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EC number: 807-748-4 | CAS number: 1154521-93-3
- 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
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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:
- 2015-03-31 and 2015-06-04
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 015
- Report date:
- 2015
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:
- EU Method B.42 (Skin Sensitisation: Local Lymph Node Assay)
- Version / remarks:
- 2012
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- mouse local lymph node assay (LLNA)
Test material
- Reference substance name:
- 1,4-phenylenebis(nitrilo-2,2-dimethylprop-1-yl-3-ylidene) didodecanoate
- Cas Number:
- 1154521-93-3
- Molecular formula:
- C40H68N2O4
- IUPAC Name:
- 1,4-phenylenebis(nitrilo-2,2-dimethylprop-1-yl-3-ylidene) didodecanoate
- Test material form:
- liquid
Constituent 1
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- CBA/Ca
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: TOXI-COOP ZRT., Hungary
- Age at study initiation: 11 weeks
- Weight at study initiation: 16.9 -21.4 g
- Housing: Grouped caging (4 animals/cage)
- Diet: ad libitum, ssniff® SM R/M-Z+H complete diet for rats
- Water: ad libitum, tap water
- Acclimation period: 14 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3
- Humidity (%): 30 – 70
- Photoperiod (hrs dark / hrs light): 12/12
Study design: in vivo (LLNA)
- Vehicle:
- acetone/olive oil (4:1 v/v)
- Concentration:
- 25%, 10%, 5%, 2.5% (w/v)
- No. of animals per dose:
- 4
- Details on study design:
- RANGE FINDING TESTS:
- Compound solubility: The test item was miscible with Acetone: Olive oil 4:1 (v/v) mixture (AOO). Since AOO is the most preferred vehicle by the relevant guidelines no other vehicles were evaluated.
- Irritation: No signs of significant irritation (indicated by an erythema score ≥ 3 and/or an increased ear thickness of ≥ 25 % on any day of measurement) were observed in the evaluated groups (50% and 25% (w/v) test item in AOO)
- Lymph node proliferation response: No assessement of lymph node proliferation was done.
- Other: Significant systemic toxicity was observed at concentrations of 100% and 50% test item concentration
MAIN STUDY
ANIMAL ASSIGNMENT AND TREATMENT
- In the main test 24 female CBA/Ca Ola Hsd mice were allocated to 6 groups of 4 animals each:
- 4 groups received the appropriate formulation of the test substance at concentrations of 25%, 10%, 5% and 2.5%
- the negative control group received the vehicle (AOO)
- the positive control group received hexyl cinnamic aldehyde (25% (w/v) in AOO)
- Each substance was applied on the dorsal surface of each ear (25 µL) of the animals once a day for three consecutive days (days 1, 2 and 3).
- There were no treatment on days 4, 5 and 6.
- Criteria used to consider a positive response: The stimulation index of 3 or greater is an indication of a positive result. - Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
Results and discussion
- Positive control results:
- The positive control item (25% (w/v) in acetone olive oil 4:1) induced the appropriate stimulation over the control (stimulation index = 8.1)
In vivo (LLNA)
Resultsopen allclose all
- Key result
- Parameter:
- SI
- Value:
- 8
- Test group / Remarks:
- Dose group 25 %
- Key result
- Parameter:
- SI
- Value:
- 3.1
- Test group / Remarks:
- Dose group 10 %
- Key result
- Parameter:
- SI
- Value:
- 2.9
- Test group / Remarks:
- Dose group 5 %
- Key result
- Parameter:
- SI
- Value:
- 1.4
- Test group / Remarks:
- Dose group 2.5 %
- Key result
- Parameter:
- SI
- Value:
- 8.1
- Test group / Remarks:
- Positive control group
- Key result
- Parameter:
- SI
- Value:
- 1
- Test group / Remarks:
- Vehicle control group
- Cellular proliferation data / Observations:
- CLINICAL OBSERVATIONS: No mortality or symptoms of systemic toxicity were observed in any treatment group. No sign of irritation (indicated by an erythema score ≥ 3) or any other local effect was observed in any treatment groups
BODY WEIGHTS: No significant, treatment related effect on the body weights was considered in any treatment group. Although ≥ 5% decrease of body weights was observed in the vehicle control group, in the 25 % and 5 % dose groups (1/4 animals in each) it was considered not relevant.
