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EC number: 944-490-2 | 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)
- Remarks:
- non-radioactive LLNA test method
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 12 April 2012
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 012
- Report date:
- 2012
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- quality assurance statement included
- Type of study:
- mouse local lymph node assay (LLNA): DA
Test material
- Reference substance name:
- 1-hydroxyoctan-2-yl octadeca-9,12,15-trienoate; 2-hydroxyoctyl octadeca-9,12,15-trienoate; 2-hydroxyoctyl octadeca-9,12-dienoate; octane-1,2-diol
- EC Number:
- 944-490-2
- Molecular formula:
- unknown
- IUPAC Name:
- 1-hydroxyoctan-2-yl octadeca-9,12,15-trienoate; 2-hydroxyoctyl octadeca-9,12,15-trienoate; 2-hydroxyoctyl octadeca-9,12-dienoate; octane-1,2-diol
- Test material form:
- liquid
Constituent 1
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- CBA:J
- Sex:
- female
- Details on test animals and environmental conditions:
- Female nulliparous and non gravid, weighing between 18 g and 23.8 g, aged of 7-8 weeks.
Acclimatisation of 5 days minimum in the laboratory animal house where the experiment took place. Air-conditioned (20-24°C) room at relative humidity of 45-65% with non-recycled filtered air changed 10-15 times/h. Artificial day/night of 12 hours light and 12 hours darkness. Water ad libitum
Study design: in vivo (LLNA)
- Vehicle:
- other: olive oil
- Concentration:
- 1%, 10%, 20%, 30%, 50%, chosen according to the results of the preliminary study
- No. of animals per dose:
- 4 mice/dose (32 mice allocated to eight groups)
- Details on study design:
- Each mouse received a cutaneous application over the dorsal surface of both ears (25 μL) every 24 hours for three consecutive days (D1, D2 and D3). Recording of local reactions was made before each application and just before euthanasia. Ear thickness measurements were made before application (on D1), on D3 and on D6. Lymphoproliferative response was measured by incorporation of 5-bromo-deoxyuridine on D6. Then, animals were euthanased by CO2 inhalation in a CO2 chamber. The results were elucidated using an Elisa system on D7.
- Positive control substance(s):
- other: 2,4-Dinitrochlorobenzene (DNCB)
- Statistics:
- Dunnett's test (analysis of variance)
Results and discussion
- Positive control results:
- No change in body weight gain. Slight erythema of the ears observed from D4 to D6. DNCB showed a statistically significant increase in ear thickness of +18% between D1 and D6, a statistically significant Stimulation Index of 3 and a cellularity index of 6.11 with a total amount of viable cells per node of 13.06 x 10E6. Amount of cells, cellularity index and increase in ear thickness were within the range usually obtained for DNCB.
Consequently, all results obtained with DNCB at 0.5% in acetone/olive oil showed that the study could be considered as valid.
In vivo (LLNA)
Results
- Key result
- Parameter:
- SI
- Value:
- >= 0 - < 3
- Variability:
- standard deviation not specified
- Cellular proliferation data / Observations:
- No change in body weight gain was seen whatever the group. No mortality nor clinical signs were recorded during the study.
No skin reaction in the 1%, 10% and 20% dose groups. Some animals treated with test item at 30% had slight erythema on D4 (5/8 ears) and D5 (4/8 ears).
Animals treated with test substance at 50% has slight erythema from D2 (6/8 ears) to D6 (8/8 ears) with an increase in ear thickness between D1 and D6 (+22%). In the preliminary study, a similar observation was seen at the same concentration tested. According to these results, test item at 50% could be considered as slightly irritant.
As the test item did not produce a stimulation index (SI) equal or greater than 3 whatever the dose tested, the EC3 value, defined as the theoretical concentration resulting in a SI value of 3, cannot be
calculated.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the experimental conditions adopted, the test substance at 1%, 10%, 20%, 30% and 50% in olive oil did not induce delayed contact hypersensitivity in the Local Lymph Node Assay using female CBA mice after three consecutive days of treatment.
- Executive summary:
No induction of delayed contact hypersensitivity in the Local Lymph Node Assay, according to OECD 429 Guideline using 32 female CBA mice, stimulation index < 3.
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