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EC number: 201-746-1 | CAS number: 87-44-5
- Life Cycle description
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- Appearance / physical state / colour
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- Endpoint summary
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- Ecotoxicological Summary
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- Short-term toxicity to fish
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- Additional toxicological data

Endpoint summary
Administrative data
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.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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