Registration Dossier

Administrative data

Hazard for aquatic organisms

Freshwater

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

Marine water

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

STP

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

Sediment (freshwater)

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

Sediment (marine water)

Hazard assessment conclusion:
PNEC sediment (marine water)
PNEC value:
0.015 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:
0.017 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 TMAEE (CAS 93240-93-8) ‘mono-constituent’:

‘Mono-constituent’ - Official classification regarding environmental hazards

Aquatic compartment

According to Regulation (EC) 1272/2008 Annex VI Table 3.1, the substance is not classified as hazardous to the environment.

According to Regulation (EC) 1272/2008 Annex VI Table 3.2, the substance is not classified as hazardous to the environment.

 

‘Mono-constituent’: Self-classification

Aquatic compartment 

In absence of experimental data for TMAEE (CAS 93240-93-8) itself, the classification of the substance was based on read-across data from the structurally analogous substance BDMAEE (CAS 3033-62-3):

Following GHS/CLP, the substance is not to be classified as acutely hazardous to the aquatic environment, based on the available acute read across data. Based on the available acute and chronic read-across data, the substance is not to be classified as chronically hazardous to the aquatic environment.

 

Rationale:

According to the criteria outlined in Table 4.1.0(a) (Commission Regulation (EU) No 286/2011 amending Regulation (EC) No 1272/2008) the substance is not to be classified as acutely hazardous to the aquatic environment as the lowest acute effect value is higher than 1 mg/L. (Read-across to BDMAEE, CAS 3033-62-3; algae: 72-h ErC50: 24 mg/L; RCC Ltd. 2008). 

Chronic toxicity data are available only for algae. Therefore, classification is based on the available chronic data for algae and acute toxicity data for the trophic levels not covered by chronic data (fish and aquatic invertebrates).

- Classification based on chronic toxicity data (algae): The substance is not rapidly degradable (based on read-across to BDMAEE, CAS 3033-62-3; see IUCLID chapter 5.2.1) and the ErC10 is > 1 mg/L (Read-across to BDMAEE, CAS 3033-62-3; algae: 72-h ErC10 = 5 mg/L, RCC Ltd., 2008). According to the criteria outlined in Table 4.1.0(b) (i) (Commission Regulation (EU) No 286/2011 amending Regulation (EC) No 1272/2008), the substance is not to be classified as chronically hazardous to the aquatic environment.

- Classification based on acute toxicity data (fish and Daphnids): The lowest EC50 was determined for aquatic invertebrates (Read-across to BDMAEE, CAS 3033-62-3:48-h EC50 = 102 mg/L; RCC Ltd., 2008), the substance is not rapidly degradable (based on read-across to BDMAEE, CAS 3033-62-3; see IUCLID chapter 5.2.1), the log Kow is < 4. According to the criteria outlined in Table 4.1.0(b) (iii) (Commission Regulation (EU) No 286/2011 amending Regulation (EC) No 1272/2008), the substance is not to be classified as chronically hazardous to the aquatic environment.

In summary,based on the available acute and chronic read-across data for BDMAEE (CAS 3033-62-3), the mono-constituent TMAEE (CAS 93240-93-8) itself is neither to be classified as acutely hazardous nor to be classified as chronically hazardous to the aquatic environment.

  

Atmospheric compartment

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

The 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 relevant impurities of TMAEE (CAS 93240-93-8):

TMAEE (CAS 93240-93-8)is a mono-constituent substance that has a purity of 80-100 % (w/w). According to the ‘Guidance on the Application of the CLP-Criteria” (v4.1; ECHA, 2015) the relevant impurities of a substance still meeting the definition ‘mono-constituent’ may influence the classification of the substance. Therefore, the following impurities of TMAEE (CAS 93240‑93-8) identified as relevant constituents were additionally considered in terms of classification purposes:

 

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

no harmonized CLP classification according to Regulation No (EC) 1272/2008 Annex VI; CLP self-classification: not classified

 

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

no harmonized CLP classification according to Regulation No (EC) 1272/2008 Annex VI; CLP self-classification: not classified

 

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

no harmonized CLP classification according to Regulation No (EC) 1272/2008 Annex VI; CLP self-classification: not classified

 

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

no harmonized CLP classification according to Regulation No (EC) 1272/2008 Annex VI; CLP self-classification: not classified

 

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

no harmonized CLP classification according to Regulation No (EC) 1272/2008 Annex VI; CLP self-classification: not classified

The data matrix used for classification purposes of the relevant constituents of TMAEE (CAS 93240-93-8) are given in ‘Read-Across Justification Document’-attachment (see e.g. IUCLID chapters 5.2.1, 6.1.1, etc.).

