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3,5,8,10,13,15,18,20,23,25,28,30,33,35,38,40,41,43,45,47,51,53,55,57,59,61,63, 65,67,69,71,73-dotriacontazapentacosacyclo [35.3.3.36,7.311, 12.316,17.321,22.326,27.331,32.22,41.236,43.13,40.15,8.110,13.115,18.120,23.125,28.130,33.135,38.145,51.147,73.153,55.157,59.161,63.165,67.169,71] octacontane-44,46,48,49,50,52,54,56,58,60,62,64,66,68,70,72-hexadecone, hydrochloride hydrate
EC number: 700-970-1 | 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:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 015
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.42 (Skin Sensitisation: Local Lymph Node Assay)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- OGYI/38593-5/2012
- Type of study:
- mouse local lymph node assay (LLNA)
Test material
- Reference substance name:
- 3,5,8,10,13,15,18,20,23,25,28,30,33,35,38,40,41,43,45,47,51,53,55,57,59,61,63, 65,67,69,71,73-dotriacontazapentacosacyclo [35.3.3.36,7.311, 12.316,17.321,22.326,27.331,32.22,41.236,43.13,40.15,8.110,13.115,18.120,23.125,28.130,33.135,38.145,51.147,73.153,55.157,59.161,63.165,67.169,71] octacontane-44,46,48,49,50,52,54,56,58,60,62,64,66,68,70,72-hexadecone, hydrochloride hydrate
- EC Number:
- 700-970-1
- Molecular formula:
- C48N32H48O16xH2O
- IUPAC Name:
- 3,5,8,10,13,15,18,20,23,25,28,30,33,35,38,40,41,43,45,47,51,53,55,57,59,61,63, 65,67,69,71,73-dotriacontazapentacosacyclo [35.3.3.36,7.311, 12.316,17.321,22.326,27.331,32.22,41.236,43.13,40.15,8.110,13.115,18.120,23.125,28.130,33.135,38.145,51.147,73.153,55.157,59.161,63.165,67.169,71] octacontane-44,46,48,49,50,52,54,56,58,60,62,64,66,68,70,72-hexadecone, hydrochloride hydrate
- Test material form:
- solid
Constituent 1
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- other: CBA/J Rj
- Sex:
- female
Study design: in vivo (LLNA)
- Vehicle:
- acetone/olive oil (4:1 v/v)
- Concentration:
- 25% CUCURBIT[8]URIL in Acetone : Olive oil 4:1 (v/v) mixture
10% CUCURBIT[8]URIL in Acetone : Olive oil 4:1 (v/v) mixture
5% CUCURBIT[8]URIL in Acetone : Olive oil 4:1 (v/v) mixture
Positive control - 25% (w/v) a-Hexylcinnamaldehyde (dissolved in AOO).
Negative control - Acetone : Olive oil 4:1 (v/v) mixture - No. of animals per dose:
- Four mice per group.
- Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
Results and discussion
In vivo (LLNA)
Resultsopen allclose all
- Key result
- Parameter:
- SI
- Value:
- 1.1
- Test group / Remarks:
- 5%
- Key result
- Parameter:
- SI
- Value:
- 1.3
- Test group / Remarks:
- 10%
- Key result
- Parameter:
- SI
- Value:
- 1
- Test group / Remarks:
- 25% (w/v)
- Parameter:
- other: disintegrations per minute (DPM)
- Remarks on result:
- other: see Remark
- Remarks:
- DPM was measured for each pooled group of nodes. The measured DPM values were corrected with the background DPM value (“DPM”). The average of the two measured DPM values of 5% (w/v) TCA solutions was used as background DPM value. The results were expressed as “DPN” (DPM divided by the number of lymph nodes) following the industry standard for data presentation. The DPM values were 2634.5, 3407.5 and 2983.5 at concentrations of 25, 10 and 5% (w/v), respectively.
