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Toxicological information

Skin sensitisation

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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:
2015
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

Constituent 1
Chemical structure
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

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.