Registration Dossier

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

Reference
Name:
Unnamed
Type:
Constituent
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 inventoryself classification & REACH disseminated dossier

camphene

79 -92 -5

H319

 ECHA C&L inventoryself classification & REACH disseminated dossier

 para-cymene  99 -87 -6

H319

ECHA C&L inventoryself classification & REACH disseminated dossier

 beta-myrcene  123 -35 -3

H319

ECHA C&L inventoryself classification & REACH disseminated dossier

 terpineol-4  562 -74 -3

H319

ECHA C&L inventoryself classification & REACH disseminated dossier

 
 alpha-terpineol  98 -55 -5

H319

ECHA C&L inventoryself classification & REACH disseminated dossier

 
 linalol  78 -70 -6

H319

ECHA C&L inventoryself classification & REACH disseminated dossier

 p-metha-1,3 -diene  99 -86 -5  H319

ECHA C&L inventoryself classification & REACH disseminated dossier

Source: ECHA disseminated dossiersor self classification