Registration Dossier

Administrative data

Endpoint:
skin sensitisation, other
Remarks:
Classification based on calculation rules for mixtures of the CLP Regulation.
Type of information:
calculation (if not (Q)SAR)
Adequacy of study:
weight of evidence
Study period:
2015
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
accepted calculation method
Justification for type of information:
Classification based on calculation rules for mixtures of the CLP Regulation. There is no experimental study reference.
But constituants data upon come from Opinion proposing harmonised classification and labelling at EU level of linalool from Committee for Risk Assessment (RAC) 2015

Data source

Reference
Reference Type:
publication
Title:
Unnamed
Year:
2015
Report Date:
2015

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
GLP compliance:
not specified
Type of study:
mouse local lymph node assay (LLNA)

Test material

Reference
Name:
Unnamed
Type:
Constituent

In vivo test system

Test animals

Species:
mouse
Strain:
not specified
Sex:
not specified

Study design: in vivo (LLNA)

Vehicle:
not specified
Concentration:
25%, 50% and 100% for Linalool (commercial) ; 25%, 50% and 100% for Linalool (purified, redistilled)

Results and discussion

In vivo (LLNA)

Resultsopen allclose all
Parameter:
SI
Value:
8.3
Remarks on result:
other: 100% of linalool (commercial)
Parameter:
SI
Value:
4.9
Remarks on result:
other: 100% of linalool (purified, redistilled)

Applicant's summary and conclusion

Interpretation of results:
Category 1 (skin sensitising) based on GHS criteria
Conclusions:
Linalool is classified as a skin sensitising substance according to CLP and GHS criteria.
No study was conducted on the lavandin oil heavy fraction iself.
The test item is a natural complex substance (NCS). It is a mixture of several constituents, and linalool represents 1% to 8% of this UVCB substance.
Literature above provided data for this major compound.
Executive summary:

The lavandin oil heavy fraction is an NCS (natural complex substance) because it is composed of several identified constituents. Therefore, it can be considered as a mixture according to the definition of the CLP Regulation.

The decision logic for classification of mixtures from the ECHA Guidance on the Application of the CLP Criteria (2015) was used to determine the skin sensitizing potential of the registered substance.

The registered substance has not been tested itself in appropriate in vitro or in vivo tests but one of its constituents is classified as skin sensitizing (Linalool between 1.8% and 8%) and is present above the CLP generic concentration limit of 1% that triggers classification of the mixture. Therefore, the registered substance is classified as a skin sensiting substance without further testing according to the Regulation (EC) No 1272/2008.


Route: .live2