Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

skin sensitisation, other
Classification based on calculation rules for mixtures of the CLP Regulation
Type of information:
calculation (if not (Q)SAR)
Adequacy of study:
key study
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
accepted calculation method

Data source

Reference Type:
other: Guidance
Guidance on the Application of the CLP Criteria - Guidance to Regulation (EC) No 1272/2008 on classification, labelling and packaging (CLP) of substances and mixtures
Bibliographic source:

Materials and methods

Test guideline
no guideline required
Principles of method if other than guideline:
Classification based on calculation rules for mixtures of the CLP Regulation

Test material

Constituent 1
Reference substance name:
(1R,4R,5S)-4-methyl-1-(propan-2-yl)bicyclo[3.1.0]hexan-3-one; 1,3,3-trimethylbicyclo[2.2.1]heptan-2-one; 4-methylidene-1-(propan-2-yl)bicyclo[3.1.0]hexan-3-yl acetate; 4-methylidene-1-(propan-2-yl)bicyclo[3.1.0]hexane
(1R,4R,5S)-4-methyl-1-(propan-2-yl)bicyclo[3.1.0]hexan-3-one; 1,3,3-trimethylbicyclo[2.2.1]heptan-2-one; 4-methylidene-1-(propan-2-yl)bicyclo[3.1.0]hexan-3-yl acetate; 4-methylidene-1-(propan-2-yl)bicyclo[3.1.0]hexane
Test material form:

Results and discussion

In vitro / in chemico

other: Classification
Remarks on result:
other: Skin sensitiser Category 1

Applicant's summary and conclusion

Interpretation of results:
Category 1 (skin sensitising) based on GHS criteria
The substance is to be classified as Skin Sensitiser 1
Executive summary:

The NCS is composed of several identified constituents and in that, 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 (2017) was used to determine the skin sensitising potential of the registered substance.

The registered substance has not been tested itself in appropriate in vitro or in vivo tests but some of its constituents are classified as skin sensitiser Cat.1B (beta-caryophyllene, alpha-pinene, beta-pinene, limonene, beta-myrcene, terpineol-4, alpha-terpinolene, delta-3 -carene, alpha-thujene, linalolp-metha-1,3 -dienene and fenchyl acetate) and each are present above the CLP generic concentration limit of 1% that triggers classification of the mixture. Therefore, the registered substance is classified as a skin sensitiser Cat. 1 without further testing according to the Regulation (EC) No 1272/2008.