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EC number: 269-642-9 | CAS number: 68308-30-5
- 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:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 04 - 30 Oct 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 guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- Version / remarks:
- adopted Jul 2010
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.42 (Skin Sensitisation: Local Lymph Node Assay)
- Version / remarks:
- 2008
- Deviations:
- not specified
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- mouse local lymph node assay (LLNA)
Test material
- Reference substance name:
- Fatty acids, montan-wax, stearyl esters
- EC Number:
- 269-642-9
- EC Name:
- Fatty acids, montan-wax, stearyl esters
- Cas Number:
- 68308-30-5
- Molecular formula:
- C18 H38 O - C66 H130 O4
- IUPAC Name:
- Fatty acids C22-30 (even numbered), octadecyl alcohol esters
Constituent 1
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- CBA:J
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Elevage Janvier, Le Genest-Saint-Isle, France
- Females nulliparous and non-pregnant: Yes
- Age at study initiation: 10 weeks
- Weight at study initiation: 20.9 - 21.9 g
- Housing: Animals were housed in groups in Type II polypropylene / polycarbonate cages with bedding.
- Diet: Ssniff SM R/M-15mm "Autoclavable complete diet for rats and mice – breeding and maintenance" (Batch number: 523 7816, produced by ssniff Spezialdiäten GmbH, Soest, Germany), ad libitum
- Water: Tap water, ad libitum
- Acclimation period: 20 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19.8 - 24.2
- Humidity (%): 30 - 70
- Air changes (per hr): 15 - 20
- Photoperiod (hrs dark / hrs light): 12/12
- IN-LIFE DATES: From: 24 Oct 2012 To: 30 Oct 2012
Study design: in vivo (LLNA)
- Vehicle:
- dimethylformamide
- Remarks:
- (DMF)
- Concentration:
- 10, 25 and 50% (w/v)
- No. of animals per dose:
- 4
- Details on study design:
- PRE-SCREEN TESTS:
2 female mice were treated by daily application of 25 μL of the test substance in concentrations of 25 and 50% on the dorsal surface of the ear, for 3 consecutive days. The body weight was recorded on Day 1 prior to dosing and on Day 6.
- Compound solubility: Based on the observation of the solubility test, the maximum available concentration was 50% (w/v).
- Irritation: The animals were observed for local skin irritation to the application site once a day. Erythema were not observed.
- Systemic toxicity: The animals were observed for signs of toxicity once a day. No clinical signs of toxicity or mortality were noted.
- Ear thickness measurements: Ear thickness was measured using a thickness gauge on Day 1, 3 and 6. At 25 and 50%, no increase of the ear thickness was determined on Day 1, 3 and 6, respectively.
- Erythema scores: Draize scoring system
MAIN STUDY
ANIMAL ASSIGNMENT AND TREATMENT
- Name of test method: 3H-methyl thymidine incorporation determined by β-scintillation counting
- Criteria used to consider a positive response: Exposure to at least one concentration of the test substance resulted in an incorporation of 3HTdR at least 3-fold or greater than recorded in control mice, as indicated by the stimulation index (SI). The data are compatible with a conventional dose response, although allowance must be made (especially at high topical concentrations) for either local toxicity or immunological suppression.
TREATMENT PREPARATION AND ADMINISTRATION: 25 µL of the test substance was applied to the entire dorsal surface of each ear of each mouse on Day 1, 2 and 3 in concentrations of 10, 25 and 50% in DMF. On Day 6 an injection of 250 µL phosphate buffered saline (PBS) containing 20 µCi of 3H-methyl thymidine (3H-TdR) was made into the tail vein of each mouse. Five hours later, the draining auricular lymph node of each ear was excised into PBS and pooled per experimental group. A single cell suspension of pooled lymph node cells was prepared by gentle mechanical disaggregating of the lymph nodes through a cell strainer using the plunger of a disposable syringe gauze and rinsed with PBS. To precipitate out the radioactive material, the pellet was resuspended in 5% trichloroacetic acid. The precipitates were incubated for approximately 18 h at 2 - 8 °C, centrifuged, resuspended in 1 mL TCA and transferred to 10 mL scintillation fluid before β-scintillation counting. - Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
Results and discussion
- Positive control results:
- The positive control substance (25% hexyl cinnamic aldehyde in DMF) was considered to be a sensitiser under the conditions of the test (SI 12.9).
In vivo (LLNA)
Resultsopen allclose all
- Key result
- Parameter:
- SI
- Value:
- 1.8
- Test group / Remarks:
- 50% (w/v)
- Key result
- Parameter:
- SI
- Value:
- 1.1
- Test group / Remarks:
- 25% (w/v)
- Key result
- Parameter:
- SI
- Value:
- 0.8
- Test group / Remarks:
- 10% (w/v)
- Cellular proliferation data / Observations:
- CELLULAR PROLIFERATION DATA
DETAILS ON STIMULATION INDEX CALCULATION
The SI of the 10, 25 and 50% treatment group was 0.8, 1.1 and 1.8%, respectively.
EC3 CALCULATION
The EC3 value could not be calculated, since all SI values are below the threshold value of 3.
CLINICAL OBSERVATIONS
No deaths occurred during the study period. No symptoms of local skin irritation at the ears of the animals and no signs of systemic toxicity were observed during the study period.
BODY WEIGHTS
No treatment related effects were observed on animal body weights.
Any other information on results incl. tables
Table 1: Summary of results
Test Group Name | Measured DPM / group | DPM | Number of lymph nodes | DPN | Stimulation Index |
Background (5 (w/v) % TCA) | 32.5 | - | - | - | - |
Negative (vehicle) control (DMF) | 1478 | 1445.5 | 8 | 180.7 | 1.0 |
50 (w/v) % in DMF | 2653 | 2620.5 | 8 | 327.6 | 1.8 |
25 (w/v) % in DMF | 1646 | 1613.5 | 8 | 201.7 | 1.1 |
10 (w/v) % in DMF | 1222 | 1189.5 | 8 | 148.7 | 0.8 |
Positive control (25 (w/v) % HCA in DMF) |
18716 | 18683.5 | 8 | 2335.4 | 12.9 |
TCA: Trichloroacetic acid
HCA: Hexyl cinnamic acid
DPM: Disintegrations per minute
DPN: Disintegrations per node
Applicant's summary and conclusion
- Interpretation of results:
- other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No. 1272/2008
- Conclusions:
- CLP: not classified
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