Registration Dossier
Registration Dossier
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EC number: 277-143-2 | CAS number: 72968-50-4 Extractives and their physically modified derivatives such as tinctures, concretes, absolutes, essential oils, oleoresins, terpenes, terpene-free fractions, distillates, residues, etc., obtained from Citrus aurantium, Rutaceae.
Endpoint summary
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 bitter orange 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).
In a supporting study, the sensitising properties of orange oil bitter were investigated in a human maximisation test (included in 7.10.4). Twenthy-five healthy male inmate volunteers completed the experiment. For induction, the test material was applied under occlusion to the forearms of all subjects for 5 alternate day 48 -hour periods. After a 10 -day rest period, challenge patches were applied under occlusion to fresh sites for 48 hours. The challenge sites were read on removal of the patch and 24 hours thereafter. None of the subjects showed sensitisation. Based on these results it can be concluded that the substance Orange oil bitter is not a sensitiser
However, as the major constituent of Orange oil bitter is limonene, which is classified for skin sensitisation, Orange oil bitter will be classified for skin sensitisation.
Migrated from Short description of key information:
Skin sensitisation:
- 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 Orange oil bitter, d-limonene, Orange oil bitter 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.
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