‘Relevant Constituents of TMAEE (CAS 93240-93-8)’ - Official classification regarding environmental hazards

Aquatic compartment

According to Regulation (EC) 1272/2008 Annex VI Table 3.1, none of the relevant constituents are classified as hazardous to the environment.

According to Regulation (EC) 1272/2008 Annex VI Table 3.2, none of the relevant constituents are classified as hazardous to the environment.

 

‘Relevant Constituents of TMAEE (CAS 93240-93-8)’ - Self-classification

Following GHS/CLP, none of the relevant constituents of TMAEE (CAS 93240-93-8) is to be classified as acutely hazardous to the aquatic environment. Furthermore, none of the relevant components is to be classified as chronically hazardous to the aquatic environment.

 

Rationales:

BDMAEE (CAS 3033-62-3):

Regarding acute toxicity,algae turned out to be the most sensitive trophic level with a 72-h ErC50 of 24 mg/L (RCC Ltd., 2008). According to the criteria outlined in Table 4.1.0(a) (Commission Regulation (EU) No 286/2011 amending Regulation (EC) No 1272/2008) the substance is not to be classified as acutely hazardous to the aquatic environment as the lowest acute effect value is higher than 1 mg/L.

Chronic toxicity data are available only for algae. Therefore, classification is based on the available chronic data for algae and acute toxicity data for the trophic levels not covered by chronic data (fish and aquatic invertebrates).

Classification based on chronic toxicity data (algae): The substance is not rapidly degradable and the ErC10 is > 1 mg/L (algae: 72 -h ErC10 = 5 mg/L). According to the criteria outlined in Table 4.1.0(b) (i) (Commission Regulation (EU) No 286/2011 amending Regulation (EC) No 1272/2008), the substance is not to be classified as chronically hazardous to the aquatic environment.

Classification based on acute toxicity data (fish and Daphnids): The lowest EC50 was determined for aquatic invertebrates (48-h EC50 = 102 mg/L), the substance is not rapidly degradable, the log Kow is < 4. According to the criteria outlined in Table 4.1.0(b) (iii) (Commission Regulation (EU) No 286/2011 amending Regulation (EC) No 1272/2008), the substance is not to be classified as chronically hazardous to the aquatic environment.

In summary, based on the available acute and chronic toxicity data BDMAEE (CAS 3033-62-3) is neither to be classified as acutely hazardous, nor to be classified as chronically hazardous to the aquatic environment.

ADAN (CAS85322-63-0):

No experimental data are available for this relevant constituent. The assessment is, therefore, based on calculated (Q)SAR data.

Regarding acute toxicity,the lowest estimated EC/LC50 value available is a LC50 of >100 mg/L for fish (SarPy/IRFMN v1.0.2; [86]); the substance was within the model’s applicability domain. According to the criteria outlined in Table 4.1.0(a) (Commission Regulation (EU) No 286/2011 amending Regulation (EC) No 1272/2008) the substance is not to be classified as acutely hazardous to the aquatic environment as the lowest acute effect value is higher than 1 mg/L.

Chronic toxicity data are not available. Therefore, classification is based on the available acute toxicity data for the trophic levels not covered by chronic data (fish, aquatic invertebrates and algae). The lowest estimated EC/LC50 value available is a LC50 of >100 mg/L for fish (SarPy/IRFMN v1.0.2; [86]); the substance was within the model’s applicability domain. The substance is estimated to be not rapidly degradable, the log Kow is estimated to be < 4; the BCF is estimated to be < 500 L/kg. According to the criteria outlined in Table 4.1.0(b) (iii) (Commission Regulation (EU) No 286/2011 amending Regulation (EC) No 1272/2008), the substance is not to be classified as chronically hazardous to the aquatic environment.

In summary,ADAN (CAS 85322-63-0)is neither to be classified as acutely hazardous, nor to be classified as chronically hazardous to the aquatic environment.

ODAN (CAS 2620-27-1):

No experimental data are available for this relevant constituent. The assessment is, therefore, based on calculated (Q)SAR data.

Regarding acute toxicity,the lowest estimated EC/LC50 value available is a LC50 of >100 mg/L for fish (SarPy/IRFMN v1.0.2; [83]); the substance was within the model’s applicability domain. According to the criteria outlined in Table 4.1.0(a) (Commission Regulation (EU) No 286/2011 amending Regulation (EC) No 1272/2008) the substance is not to be classified as acutely hazardous to the aquatic environment as the lowest acute effect value is higher than 1 mg/L.

