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EC number: 286-056-9 | CAS number: 85186-72-7
- 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:
- 01 - 30 Jun 2016
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP-Guideline study
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)
- Version / remarks:
- 2010
- Deviations:
- yes
- Remarks:
- no radioactive labelling was used to measure cell proliferation
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.42 (Skin Sensitisation: Local Lymph Node Assay)
- Version / remarks:
- 2012
- Deviations:
- yes
- Remarks:
- no radioactive labelling was used to measure cell proliferation
- Principles of method if other than guideline:
- The study was performed according to OECD 429, however not employing the use of radioactive labelling to measure cell proliferation. The alternative method used for the study employing the lymph node weight and lymph node cell count to assess proliferation has been established by an European interlaboratory validation exercise, as described in the two publications by Ehling et al. 2005a and 2005b. In addition, the acute inflammatory skin reaction is measured by ear weight determination of circular biopsies of the ears and ear thickness measurements on test day 1 and test day 4 to identify skin irritation properties of the test item.
References:
Ehling, G., M. Hecht, A. Heusener, J. Huesler, A. O. Gamer, H. van Loveren, T. Maurer, K. Riecke, L. Ullmann, P. Ulrich, R. Vandebriel, H.-W. Vohr: An European inter-laboratory validation of alternative endpoints of the murine local lymph node assay: First round; Toxicology 212, 60-68 (2005a)
Ehling, G., M. Hecht, A. Heusener, J. Huesler, A. O. Gamer, H. van Loveren, T. Maurer, K. Riecke, L. Ullmann, P. Ulrich, R. Vandebriel, H.-W. Vohr: An European inter-laboratory validation of alternative endpoints of the murine local lymph node assay: 2nd round; Toxicology 212, 69-79 (2005b) - GLP compliance:
- yes (incl. QA statement)
- Remarks:
- FREIE UND HANSESTADT HAMBURG, Behörde für Gesundheit und Verbraucherschutz, Hamburg, Germany
- Type of study:
- mouse local lymph node assay (LLNA)
Test material
- Reference substance name:
- Fatty acids, C14-18 and C18-unsatd., branched and linear, esters with pentaerythritol
- EC Number:
- 286-056-9
- EC Name:
- Fatty acids, C14-18 and C18-unsatd., branched and linear, esters with pentaerythritol
- Cas Number:
- 85186-72-7
- IUPAC Name:
- Fatty acids, C14-18 and C18-unsatd., branched and linear, esters with pentaerythritol
Constituent 1
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- NMRI
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Charles River Laboratories, Research Models and Services, Germany GmbH, Sulzfeld, Germany
- Females nulliparous and non-pregnant: yes
- Age at study initiation: 62 days (on test day 1)
- Weight at study initiation: 29 - 34 g (test day 1)
- Housing: animals were kept individually in in MAKROLON cages (type III) supplemented with granulated textured wood as bedding material (Granulat A2, J. Brandenburg, Goldenstedt, Germany)
- Diet: commercial diet ssniff R/M-H V1534 (ssniff Spezialdiäten GmbH, Soest, Germany), ad libitum
- Water: tap water, ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3
- Humidity (%): 55 ± 15
- Photoperiod (hrs dark / hrs light): 12/12
Study design: in vivo (LLNA)
- Vehicle:
- acetone/olive oil (4:1 v/v)
- Concentration:
- 50, 75 and 100%
- No. of animals per dose:
- 6
- Details on study design:
- PRE-SCREEN TESTS
A preliminary experiment was carried out in 4 animals to examine the irritating potential and handling/application of the test item in order to select the appropriate concentrations. Four concentrations of 25%, 50% and 75% dissolved in acetone / olive oil (4:1, v/v) and the undiluted test item were examined. Doses were selected according to OECD guideline from the concentration series 100%, 50%, 25%, 10%, 5%, 2.5%, 1%, 0.5% etc. The preliminary experiment was conducted under conditions identical to the main LLNA study, except there was no assessment of lymph node proliferation and only 1 animal per concentration was used. Both ears of each mouse were observed for erythema and scored using following pattern: 0 (no erythema), 1 (very slight erythema), 2 (well-defined erythema) and 4 (moderate to severe erythema).
