Registration Dossier

Diss Factsheets

Administrative data

eye irritation, 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
1 (reliable without restriction)
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:
Carrot, ext.
EC Number:
EC Name:
Carrot, ext.
Cas Number:
Molecular formula:
Not applicable
(2E)-3,7-dimethylocta-2,6-dien-1-yl acetate; (3R,3aS,8aR)-6,8a-dimethyl-3-(propan-2-yl)-1,2,3,3a,4,5,8,8a-octahydroazulen-3a-ol; (4S)-1-methyl-4-(6-methylhepta-1,5-dien-2-yl)cyclohex-1-ene; 2,6,6-trimethylbicyclo[3.1.1]hept-2-ene; 4-methylidene-1-(propan-2-yl)bicyclo[3.1.0]hexane

Results and discussion

In vitro

Irritation parameter:
other: classification
Remarks on result:
other: eye iritant category 1 or 2 depending on geraniol content

Applicant's summary and conclusion

Interpretation of results:
other: category 1 or 2 based on GHS criteria, depending on geraniol content
Category 1 if geraniol ≥ 3%; category 2 if geraniol < 3%
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 eye irritation hazard of the registered substance. The decision of classification as eye irritant was based on existing data on constituents (additivity principles):the registered substance has more than 10% (w/w) of constituents classified as Eye irritant category 2 (beta-myrcene, caryophylene oxide and linalool) and it can potentially have more than 3% of its constituents classified as eye irritant Category 1 (geraniol). Therefore the registered substance should be classified as a eye irritant Category 1 or 2 depending on the geraniol content (category 1 if geraniol≥ 3%; category 2 if geraniol < 3%) without further testingaccording to the rules for classification of mixtures of Regulation (EC) No 1272/2008.