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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 4-amino-3,6-bis[[4-[[4-chloro-6-[(3-sulphophenyl)amino]-1,3,5-triazin-2-yl]amino]-2-sulphophenyl]azo]-5-hydroxynaphthalene -2,7-disulphonic acid for effects in the environment:

 

The chemical4-amino-3,6-bis[[4-[[4-chloro-6-[(3-sulphophenyl)amino]-1,3,5-triazin-2-yl]amino]-2-sulphophenyl]azo]-5-hydroxynaphthalene -2,7-disulphonic acid(CAS no. 51357-74-5) is used as a dye. The aim was to assess whether the PBT criterion within Annex XIII was fulfilled for 4 -amino-3,6 -bis[[4 -[[4 -chloro-6 -[(3 -sulphophenyl)amino]-1,3,5 -triazin-2 -yl]amino]-2 -sulphophenyl]azo]-5 -hydroxynaphthalene -2,7 -disulphonic acid. 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 chemical4-amino-3,6-bis[[4-[[4-chloro-6-[(3-sulphophenyl)amino]-1,3,5-triazin-2-yl]amino]-2-sulphophenyl]azo]-5-hydroxynaphthalene -2,7-disulphonic acid(CAS no. 51357-74-5)was predicted by using OECD QSAR tool box v3.4 and considering five closest read across chemical with log Kow as primary descriptor. The test chemical 4-amino-3,6-bis[[4-[[4-chloro-6-[(3-sulphophenyl)amino]-1,3,5-triazin-2-yl]amino]-2-sulphophenyl]azo]-5-hydroxynaphthalene -2,7-disulphonic acid undergoes 0.11 % biodegradation by considering BOD as parameter and microorganisms as inoculum  in 28 days. Based on percent biodegrdability value it is concluded that this test chemical 4-amino-3,6-bis[[4-[[4-chloro-6-[(3-sulphophenyl)amino]-1,3,5-triazin-2-yl]amino]-2-sulphophenyl]azo]-5-hydroxynaphthalene -2,7-disulphonic acid is not readily biodegradable.

 

Estimation Programs Interface Suite (EPI suite, 2017) was run to predict the biodegradation potential of the test compound 4 -amino-3,6 -bis[[4 -[[4 -chloro-6 -[(3 -sulphophenyl) amino]-1,3,5 -triazin-2 -yl]amino]-2 -sulphophenyl]azo]-5 -hydroxynaphthalene -2,7-disulphonic acid(CAS no. 51357-74-5)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 as Biowin 1-7, respectively) of the BIOWIN v4.10 software. The results indicate that chemical 4-amino-3,6-bis[[4-[[4-chloro-6-[(3-sulphophenyl)amino]-1,3,5-triazin-2-yl]amino]-2-sulphophenyl]azo]-5-hydroxynaphthalene -2,7-disulphonic acidis expected to be not readily biodegradable.

 

Experimental results from the read across substance (CAS no: 17095-24-8) also indicate that they are not readily biodegradable.

 

Bioaccumulation assessment

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

 

The estimated BCF value from authoritative database was determined to be ranges from 1 to 3.162, respectively. 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

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 (solubility: 0.000000004373 mg/L at 25° C). The chemical 4 -amino-3,6 -bis[[4 -[[4 -chloro-6 -[(3 -sulphophenyl)amino]-1,3,5 -triazin-2 -yl]amino]-2 -sulphophenyl]azo]-5-hydroxynaphthalene -2,7-disulphonic acidwas 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.