Registration Dossier

Administrative data

Description of key information

In a study performed to the standardised guideline OECD 429, under GLP conditions, the test item is classified as a non-sensitizer, according to GHS.

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:
19 December 2017 to ****
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
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)
Specific details on test material used for the study:
Purity: >93%
Physical State/Appearance: Dark amber viscous liquid
Species:
mouse
Strain:
CBA/Ca
Sex:
female
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)
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
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.

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

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification