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Diss Factsheets
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EC number: 263-061-4 | CAS number: 61789-45-5
- 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:
- migrated information: read-across based on grouping of substances (category approach)
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 2 008
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- Version / remarks:
- adopted 2002
- Deviations:
- yes
- Remarks:
- no results for range-finding study and for positive control presented; no data on ear swelling response presented;
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.42 (Skin Sensitisation: Local Lymph Node Assay)
- Version / remarks:
- EC 2004
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2600 (Skin Sensitisation)
- GLP compliance:
- yes
- Type of study:
- mouse local lymph node assay (LLNA)
Test material
- Reference substance name:
- Oleic acid
- EC Number:
- 204-007-1
- EC Name:
- Oleic acid
- Cas Number:
- 112-80-1
- Molecular formula:
- C18H34O2
- IUPAC Name:
- octadec-9-enoic acid
- Details on test material:
- - Name of test material (as cited in study report): oleic acid
- Analytical purity: 99%
Constituent 1
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- other: SPF-CBA/Ca01aHsd
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Harlan Winkelmann, Borchen, Germany
- Age at study initiation: 6 - 13 weeks
- Housing: Mice were housed in groups in Macrolon cages on Altromin saw fiber bedding
- Diet: Altromin 1324 maintenance diet for rats and mice, totally pathogen free, ad libitum
- Water: tap water, ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3
- Humidity (%): 55 ± 10
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12 / 12
Study design: in vivo (LLNA)
- Vehicle:
- other: acetone / olive oil (3 + 1 (v/v))
- Concentration:
- 10, 25 and 50%
- No. of animals per dose:
- 5
- Details on study design:
- RANGE FINDING TESTS:
A preliminary test was performed with 3 animals to detect the highest tolerable concentration. For this, 3 different concentrations were applied daily to the ears of the animals which were observed for local skin irritation (ear swelling measured on day 1 and 4) and systemic effects.
MAIN STUDY
ANIMAL ASSIGNMENT AND TREATMENT
- Name of test method: 3H-methyl thymidine incorporation determined by ß-scintillation
- Criteria used to consider a positive response: SI ≥ 3
TREATMENT PREPARATION AND ADMINISTRATION:
25 µl of the test or control solution was applied to the entire dorsal surface of each ear of each mouse. The application was repeated on days 2 and 3. On day 6, 20 µCi 3H-methyl thymidine was injected intravenously into the tail vein. Approximately 5 h later, the draining auricular lymph nodes were excised, weighed, individually pooled for each animal and collected in phosphate buffered saline (PBS). A single cell suspension of pooled lymph node cells was prepared by gentle mechanical disaggregation through polyamide gauze (200 mesh size). After washing with PBS, the cell suspension was pelleted. For further washing, cells were resuspended in PBS. After the final wash, each pellet was resuspended in approx. 1 mL 5% trichloracetic acid (TCA) and incubated at 4 °C overnight for precipitation of macromolecules. After washing, each precipitate was re-suspended in 10 mL scintillation fluid, transferred in scintillation vials and stored at room temeperature overnight. - Positive control substance(s):
- other: p-phenylenediamine (1%)
- Statistics:
- Arithmetic mean values were calculated and one-sided Student´s t-tests (p < 0.01) were performed to evaluate statistical significance.
Results and discussion
In vivo (LLNA)
Resultsopen allclose all
- Parameter:
- SI
- Remarks on result:
- other: The calculation revealed a bell-shaped dose-response curve with the SI at 50% test substance being lower than the SI at 25%. The SIs of 25 and 50% are above the threshold of 3 where as the SI for 10% test substance is lower than 3.
- Parameter:
- other: disintegrations per minute (DPM)
- Remarks on result:
- other: no data
Any other information on results incl. tables
Table 1: Stimulation indices (SI) and lymph node weight indices (LNWI) after exposure to oleic acid
|
10% |
25% |
50% |
SI ± SD |
2.6 ± 1.6 |
14.9 ± 6.8 |
6.9 ± 3.6 |
LNWI ± SD |
1.1 ± 0.3 |
2.3 ± 0.2* |
2.2 ± 0.2* |
* Statistically significant increase compared to vehicle control (p < 0.01)
Applicant's summary and conclusion
- Interpretation of results:
- ambiguous
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
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