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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 3,7-bis(diethylamino)phenoxazin-5-ium acetate for effects in the environment:

 

The chemical 3,7-bis(diethylamino)phenoxazin-5-ium acetate (CAS no. 79916-07-7) is used as a dye in paper, leather and textile industry.The aim was to assess whether the PBT criterion within Annex XIII was fulfilled for 3,7-bis(diethylamino)phenoxazin-5-ium acetate. 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 3,7-bis(diethylamino)phenoxazin-5-ium acetate (CAS no.79916 -07 -7) is predicted using OECD QSAR toolbox version 3.3 with logKow as the primary descriptor. Test substance undergoes 0.7666 % degradation by BOD in 28 days. Thus, based on percentage degradation, the test chemical 3,7-bis(diethylamino) phenoxazin-5-ium acetate was estimated to be not readily biodegradable in water.

                                                                 

Experimental results from the read across substances (CAS: 2465-27-2, 509-34-2 and 81-88-9) also indicate that they are not readily biodegradable.

 

As the half-life value of chemical 3,7-bis(diethylamino)phenoxazin-5-ium acetateis not known and only predicted data is available for the substance, it has been concluded that chemical 3,7-bis(diethylamino)phenoxazin-5-ium acetate is likely to be persistent (P) in nature.

 

Bioaccumulation assessment

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

 

Theestimated BCF value from authoritative database was determined to be 54.6, respectively and theoctanol water partition coefficient of the test chemical was estimated to be 4.4, respectively, 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 fulfils 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 in the range 0.349 – 0.838 mg/L. These value suggest that the substance is likely to be hazardous to Aquatic organisms at environmentally relevant concentrations and can be considered to be classified in ‘Aquatic Acute Category 1’/‘Aquatic Chronic Category 1’ as per the CLP regulation.

 

There are no available long-term toxicity evaluations for 3,7-bis(diethylamino)phenoxazin-5-ium acetate. By speculation, long-term NOEC for aquatic organisms were expected for the substance at concentration below 0.01 mg/L based on the data mentioned above

 

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