Registration Dossier

Diss Factsheets

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