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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
Study period:
19 December 2017 to ****
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2018

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
Deviations:
no
GLP compliance:
yes (incl. certificate)
Type of study:
mouse local lymph node assay (LLNA)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid
Details on test material:
CAS number: Not yet known
EC Number: Not yet known
Specific details on test material used for the study:
Purity: >93%
Physical State/Appearance: Dark amber viscous liquid

In vivo test system

Test animals

Species:
mouse
Strain:
CBA/Ca
Sex:
female

Study design: in vivo (LLNA)

Vehicle:
acetone/olive oil (4:1 v/v)
Concentration:
25, 50, 100 (%v/v) in acetone/olive oil 4:1
No. of animals per dose:
Five
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:
2.39
Test group / Remarks:
25 (%v/v) in acetone/olive oil 4:1
Key result
Parameter:
SI
Value:
1.58
Test group / Remarks:
50 (%v/v) in acetone/olive oil 4:1
Key result
Parameter:
SI
Value:
1.14
Test group / Remarks:
100 (%v/v) in acetone/olive oil 4:1

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The test item is classified as a non-sensitizer, according to GHS.
Executive summary:

The skin sensitization potential of the test material was assessed in female CBA/Ca mice following topical application to the dorsal surface of the ear. The undiluted test item was selected as the highest dose investigated in the main test of the Local Lymph Node Assay following a preliminary screening test using one mouse.

Three groups, each of five mice, were treated with 50 µL (25 µL per ear) of the undiluted test material or the test material as a solution in acetone/olive oil 4:1 at concentrations of 50% or 25% v/v.  A further group of five female animals was treated with acetone/olive oil 4:1 alone in the same manner. The Stimulation Indices (SI) were as follows: 2.39, 1.58, and 1.14 for test material concentrations of 25%, 50%, and 100%, respectively.

The test material was considered to be a non-sensitizer under the conditions of the test and is not classified according to GHS.