Registration Dossier
Registration Dossier
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EC number: 284-521-0 | CAS number: 84929-38-4 Extractives and their physically modified derivatives such as tinctures, concretes, absolutes, essential oils, oleoresins, terpenes, terpene-free fractions, distillates, residues, etc., obtained from Citrus nobilis, Rutaceae.
Endpoint summary
Administrative data
Description of key information
Key value for chemical safety assessment
Additional information
A 28-day repeated dose oral toxicity study is not required based on the information requirements outlined in the ECHA REACH fact sheet of 15/09/2009 (ref: ECHA-09-FS-05-EN), as a proposal to address the 90-day repeated dose oral toxicity study in rats with lime oil is included in the dossier (as part of the citrus category).
The test proposal for a 90-day repeated dose toxicity study is part of an integrated test strategy (ITS), which comprises the following steps:
1. Data for all major constituents of mandarin oil should be considered as a first step:
- the currently available data (available data on main constituent d-limonene already included in this dossier)
- data which are expected to become available as a result of the REACH registration of the constituents as such, later during the phase-in period
2. When data from constituents are not sufficient, testing with lime oil should be considered.
Justification for classification or non-classification
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
