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EC number: 947-849-1 | 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)
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- 26 May - 10 Sep 2010
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
- Remarks:
- no concurrent positive control
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 010
- Report date:
- 2010
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- Version / remarks:
- adopted in 2002
- Deviations:
- no
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- Version / remarks:
- adopted in 2010
- Deviations:
- yes
- Remarks:
- instead of concurrent positive control, reliability check all 6 months
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.42 (Skin Sensitisation: Local Lymph Node Assay)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2600 (Skin Sensitisation)
- Version / remarks:
- 2003
- Deviations:
- no
- GLP compliance:
- yes
- Type of study:
- mouse local lymph node assay (LLNA)
Test material
- Reference substance name:
- Decyl oleate
- EC Number:
- 222-981-6
- EC Name:
- Decyl oleate
- Cas Number:
- 3687-46-5
- Molecular formula:
- C28H54O2
- IUPAC Name:
- decyl octadec-9-enoate
Constituent 1
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- other: CBA/J
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Janvier, Le Genest-Saint-Isle, France
- Age at study initiation: approximately 10 weeks
- Weight at study initiation: 22-25 g (range)
- Housing: animals were housed individually in labelled Makrolon cages (MI type, height 12.5 cm) containing sterilised sawdust as bedding material (Litalabo, S.P.P.S., Argenteuil, France) and paper as cage-enrichment (Enviro-dri, Wm. Lillico & Son (Wonham Mill Ltd.), Surrey, UK). The paper was removed on Day 1 prior to dosing and was supplied again after scoring of the ears on the third day 3. During the acclimation period the animals were housed in groups in Macrolon cages (MIII type, height 18 cm).
- Diet: pelleted rodent diet (SM R/M-Z from SSNIFF Spezialdiäten GmbH, Soest, Germany), ad libitum
- Water: tap water, ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20.5-23.1
- Humidity (%): 41-68
- Air changes (per hr): approximately 15
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 26 May 2010 To: 23 Jun 2010
Study design: in vivo (LLNA)
- Vehicle:
- acetone/olive oil (4:1 v/v)
- Concentration:
- 25, 50 and 100% (w/w)
- No. of animals per dose:
- 5
- Details on study design:
- RANGE FINDING TESTS:
- Irritation: A preliminary irritation study was performed according to the procedure of the main study. Two mice were treated daily for 3 consecutive days with either a 50% solution or 100% test substance. 3-4 hours after the last exposure, the irritation severity on the treated skin site was assessed. The body weight was recorded on Day 1 and 3. Very slight erythema (grade 1 of 4) was observed on both the treated sites in the animal exposed to 100% concentration. None of the animals exhibited signs of toxicity during the study period and the body weight was not affected by the treatment. Based on these results, the highest test substance concentration selected for the main study was 100%.
MAIN STUDY
ANIMAL ASSIGNMENT AND TREATMENT
- Name of test method: 3H-methyl thymidine incorporation determined by beta-scintillation counting
- Criteria used to consider a positive response: DMP values will be measured for each animal and for each dose group. The stimulation Index (SI) will be calculated for each group. The SI is the ratio of the DPM/group compared to DPM/vehicle control group. If the results indicate a SI ≥3, the test substance may be regarded as a skin sensitiser, based on the test guidelines and the recommendations done by ICCVAM.
TREATMENT PREPARATION AND ADMINISTRATION:
The test substance formulations (w/w) were prepared within 4 hours prior to each treatment. No adjustment was made for specific gravity of the vehicle. Homogeneity was obtained to visually acceptable levels.
During the induction phase (Day 1-3), the dorsal surface of both ears was epidermally treated (25µL/ear) with the vehicle control or 25, 50 and 100% test substance, at approximately the same time each day for 3 consecutive days. On Day 6, all the animals were injected via the tail vein with 0.25 mL sterile phosphate buffered saline (PBS), containing 20 µCi 3H-methyl thymidine. After approximately 5 hours, all the animals were sacrificed by intraperitoneal injection of Euthasol 20% and the draining (auricular) lymph node of both ears was excised. The relative size of the nodes (as compared to normal) was estimated by visual examination, and abnormalities of the nodes and surrounding area were recorded. The nodes were pooled for each animal in approximately 3 mL PBS. A single cell suspension of lymph node cells (LNC) was prepared the same day in PBS by gentle separation through a stainless steel gauze (diameter 125 µm).
