Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Toxicological information

Skin irritation / corrosion

Currently viewing:

Administrative data

Endpoint:
skin irritation / corrosion, 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:
2015
Bibliographic source:
ECHA-15-G-05-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:
Eucalyptus oil globulus
IUPAC Name:
Eucalyptus oil globulus
Test material form:
gas under pressure: refrigerated liquefied gas
Details on test material:
- Name of test material (as cited in study report): eucalyptus oil globulus
- Molecular formula (if other than submission substance): see confidential
- Molecular weight (if other than submission substance): see confidential
- Smiles notation (if other than submission substance): see confidential
- Structural formula attached as image file (if other than submission substance): see confidential
- Substance type: Natural Complex Substance
- Physical state: see confidential
- Analytical purity: see confidential
- Impurities (identity and concentrations): see confidential
- Composition of test material, percentage of components: see confidential
- Purity test date: see confidential
- Lot/batch No.: see confidential
- Expiration date of the lot/batch: see confidential
- Storage condition of test material: room temperature

Results and discussion

In vivo

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

Applicant's summary and conclusion

Interpretation of results:
Category 2 (irritant) 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 (2015) was used to determine the skin irritation/corrosion hazard of the registered substance. The decision of classification as skin irritant was based on existing data on constituents (additivity principles): the registered substance has more than 10% of its constituents classified as Skin irritant Category 2 and should be classified as a skin irritant without further testing according to the rules for classification of mixtures of Regulation (EC) No 1272/2008

Constituent

 

CAS

Classification

Source

Pinene alpha

80 -56 -8

H315

ECHA C&L inventoryself classification

Pinene beta

127 -91 -3

H315

ECHA C&L inventory - self classification

 Myrcene beta  123 -35 -3  H315

ECHA C&L inventory - self classification

 dipentene  138 -86 -3

H315

Harmonised classification Annex VI of Regulation (EC) No 1272/2008 (CLP Regulation)

 alpha-terpineol  98 -55 -5

H315

ECHA C&L inventory - self classification

Source: ECHA disseminated dossiers or self classification