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Description of key information

A skin sensitiser is an agent that will lead to an allergic response in susceptible individuals following skin contact. Human experimental studies are not recommended to fulfil REACH Annex VII information requirements. However, all existing available information should be evaluated, including any available human data. The human patch test is a confirmatory test in the safety evaluation of skin sensitisers involving the repeat exposure of small patches of skin to the test item.

Out of 1606 consecutive patients, 10 people (0.6%) exhibited reactions to 5% caryophyllene in petrolatum. About 0.5% of the patients (n = 1511) reacted to a 3.0% oxidation mixture of caryophyllene in non-stabilised white petrolatum (containing 25% β-caryophyllene and 35% caryophyllene oxide) and 0.1% (n = 1511) of patients reacted to caryophyllene oxide in non-stabilised white petrolatum. Caryophyllene oxide gave positive reactions in only 2 out of 8 patients also reacting to the mixture of oxidised caryophyllene. Whilst the CLP regulation does not contain clear criteria for classification for skin sensitisation based on human data, the two studies detailed substantiate the absence of significant sensitisation and non-classification of the test item.

Additional information

Two reliable studies (Klimisch 2) reported in peer-reviewed journals are available for use as supporting data for skin sensitisation (2002, 2005). Patch tests were performed with consecutive patients in 6 European dermatology centres (Dortmuch, Gentofte, London, Malmö, Leuven and Odense). Out of 1606 consecutive patients, 10 people (0.6%) exhibited reactions to 5% caryophyllene in petrolatum. About 0.5% of the patients (n = 1511) reacted to a 3.0% oxidation mixture of caryophyllene in non-stabilised white petrolatum (containing 25% β-caryophyllene and 35% caryophyllene oxide) and 0.1% (n = 1511) of patients reacted to caryophyllene oxide in non-stabilised white petrolatum. Caryophyllene oxide gave positive reactions in only 2 out of 8 patients also reacting to the mixture of oxidised caryophyllene.

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