Registration Dossier

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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

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 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:
Concrete of Salvia sclarea L. (Lamiaceae) obtained from leaves, flowers and twigs by apolar hydrocarbon solvent extraction with or without purification by molecular distillation
EC Number:
947-717-3
IUPAC Name:
Concrete of Salvia sclarea L. (Lamiaceae) obtained from leaves, flowers and twigs by apolar hydrocarbon solvent extraction with or without purification by molecular distillation
Test material form:
not specified

Results and discussion

In vivo

Results
Irritation parameter:
other: classification
Remarks on result:
other: eye irritant category 2

Applicant's summary and conclusion

Interpretation of results:
Category 2 (irritating to eyes) based on GHS criteria
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 irritant to the eyes was based on existing data on constituents (additivity principles) the registered substance has more than 10% of its constituents classified as Eye irritant Category 2 and should be classified as a Eye irritant Category 2 without further testingaccording to the rules for classification of mixtures of Regulation (EC) No 1272/2008.

Constituent

 

CAS

Classification

Source

linalyl acetate

115 -95 -7

H319

ECHA C&L inventoryself classification

Linalool

78-70-6

H319

ECHA C&L inventory - self classification

 terpineol  8000 -41 -7  H319

ECHA C&L inventory - self classification