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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 4-chlorobenzophenone for effects in the environment:


The chemical 4-chlorobenzophenone (CAS no. 134-85-0) is used as an intermediate in pharmaceutical industry and for chemical synthesis as well as a laboratory reagent. The aim was to assess whether the PBT criterion within Annex XIII was fulfilled for 4-chlorobenzophenone. 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 fulfil the P criterion within Annex XIII based on the assessment that here follows:


 


Biotic degradation


On the basis of experimental results of biodegradation study (from lab report) , the percentage degradation of test chemical 4-chlorobenzophenone (CAS no. 134-85-0)was determined to be 32.71% after 42 days, it indicates as test chemical as not readily biodegradable in water and thus likely to be persistent ( P) in nature.


 


Bioaccumulation assessment


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


 


The experimental octanol-water partition for the substance is 3.748 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 fulfils 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 estimation for fish, invertebrates and algae for the substance indicates the LC50/EC50 value to be in the range >0.29 to <3.8 mg/L. These value suggest that the substance is likely to be hazardous to Aquatic organisms at environmentally relevant concentrations and hence, considered to be  classified as  ‘Aquatic acute /Chronic 1’ as  per the CLP regulation.


 


There are no available long-term toxicity evaluations for 4-chlorobenzophenone. By speculation, long-term NOEC for aquatic organisms were expected for 4-chlorobenzophenone at concentration below 0.01 mg/L based on the data mentioned above.


 


The chemical was therefore  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 fulfills P and T criteria but does not fulfil the B criterion and has therefore not been classified as a PBT compound within Annex XIII.