Registration Dossier

Administrative data

Description of key information

Key value for chemical safety assessment

Skin sensitisation

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

A study was performed in accordance with GLP and OECD Guideline 429 to assess the skin sensitisation potential of Patchouli Essential Oil in the CBA/J strain mouse following topical applications of the test material to the dorsal surface of the ear (Robertet Grasse, 2008). Four groups, each of four animals, were treated for three consecutive days with 50 μL (25 μL per ear) of the undiluted test item and the test item as a solution in Acetone/ Olive oil (4:1) at concentrations of 10%, 25%, 50% and 100% (v/v). The Stimulation Index, when using the pooled approach, is expressed as the cell count for each treatment group divided by the cell count of the control group and was 1.01, 1.45, 2.24 and 2.53 at concentrations of 10%, 25%, 50% and 100%, respectively. Therefore, the test material was considered not to be a sensitiser under the conditions of the test.

Additional information is available from two human repeat insult patch tests (Hill Top Research, Inc, 1971 and Harrison Research Laboratories, Inc, 1983) which demonstrate that the test material is not a skin sensitiser. In the Harrison Laboratories study (1983), a total of 51 subjects completed the study in which 0.2 mL of a 2% solution of Patchouli was applied to the skin in a series of nine induction patches for a period of three weeks. During both the induction and challenge phases, the test areas were observed and the reaction scored and recorded. The original patch sites exhibited no reactions during rest or at the challenge and no reactions were observed during the induction or challenge phases of the study. In the study performed at Hill Top Research (1971) 22 subjects were treated with 0.5 mL of a 9.25% solution of Patchouli oil, light. All 22 subjects showed little or no primary irritation and two subjects showed evidence of possible sensitisation.


Migrated from Short description of key information:
Local lymph node assay: Not sensitising (OECD 429)

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

In a GLP study performed according to OECD Guideline 429 the substance produced a Stimulation Index ( expressed, using the pooled approach as the cell count for each treatment group divided by the cell count of the control group) of 1.01, 1.45, 2.24 and 2.53 at concentrations of 10%, 25%, 50% and 100%, respectively. Therefore, the test material was considered not to be a sensitiser under the conditions of the test and no classified is required.