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Administrative data

Description of key information

- Skin irritation/corrosion: irritating, based on additivity principles.
 - Eye irritation: irritating, based on additivity principles.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records
Reference
Endpoint:
skin irritation / corrosion
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
other:
Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Eye irritation

Link to relevant study records
Reference
Endpoint:
eye irritation
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
other:
Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

The decision logic for classification of mixtures from the ECHA Guidance on the Application of the CLP Criteria (2013) was used to determine the skin irritation/corrosion and eye irritation hazards of Niaouli oil. Niaouli oil has not been tested itself, but they are sufficient data on its individual ingredients to adequately characterize the hazard of the mixture. Additivity principles were therefore applied.

Conclusion on skin irritation/corrosion:

- all Niaouli oils having more than 10% of their constituents classified as Skin irritant Category 2 should be classified as skin irritant without further testing according to the Regulation (EC) No. 1272/2008.

- all Niaouli oils having more than 20% of their constituents classified as Skin irritant - R38 - should be classified as skin irritant without further testing according to the Directive 1999/45/EEC.

Conclusion on eye irritation:

- all Niaouli oils having more than 10% of their constituents classified as Eye irritant Category 2 should be classified as eye irritant without further testing according to the Regulation (EC) No. 1272/2008 .

- all Niaouli oils having more than 20% of their constituents classified as Eye irritant - R36 - should be classified as eye irritant without further testing according to the Directive 1999/45/EEC.

Constituent

Classification according to the Regulation (EC) No. 1272/2008 (CLP)

Classification according to the Directive 67/548/EEC

Source

Skin irritation

Eye irritation

Skin irritation

Eye irritation

Terpinyl acetate alpha

-

-

Xi ; R38

-

http://apps.echa.europa.eu/registered/data/dossiers/DISS-e18edfe9-02a4-58ce-e044-00144f67d031/AGGR-d1ceae94-f7e1-4639-ac42-5f4db23f966f_DISS-e18edfe9-02a4-58ce-e044-00144f67d031.html#L-6b543686-8148-4353-8658-f1f059710038

Pinene

SCI2, H315

-

Xi ; R38

-

http://apps.echa.europa.eu/registered/data/dossiers/DISS-9d952924-c8ed-4614-e044-00144f67d249/DISS-9d952924-c8ed-4614-e044-00144f67d249_DISS-9d952924-c8ed-4614-e044-00144f67d249.html

Terpineol

SCI2, H315

EDI2, H319

Xi ; R38

Xi ; R36

http://apps.echa.europa.eu/registered/data/dossiers/DISS-9d944137-bb01-5d50-e044-00144f67d249/DISS-9d944137-bb01-5d50-e044-00144f67d249_DISS-9d944137-bb01-5d50-e044-00144f67d249.html

Myrcene

SCI2, H315

EDI2, H319

Xi ; R38

-

http://apps.echa.europa.eu/registered/data/dossiers/DISS-9d82fafa-8716-3e64-e044-00144f67d249/DISS-9d82fafa-8716-3e64-e044-00144f67d249_DISS-9d82fafa-8716-3e64-e044-00144f67d249.html

Linalool

SCI2, H315

EDI2, H319

Xi ; R38

-

http://apps.echa.europa.eu/registered/data/dossiers/DISS-9d93c699-8de9-6b59-e044-00144f67d249/DISS-9d93c699-8de9-6b59-e044-00144f67d249_DISS-9d93c699-8de9-6b59-e044-00144f67d249.html

p-cymene

SCI2, H315

EDI2, H319

Xi ; R38

Xi ; R36

http://apps.echa.europa.eu/registered/data/dossiers/DISS-d7f35eaa-981f-389d-e044-00144f67d031/AGGR-b9e03e4c-dc82-4f4c-99cd-2c0981c86ef2_DISS-d7f35eaa-981f-389d-e044-00144f67d031.html#L-5fc88447-f9cc-4eb8-a968-062a805f4b85

Source: ECHA disseminated dossiers

 


Justification for selection of skin irritation / corrosion endpoint:
Available data indicates that the criteria are met for classification as irritating to the skin

Justification for selection of eye irritation endpoint:
Available data indicates that the criteria are met for classification as irritating to the eyes

Effects on skin irritation/corrosion: irritating

Effects on eye irritation: irritating

Justification for classification or non-classification

Harmonized classification:

Niaouli oil has no harmonized classification according to the Regulation (EC) No. 1272/2008.

Self-classification:

Based on the typical composition provided by the Lead Registrant, Niaouli oil is classified as skin irritant:

- Irritating to skin (Xi; R38) according to the criteria of the Directive 1999/45/EEC,

- Skin Irritant Category 2 (H315: Causes skin irritation) according to the criteria of the Regulation (EC) No. 1272/2008 (CLP).

Based on the concentration ranges provided by the Lead Registrant, Niaouli oil is also classified as eye irritant: Irritating to eyes Category 2 (H319: Causes serious eye irritation) according to the criteria of the Regulation (EC) No. 1272/2008 (CLP) but is not classified as eye irritant according to the criteria of the Directive 1999/45/EEC.

No information was available regarding respiratory irritation.