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EC number: - | 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
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- 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
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- Endpoint summary
- Stability
- Biodegradation
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- 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
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Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 24 Apr to 17 Jun 2018
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 018
- Report date:
- 2018
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 2010
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2600 (Skin Sensitisation)
- Version / remarks:
- adopted in 2003
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.42 (Skin Sensitisation: Local Lymph Node Assay)
- Version / remarks:
- adopted in 2012
- GLP compliance:
- yes
- Type of study:
- mouse local lymph node assay (LLNA): DA
Test material
- Reference substance name:
- Fatty acids, vegetable-oil, polymd., esters with 1,2-hexadecanediol
- Cas Number:
- 68910-99-6
- Molecular formula:
- Not applicable (i.e., UVCB substance)
- IUPAC Name:
- Fatty acids, vegetable-oil, polymd., esters with 1,2-hexadecanediol
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: Janvier, Le Genest-Saint-Isle, France
- Females nulliparous and non-pregnant: yes
- Microbiological status of animals: SPF
- Age at study initiation: 12-13 weeks old
- Weight at study initiation: 20.9 - 27.0 g
- Housing: group housing; up to 5 animals per cage in polycarbonate cages (Makrolon MIII type; height 18 cm)
- Diet: pelleted rodent diet (SM R/M-Z from SSNIFF® Spezialdiäten GmbH, Soest, Germany), ad libitum
- Water: municipal tap-water in water bottles, ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 - 24
- Humidity (%): 40 - 70
- Air changes (per hr): at least 10
- Photoperiod (hrs dark / hrs light): 12/12
- IN-LIFE DATES: From: 25 Apr 2018 To: 10 Jun 2018
Study design: in vivo (LLNA)
- Vehicle:
- acetone/olive oil (4:1 v/v)
- Concentration:
- Pre-screen test: 25 and 60% (w/w)
Main study: 10, 25 and 60% (w/w) - No. of animals per dose:
- 5 females/group
- Details on study design:
- PRE-SCREEN TESTS:
- Compound solubility: test item dosing formulations (w/w) were homogenized to visually acceptable levels at appropriate concentrations to meet dose level requirements
- Concentrations tested: 25 and 60%
- Irritation: the highest concentration to be used in the main study should induce well-defined irritation as the most pronounced response (maximum grade 2 and/or an increase in ear thickness < 25%) and/or is the highest possible concentration that can technically be applied
- Systemic toxicity: the highest concentration should cause no systemic toxicity
- Ear thickness measurements: conducted prior to dosing on Days 1 and 3, and on Day 6 with a digital thickness gauge (Kroeplin C110T-K)
- Erythema scores: determined according to numerical scoring system ranging from 0 (no erythema) to 4 (severe erythema)
MAIN STUDY :
ANIMAL ASSIGNMENT AND TREATMENT
- Name of test method: 3H-methyl thymidine incorporation determined by beta-scintillation
- Criteria used to consider a positive response: SI ≥ 3
TREATMENT PREPARATION AND ADMINISTRATION:
Test item dosing formulations were homogenized to visually acceptable levels at appropriate concentrations to meet dose level requirements.
The dosing formulations were prepared daily and dosed within 4 hours after adding the vehicle to the test item. The dosing formulations were kept at room temperature until dosing. The dosing formulations were stirred until and during dosing.
During the induction phase (days 1 - 3) the dorsal surface of both ears was topically treated (25 μL/ear) with the test item, at approximately the same time on each day; local irritation reactions were assessed.
IN-LIFE DATES: 25 Apr to 10 Jun 2018
EXCISION OF NODES AND TISSUE PROCESSING
On day 6, an injection of 0.250 mL phosphate buffered saline (PBS) containing 20 µCi of 3H-methyl thymidine (3H-TdR) was made into the tail vein of each experimental mouse. Five hours later, all animals were killed by intraperitoneal injection (0.2 mL/animal) of Euthasol® 20% (AST Farma BV, Oudewater, The Netherlands). The draining auricular lymph node of each ear 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 PBS.
A single cell suspension of lymph node cells (LNC) was prepared from each mouse in PBS by gentle separation through stainless steel gauze (maze size: 200 μm, diameter: ± 1.5 cm). LNC were washed twice with an excess of PBS followed by centrifugation at 200 g for 10 minutes at 4ºC. To precipitate the DNA, the LNC were exposed to 5% trichloroacetic acid (TCA) (Merck, Darmstadt, Germany) and then stored in the refrigerator until the next day.
RADIOACTIVITY MEASUREMENTS
Precipitates were recovered by centrifugation, resuspended in 1 mL TCA and transferred to 10 mL of Ultima Gold cocktail (PerkinElmer Life and Analytical Sciences, Boston, MA, US) as the scintillation fluid. Radioactivity measurements were performed using a Packard scintillation counter (2910TR). Counting time was to a statistical precision of ± 0.2% or a maximum of 5 minutes whichever came first. The scintillation counter was programmed to automatically subtract background and convert Counts Per Minute (CPM) to Disintegrations Per Minute (DPM).
IN-LIFE PROCEDURES, OBSERVATIONS, MEASUREMENTS
Mortality/Moribundity Checks
Throughout the study, animals were observed for general health/mortality and moribundity twice daily, in the morning and at the end of the working day. Animals were not removed from the cage during observation, unless necessary for identification or confirmation of possible findings.
