Registration Dossier
Registration Dossier
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EC number: 285-377-1 | CAS number: 85085-48-9 Extractives and their physically modified derivatives such as tinctures, concretes, absolutes, essential oils, oleoresins, terpenes, terpene-free fractions, distillates, residues, etc., obtained from Melaleuca alternifolia, Myrtaceae.
Ecotoxicological Summary
Administrative data
Hazard for aquatic organisms
Freshwater
- Hazard assessment conclusion:
- PNEC aqua (freshwater)
- PNEC value:
- 0.008 mg/L
- Assessment factor:
- 1 000
- Extrapolation method:
- assessment factor
- PNEC freshwater (intermittent releases):
- 0.077 mg/L
Marine water
- Hazard assessment conclusion:
- PNEC aqua (marine water)
- PNEC value:
- 0.001 mg/L
- Assessment factor:
- 10 000
- Extrapolation method:
- assessment factor
- PNEC marine water (intermittent releases):
- 0.008 mg/L
STP
- Hazard assessment conclusion:
- PNEC STP
- PNEC value:
- 2.57 mg/L
- Assessment factor:
- 100
- Extrapolation method:
- assessment factor
Sediment (freshwater)
- Hazard assessment conclusion:
- PNEC sediment (freshwater)
- PNEC value:
- 37.11 mg/kg sediment dw
- Extrapolation method:
- equilibrium partitioning method
Sediment (marine water)
- Hazard assessment conclusion:
- PNEC sediment (marine water)
- PNEC value:
- 3.711 mg/kg sediment dw
- Extrapolation method:
- equilibrium partitioning method
Hazard for air
Air
- Hazard assessment conclusion:
- no hazard identified
Hazard for terrestrial organisms
Soil
- Hazard assessment conclusion:
- PNEC soil
- PNEC value:
- 7.42 mg/kg soil dw
- Extrapolation method:
- equilibrium partitioning method
Hazard for predators
Secondary poisoning
- Hazard assessment conclusion:
- insufficient hazard data available (further information necessary)
Additional information
Conclusion on classification
The environmental classification hazard categories for acute and chronic aquatic toxicity and their related criteria are set out in the CLP Regulation, Annex I, Section 4.1, Table 4.1.0.
(a) Short-term (acute) aquatic hazard
The criteria for classification as Category Acute 1 are as follows:
96 hr LC50 (for fish) ≤1 mg/l and/or
48 hr EC50 (for crustacea) ≤ 1 mg/l and/or
72 or 96 hr ErC50 (for algae or other aquatic plants) ≤ 1 mg/l.
Given that the lowest LC50 value for tea tree oil is 7.75 mg/L (obtained in rainbow trout), it is concluded that the substance should not be classified on the basis of acute aquatic toxicity.
(b) Long-term (chronic) aquatic hazard
In the absence of chronic aquatic toxicity data, tea tree oil falls into part (b) (iii) of Table 4.1.0 of the CLP Regulation, "Substances for which adequate chronic toxicity data are not available".
The criteria for classification as Category Chronic 2 are as follows:
96 hr LC50 (for fish) >1 to ≤ 10 mg/l and/or
48 hr EC50 (for crustacea) >1 to ≤ 10 mg/l and/or
72 or 96 hr ErC50 (for algae or other aquatic plants) >1 to ≤ 10 mg/l.
and the substance is not rapidly degradable and/or the experimentally determined BCF ≥ 500 (or, if absent, the log Kow ≥ 4).
Given that the lowest LC50 value for tea tree oil is 7.75 mg/L (obtained in rainbow trout) and that several of its main components ( ≥ 10%) have measured log Kow values > 4.0, (mean of main components = 4.1), it is concluded that the substance meets the criteria for classification as Category Chronic 2 (H411: Toxic to aquatic life with long lasting effects).
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