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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 N-(2-chloroethyl)pyrrolidine hydrochloride for effects in the environment:

 

The chemical N-(2-chloroethyl)pyrrolidine hydrochloride (CAS no. 7250-67-1) are used for chemical synthesis and as a laboratory agent. The aim was to assess whether the PBT criterion within Annex XIII was fulfilled for N-(2-chloroethyl)pyrrolidine hydrochloride. 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

In a prediction done by SSS (2017) using OECD QSAR toolbox version 3.3 with log Kow as the primary descriptor, percentage biodegradability of test chemical 1-(2-chloroethyl)pyrrolidine hydrochloride (CAS no. 7250-67-1) was estimated. Test substance undergoes 37.5% degradation by BOD in 28 days. Thus, based on percentage degradation, the test chemical 1-(2-chloroethyl)pyrrolidine hydrochloride was estimated to be not readily biodegradable in water.

 

The experimental data for read-across substances (CAS: 107-06-2 and 75-09-2) also indicate that they are not readily biodegradable.

 

Hence it has been concluded that N-(2-chloroethyl)pyrrolidine hydrochloride 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:

 

The estimatedoctanol water partition coefficient of the test chemical is 1.65 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 estimation 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 at environmentally relevant concentrations and hence it was considered to be not classified as per the CLP regulation.

 

There are no available long-term toxicity evaluations for N-(2-chloroethyl)pyrrolidine hydrochloride. 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 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.