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PBT assessment

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PBT assessment: overall result

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

Classification of Tetraethylammonium chloride for effects in the environment:

 

The chemical Tetraethylammonium chloride (CAS no. 56-34-8) is used in chemical synthesis and as a pharmaceutical intermediate. The aim was to assess whether the PBT criterion within Annex XIII was fulfilled for Tetraethylammonium chloride. 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 does not fulfil the P criterion within Annex XIII based on the assessment that here follows:

 

Biotic degradation

Biodegradability of test chemical N,N,N-triethylethanaminium chloride (CAS no. 56-34-8) is predicted using OECD QSAR tool box v.3.4 using log Kow as primary descriptor. The test chemical N,N,N-triethylethanaminium chloride undergoes 75.69 % degradation by taking microorganisms as inoculum and considering BOD as parameter in 28 days. Thus based on percent biodegradability it is concluded that test chemical N,N,N-triethylethanaminium chloride is readily biodegradable.

 

Another prediction done by using Estimation Programs Interface Suite (EPI suite, 2017) to estimate the biodegradation potential of the test compound N,N,N-triethylethanaminium chloride (CAS no. 56-34-8) 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 N,N,N-triethylethanaminium chloride is expected to be readily biodegradable.

 

Experimental data for similar substances (CAS: 67-48-1 and 75-59-2) also indicates the substances to be 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 80.3%). In soil, Tetraethylammonium chloride was expected to have rapid to moderate mobility based upon a LogKOC in the range 0 – 1.96. Thehalf-life in soil (30 days estimated by EPI suite) indicates that the chemical is not persistent in soil and the exposure risk to soil dwelling animals is moderate to low.

 

If released in to the environment, 19.6 % of the chemical will partition into water according to the Mackay fugacity model level III in EPI suite version 4.1 (2017). However, the half-life (15 days estimated by EPI suite) indicates that the exposure risk to aquatic animals is moderate to low.

 

Moreover, its persistent characteristic is only observed in the sediment compartment but Fugacity modelling shows that sediment is not an important environmental fate (less than 1% when estimated by EPI Suite version 4.1).

 

Hence it has been concluded that Tetraethylammonium chloride is not persistent 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 in the range 1.0 – 14.2 and theoctanol water partition coefficient of the test chemical is -3.15 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 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 to be not classified as per the CLP regulation.

 

There are no available long-term toxicity evaluations for Tetraethylammonium chloride. By speculation, long-term NOEC for aquatic organisms were not expected for the substance at concentration below 0.01 mg/L based on the data mentioned above

 

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