Eucalyptus globulus, ext.

Long-term toxicity to fish

Administrative data

Endpoint:

long-term toxicity to fish

Data waiving:

study scientifically not necessary / other information available

Justification for data waiving:

other:

Justification for type of information:

Eucalyptus globulus oil is a Natural Complex Substance (NCS) and hazard properties are derived from the hazard properties of the main constituents (greater than 10% in the NCS: 1,8-cineol, d/l-limonene and α-pinene). According to column 2 of Annex VII, section 9.1.1 of the REACH Regulation, a long-term study shall be considered if the substance is poorly water soluble. In the ECHA Guidance document chapter R7b, the limit value of 1 mg/L is given to consider poorly water soluble substances (TGD, 2003). The water solubility of the known constituent are 2.65 mg/L ((d,l)-limonene), 1.82 mg/L (alpha-pinene) and 3500 mg/L (1,8-cineol). Therefore, all main constituent exhibit a low water solubility but do not meet the criterion for poorly water soluble substance. Moreover, for a substance with a low water solubility, long-term tests are performed when short-term toxicity tests do not reveal any toxicity (ECHA Guidance document chapter R.7b). Reliable short-term toxicity studies revealed toxicity for any main constituent tested individually or the Eucalyptus globulus oil tested itself. The information on the Mode of Action (MoA) of the main constituents is available. They have a narcotic MoA, which is considered to be the baseline toxicity MoA, the least toxic MoA. The aquatic toxicity data available on main constituent suggest a similar sensitivity between the three taxonomic groups towards the main constituent, which has a non-specific mode of action (non-polar narcosis). This is in accordance with ECHA Guidance document chapter R.10 where it is stated that interspecies variations may be low for substances with a known non-specific mode of action. As a consequence, deriving the PNECwater by using acute toxicity data and an assessment factor is considered conservative enough to cover among others the acute-to-chronic extrapolation. The chemical safety assessment has been conducted in accordance. Moreover, all constituent are readily biodegradable and exhibit a log Kow < 4.5 and estimated BCF below 2000 L/kg. Consequently, the constituent are definitively not P and not B. Therefore, a long-term testing to fish is not considered as necessary to refine the chemical safety assessment and the PBT assessment.