Essential oil of Platycladus orientalis (L.) Franco obtained from branches and leaves by steam distillation followed by vacuum distillation

Eye irritation

Administrative data

Endpoint:

eye irritation, other

Remarks:

Classification based on calculation rules for mixtures of the CLP Regulation

Type of information:

calculation (if not (Q)SAR)

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

accepted calculation method

Data source

Reference

Reference Type:

other: Guidance

Title:

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

Author:

ECHA

Year:

2017

Bibliographic source:

ECHA-17-G-21-EN

Materials and methods

Test guideline

Qualifier:

no guideline required

Principles of method if other than guideline:

Classification based on calculation rules for mixtures of the CLP Regulation

Test material

Test material information

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

IUPAC 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

Test material form:

liquid

Results and discussion

In vitro

Results

Irritation parameter:

other: classification

Remarks on result:

other: Eyeb damage category 2

Applicant's summary and conclusion

Interpretation of results:

Category 2 (irritating to eyes) based on GHS criteria

Conclusions:

The substance is to be classified as Eye irritant category 2

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 serious eye damage/ eye irritant hazard of the registered substance. The decision of classification as eye Damage category 2 was based on existing data on constituents (additivity principles) the registered substance has a constituent classified as Eye Damage Category 2 present at more than 10% and more than 10% of its constituents classified as eye irritant Category 2

and should be classified as a Eye damage category 2 without further testingaccording to the rules for classification of mixtures of Regulation (EC) No 1272/2008.

Constituent	CAS	Classification	Source
beta-thujone	471 -15 -8	H319	ECHA C&L inventory–self classification & REACH disseminated dossier
camphene	79 -92 -5	H319	ECHA C&L inventory–self classification & REACH disseminated dossier
para-cymene	99 -87 -6	H319	ECHA C&L inventory–self classification & REACH disseminated dossier
beta-myrcene	123 -35 -3	H319	ECHA C&L inventory–self classification & REACH disseminated dossier
terpineol-4	562 -74 -3	H319	ECHA C&L inventory–self classification & REACH disseminated dossier
alpha-terpineol	98 -55 -5	H319	ECHA C&L inventory–self classification & REACH disseminated dossier
linalol	78 -70 -6	H319	ECHA C&L inventory–self classification & REACH disseminated dossier
p-metha-1,3 -diene	99 -86 -5	H319	ECHA C&L inventory–self classification & REACH disseminated dossier

Source: ECHA disseminated dossiersor self classification