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
Additional information
For Lemon oil, no valid studies on the aquatic toxicity are available for daphnia, fish and algae. For these endpoints, read-across is conducted from the citrus oils (orange oil, mandarin oil, lime oil). The justification of this read-across is described in detail in the read-across justification document.
Daphnia
Valid WAF studies are available for orange oil, mandarin oil and lime oil. The highest toxicity (lowest WAF values) was observed in the studies with orange oil (Vinken and Wydra 2007, Rel. 2):
The study was carried out in closed glass containers and during the preparation of the test media, precautions were taken related to the volatility of the test substance. The level of the concentrations was followed by GC-MS analytics to ensure that the exposure remained stable during the test period. The highest concentrations were prepared according to the WAF procedure, whereas the concentrations below 1 mg/l were diluted from the WAF of 1 mg/l. However, the effects were observed in the range of the true WAF.
The values of the other citrus oils are used as supporting studies.
Algae
Key WAF studies are available for orange oil, mandarin oil and lime oil. The studies are conducted according to OECD 201 and are validated with reliability 1 or 2. The WAF toxicity values (ErL50) for mandarin oil and lime oil are very similar, while for orange oil the WAF result showed an ErL50 10 times higher (less toxic). The study with lime oil distilled constitutes the lowest toxicity value (lowest WAF value, highest toxicity) for this category and is selected as key study. The values for orange oil, mandarin oil and the other quality of lime oil are used as supporting studies.
Fish
For fish read-across studies are available for orange oil, mandarin oil and lime oil.
The orange oil study (reporting a 96h-EL50 of 5.65 mg/l) was selected as key study for read across, as the composition of orange oil most closely resembles the composition of lemon oil.
An overview of all results with Reliability 1 or 2 is presented in the table below:
Test |
Substance and Reference |
Result (nominal, WAF tests) |
Daphnia OECD 202 KEY STUDY |
Orange oil, IBACON 2007 |
WAF: 48h-EL50 = 1.1 mg/L 48h-NOEL = 0.48 mg/L |
Daphnia OECD 202 Supporting study
|
Mandarin oil, Harlan 2011 |
WAF: 48h-EL50 = 8.9 mg/L 48h-NOEL = 2.2 mg/L
|
Daphnia OECD 202 Supporting study
|
Lime oil distilled, Harlan 2011 |
WAF: 48h-EL50 = 5.0 mg/L 48h-NOEL = 2.2 mg/L
|
Daphnia OECD 202 Supporting study
|
Lime oil CP, Harlan 2011 |
WAF: 48h-EL50 = 12 mg/L 48h-NOEL = 4.8 mg/L
|
Algae OECD 201 Supporting study
|
Mandarin oil, Harlan 2011 |
72h-NOELr = 3.2 mg/L 72h-ErL50 = 9.7 mg/L |
Algae OECD 201 Supporting study |
Orange oil, Fresenius 05.12.2007 |
72h-NOELr = 50 mg/L72h-ErL50 ~ 150 mg/L |
Algae OECD 201 KEY study |
Lime oil distilled Harlan 2011 |
72h-NOELr = 3.2 mg/L 72h-ErL50 = 8 mg/L
|
Algae OECD 201 Supporting study |
Lime oil CP Harlan 2011 |
72h-NOELr = 3.2 mg/L 72h-ErL50 = 11 mg/L |
Fish OECD 203 KEY STUDY |
Orange oil SGS Fresenius, 2011 |
WAF: 96h-EL50: 5.65 mg/l; 96h-NOEC: 4.0 mg/l |
| FishOECD 203Supporting study | Mandarin oilHarlan, 2011 | WAF: 96h-EL50: >100 mg/l; 96h-NOEL: 10 mg/l |
Fish OECD 203 Supporting study |
Lime oilHarlan, 2011 | WAF: 96h-EL50: >18 mg/l; 96h-NOEL: 18 mg/l |
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