MAIN STUDY
ANIMAL ASSIGNMENT AND TREATMENT
- Name of test method: Alternative endpoints of the murine local lymph node (measurement of lymph node weight and lymph node cell count, ear weight/thickness measurement to detect skin irritation potential)
- Criteria used to consider a positive response: Stimulation indices were calculated for the lymph node cell count, lymph node weight, ear weight and ear thickness by dividing the average values per group of the test item treated animals by the vehicle treated ones. Values above 1.4 (lymph node cell count to identify sensitisation) or 1.1 (ear weight to identify irritation) are considered positive (these values were fixed empirically during the interlaboratory validation of this method (Ehling et al. 2005a and 2005b).
TREATMENT PREPARATION AND ADMINISTRATION
The test item was used undiluted or diluted in acetone / olive oil (4:1, v/v). The vehicle acetone / olive oil (4:1, v/v) was used as negative reference item. The test item solution was administered to the dorsum of both animals´ ears at an application volume of 25 µL/ear. Five groups of 6 female animals each were examined. The concentrations (50, 75 and 100%) were chosen based on a preliminary experiment. The study was performed according to OECD 429, however not employing the use of radioactive labelling to measure cell proliferation. The alternative method used for the study employing the lymph node weight and lymph node cell count to assess proliferation has been established by an European interlaboratory validation exercise, as described in the two publications by Ehling et al. 2005a and 2005b. In addition, the acute inflammatory skin reaction is measured by ear weight determination of circular biopsies of the ears and ear thickness measurements on test day 1 and test day 4 to identify skin irritation properties of the test item. The experimental schedule of the assay was as follows:
- Day 1: The weight of each animal was individually identified and recorded. The weights and any clinical observation were recorded. In addition, ear swelling measurements were carried out at the helical edge of both ears using an Oditest micrometer. Open application of 25 μL of the appropriate dilution of the test item, the vehicle alone or the positive control (as appropriate) were administered to the dorsum of each ear.
- Days 2 and 3: The application procedure carried out on day 1 was repeated.
- Day 4 (24 hours after the last application): Ear swelling measurements (immediately before sacrificing the mice) were carried out at the helical edge of both ears using an Oditest micrometer. The animals were euthanized by carbon dioxide (CO2) inhalation and laparotomised. Punch biopsies of 8 mm in diameter of the apical area of both ears were prepared and immediately weighed on an analytical balance. Lateral pairs of auricular lymph nodes draining the ear tissue were excised, carefully separated from remaining fatty tissue and weighed on an analytical balance immediately following preparation. The lymph nodes were then stored on ice in PBS/0.5% BSA and subjected to the preparation of single cell suspensions by mechanical tissue disaggregation. The cells were counted automatically in a cell counter. - Positive control substance(s):
- other: 20% solution (v/v) of α-hexyl cinnamic aldehyde in acetone / olive oil (4:1, v/v)
- Statistics:
- For lymph node weight significance at p ≤0.01 is considered positive (U-test according to MANN and WHITNEY). A possible concentration-response-relationship for the lymph node weight in order to determine a possible sensitising potential was examined by linear regression analysis employing PEARSON's correlation coefficient. U-test was performed for cell count, too. Outliers were determined according to the Nalimov test. Hence, in addition, the acute inflammatory skin reaction (irritating potential) was measured by ear weight determination of circular biopsies of the ears and ear thickness measurements on test day 1 and test day 4 to identify skin irritation properties of the test item employing the U-test according to MANN and WHITNEY by comparing the test groups to the vehicle control. The stimulation indices were calculated by dividing the average ear weight and average ear thickness on test day 4 per group of the test item treated animals by the vehicle treated ones. The cut-off threshold value for the ear weight stimulation index was set at 1.1.
Results and discussion
- Positive control results:
- The positive control was dissolved in acetone / olive oil (4:1, v/v). Positive controls were used to demonstrate appropriate performance of the assay and competence of the laboratory to successfully conduct the assay. An index for the lymph node cell count above 1.4 is considered positive. The positive control group caused the expected increases in lymph node cell count and lymph node weight (statistically significant at p ≤0.01). Therefore, the study can be regarded as valid.
