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EC number: 942-376-7 | 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:
- key study
- Study period:
- 08 Sep - 09 Dec 2015
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- 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:
- 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:
- Reaction mass of 5,9-Undecadienal-2,6,10-trimethyl-, (5E)- and 5,9-Undecadienal-2,6,10-trimethyl-, (5Z)-
- EC Number:
- 942-376-7
- Molecular formula:
- C14H24O
- IUPAC Name:
- Reaction mass of 5,9-Undecadienal-2,6,10-trimethyl-, (5E)- and 5,9-Undecadienal-2,6,10-trimethyl-, (5Z)-
Constituent 1
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- CBA
- Remarks:
- /Jcr
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Females nulliparous and non-pregnant: yes
- Weight at study initiation: 18.8 - 24.0 g
- Housing: 1 to 5 animals per cage in polycarbonate boxes, with bedding
- Diet: Formulab #5008 (PMI Feeds Inc.), ad libitum
- Water: municipal water, ad libitum
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-23
- Humidity (%): 30-94
- Air changes (per hr): minimum 10
- Photoperiod (hrs dark / hrs light): 12/12
Study design: in vivo (LLNA)
- Vehicle:
- acetone/olive oil (4:1 v/v)
- Concentration:
- Test substance: 25, 50 and 100%
Positive control: 100% - No. of animals per dose:
- 5
- Details on study design:
- PRE-SCREEN TEST:
No range-finding test was conducted.
ANIMAL ASSIGNMENT AND TREATMENT
- Name of test method: 3H-methyl thymidine incorporation determined by ß-scintillation
- Criteria used to consider a positive response: A stimulation index (SI) was calculated for each group using the activity of each test group divided by the activity of the vehicle control group. The criterion for a positve response is that one or more concentrations of the test substance should elicit a 3-fold or greater increase in isotope incorporation relative to the vehicle control group.
TREATMENT PREPARATION AND ADMINISTRATION: The dorsal surface of both ears was topically treated (25 μL/ear) with the test substance on Day 1. The application was repeated on Day 2 and 3. Three days after the third application an injection of 250 µL phosphate buffered saline (PBS) containing 20 µCi of 3H-methyl thymidine (³HTdR) was made into the tail vein of each experimental mouse. Five hours after injection of ³HTdR, the mice were sacrificed and draining auricular lymph nodes were excised and pooled for each individual animal. A single cell suspension was prepared by gentle separation through a 200 mesh stainless steel gauze. The cell suspensions were washed two times with an excess of PBS and precipitated with 5% trichloroacetic acid at 4 °C for 18 h. The pellets were resuspended in 1 mL of trichloroacetic acid and transferred to 10 mL of scintillation fluid. - Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
- Statistics:
- A one-way parametric analysis of variance (ANOVA) with Dunnett's Multiple Comparisons Test, using GraphPad InStat version 3.06, was performed on DPM counts.
If test groups showed a SI >3, then an extrapolated EC3 value was calculated from SI values at low% and either mid or high% concentrations.
If at least one concentration shows SI < 3, then the formula is: EC3 = [(3-d)/(b-d)] x (a-c) + c
a = the dose concentration with higher SI
b = the higher SI value
c = the dose cocentration with lower SI
d = the lower SI value using SI values closest to 3, one above and one below
Results and discussion
- Positive control results:
- The SI value calculated for the positive control was 5.2.
In vivo (LLNA)
Resultsopen allclose all
- Parameter:
- SI
- Value:
- 1.9
- Test group / Remarks:
- 25%
- Parameter:
- SI
- Value:
- 3.5
- Test group / Remarks:
- 50%
- Parameter:
- SI
- Value:
- 3.4
- Test group / Remarks:
- 100%
- Parameter:
- EC3
- Value:
- 42.3
- Cellular proliferation data / Observations:
- CELLULAR PROLIFERATION DATA: The lymph nodes of each individual animal were pooled and disintegration per minute (DPM) values were measured from the pooled lymph node cell suspensions. Treatment with test substance concentrations of 25 and 50% in acetone/olive oil (4:1) and undiluted test substance resulted in DPM values per mouse of 4649, 8368 and 8274, respectively. The DPM value per mouse of the vehicle control was 2405. Compared to the vehicle control, the 50%, 100% and positive control groups had significantly higher DPM counts (p > 0.1 per ANOVA).
EC3 CALCULATION: The EC3 was 42.3% using the 25% and 50% concentrations.
CLINICAL OBSERVATIONS: All animals appeared normal for the duration of the study. However, one positive control animal was found dead following Day 6 injection.
BODY WEIGHTS: Four animals each of the 50 and 100% concentration test group failed to gain weight during the study. Some animals in both control groups also lost weight.
Any other information on results incl. tables
Table 1: Body weights and DPM counts.
|
Animal |
Body weight (g) |
DPM count |
Mean DPM ± SD |
|
Day 1 |
Day 6 |
||||
Vehicle Control Group |
1 |
24.0 |
22.9 |
3583 |
2405 ± 817 |
2 |
21.7 |
21.2 |
2231 |
||
3 |
20.9 |
21.6 |
1288 |
||
4 |
22.1 |
21.5 |
2468 |
||
5 |
20.9 |
19.6 |
2456 |
||
Test Group I - 25% |
1 |
21.9 |
22.0 |
2371 |
4649 ± 2127 |
2 |
18.8 |
19.7 |
3271 |
||
3 |
20.8 |
21.3 |
3992 |
||
4 |
20.3 |
20.8 |
7604 |
||
5 |
21.2 |
22.0 |
6006 |
||
Test Group II - 50% |
1 |
23.4 |
21.7 |
11118 |
8368 ± 2866 |
2 |
21.2 |
21.1 |
11854 |
||
3 |
21.8 |
21.8 |
5965 |
||
4 |
19.7 |
20.0 |
6526 |
||
5 |
20.9 |
20.8 |
6375 |
||
Test Group III - 100% |
1 |
20.1 |
20.0 |
7400 |
8274 ± 2794 |
2 |
22.0 |
22.3 |
6121 |
||
3 |
22.1 |
21.3 |
5709 |
||
4 |
23.1 |
22.4 |
12412 |
||
5 |
21.8 |
22.0 |
9728 |
||
Positive Control Group |
1 |
20.9 |
21.1 |
7950 |
12508 ± 3323 |
2 |
20.4 |
20.0 |
15924 |
||
3 |
21.2 |
21.3 |
13209 |
||
4 |
23.2 |
22.1 |
12949 |
||
5 |
22.1 |
16.1 |
* |
* Animal was found dead following Day 6 injection
Applicant's summary and conclusion
- Interpretation of results:
- other: Skin Sens. 1B according to Regulation (EC) No 1272/2008
- Conclusions:
- Under the conditions of the mouse Local Lymph Node Assay the test substance revealed a SI ≥ 3 at concentrations of 50 and 100%. The EC3 value was calculated to be 42.3%. Therefore, the test substance is considered as weak sensitiser.
- Executive summary:
The skin sensitisation potential of the test substance was determined by a LLNA according to OECD Guideline 429 in compliance with GLP (2016). After treatment of CBA/Jcr mice with the test substance, test substance produced stimulation indices of 1.9, 3.5 and 3.4 at concentrations of 25, 50 and 100%, respectively. The EC3 value was calculated as 42.3%. In conclusion, based on the available data the test substance is considered to be a weak skin sensitiser.
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