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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 Methylammonium chloride for effects in the environment:

 

The chemical Methylammonium chloride (CAS no. 593-51-1) is used as intermediate for chemical synthesis and as a laboratory chemical. The aim was to assess whether the PBT criterion within Annex XIII was fulfilled for Methylammonium 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 fulfils the P criterion within Annex XIII based on the assessment that here follows:

 

Biotic degradation

Biodegradation study was conducted for 14 days for evaluating the percentage biodegradability of test substance Methylamine hydrochloride (CAS no. 593 -51 -1). Concentration of inoculum i.e., sludge used was 30 mg/l and initial test substance conc. used in the study was 100 mg/l, respectively. The percentage degradation of test substance was determined to be 84, 96 and 100% degradation by O2consumption, BOD (NH3), TOC removal, test material analysis and HPLC parameter in 14 days. Thus, based on percentage degradation, Methylamine hydrochloride is considered to be readily biodegradable in nature.

 

In a predicted data done using the Estimation Programs Interface Suite (EPI suite, 2017), the biodegradation potential of the test compound methanaminium chloride (CAS no. 593-51-1) in the presence of mixed populations of environmental microorganisms was estimated. 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 methanaminium chloride is expected to be readily biodegradable.

 

Various biodegradation studies available for read-across substance (CAS: 74-89-5) also indicate that it is readily biodegradable in nature.

 

Environmental fate

According to the fugacity model levels III, the most likely environmental fate for this test chemical is soil (i.e.estimated to 71%).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 low.

 

If released in to the environment, 29 % 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 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 Methylammonium 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:

 

The estimated BCF value from various databases was determined to be in the range 3.1-3.2 and the octanol water partition coefficient (Log Pow) of the test chemical is estimated as -3.82 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 fish, 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 Methylammonium chloride.

By speculation, long-term NOEC for aquatic organisms were not expected for Methylammonium chloride 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.