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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Description of key information

- Skin Corrosion/ irritation : irritating based on the rules of the CLP Regulation for classification of mixtures

- Seriou eye damage/ eye irritant:irritant, based on the rules of the CLP Regulation for classification of mixtures

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records
Reference
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
Qualifier:
no guideline required
Principles of method if other than guideline:
Classification based on calculation rules for mixtures of the CLP Regulation
Irritation parameter:
other: classification
Remarks on result:
other: skin irritant category 2
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 (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 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

Linalool

78-70-6

H315

ECHA C&L inventory - self 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

ECHA C&L inventory - self classification

 alpha-terpineol  98 -55 -5

H315

ECHA C&L inventory - self classification

Source: ECHA disseminated dossiers or self classification

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Eye irritation

Link to relevant study records
Reference
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
Qualifier:
no guideline required
Principles of method if other than guideline:
Classification based on calculation rules for mixtures of the CLP Regulation
Irritation parameter:
other: Classification
Remarks on result:
other: Eye damage category 2
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 testing according to the rules for classification of mixtures of Regulation (EC) No 1272/2008.

Constituent

 

CAS

Classification

Source

Camphene

79 -92 -5

H319

ECHA disseminated dossier and C&L inventoryself classification

 linalool 78 -70 -6   H319

ECHA C&L inventoryself classification

 myrcene beta  123 -35 -3  H319  ECHA C&L inventory - self classification
 terpineol alpha  98 -55 -5  H319

ECHA C&L inventoryself classification

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

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 Eye and skin irritation/corrosion hazard of the registered substance. The decision of classification as skin irritant and eye 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 more than 10% classified as Eye irritant Category 2 and should be classified as a skin irritant and eye irritant without further testing according to the rules for classification of mixtures of Regulation (EC) No 1272/2008

Skin irritation

Constituent

 

CAS

Classification

Source

Pinene alpha

80 -56 -8

H315

ECHA C&L inventoryself classification

Linalool

78-70-6

H315

ECHA C&L inventory - self 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

ECHA C&L inventory - self classification

 alpha-terpineol  98 -55 -5

H315

ECHA C&L inventory - self classification

Eye irritation

Constituent

 

CAS

Classification

Source

Camphene

79 -92 -5

H319

ECHA disseminated dossier and C&L inventoryself classification

 linalool 78 -70 -6   H319

ECHA C&L inventoryself classification

 myrcene beta  123 -35 -3  H319  ECHA C&L inventory - self classification
 terpineol alpha  98 -55 -5  H319

ECHA C&L inventoryself classification

Source: ECHA disseminated dossiers or self classification

Justification for classification or non-classification

Harmonized classification:

The registered substance has no harmonized classification according to the Regulation (EC) No. 1272/2008.

Self-classification:

Based on the available information and typical composition provided by the Lead Registrant, the registered substance is classified as skin irritant: Skin Irritant Category 2 (H315: Causes skin irritation) and Eye irritant category 2 (H319: Causes serious eye irritation) according to the criteria of the Regulation (EC) No. 1272/2008 (CLP).