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EC number: 203-142-3 | CAS number: 103-76-4
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
PBT assessment
Administrative data
PBT assessment: overall result
- Name:
- N-Hydroxyethylpiperazine
- Type of composition:
- boundary composition of the substance
- State / form:
- liquid
- Reference substance:
- N-Hydroxyethylpiperazine
- PBT status:
- the substance is not PBT / vPvB
- Justification:
PBT / vPvB - Assessment for the parent compound 2-piperazine-1-ylethanol (CAS 103-76-4):
Following a weight-of-evidence approach, 2-piperazine-1-ylethanol (CAS 103-76-4) is not readily biodegradable (according to OECD criteria). In a marine ready biodegradability test the substance was degraded to < 10% after 28 d (based on O2 consumption, Eide-Haugmo et al., 2009). In addition, the substance is calculated to be poorly degraded by three estimation models (degradation ranges from 9 to 28% within 28 days; BASF SE, 2020). Therefore, 2-piperazine-1-ylethanol should be assessed P from a precautionary point of view.
The log Kow (-1.47 at 25 °C, pH 10.5-10.9, BASF AG, 1989, report no.: 105629) as well as several QSAR calculations (calculated BCF values range between 0.9 L/kg and 9.23 L/kg, BASF SE 2015, 2016, 2020) indicate no potential for bioaccumulation (not B/vB).
The substance is not toxic (not T) since the lowest NOEC is > 0.01 mg/L (daphnids, 21-d NOEC reproduction >= 12 mg/L, BASF SE 2019, report no.: 51E0573/15E065) and it holds no relevant classification.
In conclusion, the substance is considered to be not PBT / not vPvB.
PBT / vPvB - Assessment for modelled metabolites of 2-piperazine-1-ylethanol (CAS 103-76-4):
ECHA Guidance on information requirements and chemical safety assessment (v3.0, June 2017), Chapter R.11.4.1 specifies that “Constituents, impurities and additives should normally be considered relevant for the PBT/vPvB assessment when they are present in concentration of ≥ 0.1% (w/w)” […] “Similar arguments apply to relevant transformation/degradation products”.
In order to identify the relevant degradation products of 2-piperazine-1-ylethanol a standard information requirement according to Column 1, Section 9.2.3. of Annex IX to REACH and for purposes of an assessment of potential PBT/vPvB properties, the metabolites were modelled using CATALOGIC 301C v11.15 – July 2018 (OASIS Catalogic v5.13.1.156).
Overall, the model CATALOGIC 301C v11.15 calculated 20 metabolites (Table 1) identifying 7 metabolites as relevant degradation products in terms of PBT/vPvB assessment, with an estimated quantity of ≥0.1% (equivalent to quantity setting in OASIS CATALOGIC: 0.001-2 [mol/mol parent]).
Table 1: QSAR prediction for CAS 103-76-4 using CATALOGIC 301C v11.15 – July 2018 (OASIS Catalogic v5.13.1.156;metabolites with a quantity > 0.001 mol/mol parent (approx. 0.1%) after 28 d are highlighted by grey background and bold type; metabolite no: according to (Q)SAR model Catalogic v11.15 – July 2018 (OASIS Catalogic v5.13.156))
#
Metabolite
NoSmiles
Substance name (CAS)
Quantity
(mol/mol parent)LogKow
BOD prediction
(% after 28 d)PBT-Assessment
(ECHA (disseminated substances)parent
1
OCCN1CCNCC1
2-piperazin-1-ylethanol (CAS 103-76-4)0.000010
-1.47
28
not checked
1
2
O=CCN1CCNCC1
not identified
0.000010
-1.586
28
not checked
2
3
OC(=O)CN1CCNCC1
2-piperazin-1-ylacetic acid
0.006192
-3.357
22
not (pre-)registered
3
4
OC(=O)C=O
Glyoxylic acid (CAS 298-12-4)
0.007177
-1.403
100
not PBT / vPvB
4
8
C1CNCCN1
Piperazine (CAS 110-85-0)
0.975300
-0.799
1
not PBT / vPvB
5
15
OC1CNCCN1CC(O)=O
not identified
0.000000
-3.897
81
not checked
6
18
OC(C(O)=O)N1CCNCC1
not identified
0.000030
-3.585
15
not checked
7
19
OC1CN(CC(O)=O)CCN1
not identified
0.000002
-3.897
58
not checked
8
5
OC(=O)C(O)=O
not identified
0.000010
-1.736
100
not checked
9
9
OC1CNCCN1
not identified
0.000052
-2.337
75
not checked
10
16
OC(=O)CNCCNCC=O
not identified
0.000000
-4.454
81
not checked
11
20
NCCN(CC=O)CC(O)=O
not identified
0.000000
-4.709
22
not checked
12
10
NCCNCC=O
not identified
0.000000
-2.151
76
not checked
13
17