Clinical Observations - Postdose Observations
Postdose observations were performed once daily on Days 1-6 (on Days 1-3 between 3 and 4 hours after dosing). All the animals were examined for reaction to dosing. The onset, intensity and duration of these signs was recorded (if appropriate), particular attention being paid to the animals during and for the first hour after dosing.
Body Weights
Animals were weighed individually on Day 1 (predose) and 6 (prior to necropsy).
Irritation
Erythema and eschar formation observations were performed once daily on Days 1-6 (on Days 1-3 within 1 hour after dosing) according to the following numerical scoring system. Furthermore, a description of all other (local) effects was recorded. Erythema and eschar formation were scored according to Draize.
Terminal procedures
No necropsy was performed, since all animals survived until the end of the observation period. - Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
- Statistics:
- All results presented in the tables are calculated using values as per the raw data rounding procedure and may not be exactly reproduced from the individual data presented. DPM values are presented for each animal and for each dose group. A Stimulation Index (SI) is calculated for each group using the individual SI values. The individual SI is the ratio of the DPM/animal compared to the DPM/vehicle control group mean.
Results and discussion
- Positive control results:
- A routine six-month reliability test (performed in November 2017; study number 20152821) was conducted to assess the sensitivity of the CBA/J mice at the testing facility to a known sensitizer. The positive control substance hexyl cinnamic aldehyde (25% (v/v) in acetone:olive oil (4+1)) was considered to be a sensitizer under the conditions of the test (SI 3.5).
In vivo (LLNA)
Resultsopen allclose all
- Key result
- Parameter:
- SI
- Value:
- 1
- Test group / Remarks:
- 10%
- Key result
- Parameter:
- SI
- Value:
- 1.6
- Test group / Remarks:
- 25%
- Key result
- Parameter:
- SI
- Value:
- 2.3
- Test group / Remarks:
- 60%
- Cellular proliferation data / Observations:
- DETAILS ON STIMULATION INDEX CALCULATION
The SI values calculated for the test item concentrations 10, 25 and 60% were 1.0, 1.6 and 2.3, respectively.
EC3 CALCULATION
The EC3 value could not be calculated, since all SI values are below the threshold value of 3.
CLINICAL OBSERVATIONS:
No mortality or signs of systemic toxicity were observed in any treatment group or in the control group.
BODY WEIGHTS
Body weights and body weight gain of experimental animals remained in the same range as controls over the study period.
MACROSCOPIC EXAMINATION OF THE LYMPH NODES AND SURROUNDING AREA
All auricular lymph nodes of the animals of the experimental and control groups were considered normal in size. No macroscopic abnormalities of the surrounding area were noted for any of the animals.
Any other information on results incl. tables
Main Study
- Skin Reactions / Irritation
The very slight irritation of the ears as shown by the animals treated at 60% between Days 1 and 3 was considered not to have a toxicologically significant effect on the activity of the nodes. Transparent test item remnants were present on the dorsal surface of the ears of all animals treated at 25 and 60% between Days 1 and 3, which did not hamper scoring of the skin reactions.
Table 1. Main Study: Relative Size Lymph Nodes, Radioactivity Counts (DPM) and Stimulation Index (SI)
Group |
TS1 (%) |
Animal |
Node size2 |
DPM3/ animal |
mean DPM ± SEM4 |
mean SI ± SEM |
||||||
left |
right |
|||||||||||
|
|
|
|
|
|
|
|
|||||
1 |
0 |
1 |
n |
n |
223 |
353 |
± |
56 |
1.0 |
± |
0.2 |
|
|
|
2 |
n |
n |
310 |
|||||||
|
|
3 |
n |
n |
285 |
|||||||
|
|
4 |
n |
n |
542 |
|||||||
|
|
5 |
n |
n |
404 |
|||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
2 |
10 |
6 |
n |
n |
254 |
366 |
± |
39 |
1.0 |
± |
0.1 |
|
|
|
7 |
n |
n |
372 |
|||||||
|
|
8 |
n |
n |
336 |
|||||||
|
|
9 |
n |
n |
499 |
|||||||
|
|
10 |
n |
n |
371 |
|||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
3 |
25 |
11 |
n |
n |
355 |
571 |
± |
143 |
1.6 |
± |
0.4 |
|
|
|
12 |
n |
n |
385 |
|||||||
|
|
13 |
n |
n |
567 |
|||||||
|
|
14 |
n |
n |
977 |
|||||||
|
|
15 |
n |
n |
25725 |
|||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
4 |
60 |
16 |
n |
n |
466 |
799 |
± |
125 |
2.3 |
± |
0.4 |
|
|
|
17 |
n |
n |
557 |
|||||||
|
|
18 |
n |
n |
1119 |
|||||||
|
|
19 |
n |
n |
871 |
|||||||
|
|
20 |
n |
n |
983 |
|||||||
|
|
|
|
|
|
|
|
1 TS = test item (% w/w).
2 Relative size auricular lymph nodes (-, -- or ---: degree of reduction, +, ++ or +++: degree of enlargement, n: considered to be normal).
3 DPM= Disintegrations per minute.
4 SEM = Standard Error of the Mean.
5 Value not used for interpretation (outlier based on Dixon’s Q-test).
Applicant's summary and conclusion
- Interpretation of results:
- other:
- Remarks:
- CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No. 1272/2008
- Conclusions:
- CLP: not classified
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
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