Registration Dossier
Registration Dossier
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
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EC number: 283-272-5 | CAS number: 84603-73-6 Extractives and their physically modified derivatives such as tinctures, concretes, absolutes, essential oils, oleoresins, terpenes, terpene-free fractions, distillates, residues, etc., obtained from Laurus nobilis, Lauraceae.
Endpoint summary
Administrative data
Description of key information
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- Endpoint:
- skin sensitisation
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- other:
Reference
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (sensitising)
- Additional information:
The decision logic for classification of mixtures from the ECHA Guidance on the Application of the CLP Criteria (2013) was used to determine the skin sensitising potential of Laurel lead oil.
Laurel leaf oil is not a skin sensitizer in the available study performed using an open epicutaneous test (Klecak, 1985). However relevant methodological deficiencies were noticed, questioning the reliability of the result. Indeed, some ingredients of Laurel leaf oil have been classified as skin sensitizers Cat.1B (cineole, pinene, limonene) and are all present above the generic concentration limit of 1%. Therefore Laurel leaf oil shall be classified as a skin sensitizer without further testing according to the Regulation (EC) No 1272/2008 and the Directive 1999/45/EEC.
This conclusion is supported by several human case-reports (Adisen, 2007; Foussereau, 1967; Ozden, 2001) in which positive reactions such as erythema, oedema, papules, dermatitis and eczema were observed following the cutaneous application of Laurel leaf oil at an unknown concentration.
No sensitisation reactions were observed in 50 healthly volunteers following patch testing with 1% Laurel (Meneghini, 1971).
Source: ECHA disseminated dossiers
-Pinene:
http://apps.echa.europa.eu/registered/data/dossiers/DISS-9d952924-c8ed-4614-e044-00144f67d249/DISS-9d952924-c8ed-4614-e044-00144f67d249_DISS-9d952924-c8ed-4614-e044-00144f67d249.html
- Limonene:
http://apps.echa.europa.eu/registered/data/dossiers/DISS-9eb16d5d-b83e-2831-e044-00144f67d031/DISS-9eb16d5d-b83e-2831-e044-00144f67d031_DISS-9eb16d5d-b83e-2831-e044-00144f67d031.html
- Cineole:
http://apps.echa.europa.eu/registered/data/dossiers/DISS-dcd757ca-6791-7505-e044-00144f67d031/DISS-dcd757ca-6791-7505-e044-00144f67d031_DISS-dcd757ca-6791-7505-e044-00144f67d031.html
Migrated from Short description of key information:
Skin sensitisation: skin sensitizer, based on available human data and the presence of classified ingredients.
Justification for selection of skin sensitisation endpoint:
Available data indicates that the criteria are met for classification as skin sensitizer.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
Harmonized classification:
Laurel leaf oil has no harmonized classification according to the Regulation (EC) No. 1272/2008.
Self-classification:
Based on the typical composition provided by the Lead Registrant, Laurel leaf oil is classified as skin sensitizer:
- May cause sensitisation by skin contact (Xi; R43) according to the Directive 1999/45/EEC,
- Skin Sens. 1B, H317 (May cause an allergic skin reaction) according to the Regulation (EC) No. 1272/2008 (CLP).
No information was available regarding respiratory sensitisation.
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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