Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 283-406-2 | CAS number: 84625-32-1 Extractives and their physically modified derivatives such as tinctures, concretes, absolutes, essential oils, oleoresins, terpenes, terpene-free fractions, distillates, residues, etc., obtained from Eucalyptus globulus, Myrtaceae.
- Skin irritation/corrosion: irritating (WoE).- Eye irritation: not irritating (OECD 405, GLP, K, rel.1).
In an acute dermal toxicity study, 10 rabbits were administered a single dermal dose of eucalyptus oil at 5000 mg/kg bw. Animals were then observed for mortality and clinical signs of toxicity for 14 days.
Dermal reactions noted were slight redness (5/10 rabbits), moderate redness (3/10 rabbits) and moderate oedema (10/10 rabbits) at the site of application.
In a study, eucalyptus oil was obtained from the leaves of Eucalyptus globulus (source: waste and uncultivated areas of Lahore, Pakistan) and purified to isolate its active compounds: 1,8-cineole, β-caryophyllene, citronellal, α-terpineol, p-cymene, cryptone (9.39 %) and other minor constituents. Each fraction (10 mg) was dissolved in acetone (10 mL) and applied to the ear of groups of albino mice (10/dose) at the dose levels of 0.078125-20 µg/5 µL. The total number of red ears per dilution and ID50 (Irritant dose in 50 % individuals) were calculated by probit analysis.
The ID50 values for 1,8-cineole, β-caryophyllene, citronellal, α-terpineol, p-cymene, cryptone were calculated to be 1.008, 2.483, 0.351, 0.706, 0.847 and 0.497 µg/5 µL, respectively.
Under the test conditions, eucalyptus oil constituents were considered as possibly harmful and irritant to the skin.
The NCS is composed of several identified constituents and in that, it can be considered as a mixture according to the definition of the CLP Regulation.
The decision logic for classification of mixtures from the ECHA Guidance on the Application of the CLP Criteria (2015) was used to determine the skin irritation/corrosion hazard of the registered substance. The decision of classification as skin irritant was based on existing data on constituents (additivity principles): the registered substance has more than 10% of its constituents classified as Skin irritant Category 2 and should be classified as a skin irritant without further testing according to the rules for classification of mixtures of Regulation (EC) No 1272/2008
80 -56 -8
ECHA C&L inventory–self classification
127 -91 -3
ECHA C&L inventory - self classification
Harmonised classification Annex VI of Regulation (EC) No 1272/2008 (CLP Regulation)
Source: ECHA disseminated dossiers or self classification
Table 7.3.2/1: Irritant/corrosive response data each animals at each observation time up to removal from the test
Score at time point / Reversibility
0 / 0 / 0
2 / 2 / 2
1 / 2 / 1
1 / 1 / 1
Average 24h, 48h, 72h
0.7 / 1 / 0.7
0.7 / 0.7 / 0.7
Average time (unit) for reversion
*) Reversibility: c. = completely reversible; n.c. = not completely reversible; n. = not reversible
In an eye irritation study performed according to the OECD guideline No. 405, and in compliance with GLP, 0.1 mL of undiluted Eucalyptus globulus oil was instilled initially into the right eye of a single New Zealand White rabbit. After consideration of the ocular responses produced in the first treated animal, two additional animals were treated. The eyes were not rinsed after administration of Eucalyptus globulus oil. The left eye of each rabbit served as control. Animals were observed 1, 24, 48 and 72 hours after dosing under a light source from a standard ophthalmoscope. The reactions in the conjunctiva (redness, chemosis and discharge), the iris and the cornea (opacity and area involved) were scored according to the Draize scale.
No corneal or iridial effects were noted during the study. Moderate conjunctival irritation was noted in all treated eyes one hour after treatment with minimal conjunctival irritation noted at the 24 and 48-Hour observations. All treated eyes appeared normal at the 72-Hour observation.
One animal showed no gain in body weight and two animals showed expected gain in body weight during the study.
Mean scores calculated for each animal over 24, 48 and 72 hours were 0.0/0.0/0.0 for cornea opacity, 0.0/0.0/0.0 for iris lesions, 0.7/1.0/0.7 for redness of the conjunctivae and 0.7/0.7/0.7 for chemosis.
