Disodium 2-[[5-carbamoyl-1-ethyl-1,6-dihydro-2-hydroxy-4-methyl-6-oxo-3-pyridyl]azo]-4-[[4-chloro-6-[[3-[[2-(sulphonatooxy)ethyl]sulphonyl]phenyl]amino]-1,3,5-triazin-2-yl]amino]benzenesulphonate

PBT assessment

PBT assessment: overall result

PBT status:

the substance is not PBT / vPvB

Justification:

Classification of Disodium 2-[[5-carbamoyl-1-ethyl-1,6-dihydro-2-hydroxy-4-methyl-6-oxo-3-pyridyl]azo]-4-[[4-chloro-6-[[3-[[2-(sulphonatooxy)ethyl]sulphonyl]phenyl]amino]-1,3,5-triazin-2-yl]amino]benzenesulphonate for effects in the environment:

 

The chemical Disodium 2-[[5-carbamoyl-1-ethyl-1,6-dihydro-2-hydroxy-4-methyl-6-oxo-3-pyridyl]azo]-4-[[4-chloro-6-[[3-[[2-(sulphonatooxy)ethyl]sulphonyl]phenyl]amino]-1,3,5-triazin-2-yl]amino]benzenesulphonate (CAS no. 84000-63-5) is used in the dyestuff industry. The aim was to assess whether the PBT criterion within Annex XIII was fulfilled for Disodium 2-[[5-carbamoyl-1-ethyl-1,6-dihydro-2-hydroxy-4-methyl-6-oxo-3-pyridyl]azo]-4-[[4-chloro-6-[[3-[[2-(sulphonatooxy)ethyl]sulphonyl]phenyl]amino]-1,3,5-triazin-2-yl]amino]benzenesulphonate. 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 by SSS (2017) using OECD QSAR toolbox version 3.3 with logKow as the primary descriptor, percentage biodegradability of test chemical 2-[(5-carbamoyl-1-ethyl-2-hydroxy-4-methyl-6-oxo-1,6-dihydropyridin-3-yl)diazenyl]-4-({4-chloro-6-[(3-{[2-(sulfonatooxy)ethyl]sulfonyl}phenyl)amino]-1,3,5-triazin-2-yl}amino)benzenesulfonate(CAS No. 84000-63-5) was estimated.Test substance undergoes 26.79% degradation by CO2 evolution parameter in 28 days. Thus, based on percentage degradation, the test chemical disodium 2 -[(5 -carbamoyl-1 -ethyl-2 -hydroxy-4 -methyl-6 -oxo-1,6 -dihydropyridin-3 -yl)diazenyl]-4 -({4 -chloro-6 -[(3 -{[2 -(sulfonatooxy)ethyl]sulfonyl}phenyl)amino]-1,3,5 -triazin-2 -yl}amino)benzenesulfonate was estimated to be not readily biodegradable in water.

 

Experimental study on read across substances (CAS: 27676-62-6 and 10254-57-6) also indicate the substances to be not readily biodegradable.

 

Environmental fate

According to the fugacity model levels III, the most likely environmental fate for this test chemical is soil (i.e.estimated to 88%).Thehalf-life in soil (360 days estimated by EPI suite) indicates that the chemical is persistent in soil.

 

If released in to the environment, 11.9 and 0.143 % of the chemical will partition into water and sediment, respectively according to the Mackay fugacity model level III in EPI suite version 4.1 (2016). However, the half-life (180 days in water and 1621 days in sediment as estimated by EPI suite) indicates that the substance is persistent in both compartments.

 

Although the half-life values in sediment suggest classification as very persistent (vP), the substance is classified only as persistent (P) since only estimated half-life values are available for the same.

 

Hence it has been concluded that the substance Disodium 2-[[5-carbamoyl-1-ethyl-1,6-dihydro-2-hydroxy-4-methyl-6-oxo-3-pyridyl]azo]-4-[[4-chloro-6-[[3-[[2-(sulphonatooxy)ethyl]sulphonyl]phenyl] amino]-1,3,5-triazin-2-yl]amino]benzenesulphonate is persistent 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 is in the range -3.19 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 to be not classified as per the CLP regulation.

 

There are no available long-term toxicity evaluations for Disodium 2-[[5-carbamoyl-1-ethyl-1,6-dihydro-2-hydroxy-4-methyl-6-oxo-3-pyridyl]azo]-4-[[4-chloro-6-[[3-[[2-(sulphonatooxy)ethyl]sulphonyl]phenyl] amino]-1,3,5-triazin-2-yl]amino]benzenesulphonate. 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 fulfils the P criterion but does not fulfil the B and T criterion and has therefore not been classified as a PBT compound within Annex XIII.