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Description of key information

Mice were treated in a study according to OECD 429 (LLNA) and proliferation of the auricular lymph nodes was determined. The increase of proliferation was in all cases below 3-fold the range of negative controls. Thus there is no indication of an sensitising potential after epidermal exposure.

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
Study period:
2007
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Recent study according to current regulations; no GLP
Qualifier:
according to guideline
Guideline:
OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
Deviations:
no
GLP compliance:
no
Type of study:
mouse local lymph node assay (LLNA)
Species:
mouse
Strain:
CBA
Sex:
female
Details on test animals and environmental conditions:
Mice, CBA/CaOlaHsd, (nulliparous and non-pregnant), 7 - 12 weeks
Vehicle:
acetone/olive oil (4:1 v/v)
Concentration:
6.25, 12.5, and 25 % (w/v)
No. of animals per dose:
4
Details on study design:
MAIN STUDY
ANIMAL ASSIGNMENT AND TREATMENT
- Name of test method: OECD 429
- Criteria used to consider a positive response: A test item is regarded as a sensitiser in the LLNA if the following criteria are fulfilled:
- First, that exposure to at least one concentration of the test item resulted in an incorporation of 3HTdR at least 3-fold or greater than that recorded in control mice, as indicated by the stimulation index.
- Second, that the data are compatible with a conventional dose response, although allowance must be made (especially at high topical concentrations) for either local toxicity or immunological suppression.

Positive control substance(s):
hexyl cinnamic aldehyde (CAS No 101-86-0)
Positive control results:
The stimulation index for the control substance was determined as 2,43 - 4,07 - 4,88 depending on the concentration used (5 - 10 - 25% resp.)
Parameter:
SI
Remarks on result:
other: 1,62
Parameter:
other: disintegrations per minute (DPM)
Remarks on result:
other: see below

Test item Concentration

Group

DPM

 

Calculation

 

Result

 

 

 

DPM-BG

Lymph nodes (LN)

DPM/LN

SI

 

BG I

30,89

 

 

 

 

 

BG II

21,80

 

 

 

 

 

1

4547,15

4520,8

8

565,1

 

6,25

2

6943,98

6917,6

8

864,7

1,53

12,5

3

6392,05

6365,7

8

765,7

1,41

25

4

7372,63

7346,3

8

918,3

1,62

Interpretation of results:
not sensitising
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The test item did not show a sensitisation potential in the LLNA in female mice.
Executive summary:

In the study the test item dissolved in acetone:olive oil (4+1) was assessed for its possible contact allergenic potential. For this purpose a local lymph node assay was performed in female mice using test item concentrations of 6.25, 12.5, and 25 %. The animals did not show any clinical signs during the course of the study and no cases of mortality were observed.

In this study Stimulation Indices (S.I.) of 1.53, 1.41, and 1.62 were determined with the test item at concentrations of 6.25, 12.5, and 25 % in acetone:olive oil (4+1), respectively. The test item was not a skin sensitiser in this assay. The EC3 value could not be calculated, since all S.I. were below 3.

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

Mice were treated in a study according to OECD 429 (LLNA) and proliferation of the auricular lymph nodes was determined. The increase of proliferation was in all cases below 3-fold the range of negative controls. Thus there is no indication of an sensitising potential after epidermal exposure.


Migrated from Short description of key information:
Topical exposure in a study according to OECD 429 (LLNA) did not cause a stimulation index above 3.

Justification for selection of skin sensitisation endpoint:
only available study

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

No classification. The LLNA provided a negative result (not sensitising).