Registration Dossier

Classification & Labelling & PBT assessment

PBT assessment

Currently viewing:

Administrative data

PBT assessment: overall result

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

PBT-Assessment justification for 2-aminoethyldiisopropylamine (CAS 121-05-1) ‘pure substance’:

The available evidence on biodegradation is not sufficient for an assessment based on the Annex XIII criteria for Persistence (P and vP). Based on a weight-of-evidence approach the substance is concluded to be not readily biodegradable; therefore, it should be considered as potentially P/vP from a precautionary point of view, until further data become available. 

The measured log Kow indicates no potential for bioaccumulation; therefore, the substance is not B/vB.

Regarding “T”, chronic toxicity data are available for algae. For daphnids and fish, acute toxicity data are available. Considering the acute toxicity to fish, the assessment is based on (Q)SAR predictions. The chronic value is clearly greater than 0.01 mg/L. The substance does not hold any relevant official classifications. In addition, the screening criteria for T based on acute toxicity data are not fulfilled.  

 

In conclusion, 2-aminoethyldiisopropylamine (CAS 121-05-1) ‘pure substance’ is assessed to neither fulfill the PBT criteria (not PBT) nor the vPvB criteria (not vPvB).

 

PBT-Assessment justification for 2-aminoethyldiisopropylamine (CAS 121-05-1) ‘crude material’:

The ‘crude material’ of 2-aminoethyldiisopropylamine (CAS 121-05-1) is a mixture that consists of the following components:

Constituent

Concentration(%w/w)

2-Aminoethyldiisopropylamine (CAS 121-05-1)

ca. 82; > 80.05–≤92.0

Ethylenediamine (CAS 107-15-3)

ca. 6.8; ≥ 4.0 – ≤ 9.0

2-Diisopropylaminoethanol (CAS 96-80-0)

ca. 2.8; ≥ 1.0 – ≤ 4.5

Diisopropyldiethylenetriamine (CAS 859799-22-7)

ca. 0.6; ≥ 0.0 – ≤ 1.1

Dimethylamine (CAS 124-40-3)

ca. 0.6; ≥ 0.0 – ≤ 1.1

Ammonium hydroxide solution (CAS1336-21-6)

ca. 2.3; ≥ 1.0 – ≤ 3.4

N-Isopropylethylenediamine (CAS 19522-67-9)

ca. 0.6; ≥ 0.0 – ≤ 1.1

Diisopropylmethylamine (CAS 10342-97-9)

ca. 0.6; ≥ 0.0 – ≤ 1.1

Tetraisopropyldiethylenetriamine (CAS 956700-19-9)

ca. 2.8; ≥ 2.0 – ≤ 5.6

N',N'-diisopropyl-N-methyl-ethane-1,2-diamine (CAS 98948-62-0)

ca. 0.6; ≥ 0.0 – ≤ 1.1

Unkown organic compounds

ca. 1.1; ≥ 0.0 – ≤ 2.3

According to the REACh guidance document chapter R.11, constituents being present in a concentration of ≥ 0.1% (w/w) are defined to be relevant for PBT/vPvB assessment. Therefore, the assessment is performed on each relevant constituent:

- 2-Aminoethyldiisopropylamine (CAS 121-05-1):

The substance does not meet the criteria for PBT classification (see PBT-Assessment justification for 2-aminoethyldiisopropylamine (CAS 121-05-1) ‘pure substance’).

- Ethylenediamine (CAS 107-15-3):

The substance does not meet the criteria for PBT classification. The substance was determined to be readily biodegradable according to OECD criteria. Hence, the substance does not fulfil the P/vP criteria. The log Kow indicates no potential for bioaccumulation; therefore, the substance is not B/vB. The substance is assessed to be “not T”, based on the lowest experimental chronic toxicity data available for daphnids; in addition, the substance does not hold any relevant official classifications. In addition, the screening criteria for T based on acute toxicity data are not fulfilled. In summary, Ethylenediamine (CAS 107-15-3) does not meet the criteria for PBT classification.

- 2-Diisopropylaminoethanol (CAS 96-80-0):

The substance does not meet the criteria for PBT classification. The available evidence on biodegradation is not sufficient for an assessment based on the Annex XIII criteria for Persistence (P and vP). As the substance is concluded to be not readily biodegradable as well as to be hydrolytically stable, it should be considered as potentially P/vP from a precautionary point of view, until further data become available. The log Kow indicates no potential for bioaccumulation; therefore, the substance is not B/vB. Long-term toxicity data are not available; however, the substance does not hold any relevant official classifications. The screening criteria for T are not fulfilled. The available acute toxicity data for fish, invertebrates and algae are > 0.1 mg/L. Therefore, the substance is assessed to be not T.

