Essential oil of Myroxylon balsamum var. pereirae (Fabaceae) obtained from the exudate by dry distillation

Endpoint summary

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: Eye damage category 1, 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
trans-cinnamic acid	140 -10 -3	H315	ECHA C&L inventory–self classification
Benzoic acid	65 -85 -0	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 1

Interpretation of results:

Category 1 (irreversible effects on the eye) 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 eye Damage category 1 was based on existing data on constituents (additivity principles) the registered substance has a constituent classified as Eye Damage Category 1 present at more than 3% and should be classified as a Eye damage category 1 without further testing according to the rules for classification of mixtures of Regulation (EC) No 1272/2008.

Constituent	CAS	Classification	Source
Benzoic acid	65 -85 -0	H318	ECHA and C&L inventory–self classification

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (irreversible damage)

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 more than 10% of its constituents classified as Skin irritant Category 2 and more than 3 % classified as Eye damage Category 1 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

Skin irritation

Constituent	CAS	Classification	Source
trans-cinnamic acid	140 -10 -3	H315	ECHA C&L inventory–self classification
Benzoi acid	65 -85 -0	H315	ECHA C&L inventory - self classification

Eye irritation

Constituent	CAS	Classification	Source
Benzoic acid	65 -85 -0	H318	ECHA and C&L inventory–self classification

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 1 (H318) according to the criteria of the Regulation (EC) No. 1272/2008 (CLP).