Registration Dossier

Toxicological information

Skin sensitisation

Currently viewing:

Administrative data

Endpoint:
skin sensitisation: in vivo (LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2008-03 to 2008-04
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2008

Materials and methods

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

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Patchouli essential oil
- Physical state: brown liquid
- Analytical purity: not applicable; considered as 100 % for the study
- Origin: Plantae (from Indonesia)
- Binomial family: Labiatae
- Binomial name: Pogostemon cablin

In vivo test system

Test animals

Species:
mouse
Strain:
other: CBA/J
Sex:
not specified
Details on test animals and environmental conditions:
No data

Study design: in vivo (LLNA)

Vehicle:
acetone/olive oil (4:1 v/v)
Concentration:
10, 25, 50, 100 % test material
No. of animals per dose:
Four
Details on study design:
- Four groups of four animals were treated for three consecutive days (days 1-3) via topical application to the dorsal surface of each ear.
- Test material was applied as 50 μL (25 μL per ear) of the undiluted test item or the test item as a solution in acetone/olive oil (4:1).
- A group of four animals received the vehicle alone.
- A further group of four animals was treated with the positive control diluted at 25 % in the vehicle.
- On day 6, the proliferation of lymphocytes in the draining auricular lymph nodes was determined by cell counting.
Positive control substance(s):
hexyl cinnamic aldehyde (CAS No 101-86-0)
Statistics:
- The Stimulation Index (SI) was calculated from the formula SI = cell count of treated group / cell count of control group.

Results and discussion

Positive control results:
- A Stimulation Index (SI) of 2.22 was recorded for the positive control diluted at 25 % in the vehicle.
- The SI result was more than 1.4 as expected.

In vivo (LLNA)

Resultsopen allclose all
Parameter:
SI
Value:
1.01
Test group / Remarks:
10%
Parameter:
SI
Value:
1.45
Test group / Remarks:
25 %
Parameter:
SI
Value:
2.24
Test group / Remarks:
50%
Parameter:
SI
Value:
2.53
Test group / Remarks:
100%

Any other information on results incl. tables

- The EC1.4 value determined by linear interpolation of points on the dose-response curve was 23.30 % (see document describing validation of EC value, attached).

- No mortality and no sign of systemic toxicity were noted in the test and control animals during the test.

- A moderate (+15.2%) to important (+41.6%) increase in ear thickness was recorded respectively at the concentration of 50% and 100%. An important increase in ear weight (+60.3%) was recorded at the concentration of 100%.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The test material was not considered to be a sensitiser under the conditions of the test.