Under the test conditions, Eucaltus globulus oil is not classified as irritating to eyes according to the criteria of the Annex VI of the Regulation (EC) No. 1272/2008 (CLP) and of the Directive 67/548/EEC.
This study is considered as acceptable and satisfies the requirement for eye irritation endpoint.
Skin irritation / corrosion:
A weight-of-evidence analysis, taking all existing and relevant data, was used to conclude on the skin irritation potential of Eucalyptus oil. The decision of classification as skin irritant was based on the following arguments:
1 - Existing human data: According to Saeed and Sahbir (1998), irritation due to Eucalyptus oil was observed in the local people, who deals with the manufacture of cosmetics and liniments, where this oil was used as their main ingredient. The composition of the Eucalyptus oil tested is not similar to the submitted dossier, therefore the data by itself was not considered sufficiently adequate to conclude on classification.
2 - Existing animal data from irritation study: Skin irritation was observed in a reliable acute dermal toxicity study (Moreno, 1973) at the dose of 5000 mg/kg bw. Dermal reactions noted were slight redness (5/10 rabbits), moderate redness (3/10 rabbits) and moderate oedema (10/10 rabbits) at the site of application. Adequate scoring of skin effects was not provided, therefore it was not possible to take a decision of classification based solely on this study.
3 - Existing data on constituents: As detailed on the publication of Saeed and Sahbir, irritant effect of Eucalyptus oil is mainly due to the monoterpenes present in oil. Indeed, more than 10% of the Eucalyptus oil constituents are classified as skin irritant (i.e. pinene, terpineol). Therefore according to the Regulation (EC) No 1272/2008, the mixture should be classified.
4- Classification of constituents: The NCS is composed of several identified constituents and in that, it can be considered as a mixture according to the definition of the CLP regulation. Alpha pinene, Limonene, Terpineol alpha, Beta myrcene and beta pinene, are all classified as Skin irritant (self or harmonised classification) and are presents above the CLP generic concentration limit of 10%. Therefore, the registered substance is classified as skin irritant according to the Regulation (EC) No 1272/2008.
Eucalyptus oil is not a skin corrosive and no damage to the eyes was reported in existing in vitro and/or in vivo studies on more than 90% of Eucalyptus oil constituents. Based on the whole data available, an in vitro test to assess corrosivity was not justified. However, based on the complexity of the substance and on the absence on in vivo data on its major constituent, a new in vivo test was performed.
This in vivo eye irritation study was performed according to the OECD guideline No. 405, and in compliance with GLP (Pooles, 2013). No corneal or iridial effects were noted during the study. Moderate conjunctival irritation was noted in all treated eyes one hour after treatment with minimal conjunctival irritation noted at the 24 and 48-Hour observations. All treated eyes appeared normal at the 72-Hour observation. One animal showed no gain in body weight and two animals showed expected gain in body weight during the study. Mean scores calculated for each animal over 24, 48 and 72 hours were 0.0/0.0/0.0 for cornea opacity, 0.0/0.0/0.0 for iris lesions, 0.7/1.0/0.7 for redness of the conjunctivae and 0.7/0.7/0.7 for chemosis.
Under the test conditions, Eucalyptus globulus oil is not classified as irritating to eyes
Justification for selection of skin irritation / corrosion endpoint: Available data indicates that the criteria are met for classification as irritating to the skin. Justification for selection of eye irritation endpoint: Only one study available, GLP-compliant and of high quality (Klimisch score = 1). Effects on skin irritation/corrosion: irritating
The substance has no harmonized classification according to the Regulation (EC) No. 1272/2008 including ATP3.
Based on the available information the substance is classified as:
- Skin Irritant Category 2 (H315: Causes skin irritation) according to the criteria of the Annex VI of the Regulation (EC) No. 1272/2008 (CLP).
No additional self-classification is proposed regarding eye irritation according to the Annex VI of the Regulation (EC) No. 1272/2008 (CLP) and of the Directive 67/548/EC. No information was available regarding respiratory irritation.
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.
Welcome to the ECHA website. This site is not fully supported in Internet Explorer 7 (and earlier versions). Please upgrade your Internet Explorer to a newer version.
Close Do not show this message again