Registration Dossier

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
Reference
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)
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records
Reference
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

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).

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).

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).