Registration Dossier
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 fish
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 fish property has been investigated using constituent approach and CLP additivity calculation. The “typical” composition proposed by the Lead registrant was then tested. The 96-h LC50 was 1.63 mg test material/L for the typical composition of Niaouli oil. LC50s was based on mortality.
Conclusion: The 96-h LC50 for fish was calculated at 1.63 mg test material/L.
Key value for chemical safety assessment
Fresh water fish
Fresh water fish
- Effect concentration:
- 1.63 mg/L
Additional information
Short-term toxicity to fish is provided in the dataset even if the tonnage band (1 -10 tonnes/year) does not require that endpoint. Indeed that endpoint is fulfilled according to environmental classification rules. Classification should be derived from the most sensible species. Because toxicity data have demonstrated the lowest LC50 values for constituents are for fishes, it has been decided to calculate fish L(E)C50, in order to ascertain the classification for environment of Niaouli oil.
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 96-h LC50 for fish was 1.63 mg test material/L for the typical composition of Niaouli oil. The LC50 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 fish toxicity endpoint.
Table 1 Niaouli oil, constituents data used to derive Niaouli oil Ecotoxicity value.
Constituents |
Ci (%w/w) |
Constituent fish toxicity (mg/L) |
Cineol 1,8 |
57.1 |
57 |
Limonene (d and l) |
7.34 |
0.71 |
Pinene alpha |
8.62 |
0.28 |
Terpinyl acetate alpha |
1.05 |
7.07 |
Terpineol |
5.81 |
60.93 |
Pinene beta |
2.14 |
0.44 |
Cymene para |
0.81 |
1.63 |
Viridiflorol |
4.16 |
0.74 |
Sum Ci |
87.03 |
|
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