Registration Dossier

Administrative data

Key value for chemical safety assessment

Effects on developmental toxicity

Additional information

A screening test for reproductive/developmental toxicity 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 developmental and reproduction toxicity with lime oil is included in the dossier (as part of the citrus category).

The test proposal for a two-generation reproduction toxicity and a developmental toxicity study is part of an integrated test strategy (ITS), which comprises the following steps:

1. Data for all major constituents of lemon 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