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EC number: 942-732-1 | CAS number: -
- 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
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From 29 January 2016 to 29 February 2016
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study was conducted by a GLP accredited laboratory using OECD Testing Guideline 429. The study was conducted on the registered substance.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 016
- Report date:
- 2016
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.42 (Skin Sensitisation: Local Lymph Node Assay)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- mouse local lymph node assay (LLNA)
Test material
- Reference substance name:
- Reaction mass of 2-aminoethanol and 6-[(p-tosyl)amino]hexanoic acid, compound with 2-aminoethanol (1:1)
- IUPAC Name:
- Reaction mass of 2-aminoethanol and 6-[(p-tosyl)amino]hexanoic acid, compound with 2-aminoethanol (1:1)
- Reference substance name:
- Reaction mass of 2-aminoethanol and 6-[(p-tosyl)amino]hexanoic acid, compound with 2-aminoethanol (1:1)
- EC Number:
- 942-732-1
- Molecular formula:
- C13H19NO4S.C2H7NO/C2H7NO/H2O
- IUPAC Name:
- Reaction mass of 2-aminoethanol and 6-[(p-tosyl)amino]hexanoic acid, compound with 2-aminoethanol (1:1)
- Test material form:
- other: Liquid
- Details on test material:
- - Name of test material (as cited in study report): Reaction mass of 2-aminoethanol and 6[(p-tosyl)amino] hexanoic acid, compound with 2-aminoethanol (1:1)- Physical state: Pale yellow liquid- Storage condition of test material: room temperature in the dark
Constituent 1
Constituent 2
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- other: CBA/CaOlaHsd
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS- Source: Envigo RMS B.V. Inc- Age at study initiation: 8-12 weeks- Weight at study initiation: 15-23g- Housing: Suspended solid floor polypropylene cages furnished with softwood woodflakes- Diet: ad libitum- Water: ad libitum- Acclimation period: 5 daysENVIRONMENTAL CONDITIONS- Temperature (°C): 19-25- Humidity (%): 30-70- Air changes (per hr): 15- Photoperiod (hrs dark / hrs light): 12 hours dark/ 12 hours light
Study design: in vivo (LLNA)
- Vehicle:
- other: 1% pluronic L92 in distilled water
- Concentration:
- 25%, 50%, and 100% v/v
- No. of animals per dose:
- 4
- Details on study design:
- Groups of four mice were treated with the test item at concentrations of 50%, or 25% w/w in propylene glycol. The preliminary screening test suggested that the test item would not produce systemic toxicity or excessive local skin irritation at the highest suitable concentration. The mice were treated by daily application of 25 μL of the appropriate concentration of the test item to the dorsal surface of each ear for three consecutive days (Days 1, 2, 3). The test item formulation was administered using an automatic micropipette and spread over the dorsal surface of the ear using the tip of the pipette.A further group of four mice received the vehicle alone in the same manner.Five days following the first topical application of the test item or vehicle (Day 6) all mice were injected via the tail vein with 250 μL of phosphate buffered saline (PBS) containing 3H-methyl thymidine (3HTdR: 80 μCi/mL, specific activity 2.0 Ci/mmoL, ARC UK Ltd) giving a total of 20 μCi to each mouse.Clinical Observations: All animals were observed twice daily on Days 1, 2 and 3 and on a daily basis on Days 4, 5 and 6. Any signs of toxicity or signs of ill health during the test were recorded.Body Weights: The body weight of each mouse was recorded on Day 1 (prior to dosing) and Day 6 (prior to termination).Termination: Five hours following the administration of 3HTdR all mice were killed by carbon dioxide asphyxiation followed by cervical separation. The draining auricular lymph nodes from the four mice were excised and pooled for each experimental group. For each group 1 mL of PBS was added to the pooled lymph nodes.Preparation of Single Cell Suspension: A single cell suspension of pooled lymph node cells was prepared by gentle mechanical disaggregation through a 200-mesh stainless steel gauze. The lymph node cells were rinsed through the gauze with 4 mL of PBS into a petri dish labeled with the study number and dose concentration. The lymph node cell suspension was transferred to a centrifuge tube. The petri dish was washed with an additional 5 mL of PBS to remove all remaining lymph node cells and these were added to the centrifuge tube. The pooled lymph node cells were pelleted at 1400 rpm (approximately 190 g) for 10 minutes. The pellet was re-suspended in 10 mL of PBS and re-pelleted. To precipitate out the radioactive material, the pellet was re-suspended in 3 mL of 5% Trichloroacetic acid (TCA).Determination of 3HTdR Incorporation: After approximately 18 hours incubation at approximately 4°C, the precipitates were recovered by centrifugation at 2100 rpm (approximately 450 g) for 10 minutes, re-suspended in 1 mL of TCA and transferred to 10 mL of scintillation fluid. 3HTdR incorporation was measured by β-scintillation counting. The "Poly Q™" vials containing the samples and scintillation fluid were placed in the sample changer of the scintillator and left to stand in darkness for approximately 20 minutes. The purpose of this period of time in darkness was to reduce the risk of luminescence, which has been shown to affect the reliability of the results. After approximately 20 minutes, the vials were shaken vigorously. The number of radioactive disintegrations per minute was then measured using the Beckman LS6500 scintillation system (Beckman Instruments Inc, Fullerton, CA, USA).
- Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
- Statistics:
- EC3 value calculated using the following equation: EC3=c+[[(3-d)/(b-d)]x(a-c)]
Results and discussion
- Positive control results:
- Concentration (% v/v) in 1% pluronic L92 in distilled water: 25Stimulation Index: 4.47Result: Positive
In vivo (LLNA)
Resultsopen allclose all
- Parameter:
- SI
- Remarks on result:
- other: 0% - N/A25% - 1.7050% - 2.39100% - 3.68
- Parameter:
- other: disintegrations per minute (DPM)
- Remarks on result:
- other: 0% - 1726.58 dpm/215.82 dpm per node25% - 2941.25 dpm /367.66 dpm per node50% - 4129.02 dpm/516.13 dpm per node100% - 6362.32dpm /795.29 dpm per node
Any other information on results incl. tables
Individual clinical observations and mortality data
Concentration (%v/v) in 1% pluronic L92 in distilled water | Animal number | Day 1 | Day 2 | Day 3 | Day 4 | Day 5 | Day 6 | |||
Pre-dose | Post-dose | Pre-dose | Post-dose | Pre-dose | Post-dose | |||||
Vehicle | 1 -1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
1 -2 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
1 -3 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
1 -4 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
25 | 2 -1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
2 -2 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
2 -3 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
2 -4 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
50 | 3 -1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
3 -2 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
3 -3 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
3 -4 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
100 | 4 -1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
4 -2 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
4 -3 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
4 -4 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
0= No signs of systemic toxicity
Individual body weights and body weight changes
Concentration (% v/v) in 1% pluronic L92 in distilled water | Animal number | Body weight (g) | Body weight change (g) | |
Day 1 | Day 6 | |||
Vehicle | 1 -1 | 20.4 | 20.9 | 0.5 |
1 -2 | 19.1 | 19.9 | 0.8 | |
1 -3 | 17.9 | 18.6 | 0.7 | |
1 -4 | 19.4 | 20.2 | 0.8 | |
25 | 2 -1 | 20.0 | 21.1 | 1.1 |
2 -2 | 19.3 | 19.8 | 0.5 | |
2 -3 | 19.4 | 19.7 | 0.3 | |
2 -4 | 17.5 | 18.2 | 0.7 | |
50 | 3 -1 | 18.4 | 19.8 | 1.4 |
3 -2 | 16.9 | 17.7 | 0.8 | |
3 -3 | 17.6 | 18.6 | 1.0 | |
3 -4 | 19.5 | 20.3 | 0.8 | |
100 | 4 -1 | 18.3 | 19.4 | 1.1 |
4 -2 | 19.7 | 20.4 | 0.7 | |
4 -3 | 17.5 | 18.2 | 0.7 | |
4 -4 | 17.4 | 18.8 | 1.4 |
The LLNA study on Reaction mass of 2-aminoethanol and 6-[(p-tosyl)amino] hexanoic acid, compound with 2-aminoethanol (1:1)
Concentration | dpm | dpm/node | Test/Control Ratio | Result |
Vehicle | 1726.58 | 215.82 | N/A | N/A |
25% | 2941.25 | 367.66 | 1.70 | Negative |
50% | 4129.02 | 516.13 | 2.39 | Negative |
100% | 6362.32 | 795.29 | 3.68 | Positive |
dpm= disintegrations per minute
dpm/node= disintegrations per minute/node obtained by dividing the disintegrations per minute value by 8 (total number of lymph nodes)
Simulation index of 3.0 or greater indicates a positive result
N/A= not applicable
Applicant's summary and conclusion
- Interpretation of results:
- sensitising
- Remarks:
- Migrated informationCategory 1BCriteria used for interpretation of results: EU
- Conclusions:
- The test item produced a positive result when tested at 100% under a LLNA. The test item was classified as a sensitiser (category 1B) according to Regulation (EC) No.1272/2008 on the Classification, Labelling and Packaging of Substances and Mixtures.
- Executive summary:
The in vivo skin sensitisation of the test substance was determined in accordance with the OECD Guideline for Testing of Chemicals 429. A Local Lymph Node Assay (LLNA) was performed to assess the skin sensitization potential of the test item in the CBA/Ca strain mouse following topical application to the dorsal surface of the ear.
Following a preliminary screening test in which no clinical signs of toxicity were noted at a concentration of 100% w/w, this concentration was selected as the highest dose investigated in the main test of the Local Lymph Node Assay. Three groups, each of four animals, were treated with 50 μL (25 μL per ear) of the test item as a suspension in propylene glycol at concentrations of 100%, 50%, or 25% w/w. A further group of four animals was treated with 1% pluronic L92 in distilled water.
The Stimulation Index expressed as the mean radioactive incorporation for each treatment group divided by the mean radioactive incorporation of the vehicle control group provided a positive result when tested at 100%. The test item was classified as a sensitiser (category 1B) according to Regulation (EC) No.1272/2008 on the Classification, Labelling and Packaging of Substances and Mixtures.
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