Registration Dossier

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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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.

Diss Factsheets

Administrative data

Description of key information

Key value for chemical safety assessment

Skin sensitisation

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (sensitising)
Additional information:
The key study is a local lymph node assay performed with major constituent limonene which was read across to mandarin oil. The study was performed in CBA/Ca strain mice according to OECD guideline 429 and in compliance with GLP.

Mean DPM for 0, 10, 25, 50, 75 or 100% d-limonene were observed to be 2511, 3319, 8554, 9916, 22063 or 16259 dpm, respectively. Stimulation index for 10, 25, 50, 75 or 100% d-limonene were calculated to be 1.3, 3.4, 4.0, 8.8 or 6.5, respectively. The estimated concentration giving rise to a 3 fold increase in lymphocyte proliferation (EC3) was 22% v/v (5500 µg/cm2). No increase in visual levels of irritancy to the ear skin was observed during the study.

Under the test conditions, d-limonene is classified as ‘R43 May cause sensitisation by skin contact’, according to the criteria of Annex VI to the Directive 67/548/EEC and ‘Category 1’ according to the CLP Regulation (EC) N° (1272-2008).

Migrated from Short description of key information:
Read across based on d-limonene content: sensitising

Justification for classification or non-classification

Based on the skin sensitising properties of the major constituent of mandarin oil, d-limonene, mandarin oil has to be labelled as skin sensitiser in accordance with the criteria outlined in Annex VI of 67/548/EEC and Annex I of 1272/2008/EC (CLP/EU-GHS)