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Registration Dossier
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EC number: 310-217-5 | CAS number: 132940-73-9 Extractives and their fisically modified derivatives such as tinctures, concretes, absolutes, essential oils, oleoresins, terpenes, terpene-free fractions, distillates, residues, etc., obtained from Melaleuca viridiflora, Myrtaceae.
Short-term toxicity to aquatic invertebrates
Administrative data
Link to relevant study record(s)
Description of key information
Niaouli 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 invertebrates property has been investigated using constituent approach and CLP additivity calculation. The “typical” composition proposed by the Lead registrant was then tested. The 48-h EC50 was 1.71 mg test material/L for the typical composition of Niaouli oil. EC50s was based on mortality.
Conclusion: The 48-h EC50 for daphnid was calculated at 1.71 mg test material/L.
Key value for chemical safety assessment
Fresh water invertebrates
Fresh water invertebrates
- Effect concentration:
- 1.71 mg/L
Additional information
Niaouli 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 Niaouli 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 48-h EC50 for daphnid was 1.71 mg test material/L for the typical composition of Niaouli oil. The EC50 was based on mortality.
Based on the results of this study, Niaouli 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 aquatic invertebrate toxicity endpoint.
Table 1 Niaouli oil, constituents data used to derive niaouli oil Ecotoxicity value.
Constituents |
Ci (%w/w) |
Constituent daphnid toxicity (mg/L) |
Cineol 1,8 |
57.1 |
100 |
Limonene (d and l) |
7.34 |
0.31 |
Pinene alpha |
8.62 |
0.48 |
Terpinyl acetate alpha |
1.05 |
9.92 |
Terpineol |
5.81 |
74.47 |
Pinene beta |
2.14 |
0.56 |
Cymene para |
0.81 |
2.05 |
Viridiflorol |
4.16 |
0.95 |
Sum Ci |
87.03 |
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