3,6-bis(diethylamino)-9-[2-(methoxycarbonyl)phenyl]xanthylium tetrachlorozincate

PBT assessment

PBT assessment: overall result

PBT status:

the substance is not PBT / vPvB

Justification:

Classification of bis{3,6-bis(diethylamino)-9-[2-(methoxycarbonyl)phenyl]xanthenium} tetrachlorozincate(2 -) for effects in the environment:

 

The chemicalbis{3,6-bis(diethylamino)-9-[2-(methoxycarbonyl)phenyl]xanthenium} tetrachlorozincate(2 -) (CAS no. 73398-89-7) is used as a hair dyeing agents in cosmetic. It isused in the dyestuff industry. The aim was to assess whether the PBT criterion within Annex XIII was fulfilled for bis{3,6-bis(diethylamino)-9-[2-(methoxycarbonyl)phenyl]xanthenium} tetrachlorozincate(2-). 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

Estimation Programs Interface Suite (EPI suite, 2018) was run to predict the biodegradation potential of the test compound 3,6-bis(diethylamino)-9-(methoxycarbonyl)phenyl]xanthylium tetrachlorozincate (CAS no. 73398-89-7)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 3,6-bis(diethylamino)-9-(methoxycarbonyl)phenyl]xanthylium tetrachlorozincate is expected to be not readily biodegradable.

 

Experimental results from the read across substances (CAS no: 81-88-9 and 509-34-2) also indicate that they are not readily biodegradable.

 

Hence it has been concluded thatchemicalbis{3,6-bis(diethylamino)-9-[2-(methoxycarbonyl)phenyl]xanthenium} tetrachlorozincate(2-)is likely to be persistent in nature.

 

Bioaccumulation assessment

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

 

Theoctanol water partition coefficient of the test chemical was determined to be 4.2, 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 data for fish and algae for the substance indicates the LC50/EC50 value to be in the range 0.1562 to 0.98 mg/L, respectively. Whereas on the basis of the various experimental studies of the structurally and functionally similar read across chemical and applying the weight of evidence approach,the LC50/EC50 value for invertebratesof the test chemicalbis{3,6-bis(diethylamino)-9-[2-(methoxycarbonyl)phenyl]xanthenium} tetrachlorozincate(2-)(CAS no. 73398-89-7) can be determined to be in the range 0.1 – 0.116 mg/L, respectively. 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 forbis{3,6-bis(diethylamino)-9-[2-(methoxycarbonyl)phenyl]xanthenium} tetrachlorozincate(2-). 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.