Chronic toxicity data are not available. Therefore, classification is based on the available acute toxicity data for the trophic levels not covered by chronic data (fish, aquatic invertebrates and algae). The lowest estimated EC/LC50 value available is a LC50 of >100 mg/L for fish (SarPy/IRFMN v1.0.2; [83]); the substance was within the model’s applicability domain. The substance is estimated to be rapidly degradable, the log Kow is estimated to be < 4; the BCF is estimated to be < 500 L/kg. According to the criteria outlined in Table 4.1.0(b) (iii) (Commission Regulation (EU) No 286/2011 amending Regulation (EC) No 1272/2008), the substance is not to be classified as chronically hazardous to the aquatic environment.

In summary,ODAN (CAS 2620-27-1)is neither to be classified as acutely hazardous, nor to be classified as chronically hazardous to the aquatic environment.

 

DMAEE (CAS 1704-62-7):

Regarding acute toxicity, aquaticinvertebrates turned out to be the most sensitive trophic level with a 48-h EC50 of >100 mg/L. According to the criteria outlined in Table 4.1.0(a) (Commission Regulation (EU) No 286/2011 amending Regulation (EC) No 1272/2008) the substance is not to be classified as acutely hazardous to the aquatic environment as the lowest acute effect value is higher than 1 mg/L.

Chronic toxicity data are available only for algae. Therefore, classification is based on the available chronic data for algae and acute toxicity data for the trophic levels not covered by chronic data.

Classification based on chronic toxicity data (algae): The substance is not rapidly degradable and the ErC10 is > 1 mg/L (algae: 72 -h ErC10 = 63 mg/L). According to the criteria outlined in Table 4.1.0(b) (i) (Commission Regulation (EU) No 286/2011 amending Regulation (EC) No 1272/2008), the substance is not to be classified as chronically hazardous to the aquatic environment.

Classification based on acute toxicity data: The lowest EC50 was determined for aquatic invertebrates (48-h EC50 >100 mg/L), the substance is not rapidly degradable, the log Kow is < 4. According to the criteria outlined in Table 4.1.0(b) (iii) (Commission Regulation (EU) No 286/2011 amending Regulation (EC) No 1272/2008), the substance is not to be classified as chronically hazardous to the aquatic environment.

In summary,based on the available acute and chronic toxicity data DMAEE (CAS 1704-62-7) is neither to be classified as acutely hazardous, nor to be classified as chronically hazardous to the aquatic environment.

NMM (CAS 109-02-4):

Regarding acute toxicity, aquaticinvertebrates turned out to be the most sensitive trophic level with a 48-h EC50 of >100 mg/L. According to the criteria outlined in Table 4.1.0(a) (Commission Regulation (EU) No 286/2011 amending Regulation (EC) No 1272/2008) the substance is not to be classified as acutely hazardous to the aquatic environment as the lowest acute effect value is higher than 1 mg/L.

Chronic toxicity data are available only for algae (read-across data from CAS 100-74-3). Therefore, classification is based on the available chronic data for algae and acute toxicity data for the trophic levels not covered by chronic data (fish and aquatic invertebrates).

Classification based on chronic toxicity data (algae): The substance is rapidly degradable and the ErC10 is > 1 mg/L (algae: 96-h ErC10 = 35.3 mg/L). According to the criteria outlined in Table 4.1.0(b) (ii) (Commission Regulation (EU) No 286/2011 amending Regulation (EC) No 1272/2008), the substance is not to be classified as chronically hazardous to the aquatic environment.

Classification based on acute toxicity data (fish and Daphnids): The lowest EC50 was determined for aquatic invertebrates (48-h EC50 of >100 mg/L), the substance is rapidly degradable, the log Kow is < 4. According to the criteria outlined in Table 4.1.0(b) (iii) (Commission Regulation (EU) No 286/2011 amending Regulation (EC) No 1272/2008), the substance is not to be classified as chronically hazardous to the aquatic environment.

In summary,based on the available acute and chronic toxicity data NMM (CAS 109-02-4) is neither to be classified as acutely hazardous, nor to be classified as chronically hazardous to the aquatic environment.

 

OVERALL CONCLUSION:

Summing up, all relevant constituents of the target substance TMAEE (CAS 93240-93-8) are not to be classified as acutely or chronically hazardous to the aquatic environment 

 

Atmospheric compartment

None of the relevant constituents of TMAEE (CAS 93240-93-8) is listed in Annex I of Regulation (EC) 2037/2000 on substances that deplete the ozone layer.

None of the relevant constituents does 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.