In vivo (LLNA)
Resultsopen allclose all
- Key result
- Parameter:
- SI
- Remarks:
- Lymph node cell count
- Value:
- 1.073
- Test group / Remarks:
- 50% test item
- Remarks on result:
- other: no indication of skin sensitisation
- Key result
- Parameter:
- SI
- Remarks:
- Lymph node cell count
- Value:
- 1.062
- Test group / Remarks:
- 75% test item
- Remarks on result:
- other: no indication of skin sensitisation
- Key result
- Parameter:
- SI
- Remarks:
- Lymph node cell count
- Value:
- 1.091
- Test group / Remarks:
- 100% test item
- Remarks on result:
- other: no indication of skin sensitisation
- Key result
- Parameter:
- SI
- Remarks:
- Lymph node cell count
- Value:
- 1.526
- Test group / Remarks:
- Positive control
- Key result
- Parameter:
- SI
- Remarks:
- Lymph node weight
- Value:
- 1.137
- Test group / Remarks:
- 50% test item
- Remarks on result:
- other: no indication of skin sensitisation
- Key result
- Parameter:
- SI
- Remarks:
- Lymph node weight
- Test group / Remarks:
- 75% test item
- Remarks on result:
- other: no indication of skin sensitisation
- Key result
- Parameter:
- SI
- Remarks:
- Lymph node weight
- Value:
- 1.176
- Test group / Remarks:
- 100% test item
- Remarks on result:
- other: no indication of skin sensitisation
- Key result
- Parameter:
- SI
- Remarks:
- Lymph node weight
- Value:
- 1.471
- Test group / Remarks:
- Positive control
- Key result
- Parameter:
- SI
- Remarks:
- Ear weight
- Value:
- 0.98
- Test group / Remarks:
- 50% test item
- Remarks on result:
- other: no indication of skin irritation
- Key result
- Parameter:
- SI
- Remarks:
- Ear weight
- Value:
- 1.005
- Test group / Remarks:
- 75% test item
- Remarks on result:
- other: no indication of skin irritation
- Key result
- Parameter:
- SI
- Remarks:
- Ear weight
- Value:
- 1.061
- Test group / Remarks:
- 100% test item
- Remarks on result:
- other: no indication of skin irritation
- Key result
- Parameter:
- SI
- Remarks:
- Ear weight
- Value:
- 1.097
- Test group / Remarks:
- Positive control
- Key result
- Parameter:
- SI
- Remarks:
- Ear thickness
- Value:
- 0.996
- Test group / Remarks:
- 50% test item
- Remarks on result:
- other: no indication of skin irritation
- Key result
- Parameter:
- SI
- Remarks:
- Ear thickness
- Value:
- 1.008
- Test group / Remarks:
- 75% test item
- Remarks on result:
- other: no indication of skin irritation
- Key result
- Parameter:
- SI
- Remarks:
- Ear thickness
- Value:
- 0.988
- Test group / Remarks:
- 100% test item
- Remarks on result:
- other: no indication of skin irritation
- Key result
- Parameter:
- SI
- Remarks:
- Ear thickness
- Value:
- 1.118
- Test group / Remarks:
- Positive control
- Cellular proliferation data / Observations:
- PRELIMINARY EXPERIMENT
In a preliminary experiment, concentrations of 25%, 50%, 75%, and 100% of the test material employing 1 animal per concentration, were examined. No systemic toxicity or excessive local skin irritation were observed in this preliminary experiment at concentrations of 25%, 50%, 75% and 100%.
MAIN STUDY
In the main study treatment with the test material at concentrations of 50%, 75% or 100% did not reveal any statistical significantly increased values for the lymph node cell count. The stimulation indices calculated for the lymph node cell count did not exceed the threshold level of 1.4. In addition, no statistical significantly increase in the lymph node weight was observed. Hence, the test item is classified as not sensitising to the skin. The threshold level of 1.1 for the ear weight stimulation index was not exceeded and no increase of ear thickness was observed, thus, no irritating properties were noted.
CLINICAL OBSERVATIONS
No signs of local or systemic intolerance were recorded.
BODY WEIGHTS
The animal body weight was not affected by the treatment.
Any other information on results incl. tables
Table 1: Summary of Stimulation indices (SI)
Parameter |
Negative control |
50% test item |
75% test item |
100% test item |
Positive control |
Lymph node cell count |
1.000 |
1.073 |
1.062 |
1.091 |
1.526** |
Lymph node weight |
1.000 |
1.137 |
1.235 |
1.176 |
1.471** |
Ear weight |
1.000 |
0.980 |
1.005 |
1.061 |
1.097** |
Ear thickness (day 4) |
1.000 |
0.996 |
1.008 |
0.988 |
1.118 |
**: significantly increased compared to negative control at p ≤0.01
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- CLP: not classified
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