Registration Dossier

Registration Dossier

Diss Factsheets

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
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.
Available data upon constituants 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
Guideline:
OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
GLP compliance:
not specified

Test material

Constituent 1
Chemical structure
Reference substance name:
Linalool
EC Number:
201-134-4
EC Name:
Linalool
Cas Number:
78-70-6
Molecular formula:
C10H18O
IUPAC Name:
3,7-dimethylocta-1,6-dien-3-ol

In vivo test system

Test animals

Species:
mouse
Strain:
not specified
Sex:
not specified

Results and discussion

In vivo (LLNA)

Resultsopen allclose all
Parameter:
SI
Value:
8.3
Remarks on result:
other: for sample 100% linalool commercial grade
Parameter:
SI
Value:
4.9
Remarks on result:
other: for sample 100% 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 spanish sage oil itself.
The test item is a natural complex substance (NCS). It is a mixture of several constituents, and linalool represents 1.37% of this UVCB substance.
The spanish sage oil is classified as a skin sensitising category 1 substance according to CLP and GHS criteria.

Executive summary:

The spanish sage oil 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 at 1.37%) according to LLNA data and according to annex 6 of regulation 1272/2008 with a harmonized classification in H317.

Linalool 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.

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