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Classification & Labelling & PBT assessment

PBT assessment

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Administrative data

PBT assessment: overall result

PBT status:
the substance is not PBT / vPvB
Justification:

Classification of Resin acids and Rosin acids, ammonium salts for effects in the environment:

 

The chemical Resin acids and Rosin acids, ammonium salts (CAS no. 68649-89-8) is used in chemical synthesis. The aim was to assess whether the PBT criterion within Annex XIII was fulfilled for Resin acids and Rosin acids, ammonium salts. The PBT criterion was herein assessed based on experimental data in conjunction with standardized environmental fate models. Here follows a description of the PBT assessment.

 

 

Persistence assessment

The tested substance does not fulfil the P criterion within Annex XIII based on the assessment that here follows:

 

Biotic degradation

Biodegradability of test chemical Resin acids and Rosin acids, ammonium salts (CAS no. 68649-89-8) is predicted using OECD QSAR tool box v3.3 using log Kow as primary descriptor. The test chemical Resin acids and Rosin acids, ammonium salts undergoes 72 % biodegradation by considering BOD as parameter and microorganisms as inoculum in 28 days. Therefore it is concluded that test chemical Resin acids and Rosin acids, ammonium salts is readily biodegradable.

 

Experimental results for similar substances (CAS: 301-08-6 and 546-68-9) also indicate that they are readily biodegradable.

 

Hence it has been concluded that Resin acids and Rosin acids, ammonium salts is not persistent in nature.

 

 

Bioaccumulation assessment

The tested substance does not fulfil the B criterion within Annex XIII based on the assessment that here follows:

 

Theestimated BCF value from authoritative database was determined to be 3.162 L/kg wet wt. and theoctanol water partition coefficient of the test chemical is in the range 2.20 which is less than the threshold of 4.5.If this chemical is released into the aquatic environment, there should be a low risk for the chemical to bioaccumulate in fish and food chains.

 

Toxicity assessment

The tested substance does not fulfil the T criterion within Annex XIII based on the assessment that here follows:

 

Mammals

The tested chemical is regarded to be not classified for carcinogenicity, mutagenicity and reprotoxicity, Further, there is no evidence of chronic toxicity, as identified by the classifications STOT (repeated exposure), category 1(oral, dermal, inhalation of gases/vapours, inhalation of dust/mist/fume) or category 2 (oral, dermal, inhalation of gases/vapours, inhalation of dust/mist/fume).

 

Aquatic organisms

All of the available short-term eco-toxicity estimations for fish, invertebrates and algae for the substance indicates the LC50/EC50 value to be > 100 mg/L. These value suggest that the substance is likely to be non-hazardous to Aquatic organisms at environmentally relevant concentrations and can be considered as not classified as per the CLP regulation

 

There are no long-term toxicity evaluations available for Resin acids and Rosin acids, ammonium salts. By speculation, long-term NOEC for aquatic organisms were not expected for the substance at concentration below 0.01 mg/L based on the data mentioned above.

 

Based on the data mentioned above, the chemical was not considered as hazardous to aquatic environments as per the criteria set out in Annex XIII.

 

Conclusion

Based on critical, independent and collective evaluation of information summarized herein, the tested compound does not fulfil the P, B and T criterion and has therefore not been classified as a PBT compound within Annex XIII.