Registration Dossier

Administrative data

Hazard for aquatic organisms

Hazard for air

Hazard for terrestrial organisms

Hazard for predators

Additional information

Conclusion on classification

One short-term toxicity test for daphnia and one aquatic toxicity study for algae is available for Copaiba Balsam oil. The EL50 value for daphnia is 0.33 mg/l, whereas the ErL50 and ErL10 for algae are > 100 and <1 mg/L, respectively. Based on the lowest available acute data for daphnids with an EL50 value of 0.33 mg/L, the substance needs to be classified for acute aquatic toxicity (Category Acute 1, H400).


As only one '<' chronic value is available (algae) which can not reliably be used for allocating the Category for Chronic toxicity, the aquatic chronic classification needs to be derived on the acute toxicity data. In view of the acute daphnid result of 0.33 mg/L, the substance being readily biodegradable but the log Kow in the range 4.40 -7.18, 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 1 (H410) classification.


Overall, it can be concluded that Copaiba Balsam oil needs to be classified for the environment in accordance with the criteria outlined in Annex I of the CLP Regulation (1272/2008/EC) as Category Acute 1, H400 and Chronic 1, H410.

Based on the acute toxicity to daphnids, an M-factor of 1 is indicated, in accordance with the CLP regulation (Table 4.1.3 of CLP)