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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  Reaction products of diazotised sodium 2-amino-5-{[2-(sulfonatooxy)ethyl]sulfonyl}benzenesulfonate coupled with sodium 2-(4-aminobenzene-1-sulfonyl)ethyl sulfate, subsequently coupled with diazotised sodium 2-(4-aminobenzene-1-sulfonyl)ethyl sulfate for effects in the environment:


 


The chemical Reaction products of diazotised sodium 2-amino-5-{[2-(sulfonatooxy)ethyl]sulfonyl}benzenesulfonate coupled with sodium 2-(4-aminobenzene-1-sulfonyl)ethyl sulfate, subsequently coupled with diazotised sodium 2-(4-aminobenzene-1-sulfonyl)ethyl sulfate (CAS no. 607724-40-3) is used as a colorant for dyeing. The aim was to assess whether the PBT criterion within Annex XIII was fulfilled for  Reaction products of diazotised sodium 2-amino-5-{[2-(sulfonatooxy)ethyl]sulfonyl}benzenesulfonate coupled with sodium 2-(4-aminobenzene-1-sulfonyl)ethyl sulfate, subsequently coupled with diazotised sodium 2-(4-aminobenzene-1-sulfonyl)ethyl sulfate. 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


The closed bottle test following the OECD guideline 301 D was performed to determine the ready biodegradability of the test chemical. The study was performed at a temperature of 20°C. The test system included control, test chemical and reference chemical. Polyseed were used as inoculum at concentration of 10E7 to 10E8 CFU/ml. At the regular interval microbial plating was also performed on agar to confirm the vitality and CFU count of microorganism. The initial concentration of test chemical and reference chemical (Sodium Benzoate) used was 4 mg/L, and the concentration of inoculum used was 32 ml/l. OECD mineral medium was used for the study. ThOD (Theoretical oxygen demand) of test and reference chemical was determined by calculation. % degradation was calculated using the values of BOD and ThOD for test chemical and reference chemical. The % degradation of procedure control (reference chemical) was also calculated using BOD & ThOD and was observed to be 93.75%. Degradation of Sodium Benzoate exceeds 40.63% on 7 days & 90.63% on 14th day. The activity of the inoculum was thus verified and the test can be considered as valid. The BOD28 value of test chemical was observed to be 0.48 mgO2/mg. ThOD was determined by calculation as 0.8 mgO2/mg. On the basis of ThOD and BOD 28 value the percent degradation of the test chemical was determined to be 59.38%. Based on the percent degradation value it is concluded that the test chemical is considered as, inherently biodegradable in water.


 


Thus, it has been concluded that chemical Reaction products of diazotised sodium 2-amino-5-{[2-(sulfonatooxy)ethyl]sulfonyl}benzenesulfonate coupled with sodium 2-(4-aminobenzene-1-sulfonyl)ethyl sulfate, subsequently coupled with diazotised sodium 2-(4-aminobenzene-1-sulfonyl)ethyl sulfate is likely to be not persistent (not 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 octanol water partition coefficient of the test chemical was determined to be -2.812±0.229 at 25 °C± 1°C (as per OECD TG 107) 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


On the basis of the various experimental studies of the test chemical Reaction products of diazotised sodium 2-amino-5-{[2-(sulfonatooxy)ethyl]sulfonyl}benzenesulfonate coupled with sodium 2-(4-aminobenzene-1-sulfonyl)ethyl sulfate, subsequently coupled with diazotised sodium 2-(4-aminobenzene-1-sulfonyl)ethyl sulfate (CAS no. 607724-40-3) was determined to be > 100 mg/L. These value suggest that the substance is likely to be not hazardous to Aquatic organisms at environmentally relevant concentrations and thus can be considered to be ‘not classified’ as per the CLP regulation.


 


There are no available long-term toxicity evaluations for Reaction products of diazotised sodium 2-amino-5-{[2-(sulfonatooxy)ethyl]sulfonyl}benzenesulfonate coupled with sodium 2-(4-aminobenzene-1-sulfonyl)ethyl sulfate, subsequently coupled with diazotised sodium 2-(4-aminobenzene-1-sulfonyl)ethyl sulfate 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.


 


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