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2,20:3,19-Dimethano-2,3,4a,5a,6a,7a,8a,9a,10a,11a, 12a,13a,14a,15a,16a,17a,19 ,20,21a,22a,23a,24a,25a,26a,27a,28a,29a,30a,31a,32a,33a,34a-dotriacontaazabispentaleno [1''',6''':5'',6'',7''] cycloocta[1'',2'',3'':3'',4'']pentaleno[1'',6'':5',6',7']cycloocta[1',2',3':3',4']pentaleno[1',6':5,6,7]cycloocta[1,2,3-gh:1',2',3'-g'h']cycloocta[1,2,3-cd:5,6,7-c'd']dipentalene-1,4,6,8,10,12,14,16,18,21,23,25,27,29,31,33-hexadecone, hexadecahydro-, stereoisomer,2,18:3,17-Dimethano-2,3, ,4a,5a,6a,7a,8a,9a,10a,11a,12a,13a,14a,15a,17,18,19a, 20a,21a,22a,23a,24a, 25a,26a,27a,28a,29a,30a-octacosaazabispentaleno[1''',6''':5'',6'',7'']cycloocta [1'',2'',3'':3'',4''] pentaleno[1'',6'':5',6',7']cycloocta[1',2',3':3',4']pentaleno[1',6':5,6,7]cycloocta[1,2,3-cd:1',2',3'-gh]pentalene-1,4,6,8,10,12,14,16,19,21,23,25,27,29-tetradecone, tetradecahydro-, stereoisomer, 1H,4H,12H,15H-2,14:3,13-Dimethano-5H,6H,7H,8H,9H,10H,11H,16H,17H,18H,19H,20H,21H,22H-2,3,4a,5a,6a,7a,8a,9a,10a,11a,13,14,15a,16a,17a,18a,19a,20a,21a,22a-eicosaazabispentaleno [1'',6'':5',6',7']cycloocta[1',2',3':3',4']pentaleno[1',6':5,6,7]cycloocta[1,2,3-cd:1',2',3'-gh]pentalene-1,4,6,8,10,12,15,17,19,21-decone, decahydro-, stereoisomer
EC number: 946-188-6 | CAS number: -
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
- Report date:
- 2015
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
- Cas Number:
- 259886-51-6
- 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
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:
- 1
- Remarks on result:
- other: 5% (w/v)
- Key result
- Parameter:
- SI
- Value:
- 1.3
- Test group / Remarks:
- 2
- Remarks on result:
- other: 10% (w/v)
- Key result
- Parameter:
- SI
- Value:
- 1
- Test group / Remarks:
- 3
- Remarks on result:
- other: 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:
- GHS criteria not met
- 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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