Registration Dossier

Administrative data

Description of key information

- Skin irritation/corrosion: irritating, based on the rules of the CLP Regulation for classification of mixtures
- Eye irritation: irritating or irreversible damage depending on geraniol content, 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% (w/w) of its constituents classified as Skin irritant Category 2 (alpha-pinene, beta-pinene, geranyl acetate, beta-myrcene, beta-bisabolene, caryophylene oxide, linalool and geraniol) therefore it should be classified as a skin irritant Category 2 without further testing according to the rules for classification of mixtures of Regulation (EC) No 1272/2008.

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 iritant category 1 or 2 depending on geraniol content
Interpretation of results:
other: category 1 or 2 based on GHS criteria, depending on geraniol content
Remarks:
Category 1 if geraniol ≥ 3%; category 2 if geraniol < 3%
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 eye irritation hazard of the registered substance. The decision of classification as eye irritant was based on existing data on constituents (additivity principles):the registered substance has more than 10% (w/w) of constituents classified as Eye irritant category 2 (beta-myrcene, caryophylene oxide and linalool) and it can potentially have more than 3% of its constituents classified as eye irritant Category 1 (geraniol). Therefore the registered substance should be classified as a eye irritant Category 1 or 2 depending on the geraniol content (category 1 if geraniol≥ 3%; category 2 if geraniol < 3%) without further testingaccording to the rules for classification of mixtures of Regulation (EC) No 1272/2008.

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Skin irritation/corrosion:

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% (w/w) of its constituents classified as Skin irritant Category 2 (alpha-pinene, beta-pinene, geranyl acetate, beta-myrcene, beta-bisabolene, caryophylene oxide, linalool and geraniol) therefore it should be classified as a skin irritant Category 2 without further testing according to the rules for classification of mixtures of Regulation (EC) No 1272/2008.

Eye irritation:

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 irritation hazard of the registered substance. The decision of classification as eye irritant was based on existing data on constituents (additivity principles): the registered substance has more than 10% (w/w) of constituents classified as Eye irritant category 2 (beta-myrcene, caryophylene oxide and linalool) and it can potentially have more than 3% of its constituents classified as eye irritant Category 1 (geraniol). Therefore the registered substance should be classified as a eye irritant Category 1 or 2 depending on the geraniol content (category 1 if geraniol ≥ 3%; category 2 if geraniol < 3%) without further testing according to the rules for classification of mixtures of Regulation (EC) No 1272/2008.

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 has more than 10% of its constituents classified as Skin irritant Category 2 and it can potentially have more than 3% of constituent geraniol, classified as Eye irritant Category 1.

Therefore, it is classified as Skin Irritant Category 2 (H315: Causes skin irritation) according to the criteria of the Regulation (EC) No. 1272/2008 (CLP).

It is classified Eye irritant Category 1 (H318: Causes serious eye damage) if geraniol ≥ 3% or Category 2 (H319: Causes serious eye irritation) if geraniol < 3%, according to the criteria of the Regulation (EC) No. 1272/2008 (CLP).

No information was available regarding respiratory irritation.