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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
Endpoint summary
Administrative data
Description of key information
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- 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
- 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)
- Species:
- mouse
- Strain:
- other: CBA/J Rj
- Sex:
- female
- 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)
- 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.
- 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.
Reference
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
|
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
The aim of this study was to determine the skin sensitisation potential of CUCURBIT[8]URIL following dermal exposure. The study was performed with vertebrate animals as no regulatory in vitro alternative is available. The minimum number of animals was used, corresponding to the regulatory guidelines being followed.
Based on the results of the preliminary solubility / compatibility test, preliminary toxicity tests and on the recommendations of the OECD Guideline, the test item was formulated in Acetone : Olive oil 4:1 (v/v) mixture (abbreviated as AOO). Due to the physical and chemical characteristics of the test item, the highest achievable concentration was 25% (w/v).
The Preliminary Irritation / Toxicity Test was performed in CBA/J Rj mice using two doses (25 and 10% (w/v) in AOO). Based on the observations recorded in the preliminary test, 25% (w/v) was selected as top dose for the main test.
In the main assay, twenty female CBA/J Rj mice were allocated to five groups of four animals each:
-three groups received CUCURBIT[8]URIL (formulated in AOO) at 25, 10 and 5% (w/v) concentrations,
-the negative control group received the vehicle (AOO),
-the positive control group received 25% (w/v) HCA (dissolved in AOO).
The test item solutions were applied on the dorsal surface of ears of experimental animals (25 μL/ear) for three consecutive days (Days 1, 2 and 3). There was no treatment on Days 4, 5 and 6. On Day 6, the cell proliferation in the local lymph nodes was measured by incorporation of tritiated methyl thymidine (3HTdR) and the values obtained were used to calculate stimulation indices (SI).
No mortality or signs of systemic toxicity were observed during the study. No treatment related body weight loss was observed in the test item treated animals. Minimal amount of test item precipitate was observed on the ears of the animals in the 25% (w/v) test item treated group on Days 1-3. There were no indications of any irritancy at the site of application.
The stimulation index values were 1.0, 1.3 and 1.1 at concentrations of 25, 10 and 5% (w/v), respectively.
The result of the positive control substance a-Hexylcinnamaldehyde (HCA) dissolved in the same vehicle was used to demonstrate the appropriate performance of the assay. A significant lymphoproliferative response (stimulation index value of 9.0) was noted for the positive control chemical, this result confirmed the validity of the assay.
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.
Migrated from Short description of key information:
Not sensitising to mice in the local lymph node assay (LLNA).
Justification for selection of skin sensitisation endpoint:
Endpoint conclusion taken from experimental study using OECD Guideline 429 and EU Method B42 in accordance with GLP.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
The substance is not classified under CLP as it does not fill the requirements for skin sensitisation classification.
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.
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