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EC number: 947-955-8
CAS number: -
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.
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)
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
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
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
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