Registration Dossier

Administrative data

Hazard for aquatic organisms

Hazard for air

Hazard for terrestrial organisms

Hazard for predators

Additional information

Conclusion on classification

No study information is available regarding the toxicity to aquatic organisms of the substance Ginger oil CO2-Total Extract. However, there is sufficient weight of evidence information available from two independent sources to provide appropriate evidence to fulfil the information requirements. Therefore, in line with section 1.2 of Annex XI in regulation (EC) No 1907/2006, a weight of evidence (WoE) approach was used. In this WoE approach the results from OECD TG 201, GLP studies, performed on two qualities of ginger oil extracts (Ginger CO2-SE extract and Ginger oil Hot Flavor CO2-TO extract) were used in order to fulfil the toxicity to aquatic organisms endpoints for Ginger oil CO2-Total Extract. These two qualities of ginger oil constitute to the volatile and the non-volatile fraction of the target UVCB (Ginger oil CO2-Total Extract). The two fractions combined cover the constituents present in Ginger oil CO2-Total Extract, albeit in higher concentration ranges in both fractions. By assessing the study results of both fractions in a WoE approach, there is adequate and reliable information available to assess if Ginger oil CO2-Total Extract has or has not a particular dangerous property.

For both extracts, toxicity to aquatic organisms was found in the same order of magnitude (difference less than a factor of 2). For the classification and labelling assessment, the Ginger oil selective extract ecotoxicity values were selected as worst-case.

C&L

Ginger selective extract aquatic toxicity data is used as worst case for Ginger oil CO2 -Total Extract. In contrast, biodegradation data were used from the Ginger hot flavor extract (not readily biodegradable) as worst case. However, log Kow data are available for the substance, but comprise the ranges from both extracts.

Short-term toxicity results for daphnia and algae are available. The EL50 and ErL50 are 6.39 and 40.4 mg/L, respectively. Based on the lowest available acute data, in this case daphnia, the substance does not need to be classified for acute aquatic toxicity according to Table 4.1.0 (a) of CLP.

As only one reliable long-term toxicity endpoint is available from the algae study, chronic classification needs to be derived on both acute and chronic data and the worst case should be taken.

Based on chronic data (ErL10 = 13.2 mg/L), the substance does not have to be classified according to CLP Table 4.1.0 b(ii). However, in view of the substance not being readily biodegradable, having a log Kow range of 2.72 -7.12 (43% of the substance with a log Kow >= 4.0) and the lowest acute data point being 6.39 mg/L for daphnids, 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 Category Chronic 2 (H411) classification.

As the worst case needs to be taken, Ginger oil CO2 - Total Extract 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