Registration Dossier
Registration Dossier
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EC number: 297-672-2 | CAS number: 93686-22-7 Extractives and their physically modified derivatives such as tinctures, concretes, absolutes, essential oils, oleoresins, terpenes, terpene-free fractions, distillates, residues, etc., obtained from Citrus reticulata, x C. sinensis, Rutaceae.
Endpoint summary
Administrative data
Description of key information
In the table below the acute aquatic toxicity data are summarised:
Species |
Substance and Reference |
Guideline(s) |
Result in mg/l |
Remarks |
Pseudokirchneriella subcapitata |
Lime oil distilled |
OECDTG 201 (2011)
|
72h-ErL50 : 8.0 72h-ErL10 : 5.1 72h-NOELR: 3.2 (nominal) |
Rel. 2, Key, WAF study |
Daphnia magna |
Orange oil |
OECDTG 202 (2004) |
48h-EL50: 1.1 (nominal) |
Rel. 2, Key, WAF study |
Danio rerio |
Orange oil |
OECDTG 203 (1992) |
96h-LL50: 5.65 (nominal) |
Rel. 2, Key, WAF study |
Additional information
For Tangerine oil, no studies on the aquatic toxicity are available for daphnia, algae and fish. 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 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
The acute toxicity of Tangerine oil was read across from a study on Orange oil according to OECD guideline 203 under GLP. Fish were exposed to nominal WAFs of 1.0, 2.0, 4.0, 8.0 and 10.0 mg/l in a semi-static setup and observed for 96 hours. The concentration of hydrocarbons were measured. Validity criteria for the test were met. The acute toxicity (96h-EL50) of orange oil towards Danio rerio with a WAF test is 5.65 mg/l and the NOEL was 4.0 mg/L.
Supporting read across studies are also available for Lime and Mandarin oil. These studies report 96h-NOEL and 96h-LL50 values of 18 and >18 and 10 and >100 mg/l respectively.
The Orange oil study was selected for read across, as the composition of orange oil closely resembles the composition of Tangerine oil and the EL50 is the lowest value.
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