Registration Dossier

Administrative data

Endpoint:
skin sensitisation, other
Type of information:
other: classification of constituents
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 skin sensitisation
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/serious eye damage.
GLP compliance:
no
Type of study:
other: calculation

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 / in chemico

Results
Remarks on result:
other: Not relevant

In vivo (non-LLNA)

Results
Remarks on result:
other: not relevant

In vivo (LLNA)

Results
Remarks on result:
other: not relevant

Any other information on results incl. tables

The most important constituents with regard to skin sensitisation are 1,(+)-citronellal (CAS 2385-77-5), citronellol (CAS 1117-61-9) and geraniol (CAS 106-24-1), present at typical concentrations of 36.27%, 12.74% and 21.56% respectively. These are all classified as skin sensitiser (Skin Sens. 1 / H317).

Applicant's summary and conclusion

Interpretation of results:
other: sensitising
Remarks:
based on CLP criteria
Conclusions:
The most important constituents are classified for skin sensitisation and are present well above the classification threshold of 1% for mixtures, as given in the CLP Regulation (1272/2008/EC). Based on this information, Cymbopogon Winterianus is also considered to be classified for skin sensitisation (Skin Sens. 1 / H317).
Executive summary:

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/serious eye damage. The most importantconstituents with regard to skin sensitisation are 1,(+)-citronellal (CAS 2385-77-5), citronellol (CAS 1117-61-9) and geraniol (CAS 106-24-1), present at typical concentrations of 36.27%, 12.74% and 21.56% respectively. These are all classified as skin sensitiser (Skin Sens. 1 / H317) and are present well above the classification threshold of 1% for mixtures, as given in the CLP Regulation (1272/2008/EC). Based on this information, Cymbopogon Winterianus is also considered to be classified for skin sensitisation (Skin Sens. 1 / H317).