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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 Sodium 5-(aminosulphonyl)-2-[7-(diethylamino)-2-oxo-2H-1-benzopyran-3-yl]benzoxazolesulphonate for effects in the environment:

 

Sodium 5-(aminosulphonyl)-2-[7-(diethylamino)-2-oxo-2H-1-benzopyran-3-yl]benzoxazolesulphonate (CAS no. 93859-32-6) is used as a fluorescent dyestuff that are generally used in non-textile applications such as plastics, synthetic resins, printing inks and for incorporation into dyed resin pigments. The aim of the PBT assessment was to evaluate whether this chemical fulfils the PBT criterion within Annex XIII. The PBT assessment were based on toxicological information in conjunction with standardized environmental fate- and bioaccumulation 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:

 

Environmental fate

According to the fugacity model levels III, the most likely environmental fate for this test chemical is soil (i.e.estimated to 73.3%). The log Koc-value was determined to be 1.151 indicating rapid mobility and negligible adsorption potential. The tested chemical is therefore expected to leach from soil. The half-life (120 days estimated by EPI suite) indicates that the exposure risk to soil-dwelling organism should therefore be moderate to low.

 

If released in to the environment, only 26.5% of the chemical will partition into water whereas 0.112% will partition into sediment according to the Mackay fugacity model level III in EPI suite version 4.1 (2016). However, the estimated half-life (60 days in water and 541.66 days in sediment estimated by EPI suite) indicates that substance is likely to be persistent.

 

 

Bioaccumulation assessment

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

 

The Log Kow value is determined to be 1.41 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 54.8 - 164 mg/L. These value suggest that the substance is likely to be hazardous to Aquatic organisms at environmentally relevant concentrations and can be considered as classified in aquatic chronic category 3 as per the CLP regulation.

 

There are no long-term toxicity evaluation available for 5-(aminosulphonyl)-2-[7-(diethylamino)-2-oxo-2H-1-benzopyran-3-yl]benzoxazolesulphonate. 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 only the P criterion within Annex XIII. The tested chemical does not fulfil the B and T criterion and has therefore not been classified as a PBT compound within Annex XIII.