Registration Dossier

Administrative data

Hazard for aquatic organisms

Freshwater

Hazard assessment conclusion:
PNEC aqua (freshwater)
PNEC value:
0.1 mg/L
Assessment factor:
1 000
Extrapolation method:
assessment factor
PNEC freshwater (intermittent releases):
1 mg/L

Marine water

Hazard assessment conclusion:
PNEC aqua (marine water)
PNEC value:
0.01 mg/L
Assessment factor:
10 000
Extrapolation method:
assessment factor

STP

Hazard assessment conclusion:
PNEC STP
PNEC value:
10 mg/L
Assessment factor:
100
Extrapolation method:
assessment factor

Sediment (freshwater)

Hazard assessment conclusion:
PNEC sediment (freshwater)
PNEC value:
3.55 mg/kg sediment dw
Extrapolation method:
equilibrium partitioning method

Sediment (marine water)

Hazard assessment conclusion:
PNEC sediment (marine water)
PNEC value:
0.355 mg/kg sediment dw
Extrapolation method:
equilibrium partitioning method

Hazard for air

Air

Hazard assessment conclusion:
no hazard identified

Hazard for terrestrial organisms

Soil

Hazard assessment conclusion:
PNEC soil
PNEC value:
0.649 mg/kg soil dw
Extrapolation method:
equilibrium partitioning method

Hazard for predators

Secondary poisoning

Hazard assessment conclusion:
no potential for bioaccumulation

Additional information

Conclusion on classification

 

Classification Justification for 2-aminoethyldiisopropylamine (CAS 121-05-1) ‘pure substance’:

‘Pure substance’ - Official classification regarding environmental hazards

Aquatic compartment

In accordance with Regulation (EC) 1272/2008 Annex VI Table 3.1, the pure substance is not officially classified as hazardous to the environment.

In accordance with Regulation (EC) 1272/2008 Annex VI Table 3.2, the pure substance is not officially classified as hazardous to the environment.

 

‘Pure substance’: Self-classification

Aquatic compartment 

Following GHS, the pure substance is not to be classified as acutely hazardous to the aquatic environment. Based on the available acute and chronic data, the pure substance is not to be classified as chronically hazardous to the aquatic environment.

 

Rationale:

The pure substance is not to be classified as acutely hazardous to the aquatic environment, since the lowest acute effect value is > 1 mg/L.

 

Chronic data are available only for algae; therefore classification is based on the available chronic and acute toxicity data.

- Chronic toxicity data:

Chronic data are available only for algae (read-across to ethyldiisopropylamine, CAS 7087-68-5; 72-h EC10 = 52 mg/L indicating that the substance does not present a long-term hazard according to the categories outlined in Table 4.1.0(b) (i) (Commission Regulation (EU) No 286/2011 amending Regulation (EC) No 1272/2008) for non-rapidly degradable substances.

- Acute toxicity data:

Acute toxicity to aquatic organisms (LC/EC50) is >100mg/L in freshwater (48 -h EC50 Daphnids: > 100 mg/L; pH-adjusted; 96 -h LC50 fish: >100 mg/L).

The substance is not rapidly biodegradable (freshwater) and the log Kow is <4.

 

Atmospheric compartment

The pure substance is not in Annex I of Regulation (EC) 2037/2000 on substances that deplete the ozone layer.

The pure substance does not belong to the greenhouse gases listed in P Forster, PV Ramaswamy et al. Changes in Atmospheric Constituents and in Radiative Forcing. In: Climate Change 2007: The Physical Basis. Contribution of Working Group I to the Fourth Assessment Report of the Intergovernmental Panel on Climate Change.

 

Classification Justification for 2-aminoethyldiisopropylamine (CAS 121-05-1) ‘crude material’:

According to the REACh ‘Guidance on the Application of CLP Criteria’, Part 4 (ECHA; June 2015) the classification of a mixture is to be based on the available information on the relevant components, if no or inadequate test data on the mixture itself are available and bridging principles based on similar tested mixtures are not applicable. According to REACh ‘Guidance on the Application of CLP Criteria’, Part 4 (ECHA; June 2015) the summation method was applied, since classification data are available for the most relevant components of the crude material. In case of absence of any classification- or toxicity data for a respective component, the classification data for the structurally analogous component 2-diisopropylaminoethanol (CAS 96-80-0) were used for classification purposes.

