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PBT assessment

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PBT assessment: overall result

Reference
Name:
1-[2-[[4-[(2-chloro-4-nitrophenyl)azo]phenyl]ethylamino]ethyl]pyridinium acetate
Type of composition:
legal entity composition of the substance
State / form:
liquid
Reference substance:
Composition 1
PBT status:
the substance is not PBT / vPvB
Justification:

Classification of (E)-1-(2-((4-((2-chloro-4-nitrophenyl)diazenyl)phenyl)(ethyl)amino)ethyl)pyridinium acetatefor effects in the environment:

 

The chemical (E)-1-(2-((4-((2-chloro-4-nitrophenyl)diazenyl)phenyl)(ethyl)amino)ethyl)pyridinium acetate (CAS no. 59709-10-3) is used for dying acrylic fibre, leather and paper etc. The aim was to assess whether the PBT criterion within Annex XIII was fulfilled for (E)-1-(2-((4-((2-chloro-4-nitrophenyl)diazenyl)phenyl)(ethyl)amino)ethyl)pyridinium acetate. 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 fulfils the P criterion within Annex XIII based on the assessment that here follows:

 

Biotic degradation

Estimation Programs Interface Suite (2018) was run to predict the biodegradation potential of the test compound (E)-1 -(2 -((4 -((2 -chloro-4 -nitrophenyl)diazenyl)phenyl)(ethyl)amino)ethyl) pyridinium acetate (CAS no. 59709-10-3) in the presence of mixed populations of environmental microorganisms. The biodegradability of the substance was calculated using seven different models such as Linear Model, Non-Linear Model, Ultimate Biodegradation Timeframe, Primary Biodegradation Timeframe, MITI Linear Model, MITI Non-Linear Model and Anaerobic Model (called Biowin 1-7, respectively) of the BIOWIN v4.10 software. The results indicate that chemical (E)-1 -(2 -((4 -((2 -chloro-4 -nitrophenyl)diazenyl)phenyl)(ethyl)amino)ethyl)pyridinium acetate is expected to be not readily biodegradable.

 

Experimental results from the read across substances also indicate that they are not readily biodegradable.

 

Thus, based on the available information, it indicates that chemical (E)-1 -(2 -((4 -((2 -chloro-4 -nitrophenyl)diazenyl)phenyl)(ethyl)amino)ethyl)pyridinium acetate can be expected to be not readily biodegradablein 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:

 

Theestimated BCF value from authoritative database was determined to be in the range from 3.162 to 279, respectively and theoctanol water partition coefficient of the test chemical was evaluated to be 3.88, 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

On the basis ofthe various experimental studies ofshort term eco-toxicity data for fish, aquatic invertebrates and aq. algaeof the structurally and functionally similar read across chemical and applying the weight of evidence approach, the LC50/EC50 value was determined to be 0.12 to 469.2 mg/l. These value suggest that the substance is likely to be hazardous to aquatic organisms at environmentally relevant concentration.

 

There are no available long-term toxicity evaluations for (E)-1 -(2 -((4 -((2 -chloro-4 -nitrophenyl)diazenyl)phenyl)(ethyl)amino)ethyl)pyridinium acetate. By speculation, long-term NOEC for aquatic organisms were expected for the substance 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 fulfils the P and T criterion but does not fulfil the B criterion and has therefore not been classified as a PBT compound within Annex XIII.