Registration Dossier

Administrative data

Description of key information

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

- Serious eye damage/ eye irritant: Eye damage category 2, 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:
2 (reliable with restrictions)
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 / corrosion parameter:
other: classification
Remarks on result:
other: skin irritant category 2
Interpretation of results:
Category 2 (irritant) based on GHS criteria
Conclusions:
The substance is to be classified as Skin irritant Category 2
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 constituents classified as Skin Irritant Category 2 present at more than 10% and more than 10% of its constituents classified as Skin irritant Category 2 and should be classified as a skin irritant without further testingaccording to the rules for classification of mixtures of Regulation (EC) No 1272/2008

Constituent

 

CAS

Classification

Source

beta-thujone

471 -15 -8

H315

ECHA C&L inventoryself classification & REACH disseminated dossier

alpha-pinene

80 -56 -8

H315

 ECHA C&L inventoryself classification & REACH disseminated dossier

 beta-pinene  127 -91 -3

H315

ECHA C&L inventoryself classification & REACH disseminated dossier

 limonene  138 -86 -3

H315

ECHA C&L inventoryself classification & REACH disseminated dossier

 para-cymene  99 -87 -6

H315

ECHA C&L inventoryself classification & REACH disseminated dossier

 beta-myrcene  123 -35 -3

H315

ECHA C&L inventoryself classification & REACH disseminated dossier

 terpineol-4  562 -74 -3

H315

ECHA C&L inventoryself classification & REACH disseminated dossier

 
 alpha-terpineol  98 -55 -5

H315

ECHA C&L inventoryself classification & REACH disseminated dossier

 
 delta-3 carene  13466 -78 -9  

H315

ECHA C&L inventoryself classification

 linalol  78 -70 -6

H315

ECHA C&L inventoryself classification & REACH disseminated dossier

Source: ECHA disseminated dossiersor 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:
2 (reliable with restrictions)
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: Eyeb damage category 2
Interpretation of results:
Category 2 (irritating to eyes) based on GHS criteria
Conclusions:
The substance is to be classified as Eye irritant category 2
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 eye Damage category 2 was based on existing data on constituents (additivity principles) the registered substance has a constituent classified as Eye Damage Category 2 present at more than 10% and more than 10% of its constituents classified as eye irritant Category 2

and should be classified as a Eye damage category 2 without further testingaccording to the rules for classification of mixtures of Regulation (EC) No 1272/2008.

Constituent

 

CAS

Classification

Source

beta-thujone

471 -15 -8

H319

ECHA C&L inventoryself classification & REACH disseminated dossier

camphene

79 -92 -5

H319

 ECHA C&L inventoryself classification & REACH disseminated dossier

 para-cymene  99 -87 -6

H319

ECHA C&L inventoryself classification & REACH disseminated dossier

 beta-myrcene  123 -35 -3

H319

ECHA C&L inventoryself classification & REACH disseminated dossier

 terpineol-4  562 -74 -3

H319

ECHA C&L inventoryself classification & REACH disseminated dossier

 
 alpha-terpineol  98 -55 -5

H319

ECHA C&L inventoryself classification & REACH disseminated dossier

 
 linalol  78 -70 -6

H319

ECHA C&L inventoryself classification & REACH disseminated dossier

 p-metha-1,3 -diene  99 -86 -5  H319

ECHA C&L inventoryself classification & REACH disseminated dossier

Source: ECHA disseminated dossiersor self 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 corrosive was based on existing data on constituents (additivity principles)the registered substance has constituent present at more than 10% classified as Skin irritant Category 2 and classified as Eye damage Category 2 and should be classified as a skin irritant and eye damage without further testing according to the rules for classification of mixtures of Regulation (EC) No 1272/2008

Constituent

 

CAS

Classification

Source

beta-thujone

471 -15 -8

H315/ H319

ECHA C&L inventoryself classification & REACH disseminated dossier

alpha-pinene

80 -56 -8

H315

 ECHA C&L inventoryself classification & REACH disseminated dossier

 beta-pinene  127 -91 -3

H315

ECHA C&L inventoryself classification & REACH disseminated dossier

 limonene  138 -86 -3

H315

ECHA C&L inventoryself classification & REACH disseminated dossier

 para-cymene  99 -87 -6

H315/ H319

ECHA C&L inventoryself classification & REACH disseminated dossier

 beta-myrcene  123 -35 -3

H315/ H319

ECHA C&L inventoryself classification & REACH disseminated dossier

 terpineol-4  562 -74 -3

H315/ H319

ECHA C&L inventoryself classification & REACH disseminated dossier

 
 alpha-terpineol  98 -55 -5

H315/ H319

ECHA C&L inventoryself classification & REACH disseminated dossier

 
 delta-3 carene  13466 -78 -9

H315

ECHA C&L inventoryself classification

 linalol  78 -70 -6

H315/ H319

ECHA C&L inventoryself classification & REACH disseminated dossier

 camphene  79 -92 -5  H319

ECHA C&L inventoryself classification & REACH disseminated

 p-mentha-1,3 -diene  99 -86 -5  H319

ECHA C&L inventoryself classification & REACH disseminated

Source: ECHA disseminated dossiersor 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) according to the criteria of the Regulation (EC) No. 1272/2008 (CLP).