Thyme, Thymus mastichina, ext.

Skin irritation / corrosion

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

Reference

Reference 1

Reference Type:

secondary source

Title:

Unnamed

Year:

2017

Report date:

2017

Reference 2

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

Test material information

Constituent 1

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

Results

Results 1

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%

Results 2

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%

Results 3

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.