and “Toxic”. Thereforeformaldehyde, reaction products with ethylenediamineis not considered to be neither a PBT nor a vPvB substance.

  

8.2. Emission characterization

 

Because the substance does not fulfil the PBT and vPvB criteria, no emission characterisation is performed. Furthermore on the basis of the risk characterisation, the risk is evaluated as adequately controlled during all steps of life cycle.