A single cell suspension of LNCs was prepared in PBS by gentle separation through stainless steel gauze (diameter 125 µm). To precipitate the DNA, the LNCs were exposed to 5% trichloroacetic acid (TCA) and stored in the refrigerator until the next day.
Radioactivity measurements were performed on Day 7, using Ultima Gold cocktail as the scintillation fluid. The scintillation counter was programmed to automatically subtract background and convert Counts Per Minute (CPM) to Disintegrations Per Minute (DPM). - Positive control substance(s):
- other: A reliability check was performed with alpha-hexylcinnamaldehyde every 6 months to demonstrate that the LLNA test system is reliable and sufficiently sensitive
Results and discussion
- Positive control results:
- A reliability check with a positive control substance was performed every 6 months to demonstrate that the LLNA test system, as used by the test laboratory, is reliable and sufficiently sensitive. In the test performed in April 2010 (project No. 494039), 5, 10 and 25% alpha-hexylcinnamaldehyde, technical grade in acetone/olive oil (4:1 v/v) was used as the positive control. The SI values calculated for the substance concentrations 5, 10 and 25% were 1.7, 2.7 and 8.8 respectively. The SI-value for the vehicle control was 1.0. An EC3 value of 10.7% was calculated using linear interpolation. The calculated EC3 value was found to be in the acceptable range of 2 and 20%. The results of the 6 -monthly HCA reliability checks in CBA/J female mice of the recent years were 14.1, 13.8, 13.9, 16.0, 11.9 and 16.9%. Based on the results, it was concluded that the Local Lymph Node Assay in the mouse as supplied by Janvier performed at NOTOX is an appropriate model for testing for contact hypersensitivity.
In vivo (LLNA)
Resultsopen allclose all
- Key result
- Parameter:
- SI
- Value:
- 1
- Test group / Remarks:
- control
- Key result
- Parameter:
- SI
- Value:
- 1.2
- Test group / Remarks:
- 25%
- Key result
- Parameter:
- SI
- Value:
- 2
- Test group / Remarks:
- 50%
- Key result
- Parameter:
- SI
- Value:
- 2.1
- Test group / Remarks:
- 100%
- Cellular proliferation data / Observations:
- The mean DPM values for the control, 25, 50 and 100% groups were 488, 571, 951 and 1013, respectively (see Table 1). The slight increase in DPM with increasing dose level was not statistically significant.
Any other information on results incl. tables
Effects on the lymph nodes:
The right auricular node was enlarged in 1/5 mice in the highest dose group. As this was a single case, it is not considered to be a sensitivity reaction. No macroscopic abnormalitites were observed in the surrounding area.
Table 1: Individual values for radioactivity measurements (disintegrations per minute) and mean stimulation indices
Group |
Animal No. |
Concentration (% w/w) |
DPM/animal |
Stimulation index (mean± SEM) |
1 |
1 |
0 |
480 |
- |
|
2 |
0 |
629 |
- |
|
3 |
0 |
367 |
- |
|
4 |
0 |
447 |
- |
|
5 |
0 |
515 |
- |
Mean ± SEM |
|
|
488 ± 43 |
1.0 ± 0.1 |
|
|
|
|
|
2 |
6 |
25 |
514 |
- |
|
7 |
25 |
516 |
- |
|
8 |
25 |
519 |
- |
|
9 |
25 |
817 |
- |
|
10 |
25 |
491 |
- |
Mean ± SEM |
|
|
571 ± 62 |
1.2 ± 0.2 |
|
|
|
|
|
3 |
11 |
50 |
928 |
- |
|
12 |
50 |
778 |
- |
|
13 |
50 |
589 |
- |
|
14 |
50 |
1084 |
- |
|
15 |
50 |
1376 |
- |
Mean ± SEM |
|
|
951 ± 134 |
1.0 ± 0.3 |
|
|
|
|
|
4 |
16 |
100 |
637 |
- |
|
17 |
100 |
796 |
- |
|
18 |
100 |
1137 |
- |
|
19 |
100 |
1013 |
- |
|
20 |
100 |
1483 |
- |
Mean ± SEM |
|
|
1013 ± 146 |
1.1 ± 0.1 |
DPM = disintegrations per minute
SEM = standard error of the mean
Skin irritation effects:
Slight erythema was observed at the test site on both ears in 5/5 mice exposed to 100% test substance, which was fully reversible within 3 days after last application. This was not considered to have affected the activity of the lymph nodes.
Systemic effects:
There was no mortality. No clinical signs were observed during the study period and there were no effects on body weight.
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.
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