OC(=O)CNCCNCC(O)=O
not identified
0.000046
-4.788
80
not checked
14
21
NCCN(CC(O)=O)CC(O)=O
not identified
0.000898
-4.043
14
not checked
15
11
NCCNCC(O)=O
2-(2-aminoethylamino)acetic acid
0.007845
-3.922
73
not (pre-)registered
16
22
OC(=O)CN(CC=O)CC(O)=O
0.000000
-4.061
11
not checked
17
12
NCCN
1,2-Ethanediamine (CAS 107-15-3)
0.001139
-1.618
67
not PBT / vPvB
18
23
OC(=O)CN(CC(O)=O)CC(O)=O
2-[bis(carboxymethyl)amino]acetic acid
0.001473
-3.809
2
not (pre-)registered
19
13
NCC=O
2-aminoacetaldehyde
0.006952
-1.637
72
not (pre-)registered
20
24
OC(=O)CNCC(O)=O
not identified
0.000023
-3.274
81
not checked
Persistence (“P/vP”):
In order to assess the biodegradation potential of the relevant degradation products, the (Q)SAR model CATALOGIC 301C v11.15 – July 2018 (OASIS CATALOGIC v5.13.1.156) was applied.
Concerning the applicability domain (OECD Principle 3) 2-piperazine-1-ylethanol is in the parametric, the structural and the metabolic domain (100%).
- The model was used to predict potential metabolites.
- 3 of the 7 metabolites identified as relevant degradation products were calculated to be not readily biodegradable (threshold value: <60% BOD). Individual biodegradation of these metabolites was estimated to be in a range of 1% to 22% after 28 days (based on BOD).
- The remaining 4 relevant metabolites were estimated to be readily biodegradable (threshold value: ≥60%), with individually calculated biodegradation values between 67% and 100% after 28 days (based on BOD).
In conclusion, 43% of the predicted metabolites present in concentration of ≥0.1% (equivalent to quantity setting in OASIS CATALOGIC: 0.001-2 [mol/mol parent]) are estimated to be not readily biodegradable while 57% of the relevant metabolites are predicted to be readily biodegradable.
The 3 degradation products of 2-piperazine-1-ylethanol (CAS 103-76-4) which are predicted as not readily biodegradable metabolites should be considered as potentially P/vP from a precautionary point of view, until further data become available.
Bioaccumulation (“B/vB”):
In a test according to OECD 107 a log Kow of -1.47 at 25 °C and pH 10.5-10.9 was measured for 2-piperazine-1-ylethanol (BASF AG, 1989, report no.: 105629, see IUCLID Ch. 4.7). This indicates a low potential for bioaccumulation.
Without exception, all the 20 modelled degradation products of 2-piperazine-1-ylethanol were estimated to exhibit log Kow values of clearly < 4.5 (see Table 1), thereby not fulfilling the screening criteria for bioaccumulation (B/vB) as laid down in Section 3.1 of REACH Annex XIII.
Based on the estimation data available for the modelled metabolites, all relevant metabolites of 2-piperazine-1-ylethanol are concluded to be “not B” and “not vB”.
Toxicity (“T”):
Considering potential “T” properties, limited data are available for the relevant metabolites of the parent compound 2-piperazine-1-ylethanol. Only few of the relevant metabolites of the CATALOGIC model are registered under REACH. None of these substances were assessed to fulfill the criteria for “T”. Based on the available data on the persistence and bioaccumulation potential of all of the relevant metabolites, it can be concluded that all relevant degradation products do neither fulfill the PBT criteria (not PBT) nor the vPvB criteria (not vPvB).
Overall conclusion:
1. Sufficient test data are available to assess the PBT/vPvB properties of 2-piperazine-1-ylethanol.
2. Potentially relevant degradation products were modeled using (Q)SARmodel CATALOGIC 301C v11.15 – July 2018:
2a. Based on modeled data relevant degradation products present in concentration of ≥ 0.1% (equivalent to quantity setting in OASIS CATALOGIC: 0.001-2 [mol/mol parent]) do neither fulfill the PBT criteria (not PBT) nor the vPvB criteria (not vPvB).
2b. However, 3 predicted relevant metabolites present in concentration of ≥0.1% (equivalent to quantity setting in OASIS Catalogic: 0.001-2 [mol/mol parent]; CATALOGIC 301C v11.15) should be considered as potentially P/vP from a precautionary point of view.
Reference
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