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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

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 is based on calculation rules for mixtures of the CLP Regulation, as this UVCB substance contains 10 constituents at a concentration above or equal to 1% as a mixture. There is no experimental study on the test item.
However, constituents data exist regarding skin sensitization.

Data source

Reference
Reference Type:
review article or handbook
Title:
Unnamed
Year:
2011
Report date:
2011

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)

Test material

Constituent 1
Chemical structure
Reference substance name:
Dipentene
EC Number:
205-341-0
EC Name:
Dipentene
Cas Number:
138-86-3
Molecular formula:
C10H16
IUPAC Name:
1-methyl-4-prop-1-en-2-ylcyclohexene
Test material form:
liquid

In vivo test system

Test animals

Species:
mouse
Strain:
not specified
Sex:
not specified

Results and discussion

In vivo (LLNA)

Resultsopen allclose all
Parameter:
EC3
Remarks:
%
Value:
< 10
Remarks on result:
other: source RIFM 2009
Parameter:
EC3
Remarks:
M (molar concentration)
Value:
< 0.73
Remarks on result:
other: source RIFM 2009
Parameter:
EC3
Remarks:
oxidised 10 weeks
Value:
3
Remarks on result:
other: source : Christensson J B, Johansson S, Hagvall L, Jonsson C, Borje A, Karlberg A T. Limonene hydroperoxide analogues differ in allergenic activity. Contact Dermatitis 2008: 59: 344-52.
Parameter:
EC3
Remarks:
pure (not oxidised)
Value:
30
Remarks on result:
other: source : Christensson J B, Johansson S, Hagvall L, Jonsson C, Borje A, Karlberg A T. Limonene hydroperoxide analogues differ in allergenic activity. Contact Dermatitis 2008: 59: 344-52.

Applicant's summary and conclusion

Interpretation of results:
Category 1 (skin sensitising) based on GHS criteria
Conclusions:
Limonene (synonym dipentene) is classified as a skin sensitising substance according to CLP and GHS criteria.
No study was conducted on the marjorm oil iself.
The test item is a natural complex substance (NCS). It is a mixture of several constituents, and limonene represents 1 to 6% of this UVCB substance (typical value at 2.1%).
Literature above provided data for this compound.
Executive summary:

The marjoram 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 (Limonene at 2.1% of typical value) according to LLNA data and according to annex 6 of regulation 1272/2008 with a harmonized classification as H317.

Limonene 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.