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Diss Factsheets

Administrative data

Description of key information

Local Lymph Node Assay in the Mouse-Individual Method

Concentration (%v/v) in acetone/olive oil 4:1              Stimulation index              Result

10                                                                             0.75                            Negative

25                                                                             0.87                            Negative

50                                                                             1.59                            Negative

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:
27 January 2016 - 09 March 2016
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
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)
Type of study:
mouse local lymph node assay (LLNA)
Specific details on test material used for the study:
SOURCE OF TEST MATERIAL
- Lot/batch No.of test material:1023R25811
- Expiration date of the lot/batch: 14 September 2019
- Purity: 100%

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: room temperature in the dark

TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing: the test item was used undiluted and freshly prepared as a solution in acetone/olive oil. The test item was formulated within 2 hours of being applied to the test system.
Species:
mouse
Strain:
CBA/Ca
Sex:
female
Vehicle:
acetone/olive oil (4:1 v/v)
Concentration:
The test item at concentrations of 50%, 25% or 10% v/v in acetone/olive oil 4: 1.
No. of animals per dose:
5
Positive control substance(s):
hexyl cinnamic aldehyde (CAS No 101-86-0)
Key result
Parameter:
SI
Value:
0.75
Test group / Remarks:
10% v/v in acetone/olive oil 4:1.
Remarks on result:
other: Negative
Key result
Parameter:
SI
Value:
0.87
Test group / Remarks:
25% v/v in acetone/olive oil 4:1.
Remarks on result:
other: Negative
Key result
Parameter:
SI
Value:
1.59
Test group / Remarks:
50% v/v in acetone/olive oil 4:1.
Remarks on result:
other: Negative
Interpretation of results:
other: a non-sensitizer
Conclusions:
The test item was considered to be a non-sensitizer under the conditions of the test.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)

Justification for classification or non-classification

Local Lymph Node Assay in the Mouse-Individual Method

The test item was considered to be a non-sensitizer under the conditions of the test.