Registration Dossier
Registration Dossier
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EC number: 294-954-7 | CAS number: 91771-61-8 Extractives and their physically modified derivatives such as tinctures, concretes, absolutes, essential oils, oleoresins, terpenes, terpene-free fractions, distillates, residues, etc., obtained from Cymbopogon winterianus, Gramineae.
Endpoint summary
Administrative data
Description of key information
- Skin irritation: not irritating
- Eye irritation: serious eye damage
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin irritation: in vitro / ex vivo
- Data waiving:
- other justification
- Justification for data waiving:
- the study does not need to be conducted because an acute toxicity study by the dermal route does not indicate skin irritation up to the relevant limit dose level (2 000 mg/kg body weight)
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation, other
- Type of information:
- other: constituent classification data
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- data from handbook or collection of data
- Remarks:
- ECHA database
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- The classification of constituents of Cymbopogon Winterianus was studied (ECHA website) and used to derive a classification for the UVCB itself using the criteria outlined in Annex I of the CLP Regulation (1272/2008/EC) for eye irritation/damage.
- GLP compliance:
- no
- Remarks on result:
- other: Not relevant
- Remarks on result:
- other: Not relevant
- Interpretation of results:
- other: serious eye damage
- Remarks:
- based on CLP criteria
- Conclusions:
- One of the major constituents Geraniol is classified for serious eye damage and is present well above the classification threshold of 3% for mixtures, as given in the CLP Regulation (1272/2008/EC). Based on this information, Cymbopogon Winterianus is also considered to be classified for serious eye damage (Eye Dam. 1 / H318).
- Executive summary:
The classification of the constituents of Cymbopogon Winterianus was studied (ECHA website) and used to derive a classification for the UVCB itself using the criteria outlined in Annex I of the CLP Regulation (1272/2008/EC) for eye irritation/damage. The most important constituent with regard to eye irritation/damage is determined to be Geraniol (CAS 106-24-1), which is present in a typical concentration of 21.56% and is classified for serious eye damage (Eye Dam. 1 / H318). This is well above the classification threshold of 3% for mixtures, as given in the CLP Regulation (1272/2008/EC). Based on this information, Cymbopogon Winterianus is also considered to be classified for serious eye damage (Eye Dam. 1 / H318).
Reference
The most important constituent with regard to eye irritation/damage was determined to be Geraniol (CAS 106-24-1), which is present in a typical concentration of 21.56% and is classified for serious eye damage (Eye Dam. 1 / H318).
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irreversible damage)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Skin irritation
A skin irritation test for this substance is waived as the acute dermal toxicity test indicates no irritation up to the highest dose tested (2000 mg/kg bw).
Eye irritation
The classification of the constituents of Cymbopogon Winterianus was studied (ECHA website) and used to derive a classification for the UVCB itself using the criteria outlined in Annex I of the CLP Regulation (1272/2008/EC) for eye irritation/damage.The most important constituent with regard to eye irritation/damage is determined to be Geraniol (CAS 106-24-1), which is present in a typical concentration of 21.56% and is classified for serious eye damage (Eye Dam. 1 / H318). This iswell above the classification threshold of 3% for mixtures, as given in the CLP Regulation (1272/2008/EC). Based on this information, Cymbopogon Winterianus is also considered to be classified for serious eye damage (Eye Dam. 1 / H318).
Justification for classification or non-classification
Based on the available data, Cymbopogon winterianus does not need to be classified as a skin irritant in accordance with the criteria outlined in Annex I of the CLP Regulation (1272/2008/EC).
Based on the eye damaging properties of the major constituent, Cymbopogon winterianus should be classified for serious eye damage (Eye Dam. 1 / H318) in accordance with the criteria outlined in Annex I of 1272/2008/EC (CLP).
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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