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Ecotoxicological information

Ecotoxicological Summary

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Hazard for aquatic organisms

Freshwater

Hazard assessment conclusion:
PNEC aqua (freshwater)
PNEC value:
2.04 µg/L
Assessment factor:
500
Extrapolation method:
assessment factor
PNEC freshwater (intermittent releases):
10.2 µg/L

Marine water

Hazard assessment conclusion:
PNEC aqua (marine water)
PNEC value:
0.204 µg/L
Assessment factor:
5 000
Extrapolation method:
assessment factor

STP

Hazard assessment conclusion:
PNEC STP
PNEC value:
10 mg/L
Assessment factor:
10
Extrapolation method:
assessment factor

Sediment (freshwater)

Hazard assessment conclusion:
PNEC sediment (freshwater)
PNEC value:
0.665 mg/kg sediment dw
Extrapolation method:
equilibrium partitioning method

Sediment (marine water)

Hazard assessment conclusion:
PNEC sediment (marine water)
PNEC value:
0.066 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:
0.134 mg/kg soil dw
Extrapolation method:
equilibrium partitioning method

Hazard for predators

Secondary poisoning

Hazard assessment conclusion:
PNEC oral
PNEC value:
20 mg/kg food
Assessment factor:
300

Additional information

Environmental fate and pathways:

Eucalyptus oil is a natural complex substance (NCS). It is a mixture of several components.

All major constituents of Eucalyptus oil are readily biodegradable. Therefore, Eucalyptus oil can be considered as a readily biodegradable mixture.

The bioaccumulation factor value (BCF) for Eucalyptus oil was determined regarding the highest log Kow value of the components. The highest log Kow value is for alpha-pinene (log Kow at 4.42), therefore it was assumed that BCF of alpha-pinene would be conservative enough for the mixture, which is 852.9 L/kg wet-wt (geometric mean between three calculation approaches).

For the adsorption potential of Eucalyptus oil, it’s not possible to determine only one adsorption coefficient (Koc) value to characterize the NCS based on the wide range of Koc values for the constituents. Therefore it is assumed that the lower and the greater Koc values should be considered for the Risk Assessment: Koc at 260.4 for 1,8-Cineol (log Koc = 2.44) and Koc at 3222.3 for alpha-pinene (log Koc = 3.49) (geometric mean between three calculation approaches).

Aquatic toxicity:

Based on a weight of evidence approach, the acute toxicity of Eucalyptus oil to aquatic organisms was estimated with the additivity formula, as recommended in the Regulation (EC) No 1272/2008 (CLP), using adequate toxicity data of major constituents, greater than 10% in the mixture. Three constituents were considered, representing 90% of the mixture. To obtain worst case estimations, the worst case percentages of each constituent were taken into account.

Based on individual toxicities of the major constituents, the L(E) C50 values for Eucalyptus oil were estimated to be 0.90 mg/L for fish, 1.02 mg/L for aquatic invertebrates and 1.64 mg/L for algae, and the NOEC value for Eucalyptus oil was estimated to be 0.88 mg/L for algae (based on growth rate). Considering these results, Eucalyptus oil should be classified as Aquatic Acute 1 and Aquatic Chronic 3, according to the 2nd ATP of the Regulation (EC) No 1272/2008. However, this constituent approach was considered as a worst case and finally not realistic. To prove that Eucalyptus oil is not classified as Aquatic Acute 1 and as fish was considered as the most sensitive species in acute conditions, two experimental acute fish studies were performed for two worst case typical mixtures of Eucalyptus oil (one mixture containing the greater percentage of Limonene: Eucalyptus crude oil, and the other the greater percentage of alpha-pinene: Eucalyptus oil globulus). As a validation that additivity approach is a real worst case, the experimental studies show 96h-LL50 of 18mg/L and 42 mg/L for both Eucalyptus crude oil and Eucalyptus oil globulus respectively. Therefore, the Aquatic Acute 1 classification should no longer be considered but the Aquatic Chronic 2 classification should be taken into account (based on estimated toxicity for aquatic invertebrates). In accordance with column 2 of REACH annex IX, further testing on the long-term effects on aquatic organisms does not need to be conducted as the chemical safety assessment does not indicate a need for further investigation.

Terrestrial toxicity:

Based on a conservative estimation from Chesar, the chemical safety assessment of Eucalyptus oil indicates no need to investigate terrestrial testing. For this reason, terrestrial toxicity studies are scientifically unjustified.

Conclusion on classification

1 mg/L < E(L)C50< 10 mg/L; readily biodegradable; worst case estimated log Kow = 4.42; worst case estimated BCF = 852.9 L/kg.

Classification according to the Annex VI of the Directive 67/548/EEC: The test substance is classified as N, R51/53 for the environment.

Classification according to the Annex VI of the Regulation (EC) No 1272/2008 (CLP): According to the 2nd ATP, the test substance is classified as Category Chronic 2 for the environment.