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:
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:
Camphor tree, ext.
EC Number:
295-980-1
EC Name:
Camphor tree, ext.
Cas Number:
92201-50-8
IUPAC Name:
1,3,3-trimethyl-2-oxabicyclo[2.2.2]octane; 1-methyl-4-(prop-1-en-2-yl)cyclohex-1-ene; 2,6,6-trimethylbicyclo[3.1.1]hept-2-ene

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 compound 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 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 cat.2 without further testing according to the rules for classification of mixtures of Regulation (EC) No 1272/2008.

Constituent

CAS

Classification

Source

1-8 cineole

 

470 -82 -6

NC

 

ECHA C&L inventory–self classification

Dipentene

 

138 -86 -3

 

Skin Irrit. 2 - H315

ECHA C&L inventory–self classification

Alpha pinene

 

80 -56 -8

Skin Irrit. 2 - H315

ECHA C&L inventory–self classification

Bornan-2 -one

 

76 -22 -2

Skin Irrit. 2 - H315

ECHA C&L inventory–self classification

Alpha terpineol

98-55-5

Skin Irrit. 2 - H315

ECHA C&L inventory–self classification

Beta pinene

127-91-3

Skin Irrit. 2 - H315

ECHA C&L inventory–self classification

p-mentha-1,4-diene

99-85-4

NC

ECHA C&L inventory–self classification

p-cymene

99-87-6

NC

ECHA C&L inventory–self classification

p-mentha-1,5-diene

99-83-2

NC

ECHA C&L inventory–self classification

7-methyl-3-methyleneocta-1,6-diene

123-35-3

Skin Irrit. 2 - H315

ECHA C&L inventory–self classification

Camphene

79-92-5

NC

ECHA C&L inventory–self classification

p-menth-1-en-4-ol

562-74-3

Skin Irrit. 2 - H315

ECHA C&L inventory–self classification

Sabinene

3387-41-5

NC

ECHA C&L inventory–self classification

p-mentha-1,4(8)-diene

586-62-9

Skin Irrit. 2 - H315

ECHA C&L inventory–self classification

5-isopropyl-2-methylbicyclo[3.1.0]hex-2-ene

2867-05-2

NC

ECHA C&L inventory–self classification

Source: ECHA disseminated dossiers or self classification