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Classification & Labelling & PBT assessment

PBT assessment

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PBT assessment: overall result

Reference
Name:
Reaction product of naphthalene, butanol, sulfonated and neutralized by caustic soda
Type of composition:
legal entity 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
Reference substance:
Composition 1
Reference substance:
Composition 1
Reference substance:
Composition 1
PBT status:
the substance is not PBT / vPvB
Justification:

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 reaction product of naphthalene, butanol, sulfonated and neutralized by caustic soda, a readily biodegradation study, an inherently biodegradation study, a biodegradation study in soil and a biodegradation study with activated sludges are available. The substance resulted not readily biodegradable, but inherently, primary biodegradable, with a 27 % of biodegradation after 28 days.

Also a hydrolysis test has been carried out, but the half life of the substance has been estimated to be higher than 1 year at 25°C and, therefore, hydrolysis is not expected to be a relevant pathway of removal from the environment.  

The logKoc for the substance is in the range of 1.78 - 2.37 and the substance is therefore expected to have a medium to high mobility in soil.

If released in the atmosphere, the substance is not expected to be present as vapour, based on a vapour pressure of 2.9 x 10 -11 Pa (water: 3,200 Pa at 25°C).

 

As a result of the previous considerations, reaction product of naphthalene, butanol, sulfonated and neutralized by caustic soda meets 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 (-0.27), reaction product of naphthalene, butanol, sulfonated and neutralized by caustic soda is 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 organisms, 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. Based 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 of Annex 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, reaction product of naphthalene, butanol, sulfonated and neutralized by caustic soda, if released in the environment, will mainly distribute into the aquatic compartment, where it is not expected to rapidly degrade through a biotic pathway. 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 conclusion, considering all the available data, the substance fulfils the criteria for the classification as “Persistent” according to Annex XIII of Regulation EC 1907/2006 but it does not meet the criteria of classification as “Bioaccumulative” and “Toxic”. Therefore the substance is not considered to be a PBT or a vPvB substance.

  

Emission characterization

As the substance does not fulfil the PBT and vPvB criteria, no emission characterisation is performed.