Registration Dossier
Registration Dossier
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
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 |
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
