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PBT assessment

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PBT assessment: overall result

Reference
Name:
4-[[5-(anilino)carbonyl-2-methoxyphenyl]azo]-3-hydroxy-N-(3-nitrophenyl)naphthalene-2-carboxamide
Type of composition:
boundary composition of the substance
Reference substance:
Composition 1
PBT status:
the substance is not PBT / vPvB
Justification:

Classification of 3-hydroxy-4-[(E)-2-[2-methoxy-5-(phenylcarbamoyl)phenyl]diazen-1-yl]-N-(3-nitrophenyl)naphthalene-2-carboxamidefor effects in the environment:

The chemical 3-hydroxy-4-[(E)-2-[2-methoxy-5-(phenylcarbamoyl)phenyl]diazen-1-yl]-N-(3-nitrophenyl)naphthalene-2-carboxamide (CAS no. 6448-96-0) is used as a agrochemical intermediate, intermediate for chemical synthesis, pharma intermediate, dyestuff intermediate and as a laboratory agent. Mainly used for rubber products coloring, also used for coating color, plastic, printing ink and textile printing etc.The aim was to assess whether the PBT criterion within Annex XIII was fulfilled for 3 -hydroxy-4 -[(E)-2 -[2 -methoxy-5 -(phenylcarbamoyl) phenyl]diazen-1 -yl]-N-(3 -nitrophenyl)naphthalene-2-carboxamide. 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

In a prediction done using the Estimation Programs Interface Suite (EPI suite, 2018) , the biodegradation potential of the test compound 3 -hydroxy-4 -[(E)-2 -[2 -methoxy-5 -(phenyl carbamoyl)phenyl]diazen-1 -yl]-N-(3 -nitrophenyl)naphthalene-2-carboxamide (CAS no. 6448 -96 -0) in the presence of mixed populations of environmental microorganisms was estimated. 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  3-hydroxy-4-[(E)-2-[2-methoxy-5-(phenylcarbamoyl)phenyl]diazen-1-yl]-N-(3-nitrophenyl)naphthalene-2-carboxamide is expected to be not readily biodegradable.

                                                                 

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

 

As the half-life value of chemical 3-hydroxy-4-[(E)-2-[2-methoxy-5-(phenylcarbamoyl)phenyl]diazen-1-yl]-N-(3-nitrophenyl)naphthalene-2-carboxamideis not known and only predicted data is available for the substance, it has been concluded that test chemical 3 -hydroxy-4 -[(E)-2 -[2 -methoxy-5 -(phenylcarbamoyl)phenyl]diazen-1 -yl]-N-(3 -nitrophenyl)naphthalene-2 -carboxamideis likely to be persistent (P) in nature.

 

Bioaccumulation assessment

The tested substance fulfils the B criterion within Annex XIII based on the assessment that here follows:

 

Theoctanol water partition coefficient of the test chemical from modelling databases was estimated to be ranges from 6.65 to 7.89, respectively, which is greater than the threshold of 4.5. If this chemical is released into the aquatic environment, there should be a high risk for the chemical to bioaccumulate in fish and food chains.

 

Since estimated value of partition coefficient is available for the substance, it has been concluded that chemical 3 -hydroxy-4 -[(E)-2 -[2 -methoxy-5 -(phenylcarbamoyl)phenyl]diazen-1 -yl]-N-(3 -nitrophenyl)naphthalene-2 -carboxamide is likely to be bioaccumulative (B) 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

As per Column 2 (Annex VIII) of the REACH regulation,testing for this end point is considered scientifically unjustified since there are mitigating factors indicating that aquatic toxicity is unlikely to occur as the substance is highly insoluble in water. The chemical 3 -hydroxy-4 -[(E)-2 -[2 -methoxy-5 -(phenylcarbamoyl)phenyl]diazen-1 -yl]-N-(3 -nitrophenyl)naphthalene-2 -carboxamidewas therefore 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 fulfils the P and B criterion but does not fulfil the T criterion and has therefore not been classified as a PBT compound within Annex XIII.