Registration Dossier

Registration Dossier

Diss Factsheets

Administrative data

Endpoint:
skin irritation / corrosion, 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
Constituants data come from an online compilation using secondary data sources. There is no experimental study reference, however data is cited in the database as peer reviewed.

Data source

Referenceopen allclose all

Reference Type:
secondary source
Title:
Unnamed
Year:
2017
Report date:
2017
Reference Type:
publication
Title:
Unnamed
Year:
2002
Report date:
2002

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Principles of method if other than guideline:
Classification based on calculation rules for mixtures of the CLP Regulation
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

Test animals

Species:
rabbit
Strain:
not specified
Details on test animals or test system and environmental conditions:
ECETOC Irritation Chemical Reference Databank

Test system

Type of coverage:
not specified

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
animal #1
Remarks:
3 animals
Time point:
other: no data
Score:
3.33
Reversibility:
not specified
Remarks on result:
other: linalol purity 97.1%
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
animal #2
Remarks:
4 animals
Time point:
other: no data
Score:
3.42
Reversibility:
not specified
Remarks on result:
other: linalol purity 97.1%
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
animal #3
Remarks:
4 animals
Time point:
other: no data
Score:
2.08
Reversibility:
not specified
Remarks on result:
other: linalol purity 97.1%

Applicant's summary and conclusion

Interpretation of results:
Category 2 (irritant) based on GHS criteria
Conclusions:
Linalool is classified as a skin irritant substance according to CLP and GHS criteria.
No study was conducted on the marjoram oil iself.
The test item is a natural complex substance (NCS). It is a mixture of several constituents, and linalool represents 14% of this UVCB substance.
Literature above provided data for this major compound.
Executive summary:

The NCS is composed of several identified constituents, so 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 irritation / corrosion 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 irritant (Linalool at 14%) and none other constituents is assessed skin corrosive.

The single constituent is present above the CLP generic concentration limit of 10% that triggers classification of the mixture. Therefore, the registered substance is classified as a skin irritant substance without further testing according to the Regulation (EC) No 1272/2008.

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