2,5,7,10-tetraoxaundecane

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:

other: GLP certified lab following OECD guideline 442B

Cross-reference

Reason / purpose for cross-reference:

reference to same study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2011

Report date:

2011

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: OECD guideline 442B (Skin sensitization: Local Lymph node assay: BrdU-ELISA

Deviations:

yes

Remarks:

One auricular node was not found during sampling

GLP compliance:

yes (incl. QA statement)

Type of study:

mouse local lymph node assay (LLNA)

Test material

Test material information

Constituent 1

Reference substance name:

2,5,7,10-tetraoxaundecane

EC Number:

224-631-8

EC Name:

2,5,7,10-tetraoxaundecane

Cas Number:

4431-83-8

Molecular formula:

C7H16O4

IUPAC Name:

2,5,7,10-tetraoxaundecane

Details on test material:

- Name of test material (as cited in study report): 2,5,7,10-tetraoxaudecane (TOU)
- Physical state: colourless liquid
- Analytical purity: 99.632% (w/w)
- Impurities (identity and concentrations): alcohols (0.064%); aldehydes (not found); water (0.142%)
- Lot/batch No.: 0804061200
- Expiration date of the lot/batch: 06/04/2014
- Storage condition of test material: stored in a glas vial at laboratory temperature during the study

In vivo test system

Test animals

Species:

mouse

Strain:

other: CDA/J

Sex:

female

Details on test animals and environmental conditions:

TEST ANIMALS
- Source: Charles Rivers Laboratories (Wilmington, MA)
- Age at study initiation: 8 weeks
- Weight at study initiation: between 18 and 25 g
- Housing: group-caged
- Diet (e.g. ad libitum): daily fed with maintenance diet for rodent
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21.2°C +-3.4°C
- Humidity (%): between 40 and 70%
- Air changes (per hr): between 10 and 30
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 2011-06-10 To: 2011-06-29

Study design: in vivo (LLNA)

Vehicle:

acetone/olive oil (4:1 v/v)

Concentration:

100%, 50%, 10%

No. of animals per dose:

4

Details on study design:

RANGE FINDING TESTS: not performed

MAIN STUDY
ANIMAL ASSIGNMENT AND TREATMENT
- Name of test method: BrdU-ELISA
- Criteria used to consider a positive response: SI>1.6

TREATMENT PREPARATION AND ADMINISTRATION:
The appropriate test item solutions (low, middle and high dose) were administered by topical application (dermal) to ears of mice for three consecutive days (day 1, 2 and 3 of the experimental schema). For each animal a microvolume pipette was filled with an appropriate volume of dosing solution (25 µl) and directly applied on the dorsum of both ear of mice. The exact application time was recorded. Animals were weighed before test item application and the weight noted on a prepared recording table. Positive (50% α-Hexylcinnamaldehyde) and negative (vehicle) controls were also included in the study in order to ensure appropriate performance of the assay. On day 5 a single intraperitoneal injection of 0.5 ml of BrdU solution (5 mg/mouse/injection) was administered to all test and control mice. For each animal a syringe was filled with an appropriate volume of BrdU solution. The syringe with its canula was weighed and the weight noted on the prepared table. After injection of the dosing solution the empty syringe with its canula was weighed and the weight noted. Approximately 24 hours after BrdU injection, the animals were killed and the draining auricular lymph nodes from each ear were excised, counted and stored individually in a centrifuge tube at -20°C until ELISA analysis.

Positive control substance(s):

hexyl cinnamic aldehyde (CAS No 101-86-0)

Results and discussion

Positive control results:

For the positive control group, a value of 2 for erythema quotation was notified from day +3 until day +5. The Draize score was reduced to 1 on the sixth day of the animal experiment. The positive control group shows a Stimulation Index of 2.901 which confirms the awareness of the compound α-hexylcinnamaldehyde when applied at a dose level of 50%.

In vivo (LLNA)

Results

Parameter:

SI

Remarks on result:

other: The calculated SI for the test item 2,5,7,10-tetraoxaundecane after three consecutive applications (on a three day basis) are 1.148, 1.119 and 1.056 for a dose level application of 10%, 50% and 100%, respectively (see Table 1).

Any other information on results incl. tables

Table 1:Stimulation Index (SI) calculation

Stimulation Index calculation
Group	Mice #	SI
Vehicle	K1	1.102
	K2	1.032
	K3	0.893
	K4	0.972
	Mean	1.000
	SD	0.089
Positive control	L1	2.581
	L2	2.994
	L3	3.806
	L4	2.223
	Mean	2.901
	SD	0.681
2,5,7,10-tetraoxaundecane 10%	M1	1.212
	M2	1.222
	M3	1.043
	M4	1.116
	Mean	1.148
	SD	0.085
2,5,7,10-tetraoxaundecane 50%	N1	1.086
	N2	1.059
	N3	1.027
	N4	1.303
	Mean	1.119
	SD	0.125
2,5,7,10-tetraoxaundecane 100%	O1	1.063
	O2	0.991
	O3	1.048
	O4	1.121
	Mean	1.056
	SD	0.053

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Remarks:

Migrated information

Conclusions:

2,5,7,10-tetraoxaundecane can be classified as a no skin sensitizer.

Executive summary:

On the basis of the mean Stimulation Index results obtained for each 2,5,7,10-tetraoxaundecane treatment groups, and on the basis of the OCDE guideline 442B, we can conclude that the tested compound 2,5,7,10-tetraoxaundecane can be classified as a no skin sensitizer.