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

Constituent

Concentration
(%
w/w)

PBT criteria

Classification data

2-Aminoethyldiisopropylamine
(CAS 121-05-1)

ca. 72

> 70.0–≤75.0

Not fulfilled

- No harmonized CLP classification[1];

- CLP self-classification: not to be classified

Diisopropylamine
(CAS 108 -18 -9)

ca. 6.0

≥ 4.0 – ≤ 8.0

Not fulfilled

- No relevant harmonized CLP classification[1];

- CLP self-classification:

Aquatic Chronic 3

2-Diisopropylaminoethanol
(CAS 96-80-0)

ca. 2.5

≥ 1.0 – ≤ 4.0

Not fulfilled

- No harmonized CLP classification[1];

- CLP self-classification:

Aquatic Chronic 3

Diisopropyldiethylenetriamine
(CAS 859799-22-7)

ca. 0.5

≥ 0.0 – ≤ 1.0

No data[2]

No classification or toxicity data available[2];

read across to structural analogue CAS 96-80-0

Dimethylamine
(CAS 124-40-3)

ca. 0.5

≥ 0.0 – ≤ 1.0

Not fulfilled

- No relevant harmonized CLP classification[1];

- CLP self-classification:

Aquatic Chronic 3

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

ca. 2.0

≥ 1.0 – ≤ 3.0

No data[2]

- Harmonized CLP classification[1]: Aquatic Acute 1

- CLP self-classification:

Aquatic Chronic 3

N-Isopropylethylenediamine
(CAS 19522-67-9)

ca. 0.5

≥ 0.0 – ≤ 1.0

Not fulfilled

- No harmonized CLP classification[1];

- No relevant CLP self-classification

Diisopropylmethylamine
(CAS 10342-97-9)

ca. 0.5

≥ 0.0 – ≤ 1.0

Not fulfilled

- No harmonized CLP classification[1];

- No relevant CLP self-classification

Tetraisopropyldiethylenetriamine
(CAS 956700-19-9)

ca. 2.5

≥ 2.0 – ≤ 5.0

No data[2]

No classification or toxicity data available[2];

read across to structural analogue CAS 96-80-0

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

ca. 0.5

≥ 0.0 – ≤ 1.0

No data[2]

No classification or toxicity data available[2];

read across to structural analogue CAS 96-80-0

Unkown organic compounds

ca. 1.0

≥ 0.0 – ≤ 2.0

-

-

Water (CAS 7732-18-5)

ca. 11.5

≥ 8.0 – ≤ 14.0

Not applicable

- No harmonized CLP classification[1];

- No relevant CLP self-classification

[1]according to Regulation No (EC) 1272/2008 Annex VI

[2]No data found on ECHA website (https://echa.europa.eu/); search date: 13. Sep. 2017

 

 

‘Crude material’ - Official classification regarding environmental hazards

Aquatic compartment

According to Regulation (EC) 1272/2008 Annex VI Table 3.1, the relevant component ammonia, aqueous solution (CAS 1336-21-6) is classified as hazardous to the environment (Acute 1). None of the remaining relevant components as well as the crude material of the substance are classified as hazardous to the environment.

 

According to Regulation (EC) 1272/2008 Annex VI Table 3.2, the relevant component ammonia, aqueous solution (CAS 1336-21-6) is classified as hazardous to the environment (Acute 1). None of the remaining relevant components as well as the crude material of the substance are classified as hazardous to the environment.

 

‘Crude material’ - Self-classification

Following GHS/CLP (summation method), 2-aminoethyldiisopropylamine (CAS 121-05-1) ‘crude material’ is not to be classified as acutely hazardous to the aquatic environment. Based on a worst-case approach the crude material should be classified as chronically hazardous to the aquatic environment (chronic 3).

 

Rationale:

The relevant component ammonia, aqueous solution (CAS 1336-21-6) is classified as acutely hazardous to the environment (Acute 1). However, the crude material of the substance is not to be classified as acutely hazardous to the aquatic environment, since the sum of the fractions of all components classified as ‘Acute 1’ x M-factor (M = 1) is < 25 %.

 

The chronic hazard classification is based on the available self classification data on the relevant components. The following six components are classified as ‘chronic 3’:

- Diisopropylamine (CAS 108 -18 -9): ca. 6.0% w/w

- Dimethylamine (CAS 124-40-3): ca. 0.5% w/w

- 2-diisopropylaminoethanol (CAS 96-80-0): ca. 2.5% w/w

- Ammonia, aqueous solution (CAS 1336 -21 -6): ca. 2.0% w/w

- Diisopropyldiethylenetriamine (CAS 859799 -22 -7): ca. 0.5% w/w

- Tetraisopropyldiethylenetriamine (CAS 956700 -19 -9): ca. 2.5% w/w

- N',N'-diisopropyl-N-methyl-ethane-1,2 -diamine (CAS98948 -62 -0): ca. 0.5% w/w

 

The sum of the concentrations (in %) of all components, classified as Chronic 3, is < 25% (ca. 14.5% w/w, based on typical concentrations). However, considering a worst-case approach, the crude material of the substance should be classified as chronically hazardous to the aquatic environment (chronic 3).