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Classification & Labelling & PBT assessment

PBT assessment

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PBT assessment: overall result

PBT status:
the substance is not PBT / vPvB
Justification:

Classification of Trisodium [2-[[α-[[2-hydroxy-5-sulpho-3-[(2,5,6-trichloro-4-pyrimidinyl)amino]phenyl]azo]benzyl]azo]-5-sulphobenzoato(5-)]cuprate(3-) for effects in the environment:

 

The chemicalTrisodium [2-[[α-[[2-hydroxy-5-sulpho-3-[(2,5,6-trichloro-4-pyrimidinyl)amino]phenyl]azo]benzyl]azo]-5-sulphobenzoato(5-)]cuprate(3-)(CAS no. 70161-20-5) is used as an intermediate in dyestuff industry. The aim was to assess whether the PBT criterion within Annex XIII was fulfilled forTrisodium [2-[[α-[[2-hydroxy-5-sulpho-3-[(2,5,6-trichloro-4-pyrimidinyl)amino]phenyl]azo]benzyl]azo]-5-sulphobenzoato(5-)]cuprate(3-). 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

Biodegradability of test chemical Trisodium [2-[[α-[[2-hydroxy-5-sulpho-3-[(2,5,6-trichloro-4-pyrimidinyl)amino]phenyl]azo]benzyl]azo]-5-sulphobenzoato(5-)]cuprate(3-) (CAS no.70161 -20 -5) was estimated by using OECD QSAR tool box v3.4 considering five closest read across chemicals with log kow as primary descriptor. Percent biodegradation of test chemical Trisodium [2-[[α-[[2-hydroxy-5-sulpho-3-[(2,5,6-trichloro-4-pyrimidinyl)amino]phenyl]azo]benzyl]azo]-5-sulphobenzoato(5-)]cuprate(3-) (CAS no. 70161-20-5) was estimated to be 0.7833 % by considering BOD as parameter and microorganisms as inoculum in 28 days. Based on this percent biodegradability value it is concluded that this test chemical is not readily biodegradable.

The experimental studies for the similar substances (CAS: 16521-38-3 and 1921-24-9) also indicate that they are 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 59.2%).Thehalf-life in soil (360 days estimated by EPI suite) indicates that the chemical is persistent in the soil environment and the exposure risk to soil dwelling animals is moderate to high.

 

If released in to the environment, 39.7 and 1.9 % of the chemical will partition into sediment and water respectively according to the Mackay fugacity model level III in EPI suite version 4.1 (2017). However, the half-life (180 days in water and 1620.83 days in sediment estimated by EPI suite) indicates that the substance is persistent in both compartments.

 

Moreover, although the half-life values indicate that the substance is very persistent (vP), since only estimated data is available, it has been concluded thatTrisodium [2-[[α-[[2-hydroxy-5-sulpho-3-[(2,5,6-trichloro-4-pyrimidinyl)amino]phenyl]azo]benzyl]azo]-5-sulphobenzoato(5-)]cuprate(3-)is persistent (P) in nature.

 

 

Bioaccumulation: aquatic/sediment

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

 

Theestimated BCF value from authoritative databases was determined to be in the range 3.162 and theoctanol water partition coefficient of the test chemical is -16.20 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

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 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 as not classified as per the CLP regulation.

 

There are no long-term toxicity evaluation available forTrisodium [2-[[α-[[2-hydroxy-5-sulpho-3-[(2,5,6-trichloro-4-pyrimidinyl)amino]phenyl]azo]benzyl]azo]-5-sulphobenzoato(5-)]cuprate(3-). By speculation, long-term NOEC for aquatic organisms cannot be expected for the substance at concentration below 0.01 mg/L based on the data mentioned above.

 

The chemical was therefore considered as non-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