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Classification & Labelling & PBT assessment

PBT assessment

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PBT assessment: overall result

Reference
Name:
Fatty acids, C10-20 neo, reaction product with diethylenetriamine
Type of composition:
legal entity composition of the substance
State / form:
other: solid (hazy) or very viscous liquid
Reference substance:
Fatty acids, C10-20 neo, reaction product with diethylenetriamine
Reference substance:
Fatty acids, C10-20 neo, reaction product with diethylenetriamine
Reference substance:
Fatty acids, C10-20 neo, reaction product with diethylenetriamine
Reference substance:
Fatty acids, C10-20 neo, reaction product with diethylenetriamine
Reference substance:
Fatty acids, C10-20 neo, reaction product with diethylenetriamine
PBT status:
the substance is not PBT / vPvB
Justification:

Persistent assessment

To evaluate the persistence of Fatty acids, C10 -20 neo, reaction products with diethylenetriamine, a biodegradability study in saltwater has been carried out. In the experiment, the substance reached a degradation of 15% within 28 days therefore it can not be considered biodegradable.

Hydrolysis is not expected to be a relevant pathway of removal from the environment: the substance is insoluble in water; furthermore most amides hydrolyze to acids extremely slowly at 25°C and pH=7.

As a result of the previous considerations, Fatty acids, C10 -20 neo, reaction products with diethylenetriamine meets the criteria of Annex XIII of Regulation EC 1907/2006 for the classification as “Persistent”.

Bioaccumulation assessment

Due to its complex composition, methods for the experimental measurement of partition coefficient octanol/water are technically not applicable. Furthermore the substance has surfactant properties, that complicate the measurement of Kow, and the resulting values are inaccurate and of limited utility for determining environmental fate and effects.

On the basis of the water insolubility and its chemical nature, Kow value for the substance is expected to be high (>10). The aquatic BCF of a substance is probably lower than 2000 if the calculated Log Kow is higher than 10. Furthermore the weight of evidence suggests that members of the Fatty Nitrogen Derived (FND) Amides Category should have low bioaccumulation potential (see Screening-level hazard characterization FND Amides Category; U.S. EPA, September, 2010).

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

Toxicity assessment

The substance is classified as STOT RE 2 according to Regulation (EC) N. 1272/2008.

On the basis of the above consideration, it can be assumed that the substance meets the criteria of Annex XIII of Regulation EC 1907/2006 for the classification as “Toxic”.

Summary and overall conclusions on PBT or vPvB properties

Fatty acids, C10-20 neo, reaction product with diethylenetriamine is insoluble in water. Its density is lower than water; if released into water the substance will float. Furthermore it has surfactant properties, tends to accumulate at the interfaces and to form aggregates, such as micelles, in the bulk aqueous phase.

In water, hydrolysis and biodegradation are not expected to be significant removal pathways. The substance is not expected to bioaccumulate, and has long-term toxicity.

In conclusion, considering all the available data, the substance does not meet the criteria of Annex XIII of Regulation EC 1907/2006 for the classification as “Persistent”, “Bioaccumulative” and “Toxic”. Therefore Fatty acids, C10-20 neo, reaction product with diethylenetriamine is not considered to be neither a PBT nor a vPvB substance.

Likely routes of exposure:

Exposure of the environment to the substance is considered negligible during the life cycle of the substance.