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PBT assessment

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PBT assessment: overall result

Reference
Name:
Ethanamine, N,N-dimethyl-2-[2-(methylamino)ethoxy]-
Type of composition:
legal entity composition of the substance
State / form:
liquid
Reference substance:
Composition 1
PBT status:
the substance is not PBT / vPvB
Justification:

PBT-Assessment justification for TMAEE (CAS 93240-93-8) 'pure substance':

No experimental data are available for TMAEE (CAS 93240-93-8). Therefore, the PBT assessment the mono-constituent substance was based on the available experimental read-across data for the structurally similar substance BDMAEE (CAS 3033-62-3):

In a readily biodegradability test following OECD 301F using activated sludge from an industrial wastewater treatment plant as inoculum, the source substance proved to be not readily biodegradable (2% DOC removal after 28 d; read-across to BDMAEE, CAS 3033-62-3). Moreover, according to the inherent biodegradability test (OECD 301B) the source substance was considered to be not inherently biodegradable (< 10% DOC removal after 28 d; read-across to BDMAEE, CAS 3033-62-3). (Q)SAR data for the target chemical itself also indicate a low biodegradation potential. As the substance is concluded by a weight-of-evidence approach to be not readily biodegradable (according to OECD criteria), it should be considered as ‘potentially P/vP’ from a precautionary point of view until further data become available. TMAEE is ‘not B/vB’ based on an estimated log Kow of -0.75 (KOWWIN, v1.68). In addition, estimation data from several QSAR calculations indicate no potential for bioaccumulation (calculated BCF values range between 0.91 L/kg and 9.42 L/kg). The substance is also not T since the lowest available chronic value is >> 0.01 mg/L (P. subcapitata: 72-h ErC10 = 5 mg/L; read-across to BDMAEE, CAS 3033-62-3) and the substance holds no relevant classification.

In conclusion, the mono-constituent TMAEE (CAS 93240-93-8) does not fulfill the PBT/vPvB criteria.

 

PBT-Assessment justification for relevant impurities of TMAEE (CAS 93240-93-8):

According to REACH guidance document chapter R.11 section R.11.4.1 thePBT/vPvB assessment has to be performed for each relevant constituent present in a mixture. Constituents are considered as ‘relevant’ if the fraction is more than 0.1% (w/w) of the mixture. Therefore, the following impurities of TMAEE (CAS 93240 93-8) identified as relevant constituents were additionally considered for PBT/vPvB assessment:

 

- 2-[2-(dimethylamino)ethoxy]-N,N-dimethylethanamine (BDMAEE; CAS 3033-62-3); 1 – 9.99 % (w/w):

The substance does not meet the criteria for PBT classification.In a readily biodegradability test following OECD 301F using activated sludge from an industrial wastewater treatment plant as inoculum, BDMAEE proved to be not readily biodegradable (2% DOC removal after 28 d). Moreover, according to an inherent biodegradability test (OECD 301B) BDMAEE was considered to be not inherently biodegradable (< 10% DOC removal after 28 d). The substance should be considered as ‘potentially P/vP’ from a precautionary point of view until further data become available. BDMAEE is ‘not B/vB’, based on a measured log Kow of -0.34 at 20°C and pH 10.2. BDMAEE is also ‘not T’ since the lowest available chronic value is >> 0.01 mg/L (P. subcapitata: 72-h ErC10 = 5 mg/L) and the substance holds no relevant classification.

In conclusion, the relevant constituent BDMAEE (CAS 3033-62-3) does not fulfill the PBT/vPvB criteria.

