Registration Dossier

Toxicological information

Skin irritation / corrosion

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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

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
not specified
Details on test material:
- Name of test material (as cited in study report): Abies Sibirica Oil

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 according to the Regulation (EC) No. 1272/2008 (CLP)

Skin irritation

Source

Pinene alpha

80-56-8

SCI2, H315

ECHA C&L inventory - self classification

Pinene Beta

127-91-3

SCI2, H315

 ECHA C&L inventory - self classification

Delta 3 carene

13466-78-9

SCI2, H315

 ECHA C&L inventory - self classification

Myrcene beta

123-35-3

SCI2, H315

 ECHA C&L inventory - self classification

Limonene

138-86-3

SCI2, H315

 ECHA C&L inventory - Harmonized Classification

Source: ECHA disseminated dossiers or self classification