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EC number: 272-379-2 | CAS number: 68815-51-0
- 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
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline study with GLP
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 009
- Report date:
- 2009
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- BASF AG, Experimental Toxicology and Ecology
- Type of study:
- mouse local lymph node assay (LLNA)
Test material
- Reference substance name:
- 9-Octadecenoic acid (Z)-, reaction products with 2-[(2-aminoethyl)amino]ethanol
- EC Number:
- 272-379-2
- EC Name:
- 9-Octadecenoic acid (Z)-, reaction products with 2-[(2-aminoethyl)amino]ethanol
- Cas Number:
- 68815-51-0
- Molecular formula:
- C18 H34 O2 . C4 H12 N2 O
- IUPAC Name:
- 2-(2-aminoethylamino)ethanol; (Z)-octadec-9-enoic acid
- Details on test material:
- - Name of test material (as cited in study report): Kerocom F 100
- Analytical purity: approx. 100 %
- Lot/batch No.: 09001529U0
- Storage condition of test material: The stability under storage conditions over the study period was guaranteed by the manufacturer, and the manufacturer holds this responsibility.
Constituent 1
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- CBA
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Charles River Laboratories, Research Models and Services, Germany GmbH, Sandhofer Weg 7, 97633 Sulzfeld
- Age at study initiation: 6-12 weeks
- Weight at study initiation: 18.0 g – 21.6 g
- Diet (e.g. ad libitum): Kliba-Labordiet
- Water (e.g. ad libitum): Tap water
- Acclimation period: 14 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-24
- Humidity (%): 30-70
- Photoperiod (hrs dark / hrs light): 12/12
Study design: in vivo (LLNA)
- Vehicle:
- methyl ethyl ketone
- Concentration:
- 3%, 10% and 30%
- No. of animals per dose:
- 5
- Details on study design:
- RANGE FINDING TESTS:
- Compound solubility: MEK (methyl ethyl ketone) was used as the vehicle because good solubility of the preparation was achieved
MAIN STUDY
ANIMAL ASSIGNMENT AND TREATMENT
Groups of 5 females were treated epicutaneous with 25 µl of 3, 10 & 30 % of the test substance preparation at the dorsal part of both ears for 3 consecutive applications (day 0 – day 2) to the same application site. Individual body weights on day 0 prior to the first application and on day 5 prior to the sacrifice of the animals. All animals were observed for signs of systemic toxicity and local changes. Mortality was observed twice on each working day.
³H-thymidine injection: On study day five (about 66 to 72 hours after the last application of test substance to the ears) the mice were injected intravenously with 20 μCi of 3H-thymidine in 250 μl of sterile saline into a tail vein.
Results and discussion
In vivo (LLNA)
Resultsopen allclose all
- Parameter:
- SI
- Remarks on result:
- other: ³H-thymidine incorporation lead to SI values in the vehicle, 3%, 10% and 30% test substance of 1.00, 5.85, 7.30 and 10.76, respectively (Table 1).
- Parameter:
- other: disintegrations per minute (DPM)
- Remarks on result:
- other: ³H-thymidine incorporation lead to values (DPM /Lymph Node Pair) in the vehicle, 3%, 10% and 30% test substance of 434.3, 2539.5, 3171.7 and 4672.7, respectively (Table 1).
Any other information on results incl. tables
No signs of systemic toxicity were noticed. When applied as 30%, 10% and 3% preparations in methyl ethyl ketone (MEK), the test substance induced a biologically relevant response (increase to 1.5 fold or above of control value = stimulation index (SI) ≥ 1.5) in the auricular lymph node cell counts (Table 1). There was an increase in lymph node weights, as well. Concomitantly, the increase of 3H-thymidine incorporation into the cells was biologically relevant (increase above the cut off stimulation index of 3) at these concentrations. Some or severe increases in ear weights were observed in mice treated with the 10% and 30% test-substance preparation as indication of ear skin irritation. On the day of lymph node removal scaling was observed on the ears of the 30% test-substance group. As increases of lymph node parameters occurred at all concentrations, the lymph node effects cannot be attributed to ear skin irritation.
Table 1. Cell count, 3H-thymidine incorporation and lymph node weight: test group mean values and stimulation indices
Treatment |
Cell counts |
|
Counts/Lymph Node Pair |
Stimulation Index |
|
Vehicle |
6,694,667 |
1.00 |
3% |
14,210,667 |
2.12 |
10% |
18,744,000 |
2.80 |
30% |
23,901,333 |
3.57 |
Treatment |
³H-thymidine incorporation |
|
DPM/Lymph Node Pair |
Stimulation Index |
|
Vehicle |
434.3 |
1.00 |
3% |
2,539.5 |
5.85 |
10% |
3,171.7 |
7.30 |
30% |
4,672.7 |
10.76 |
Treatment |
Lymph Node Weight |
|
mg/Lymph Node Pair |
Stimulation Index |
|
Vehicle |
4.7 |
1.00 |
3% |
8.2 |
1.77 |
10% |
10.0 |
2.15 |
30% |
13.3 |
2.85 |
Applicant's summary and conclusion
- Interpretation of results:
- sensitising
- Remarks:
- Migrated information
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