2-(hydroxymethylamino)ethanol

PBT assessment

PBT assessment: overall result

PBT status:

the substance is not PBT / vPvB

Justification:

Classification of 2-(hydroxymethylamino)ethanol for effects in the environment:

 

The chemical 2-(hydroxymethylamino)ethanol (CAS no. 34375-28-5) is used as a biocide and preservative for the protection of water based systems such as resin emulsions, adhesives, dispersed colours and ready-mixed joint cements. The aim was to assess whether the PBT criterion within Annex XIII was fulfilled for 2-(hydroxymethylamino)ethanol. 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 for the target compound2-(hydroxymethylamino)ethanol(CAS No. 34375-28-5) were reviewed for the biodegradation end point which are summarized as below:

 

In an experimental study from secondary source (EnviChem, 2014), biodegradation experiment was conducted for 14 days for evaluating the percentage biodegradability of test substance 2 -[hydroxy(methyl)amino]ethanol (CAS no. 34375-28-5). Concentration of inoculum i.e, sludge used was 30 mg/l and initial test substance conc. used in the study was 100 mg/l. The percentage degradation of test substance was determined to be 68% degradation by BOD parameter in 14 days. Thus, based on percentage degradation, test substance 2 -[hydroxy(methyl)amino]ethanol was 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 2-[hydroxy(methyl)amino]ethanol(CAS No. 34375-28-5) 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 2 -[hydroxy(methyl) amino]ethanol is expected to be readily biodegradable.

 

Further, various supporting studies for read across substances (CAS: 110-63-4, 110-54-3 and 1442-82-5), also indicate that the substances are not 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 66.1%).In soil, 2-(hydroxymethylamino)ethanolwas expected to have rapid mobility based upon an estimated Log KOC in the range 0-1.06. Thehalf-life in soil (17.33 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, 33.9% and 0.059 % of the chemical will partition into water and sediment according to the Mackay fugacity model level III in EPI suite version 4.1 (2017). The half-life (8.66 days in water and 77.91 days in sediment estimated by EPI suite) indicates that the substance is not persistent in both the compartments.

 

Hence it has been concluded that 2-(hydroxymethylamino)ethanol 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 1 – 3.2 and theestimatedoctanol water partition coefficient of the test chemical is -2.20 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 in the range 27 - 447000 mg/L. Further, the substance was determined to be readily biodegradable in nature. These conditions 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 2-(hydroxymethylamino)ethanol. 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.