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Classification & Labelling & PBT assessment

PBT assessment

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PBT assessment: overall result

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

Classification of 3-aminopropylmethylamine for effects in the environment:

 

The chemical 3-aminopropylmethylamine (CAS no. 6291-84-5) is used as intermediate in chemical synthesis and as a laboratory agent. The aim was to assess whether the PBT criterion within Annex XIII was fulfilled for 3-aminopropylmethylamine. 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

Various experimental studies and predicted data for the target compound (3-aminopropyl)(methyl) amine (CAS No. 6291-84-5) were reviewed for the biodegradation end point which are summarized as below:

 

In an experimental key study from peer reviewed journal (Ingvild Eide-Haugmo et. al; 2012), biodegradation study was conducted for 28 days for evaluating the percentage biodegradability of test substance (3-aminopropyl)(methyl)amine (CAS no. 6291 -84 -5). The study was performed according to OECD Guideline 306 (Biodegradability in Seawater).The test chemical was obtained commercially (Sigma-aldrich or Fluka) with purity of >95%. No further purification was necessary before testing. Seawater was used as a test inoculum for the study collected from an expected non-polluted location (90 m depth in the Trondheimsfjord, Norway)and filtered (50µm).Seawater was stored in dark conditions for 2-5 days in 10 L tanks at 20 ± 2°C.The aged seawater was aerated for 20 min and fortified with nutrient solutions enhancing bacterial growth. Test solutions were prepared by diluting the compound tested to 2 mg/l. Aged and fortified seawater was used as a test medium for the study. Additional nutrient solutions were added to the test medium. Aniline (diluted to 2 mg/l in the aged and nutrient-fortified seawater) was used as a reference substance for the study. Aged and fortified seawater without any test or reference chemical was used as a blank sample. The solutions were distributed as duplicates in bottles with stoppers, each bottle was completely filled without air bubbles present. The bottles were incubated for upto 28 days at 20 ± 2°C.Bottles in each series with blank, test and reference solutions were removed for measurements at day 0, 5, 15 and 28, during the incubation period. The concentrations of dissolved oxygen (DO) in separate bottles were measured with a probe connected to a dissolved oxygen meter (YSI Instruments, YSI Inc., Yellow Springs, OH). The content of each bottle was discarded after measurement. During each measurement the temperature in one of the blank bottles was recorded with the temperature sensor of the oxygen probe. The BOD values were calculated as the difference in DO between blank solution and the test solutions. BOD was calculated as mg BOD/mg test solution. The final results were given as percentage BOD relative to the theoretical oxygen demand (ThOD) calculated under the assumption that nitrogen is eliminated as ammonia. The percentage degradation of test substance (3-aminopropyl)(methyl)amine was determined to be70.9% by BOD parameter in 28 days. Thus, based on percentage degradation, (3-aminopropyl)(methyl)amine is considered to be readily biodegradable in nature.  

 

In a supporting study, biodegradation study was conducted for 28 days for evaluating the percentage biodegradability of test substance (3-aminopropyl)(methyl)amine (CAS no. 6291 -84 -5)(Ingvild Eide-Haugmo et. al; 2009). The study was performed according to OECD Guideline 306 (Biodegradability in Seawater). The test chemical was diluted in normal seawater which had been aged for 3-5 days, and essential nutrients for the bacteria in the seawater were added. Seawater without chemical was used for blank samples. Aniline (diluted in sea water) was used as a reference substance for the study. The solutions were distributed as duplicates in bottles with stoppers, and incubated in the dark for 28 days at 20 ± 2°C. A dissolved oxygen meter was used to measure the concentration of dissolved oxygen in solution.At the start of the experiment and after 5, 15 and 28 days bottles in each series with blank, test and reference solutions were removed for measurements. After measurement the bottles were discharged. The biological oxygen demand (BOD) was used as a measure for biodegradation. The BOD values were calculated as the difference in dissolved oxygen between solution with blank and test solutions, and the percentage of the theoretical oxygen demand (ThOD) was calculated. The percentage degradation of test substance (3-aminopropyl)(methyl)amine was determined to be 70% by BOD parameter in 28 days. Thus, based on percentage degradation, (3-aminopropyl) (methyl)amine is considered to be readily biodegradable in nature.

 

Another biodegradation study (from authoritative database J-CHECK, 2017) was conducted for 28 days for evaluating the percentage biodegradability of test substance (3-aminopropyl) (methyl)amine (CAS no. 6291-84-5). 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 (3 -amino propyl)(methyl)amine was determined to be 89, 95 and 100% by BOD(NH3), TOC removal and HPLC parameter in 28 days. Thus, based on percentage degradation, (3 -amino propyl)(methyl)amine is considered to be readily biodegradable in nature.

 

In a prediction using the Estimation Programs Interface Suite (EPI suite, 2017), the biodegradation potential of the test compound(3-aminopropyl)(methyl) amine(CAS No. 6291-84-5) 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 chemical (3-aminopropyl)(methyl)amine is expected 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 75.2%). In soil, 3-aminopropylmethylamine was expected to have rapid mobility based upon a Log KOCin the range 0 – 1.48. 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, 24.7 % 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 3-aminopropylmethylamine 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 various databases was determined to be in the range 1.0 – 3.162 and theoctanol water partition coefficient of the test chemical is -0.66 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 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 for aquatic toxicity as per the CLP regulation.

 

There are no available long-term toxicity evaluations for 3-aminopropylmethylamine. 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.