Registration Dossier

Administrative data

Hazard for aquatic organisms

Freshwater

Hazard assessment conclusion:
no data available: testing technically not feasible

Marine water

Hazard assessment conclusion:
no data available: testing technically not feasible

STP

Hazard assessment conclusion:
no data available: testing technically not feasible

Sediment (freshwater)

Hazard assessment conclusion:
no data available: testing technically not feasible

Sediment (marine water)

Hazard assessment conclusion:
no data available: testing technically not feasible

Hazard for air

Air

Hazard assessment conclusion:
no hazard identified

Hazard for terrestrial organisms

Soil

Hazard assessment conclusion:
no data available: testing technically not feasible

Hazard for predators

Secondary poisoning

Hazard assessment conclusion:
no data available: testing technically not feasible

Additional information

Conclusion on classification

For Litsea cubeba oil, acute toxicity studies for three trophic levels are available. The EL50 and LL50 for daphnia and fish respectively, were both 4.2 mg/L. While for algae, an ErL50 and NOErL of 25 and 10 mg/L were derived. Based on the lowest available acute data of 4.2 mg/L from the daphnia and fish studies, the substance does not need to be classified for acute aquatic toxicity according to Table 4.1.0 (a) of CLP.

As only one chronic value is available (Algae 72h-NOErL of 10 mg/L), the aquatic chronic classification needs to be derived on both chronic and acute toxicity data and the most stringent outcome needs to be taken into consideration. Based on the NOErL, Litsea cubeba oil does not require classification for chronic toxicity. However, in view of the substance being readily biodegradable, a log Kow range of 2.06 - 6.3. (16.90% of the constituents has a log Kow >= 4) and the lowest acute data point being 4.2 mg/L for fish and daphnia, the substance needs to be classified for long term aquatic toxicity according to Figure 4.1.1 and Table 4.1.0, (b) iii of CLP, resulting in aquatic Chronic Category 2 (H411) classification.

 As the worst case needs to be taken, Litsea cubeba oil needs to be classified Chronic Category 2 (H411) according to EU CLP (EC 1272/2008 and its updates). M factor for acute and chronic toxicity is not applicable.