Registration Dossier

Administrative data

Description of key information

Key value for chemical safety assessment

Skin sensitisation

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (sensitising)
Additional information:

Multiple studies on the skin sensitising potential of Vetiver Oil were available for the dossier. Because of the comparable reliability between the studies and differing outcomes, a Weight of Evidence approach was used to describe the endpoint of skin sensitisation.

A Buehler test was conducted with Vetivert Oil Haïti and showed clear sensitisation in approximately half of the guinea pigs over the observation period. Two out of three guinea pig maximisation tests indicated skin sensitisation. One test challenged two times with Vetyver Oil Haïti and additionally cross-challenged with Vetyver Oil Blend Java, while the other was performed in the same way although the test substances were switched. In both cases, also the cross-challenge indicated sensitisation. One last guinea pig maximisation test was available, performed with Vetyvert Bourbon, which did not indicate a clear sensitising potential. All above mentioned animal studies were considered highly reliable, although the Buehler test (Klimisch 1) was assigned a higher Klimisch rating over the GPMT's (Klimisch 2) due to the relatively concise and unclear report of the maximisation tests.

Additionally, three human repeated insult patch tests were available of which only one indicated some sensitising potential of Vetiver Oil. These studies were not included in the dossier, for the reason that they were considered less reliable (Klimisch 4) and therefore not valuable enough to influence the conclusion on the classification for the endpoint skin sensitisation.

Based on the above information, it was concluded that Vetiver Oil is a substance that possesses the ability to induce sensitisation. Three out of 4 available animal studies indicated sensitisation, especially the Buehler test, which is the least sensitive test (as it is non-invasive) available for this endpoint.


Migrated from Short description of key information:
Skin sensitisation:
- Buehler test (2.5% Vetivert Oil Haïti): sensitising (method similar to OECD 406)
- GPMT (100% and 5% Vetyver Oil Haïti): sensitising (method similar to OECD 406)
- GPMT (5% Vetyver Oil Blend Java): sensitising (method similar to OECD 406)
- GPMT (2.5% Vetyver Bourbon): not sensitising (method similar to OECD 406)

Justification for selection of skin sensitisation endpoint:
Four studies were available and used in a Weight of Evidence approach

Justification for classification or non-classification

Based on the available data and the Weight of Evidence approach, Vetiver Oil needs to be classified as sensitising when taking into account the criteria outlined in Annex I of 1272/2008/EC and Annex VI of 67/548/EEC.