In summary, 2-diisopropylaminoethanol (CAS 96-80-0) does not meet the criteria for PBT classification.

- 1,2-Ethanediamine, N2-(2-aminoethyl)-N1,N1-bis(1-methylethyl)- (CAS 859799-22-7):

1,2-Ethanediamine, N2-(2-aminoethyl)-N1,N1-bis(1-methylethyl)- (CAS 859799-22-7) is a relevant constituent of the 'crude material' (typical concentration: ca. 0.6%). No information are available on the environmental fate, toxicity and classification of the substance. Therefore, a read-across to the structurally similar component 2-diisopropylaminoethanol (CAS 96-80-0) is performed. According to the read-across approach, the substance does not meet the criteria for PBT classification.

- Dimethylamine (CAS 124-40-3):

The substance does not meet the criteria for PBT classification. Based on the results from a MITI-I (OECD 301C) test the substance is assessed to be readily biodegradable according to OECD criteria (not P/vP). The log Kow indicates no potential for bioaccumulation; therefore, the substance is not B/vB. The lowest chronic toxicity value is > 0.01 mg/L and the substance does not hold any relevant official classifications. In addition, the screening criteria for T are not fulfilled. The available acute toxicity data for fish, invertebrates and algae are > 0.1 mg/L. Therefore, the substance is assessed to be not T.

In summary, dimethylamine (CAS 124-40-3) does not meet the criteria for PBT classification.

- Ammonia, aqueous solution (CAS 1336-21-6):

The log Kow indicates no potential for bioaccumulation; therefore, the substance is not B/vB. According to Regulation (EC) 1272/2008 Annex VI Table 3.1, ammonia, aqueous solution (CAS 1336-21-6) is officially classified as hazardous to the environment (acute 1) with an given M-factor of 1. Considering environmental toxicity, a multiplying factor of 1 corresponds to L(E)C50 values in a range of >0.1 - ≤ 1 mg/L . Therefore, the substance does not fulfill the screening criteria for T; hence, the substance is assessed to be not T. Regarding persistency, there are no data available for the substance; therefore, no conclusion can be reached at this juncture. However, as the substance neither fulfills the criteria for B/vB nor the criteria for T, it is consequently concluded to not fulfill the criteria for PBT/vPvB classification.

In summary, ammonia, aqueous solution (CAS 1336-21-6) does not meet the criteria for PBT classification.

- N-Isopropylethylenediamine (CAS 19522-67-9):

Since there are no adequate data available for the substance itself, the PBT-assessment is based on a read-across approach to the structurally analogous component 2-diisopropyaminoethanol (CAS 96-80-0). The substance does not meet the criteria for PBT classification (see PBT-Assessment justification for 2-diisopropyaminoethanol, CAS 96-80-0).

- 1,2-Ethanediamine, N2-[2-[bis(1-methylethyl)amino]ethyl]-N1,N1-bis(1-methylethyl)- (CAS 956700-19-9)

1,2-Ethanediamine, N2-[2-[bis(1-methylethyl)amino]ethyl]-N1,N1-bis(1-methylethyl)- (CAS 956700-19-9) is a relevant constituent of the 'crude material' (typical concentration: ca. 0.6%). No information are available on the environmental fate, toxicity and classification of the substance. Therefore, a read-across to the structurally similar component 2-diisopropylaminoethanol (CAS 96-80-0) is performed. According to the read-across approach, the substance does not meet the criteria for PBT classification.

- N',N'-diisopropyl-N-methyl-ethane-1,2-diamine (CAS 98948-62-0)

N',N'-diisopropyl-N-methyl-ethane-1,2-diamine (CAS 98948-62-0) is a relevant constituent of the 'crude material' (typical concentration: ca. 0.6%). No information are available on the environmental fate, toxicity and classification of the substance. Therefore, a read-across to the structurally similar component 2-diisopropylaminoethanol (CAS 96-80-0) is performed. According to the read-across approach, the substance does not meet the criteria for PBT classification.

 

Conclusion:

Based on the single PBT/vPvB assessments performed on each relevant constituent, the ‘crude material’ of 2-aminoethyldiisopropylamine (CAS 121-05-1) is concluded to neither fulfill the PBT criteria (not PBT) nor the vPvB criteria (not vPvB).