Any other information on results incl. tables
Individual Body Weights for all Animals with Group Means
Identity Number |
Animal Number |
Test group name |
Initial body weight (g) |
Terminal body weight (g) |
Change (%)# |
7467 |
1 |
Negative vehicle control (AOO) |
22.0 |
22.1 |
0.5 |
7539 |
2 |
21.5 |
21.5 |
0.0 |
|
7484 |
3 |
21.9 |
22.4 |
2.3 |
|
7508 |
4 |
21.6 |
22.3 |
3.2 |
|
|
|
Mean |
21.8 |
22.1 |
1.5 |
7469 |
5 |
CUCURBIT[8]URIL 25% (w/v) in AOO |
22.1 |
21.6 |
-2.3 |
7546 |
6 |
21.7 |
21.0 |
-3.2 |
|
7490 |
7 |
21.7 |
22.5 |
3.7 |
|
7516 |
8 |
21.9 |
21.7 |
-0.9 |
|
|
|
Mean |
21.9 |
21.7 |
-0.7 |
7475 |
9 |
CUCURBIT[8]URIL 10% (w/v) in AOO |
22.0 |
21.3 |
-3.2 |
7550 |
10 |
21.7 |
22.9 |
5.5 |
|
7494 |
11 |
21.6 |
22.3 |
3.2 |
|
7525 |
12 |
21.9 |
22.2 |
1.4 |
|
|
|
Mean |
21.8 |
22.2 |
1.7 |
7480 |
13 |
CUCURBIT[8]URIL 5% (w/v) in AOO |
22.1 |
23.3 |
5.4 |
7554 |
14 |
21.9 |
20.7 |
-5.5 |
|
7498 |
15 |
21.5 |
22.6 |
5.1 |
|
7532 |
16 |
21.7 |
21.7 |
0.0 |
|
|
|
Mean |
21.8 |
22.1 |
1.3 |
7472 |
17 |
Positive control (25% (w/v) HCA in AOO) |
22.0 |
22.4 |
1.8 |
7493 |
18 |
21.9 |
22.3 |
1.8 |
|
7512 |
19 |
21.7 |
23.0 |
6.0 |
|
7537 |
20 |
21.5 |
22.2 |
3.3 |
|
|
|
Mean |
21.8 |
22.5 |
3.2 |
Notes:
*: Terminal body weights were measured on Day 6.
#: = (Terminal Body Weight – Initial Body Weight) / Initial Body Weight x 100
DPM, DPN and Stimulation Index Values for all Groups
Test Group Name |
Measured DPM / group |
DPM |
Number of Lymph Nodes |
DPN |
Stimulation Index |
Background (5% (w/v) TCA) |
31 28 |
- |
- |
- |
- |
Negative vehicle control (AOO) |
2638 |
2608.5 |
8 |
326.1 |
1.0 |
CUCURBIT[8]URIL 25% (w/v) in AOO |
2664 |
2634.5 |
8 |
329.3 |
1.0 |
CUCURBIT[8]URIL 10% (w/v) in AOO |
3437 |
3407.5 |
8 |
425.9 |
1.3 |
CUCURBIT[8]URIL 5% (w/v) in AOO |
3013 |
2983.5 |
8 |
372.9 |
1.1 |
Positive control (25% (w/v) HCA in AOO) |
23468 |
23438.5 |
8 |
2929.8 |
9.0
|
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- In conclusion, under the conditions of the present assay, CUCURBIT[8]URIL, tested in a suitable vehicle, was shown to have no sensitisation potential
(non-sensitizer) in the Local Lymph Node Assay. - Executive summary:
The purpose of this study was to determine the skin sensitisation potential of CUCURBIT[8]URIL test item following dermal exposure in the Local Lymph Node Assay. Study performed to OECD Guidelines for Testing of Chemicals No. 429 “Skin Sensitisation: Local Lymph Node Assay”(22 July 2010) Commission Regulation (EC) No 440/2008 of 30 May 2008, B.42. “Skin Sensitisation: Local Lymph Node Assay” (Official Journal L 142, 31/05/2008) as amended by Commission Regulation (EU) No 640/2012 of 6 July 2012 (Official Journal L 193, 20/07/2012).
In conclusion, under the conditions of the present assay, CUCURBIT[8]URIL, tested in a suitable vehicle, was shown to have no sensitisation potential (non-sensitizer) in the Local Lymph Node Assay.
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