Registration Dossier
Registration Dossier
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EC number: 287-316-4 | CAS number: 85480-37-1 Extractives and their physically modified derivatives such as tinctures, concretes, absolutes, essential oils, oleoresins, terpenes, terpene-free fractions, distillates, residues, etc., obtained from Melaleuca leucadendron, Myrtaceae.
Endpoint summary
Administrative data
Description of key information
Acute toxicity, oral: LD50 = 3870 mg/kg bw (WoE).
Key value for chemical safety assessment
Acute toxicity: via oral route
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 3 870 mg/kg bw
- Quality of whole database:
- Only basic data given in the two available studies, however results are consistent and were therefore considered sufficiently robust to cover this endpoint.
Acute toxicity: via inhalation route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Acute toxicity: via dermal route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Acute toxicity: via oral route
LD50 of 3870 mg/kg bw (Jeyner, 1964, Rel.4) and 5000 mg/kg bw (Wohl, 1974, Rel.4) in rats were reported on Cajeput oil.
The two available studies were only poorly described but taken together they give consistent results. Therefore a weight-of-evidence approach was followed for this endpoint. As a worst-case, the lowest LD50 value was selected as the key effect level for this endpoint.Justification for selection of acute toxicity – oral endpoint
No study was selected since a weight-of-evidence approach was followed to conclude on the acute toxicity via oral route. As a worst-case, the lowest LD50 value was selected as the key effect level for this endpoint.
Justification for classification or non-classification
Harmonized classification:
Cajuput oil has no harmonized classification according to the Regulation (EC) No. 1272/2008.
Self-classification:
Acute toxicity via Oral route:
Based on the available information, Cajuput oil is:
- not classified according to the Regulation (EC) No. 1272/2008 as the LD50 is greater than 2000 mg/kg bw
- not classified according to the Directive 67/548/EEC as the LD50 is greater than 2000 mg/kg bw.
Acute toxicity via Dermal route:This information is not available
Acute toxicity via Inhalation:This information is not available.
Specific target organ toxicity: single exposure (Oral):
The classification criteria according to the Annex VI of the Regulation (EC) No. 1272/2008 as specific target organ toxicant (STOT) – single exposure, oral are not met since no reversible or irreversible adverse health effects were observed immediately or delayed after exposure and no effects were observed at the guidance value (oral) for a Category 1 classification (C ≤ 300 mg/kg bw) and at the guidance value (oral) for a Category 2 classification (2000 mg/kg bw ≥ C > 300 mg/kg bw). No classification is required.
Specific target organ toxicity: single exposure (Dermal):This information is not available
Specific target organ toxicity: single exposure (Inhalation):This information is not available.
Based on its composition (> 10% of aspiration toxicants, i.e. limonene, pinene, myrcene), Cajuput oil should be classified for aspiration hazard:
- H304,May be fatal if swallowed and enters airways according to the regulation (EC) No. 1272/2008
- Xn, R65, Harmful: may cause lung damage if swallowed according to the Directive 67/548/EEC.
Source: ECHA disseminated dossiers
-Pinene:
http://apps.echa.europa.eu/registered/data/dossiers/DISS-9d952924-c8ed-4614-e044-00144f67d249/DISS-9d952924-c8ed-4614-e044-00144f67d249_DISS-9d952924-c8ed-4614-e044-00144f67d249.html
- Limonene:
http://apps.echa.europa.eu/registered/data/dossiers/DISS-9eb16d5d-b83e-2831-e044-00144f67d031/DISS-9eb16d5d-b83e-2831-e044-00144f67d031_DISS-9eb16d5d-b83e-2831-e044-00144f67d031.html
-Myrcene:
http://apps.echa.europa.eu/registered/data/dossiers/DISS-9d82fafa-8716-3e64-e044-00144f67d249/DISS-9d82fafa-8716-3e64-e044-00144f67d249_DISS-9d82fafa-8716-3e64-e044-00144f67d249.html
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.
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