Registration Dossier
Registration Dossier
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EC number: 287-316-4 | CAS number: 85480-37-1 Extractives and their physically modified derivatives such as tinctures, concretes, absolutes, essential oils, oleoresins, terpenes, terpene-free fractions, distillates, residues, etc., obtained from Melaleuca leucadendron, Myrtaceae.
Toxicity to aquatic algae and cyanobacteria
Administrative data
Link to relevant study record(s)
Description of key information
Cajeput oil is a Natural Complex Substance (UVCB) with a well-defined composition for which the relative percentage and its reported variation of each constituent is known. The acute toxicity to aquatic algae and cyanobacteria property has been investigated using constituent approach and CLP additivity calculation. The “typical” composition proposed by the Lead registrant was then tested. The 72-h EC50 was 6.94 mg test material/L for the typical composition of Cajeput oil. EC50s was based on growth rate.
Conclusion: The 72-h EC50 for algae and cyanobacteria was calculated at 6.94 mg test material/L.
Key value for chemical safety assessment
- EC50 for freshwater algae:
- 6.94 mg/L
Additional information
Cajeput oil is a Natural Complex Substance (UVCB) with a well-defined composition for which the relative percentage of each constituent is known. Therefore, it has been decided that the ecotoxicity of Cajeput oil will be derived from knowledge of the constituents, constituent approach.
The mixture ecotoxicity properties may be derived from the ecotoxicity of the individual constituents (table 1) using the CLP additivity calculation approach. However, CLP additivity approach is calculated on the basis that all the substances are at their maximum solubility and it has been observed that CLP additivity calculations for mode of action 1 compounds are unreasonably conservative when compared to classic WAF studies. However, regarding its conservativeness, it has been agreed to fulfill the endpoint with.
The “typical” composition proposed by the Lead registrant has been investigated.
Using this approach, the 72-h EC50 for fish was 6.94 mg test material/L for the typical composition of Cajeput oil. The EC50 was based on growth rate.
Based on the results of this study, Cajeput oil would not be classified as acutely toxic to aquatic organisms in accordance with the classification of the CLP.
This toxicity calculation is considered acceptable to fulfill the algae and cyanobacteria toxicity endpoint.
Table 1 Cajeput oil, constituents data used to derive Cajeput oil Ecotoxicity value.
Constituents |
Ci (%w/w) |
Constituentalgae and cyanobacteria toxicity (mg/L) |
Cineol 1,8 |
61 |
74 |
Limonene (d and l) |
5 |
1.13 |
Pinene alpha |
1.8 |
0.49 |
Terpineol |
13 |
66.85 |
Pinene beta |
1.4 |
0.45 |
Linalol |
3 |
60.4 |
Sum Ci |
85.2 |
|
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