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Description of key information

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records
Reference
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
Reason / purpose for cross-reference:
reference to same study
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)
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
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)
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%.
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).

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

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.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:

Migrated from Short description of key information:

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, it can be concluded that the tested compound 2,5,7,10-tetraoxaundecane can be classified as a no skin sensitizer.

Justification for selection of skin sensitisation endpoint:

This OECD 442b and GLP test was selected as the only one available.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

The test substance is not classified as skin sensitizer.

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