Registration Dossier

Administrative data

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

Data source

Reference
Reference Type:
secondary source
Title:
Calculation of classification for eye irritation
Author:
Royal HaskoningDHV
Year:
2017
Bibliographic source:
Not relevant
Report Date:
2017

Materials and methods

Test guideline
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

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Cymbopogon winterianus
- Physical state: Liquid
- Analytical purity: Confidential information
- Lot/batch No.: Confidential information
- Expiration date of the lot/batch: Confidential information
- Storage condition of test material: Room temperature in the dark

Results and discussion

In vitro

Results
Remarks on result:
other: Not relevant

In vivo

Results
Remarks on result:
other: Not relevant

Any other information on results incl. tables

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).

Applicant's summary and conclusion

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).