Any other information on results incl. tables
DPM in the main test
Test Group |
Measured DPM/group |
Group* DPM |
DPN# (DPM/Node) |
Vehicle control (AOO) |
9786 |
9767.5 |
1220.9 |
Positive control (25 % HCA in AOO) |
79499 |
79480.5 |
9935.1 |
25% test item |
78576 |
78557.5 |
9819.7 |
10% test item |
30356 |
30337.5 |
3792.2 |
5% test item |
28735 |
28716.5 |
3589.6 |
2.5% test item |
13456 |
13437.5 |
1679.7 |
HCA = α-Hexylcinnamaldehyde
AOO = Acetone: Olive oil 4:1 (v/v) mixture
# No. of lymph nodes per group = 8
*Group DPM = measured DPMgroup- average DPMbackground
Average DPMbackground= 18.5
No mortality was observed during the main study. No significant, treatment related effect on body weights or any other sign of systemic toxicity were observed in any treatment group. No signs of irritation or any other local effect were observed at the treatment site (ears) in any treatment group.
Applicant's summary and conclusion
- Interpretation of results:
- Category 1B (indication of skin sensitising potential) based on GHS criteria
- Conclusions:
- The calculated EC3 value based on dose-response curve analysis was 7.5% (w/v) in this LLNA. Based on this value, the test item is considered to be a moderate skin sensitizer(1 ≤ EC3 < 10).
- Executive summary:
The aim of this study was to determine the skin sensitization potential of the test item following dermal exposure in the Local Lymph Node Assay. Pooled treatment group approach was used in this test. Selection of test item concentrations based on the results of a formulation evaluation and also resulted from a preliminary irritation/toxicity test according to the relevant guidelines. The test item was a liquid and adequately miscible with Acetone: Olive oil 4:1 (v/v) mixture (AOO). Since AOO is the most preferred vehicle by the relevant guidelines no other vehicles were evaluated. Based on results of the preliminary irritation/toxicity test (where significant systemic toxicity was observed at concentrations of 100 % and 50 % (w/v)) the test item was examined in the main test at 25 %, 10 %, 5 % and 2.5 % (w/v) as formulations in AOO. Appropriate positive control, furthermore a negative control group dosed with the vehicle (AOO) of the test and positive control groups were employed. The positive control item (α-Hexylcinnamaldehyde [HCA]; 25 % (w/v) in AOO) induced the appropriate stimulation over the control (SI = 8.1), thus confirming the validity of the assay. No mortality was observed during the main test. No significant, treatment related effect on body weights or any other sign of systemic toxicity were observed in any treatment group. No signs of irritation or any other local effect were observed at the treatment site (ears) in any treatment group. Based on the calculated SI values significant lymphoproliferation (SI ≥ 3) was observed for the test item at concentrations of 25 % and 10 % (w/v). The corresponding stimulation index values were 8.0, 3.1, 2.9 and 1.4 at treatment concentrations of 25 %, 10 %, 5 % and 2.5 % (w/v), respectively. Statistically significant (p = 0.02) and biologically relevant dose-response relationship was observed (linear regression using the SI values). According to evaluation criteria of the relevant guidelines, the significantly increased lymphoproliferation at the maximum applicable (non-toxic, non-irritant) concentration of 25 % (w/v) and also at 10 % (w/v) concentration and the significant dose-response relationship are considered evidence that the test item is a skin sensitizer. The calculated EC3 value based on dose-response curve analysis was 7.5 % (w/v) in this LLNA. Based on this value the test item can be ranked among moderate sensitizers (1 ≤ EC3 < 10).
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