Registration Dossier
Registration Dossier
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EC number: 284-515-8 | CAS number: 84929-31-7 Extractives and their physically modified derivatives such as tinctures, concretes, absolutes, essential oils, oleoresins, terpenes, terpene-free fractions, distillates, residues, etc., obtained from Citrus limonum, 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 lemon 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, a human patch test was performed in which human volunteers were exposed to lemon oil repeatedly during three weeks (study summary included in 7.10.4). Skin reactions were noted in 4% of the subjects at 24 hr, no reaction was noted at any other reading (48 hr, 72 hr) or in the control group. It can be concluded that lemon oil does not have sin sensitising properties. However, as the major constituent of lemon oil is limonene, which is classified for skin sensitisation, lemon oil will be classified for skin sensitisation.
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 lemon oil, d-limonene, lemon 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)
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