A more recent version of this regulatory record is available. This version is kept only as a historical record. Please see the Record history section for link to the most recent version.
List details
Basic info
Status | Submitted |
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Submitter | Poland |
Submitter email | clh@chemikalia.gov.pl |
Regulatory programme |
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Description | Extractives and their physically modified derivatives such as tinctures, concretes, absolutes, essential oils, oleoresins, terpenes, terpene-free fractions, distillates, residues, etc., obtained from Melaleuca alternifolia, Myrtaceae. |
Further substance information | No chemical denomination can be assigned to Tea Tree Oil (TTO) because it is a complex mixture of chemical substances. TTO is composed of terpene hydrocarbons, mainly monoterpenes, sesquiterpenes and their associated alcohols. |
Classification
Proposed harmonised classification by the dossier submitter |
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Intention timeline
Date of intention | 2020-10-02 |
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Expected date of submission | 2020-10-09 |
Submitted for accordance check | 2020-10-16 |
Documents
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Record history
The following timeline shows when we detected changes of this regulatory record (the date might slightly differ from the date of the actual change). Additions between versions are hightlighted in green color, red color shows data removed between versions.
Oct. 8, 2021
- Proposed specific concentration limits by the dossier submitter: ATE acute oral = 1049 mg/kg bw ATE acute inhal.= 3.64 mg/L
Feb. 18, 2022
- Proposed harmonised classification by the dossier submitter: Aquatic Chronic 3, H412
- Proposed harmonised classification by the dossier submitter: Repr. 2, H361f
- Proposed specific concentration limits by the dossier submitter: ATE acute oral = 1049 mg/kg bw ATE acute inhal.= 3.64 mg/L → oral: ATE = 1049 mg/kg bw inhalation: ATE = 3.64 mg/L (mist)
- Proposed harmonised classification by the dossier submitter: Skin Sens. 1B, H317
Jan. 18, 2023
- Annexes to the CLH Report: https://echa.europa.eu/documents/10162/4ffe0359-9c10-7e10-e919-6184d9c0c1c4
- CLH report: https://echa.europa.eu/documents/10162/8c7afcac-b2d2-9b9a-fe58-5a7173b1223c
- Deadline for commenting: 2023-01-27
- Further substance information: No chemical denomination can be assigned to Tea Tree Oil (TTO) because it is a complex mixture of chemical substances. TTO is composed of terpene hydrocarbons, mainly monoterpenes, sesquiterpenes and their associated alcohols. → Melaleuca alternifolia, ext. [1] Melaleuca alternifolia, essential oil; tea tree oil [2]
- Final submission date: 2022-11-17
- Hazard classes open for commenting: All hazard classes (physical hazards as well as hazards to human health and the environment) with the exception of respiratory sensitisation, and hazardous to the ozone layer in the event that there are no data for these hazard classes
- Legal deadline for opinion adoption: 2024-05-18
- Status: Submitted → Consultation
- Start of consultation: 2022-11-28
This version
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