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:
1 (reliable without restriction)
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 followed
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:
not specified

Results and discussion

In vitro

Results
Irritation parameter:
other:
Remarks on result:
other: Eye irritation Category 2

Applicant's summary and conclusion

Interpretation of results:
Category 2 (irritating to eyes) based on GHS criteria
Conclusions:
A component (alpha-guaiene) is present at a content superior to 10 % and is classified H319. Thereore the substance is by default classified H319.
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 should be classified as a Eye damage category 2 without further testing according to the rules for classification of mixtures of Regulation (EC) No 1272/2008.

The component alpha-guaiene (EC N°641 -402 -1) is present at a content superior to 10 % and is classified H319 (IFRA elbelling manual). Thereore the substance is by default classified H319.