 

 

- 2-[2-(dimethylamino)ethoxy]ethanamine (ADAN, CAS 85322-63-0); 1 – 9.99 % (w/w)

No experimental data are available for this relevant constituent. The assessment is, therefore, based on calculated (Q)SAR data. The biodegradation potential of ADAN was assessed using three ready biodegradability models of OASIS Catalogic v5.12.1: Kinetic 301B v02.09, 301C v10.14 and Kinetic 301F v13.16. The removal rates of TMAEE were 1.2%, 51%, and 17%, respectively. Furthermore, BIOWIN v4.10 of EPI Suite v4.11 was applied to estimate the biodegradability of constituent; the model predicted ADAN to be not readily biodegradable. The constituent should be considered as ‘potentially P/vP’ from a precautionary point of view until further data become available. ADAN is considered to be ‘not B/vB’, based on an estimated log Kow of -1.22 (KOWWIN v1.68; substance within AD). Furthermore, ADAN is concluded to be ‘not T’ since the lowest calculated effect value available is >> 0.1 mg/L (fish: LC50 >100 mg/L; SarPY/IRFMN v1.0.2; substance in AD) and the screening criteria for toxicity according to the ‘Guidance on Information Requirements and Chemical Safety Assessment, Chapter R.11’ (ECHA, 2017) are, therefore, not fulfilled. In addition, the substance holds no relevant classification.

In conclusion, the relevant constituent ADAN (CAS 85322-63-0) does not fulfill the PBT/vPvB criteria.

 

- N-methyl-2-[2-(methylamino)ethoxy]ethanamine (ODAN, CAS 2620-27-1); 4 % (w/w)

No experimental data are available for this relevant constituent. The assessment is, therefore, based on calculated (Q)SAR data. The biodegradation potential of ODAN was assessed using three ready biodegradability models of OASIS Catalogic v5.12.1: Kinetic 301B v02.09, 301C v10.14 and Kinetic 301F v13.16. The removal rates of TMAEE were 78.7%, 66%, and 86%, respectively. Furthermore, BIOWIN v4.10 of EPI Suite v4.11 was applied to estimate the biodegradability of constituent; the model predicted ODAN to be readily biodegradable. The constituent assessed to be ‘not P’. ODAN is considered to be ‘not B/vB’, based on an estimated log Kow of -0.96 (KOWWIN v1.68; substance within AD). Furthermore, ODAN is concluded to be ‘not T’ since the lowest calculated effect value available is >> 0.1 mg/L (fish: LC50 >100 mg/L; SarPY/IRFMN v1.0.2; substance in AD) and the screening criteria for toxicity according to the ‘Guidance on Information Requirements and Chemical Safety Assessment, Chapter R.11’ (ECHA, 2017) are, therefore, not fulfilled. In addition, the substance holds no relevant classification.

In conclusion, the relevant constituent ODAN (CAS 2620-27-1) does not fulfill the PBT/vPvB criteria.

 

- 2-[2-(dimethylamino)ethoxy]ethanol (DMAEE, CAS 1704-62-7);0 – 0.75 %(w/w)

In a study following OECD 302B using non-adapted activated sludge from an industrial wastewater treatment plant as inoculum, DMAEE proved to be not readily biodegradable (<10-20 % DOC removal after 28 d). The substance should be considered as ‘potentially P/vP’ from a precautionary point of view until further data become available. DMAEE is ‘not B/vB’, based on a measured log Kow of -0.78 at 20°C. DMAEE is also ‘not T’ since the lowest available chronic value is >> 0.01 mg/L (P. subcapitata: 72-h ErC10 = 65 mg/L) and the substance holds no relevant classification.

In conclusion, the relevant constituent DMAEE (CAS 1704-62-7) does not fulfill the PBT/vPvB criteria. 

 

 - N-Methylmorpholine (NMM, CAS 109-02-4); 0.1 – 0.5 % (w/w)

In a study following OECD 301F using domestic activated sludge as inoculum, NMM proved to be readily biodegradable (75%, based on O2 consumption after 28 d). Moreover, degradation of NMM was 90% after 28 d (based on DOC removal) in an OECD 302B guideline study. The constituent assessed to be ‘not P’. NMM is ‘not B/vB’, based on a measured log Kow of -0.32 at 25°C. NMM is also ‘not T’ since the lowest available chronic value is >> 0.01 mg/L (96-h ErC10 = 35.3 mg/L; read-across data from CAS 100-74-5) and the substance holds no relevant classification.

In conclusion, the relevant constituent NMM (CAS 109-02-4) does not fulfill the PBT/vPvB criteria.

 

Summing up, none of the relevant constituents of the target substance TMAEE (CAS 93240-93-8) fulfills the PBT/vPvB criteria.